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Treating Patients With HypertensionWhat's the Rx?

Learning Objectives
1. Discuss recommendations and evidence supporting the use of multiple medication classes for controlling blood pressure (BP)
2. Identify barriers to using multiple medication classes to treat patients with hypertension
3. Discuss how to integrate the use of multiple medication classes into treatment for patients with hypertension, including the use of single-pill combination medications
1 Credit CME

The Million Hearts Learning Lab is a bi-monthly learning series focused on cardiovascular disease prevention and management topics. The series is open to clinicians, quality improvement, and other interested staff across the country, but with a focus on community health centers. Clinicians may earn 1.0 CME credit per session and up to 6.0 credits for attending the full series through the American Medical Association's Ed Hub.

This project aims to utilize a mixed-method learning model to host bi-monthly “events”. Please watch the videos below, then select “Take Quiz” to earn CME.

Video 1
Medication Treatment Intensification to Improve Blood Pressure Control

Listen to this brief discussion on medication treatment intensification for patients with hypertension.

Video 2
Treating Patients With Hypertension: What's the Rx?

Trained family physicians will discuss recommendations and evidence supporting the use of multiple medication classes for controlling blood pressure and identify barriers to using multiple medication classes. This is followed by a discussion on how to integrate the multiple medication classes into treatment for patients with hypertension.

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Article Information:

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships.

If applicable, all relevant financial relationships have been mitigated.

Medication Treatment Intensification to Improve Blood Pressure Control

Neha Sachdev, MD: [00:03] Hi, everyone, and welcome to this brief podcast on medication treatment intensification for patients with hypertension. My name is Neha Sachdev and I work at the American Medical Association as the director of Health Systems Relationships. Joining me is my colleague, Dr Michael Rakotz, who is the vice president of Health Outcomes at the AMA. Mike and I are both trained family physicians, and we work with health care organizations, physicians, and other providers and care teams to implement evidence-based strategies and action steps to improve blood pressure control. Over the next few minutes, we'll discuss using combination therapy, or multiple medication classes, to initiate and intensify treatment for patients who have hypertension and uncontrolled high blood pressure, or BP.

[00:55] I do want to take a quick moment to acknowledge the importance of nonpharmacological interventions. Lifestyle changes that have been proven to lower blood pressure should be included in the treatment plan for all patients with elevated BP or hypertension. It's important to counsel and support patients to make sustainable lifestyle changes that can help improve their BP. So getting back to antihypertensive medications, I've got two words to start with: therapeutic inertia.

Mike Rakotz, MD, FAHA, FAAFP: [01:27] Therapeutic inertia—two words that keep me up at night. Let's talk about why therapeutic inertia is so important. Therapeutic inertia, which is a lack of treatment intensification when indicated, is one of the leading barriers to controlling blood pressure. There are a lot of contributing factors that can lead to therapeutic inertia, including health system, patient, and physician factors. One that I'd like to highlight is something we've all experienced: the use of soft reasons to delay treatment intensification. Some examples of soft reasons include not intensifying treatment for uncontrolled hypertension because a patient or provider believes that the blood pressure is high due to something other than hypertension, such as having a hard day at work, or just finishing a coffee drink before coming in, or having recently smoked a cigarette, or being off their medication at the time of the appointment, rather than due to hypertension.

[02:23] These are just a few of the reasons that can contribute to hesitation, or inertia, in intensifying treatment. If we can reduce therapeutic inertia, it would make a big difference in achieving blood pressure control for patients, possibly the biggest difference. Let me explain what I mean by that. A study published by Bellows and colleagues in 2019 looked at three key processes in the management of hypertension: adherence to treatment, intensifying treatment when blood pressure is uncontrolled, and frequency of follow-up visits when blood pressure is uncontrolled. The study estimated where we are currently in the United States with each of these three processes, and what would happen to blood pressure control if we optimized each process independently of the others.

[03:07] Here's what they found. If adherence to antihypertensive medication at one year, which is currently 57%, was improved to 100% blood pressure control would improve from 46 to 57%, an 11-percentage point improvement in blood pressure control rates. If visit frequency was increased from every 14 weeks every one week, blood pressure control would improve from 46% to 68%. That's an improvement of 22 percentage points—much better, but it's probably very unrealistic to think that patients could be seen every seven days. And finally, let's talk about the probability of intensifying treatment during a visit when blood pressure is uncontrolled. If we increase the probability of intensifying treatment from one in seven visits to two out of every three visits, blood pressure control would improve from 46% to more than 80%, by far the most impactful and by itself would move the population to meeting the Million Hearts target of 80% blood pressure control. The main point I want to make is that focusing on all three of these processes will improve blood pressure control, but focusing on treatment intensification will have a much greater impact on improving blood pressure control than the others.

Sachdev: [04:20] That Bellows article really demonstrates how much of an impact treatment intensification can have on BP control. So how can providers and care teams improve treatment intensification? Well, one key change would be if more physicians and providers use multiple medication classes at lower doses to treat patients who have uncontrolled high blood pressure. What I mean by that is right now a treatment approach that we commonly see is to start one antihypertensive medication class and then titrate it up to the maximal dose over several visits before starting an additional medication class. The alternative that I just mentioned is to initiate multiple medication classes, or combination therapy, at lower doses. Combination therapy leverages the therapeutic effect of each medication class, because the medication initiated at half standard dose will have 80% of the BP lowering effect of that same medication class at a standard dose. Another way to think of this point is that initiating a medication class has about three times the BP lowering effect, as titrating the dose of an existing medication.

Rakotz: [05:41] That's a really great way to describe the impact of adding a medication class. In addition to lowering blood pressure more, using combination therapy can also help patients reach their blood pressure goal faster. US and international hypertension guidelines have recommended the use of combination therapy for years. The evidence for these recommendations is rooted in the fact that most patients will need two or more medication classes to achieve blood pressure control, and will not be controlled with just a single medication. Probably the most important point about combination therapy that we haven't discussed yet, is that initiating treatment for hypertension using two drug classes improves outcomes compared to using one drug.

[06:23] Rea and colleagues published a study in 2018 that compared the risk of cardiovascular outcomes and death between patients who were prescribed initial antihypertensive treatment with one drug versus two-drug combinations. These patients were then followed for the next three years. For those initiated on two drug combinations, compared to monotherapy, the risk was 16% lower for having any cardiovascular event, 35% lower for heart failure, and 20% lower for ischemic heart disease. There was also a 20% lower risk for all-cause mortality. Those are all very compelling reasons to initiate treatment with two medication classes compared to monotherapy whenever possible. The same study looked at the percentage of patients started on mono therapy versus combination therapy, who remained on treatment three years later. Of the patients started on monotherapy, nearly two-thirds remained on mono therapy at the end of the three years. For those started on combination therapy, nearly 80% remained on two or more medications at the end of the three years. This is important because as I said earlier, most patients with hypertension will need two or more medications to get to goal. And if they're started on one medication, they're much more likely to remain on one medication over time, increasing the risk of a bad outcome.

Sachdev: [07:45] So I think we've covered why a combination therapy is an effective approach to treatment intensification. Now, let's address some of the common concerns and barriers about using this approach in practice. The first question I'll raise is about adverse events or side effects. If two medication classes are initiated at the same time, does the risk of adverse events or side effects increase?

Rakotz: [08:11] That's a very valid concern, and one that we hear raised by prescribers frequently. Obviously, each situation is unique, and you have to use your best clinical judgment when prescribing medications for patients. What I can say is that when the data from studies comparing standard dose monotherapy and two-drug combination therapy using low to standard dosing were compared in a systematic review and meta-analysis, using a combination therapy approach was better at lowering blood pressure, which you would expect, but without increasing the rate of medication withdrawals due to adverse events, which I think is surprising but very important. Again, going back to the point earlier about the therapeutic effect, there is a greater impact on lowering blood pressure, adding a new class of medications, even at low dose, compared to increasing the dose of an existing medication. So rather than spending months or years increasing the dose of a single medication, which may increase adverse effects from the medication, it makes sense to use lower dose of a combination of medications and potentially reduce the risk of patients discontinuing their medication.

Sachdev: [09:18] That makes a lot of sense. It also strikes me that avoiding side effects may help with adherence to medications. Thinking about the patient perspective, less side effects is great, but taking two medications instead of one might be concerning to some patients. As you mentioned already, using clinical judgment is essential, and so is engaging in collaborative communication with patients about their blood pressure, their treatment goals, and their treatment plan.

Rakotz: [09:48] Now might be a great time to introduce single pill combination medication.

Sachdev: [09:51] I was thinking the exact same thing. Single pill combinations can be a great way to prescribe combination therapy since the number of pills a patient has to take remains the same, while the number of medication classes may be two or three. And they are usually dosed once a day, which makes them convenient for patients. When we've looked at prescribing data, the numbers of single pill combinations used tend to be very low. Compared to individual medication prescriptions for classes like ACE inhibitors or diuretics, single pill combination medications are just not prescribed as often. One concern that might contribute and that comes up often is the cost and availability of single pill combinations. There are combinations available as generic medications and many insurance formularies including Medicaid and 340-B have options for single pill combinations as preferred medications that do not need prior authorization. Discount pharmacy programs may also have single poll combinations available.

Rakotz: [11:00] Single pill combinations are usually available. In my experience, I found that many prescribers are unfamiliar with their availability as first-tier medications on formularies. I also want to mention that using single pill combinations as first line treatment for patients with uncontrolled high blood pressure has been shown to be feasible and effective in real world primary care settings. Many organizations and practices have been able to implement treatment protocols that use single pill combinations as first line medications, which have contributed to attaining very high blood pressure control rates in their patients.

Sachdev: [11:34] And you just mentioned treatment protocols, so I do want to elaborate a bit more on that point. An evidence-based hypertension medication treatment protocol can serve as a great resource and guide prescribers and care teams at the point of care. A protocol does not replace clinical judgment or individual decisions. What it can do is help teams determine which patients need treatment intensification and what the treatment should be, including options for specific antihypertensive medications. We've seen protocols developed by organizations in house, or adaptations or adoptions of existing sample treatment protocols. We've also seen protocols be embedded in the electronic health record, incorporated into clinical decision support tools like order sets, or best practice alerts, or be printed and posted in clinical environments.

Rakotz: [12:31] I truly believe that one of the best ways to integrate and increase the use of combination therapy and single pill combinations is to develop and implement a treatment protocol that lists specific examples of combinations that are low cost and dosed once daily, in conjunction with frequent follow up intervals for patients who have uncontrolled hypertension. Protocols like this can serve as an important component of a systematic, team-based approach to addressing therapeutic inertia, effectively treating hypertension, and improving blood pressure control.

Sachdev: [13:03] I completely agree with you. And I know we could keep talking, but we've covered a lot of information already. So to wrap up, we'd like to ask everyone listening to reflect on how you can improve treatment intensification in your practice or organization. Do you currently use combination therapy? And if not, why not? What can you do to improve treatment for your patients with hypertension, and help everyone achieve their blood pressure goal? Thanks so much for listening. Bye now.

Rakotz: [13:37] Thanks, everyone.

Treating Patients With Hypertension: What's the Rx?

Elizabeth Breitenbach: [00:00] [Million] Heart's Learning Lab, Treating Patients With Hypertension: What's the Rx? My name is Elizabeth Breitenbach. On behalf of NAC, thank you so much for joining us. Just going to go over very brief housekeeping reminders. Number one, this event is being recorded. It will be available for on demand playback at a later time. You are in Zoom Webinars. So again, this event, like I just mentioned, is being recorded. If for some odd reason you do not agree with this consent, please exit. But again, I think everybody's okay with this. So we're good to go. Chat box is going to be disabled for today's session. The Q&A box is open though, so you can ask your put your comments, questions, or concerns into this box at any time. You may need to take your cursor and toggle down to the bottom of the Zoom bar. Maybe it's at the top of your Zoom bar, depending on how your settings are put out. Again, feel free to type your comments, questions, or concerns into this box. And there's a cool little function within Zoom. If you see one of your colleagues that has posted a question that you really want to get answered, you can upvote that by simply clicking either the heart or the little thumbs up. That kind of bumps that question at the top of it so that way panelists can see that question as a priority item to you. With that being said, I want to turn things over to Meg—I'm sorry, to Judy, my apology, who's going to be setting the stage for us. Judy, the floor is yours.

Judy Hannon: [01:12] Thank you, Elizabeth. And I'm Judy Hannon, the senior advisor for the Million Hearts Initiative. And I want to thank you all for joining on today's call, and I hope you were as delighted as I was with the pre-work video, YouTube, that really succinctly talked about the challenges and opportunities in front of us. As you know, improving hypertension control is one of the main strategies to preventing a million cardiovascular events over the next 5 years. And so as senior advisor for the initiative, I'm really happy that you are attending this session, and I hope you explore ways that you can change your practice after this webinar. With that I'll turn it over to Meg. Meg?

Meg Meador, MPH, CPHI: [01:52] Thanks, I really appreciate the opportunity to host or moderate the session today. I'm Meg Meador, director of Clinical Integration and Education with the National Association of Community Health Centers. Next slide. And just a little bit about the format of our learning lab: so this is really a mixed methods approach that we take. So we have a pre-work recording, that's usually about 13 minutes, with a very short survey to gather your input and questions. And then we'd like to take this time, this opportunity of the live event, to really focus in on the questions you submitted, and then offer up some additional time for live questions. So in total, the time is 60 minutes. And then for those of you who are clinicians, you can actually apply to earn CME credit with this. Next slide.

[02:45] So we have three learning objectives today. The first is to discuss recommendations and evidence supporting the use of multiple medication classes for controlling blood pressure. And then we're going to talk about identifying, and also some…identifying barriers and also sharing some solutions to using multiple classes of medication to treat patients with hypertension. And then we're going to discuss how to intentionally use multiple medication classes for treatment of patients, including the use of single pill combination medications. So I'd like to turn it over actually, this time, if I can to you Dr Rakotz and Dr Sachdev from the American Medical Association. They're going to introduce themselves, but I just want to say we're very, very excited to have them on the call today and with us to address your questions. Mike, can we turn it over to you?

Mike Rakotz, MD, FAHA, FAAFP: [03:38] That sounds great. Thanks so much, Meg. Good afternoon, everyone. I'm Mike Rakotz. I'm a family physician. I've been a family physician for about 25 years now. I came to work at the Improving Health Outcomes team at the American Medical Association about eight years ago. And just to give you a little bit of background, we're a team of 50 people who spend our time creating and testing quality improvement programs, clinically useful tools, and national policies that hopefully will over time, reduce the impact of cardiovascular disease in the United States. As many of you already know, our initial focus has been on hypertension and more specifically improving blood pressure control. We work hand in hand with health centers, health systems, medical groups, and health care professional schools, all with the goal of improving health outcomes for patients. And we've had the really great fortune and pleasure to be able to collaborate on this work with the Million Hearts team in the Division of Heart Disease and Stroke Prevention at the CDC, as well as with NAC and the American Heart Association, and we're grateful for the opportunity to talk with you today. And with that, I'll pass the mic along to my colleague on our team Dr Neha Sachdev.

Neha Sachdev, MD: [04:45] Thanks, Mike. Hi, everyone, and we go by Mike and Neha, so that's what we'll be calling each other and you can call us as well. So just to quickly introduce myself, I'm also a family medicine physician. I have been at the AMA now, full time, almost five years. And in my role, I work really closely with health care organizations, care teams, physicians, and other providers to implement evidence-based strategies to improve blood pressure control. And so myself and the team provide practice facilitation and coaching to teams that are implementing strategies to improve blood pressure. They're excited to be here with you today and Mike and I are excited to share some things over the next 40-ish minutes or so. And what we really want is for you all to walk away with a really good understanding of what you personally can do to improve treatment intensification. And so with that, I'll pass it back to you, Meg to get us started.

Meador: [05:46] Thank you, Neha. So we're going to actually start with five key questions that we put together and crafted based on excellent feedback and questions that you submitted to us during the pre-work opportunity. So the first question here really is why does this matter?

Sachdev: [06:07] Yeah, I can start. And I'll say that I think it really matters because of the number of people with hypertension. Currently, it's about 128 million, but some recent modeling research is say showing that by the year 2060, that number is projected to increase to 163 million. So it's projected to climb, and to me that number is just staggering. And when I think about people with hypertension, and how uncontrolled blood pressure is a leading contributor to heart attacks and strokes, and the impact that that makes on people's lives, I feel like we need to do something. And treatment intensification is something we can do about…do something about starting today.

Rakotz: [06:58] And I can jump in here. Looking at the gear on the right side of the slide, it's meant to represent treatment intensification or therapeutic intensification. And in the United States, and many parts of the world, this gear is completely stuck. It's fused, it's not working. And we need to try to figure out a way to get it moving. So treatment intensification is absolutely an essential component of improving blood pressure control. Again, this gear has to get put into action if we want to see significant improvement in blood pressure control.

[07:28] And so what do I mean by that? Well, when we look at national data, therapeutic intensification, which is the addition of a medication or increase in dose of a medication, occurs in only about one in seven visits for a patient visiting a primary care provider. That means that a patient with uncontrolled hypertension has to see on average their providers seven times to get one treatment intensification. If we can improve therapeutic intensification from occurring at only one in seven visits to most of the time, say two of three visits, we'd likely achieve a nearly doubling in blood pressure control rates in the United States over the next couple of years, somewhere in the neighborhood of 80% control. And again, this would happen very rapidly, probably within two years. So this is why we're using this example of getting this gear moving, we really don't have a choice, we have to get it.

Meador: [08:25] So we already saw one emoji of wow, coming up the screen. And I think, you know, obviously, this is the critical gear, as you said, Mike. So to you Neha and Mike, what can be done? What do we need to do to improve treatment intensification?

Sachdev: [08:42] Yeah, and I'll start again, and I'll say that before we can talk about what to do, I think we need to do a little self-reflection and some diagnosis of our current state. And Mike already said, it's not working. I agree, I think we could do a lot better. And here's why. Based on our experience at the AMA, and you heard Mike say one out of every seven visits has an intensification—we're not doing enough, and it's taking too long. So we know it can take months to years to have an intensification occur. On top of that, what we do when we intensify is not always the most effective approach. And we'll talk about that more in a minute. But what we really so what we really need to do is addressed those things. And one way to do that, and one of the reasons it doesn't always happen is just a lack of knowledge, right? So physicians and providers may not be aware of what the recommendations and evidence are for treatment intensification. So we can do things like we're doing today and educate everyone, but beyond that, we also need to acknowledge that the change needs to happen. So what we're doing right now is not working and we need to do more. We need to change not only how quickly we act, but also what we do when we act, and what we do when we prescribe medications, and what medications we use when we're prescribing an intensifying treatment. And so I'm going to hand it over to Mike to make the case for combination therapy.

Rakotz: [10:18] Right. So if you can go to the next slide. So I want to, I want to talk a little bit about, we talked about what needs to change, and I'm going to be repetitive here. And I just want you to know, it's absolutely intentional. So we believe that what needs to change is moving away from slow increases in the doses of single medications over long periods of time, and moving towards more frequent use of combination therapy to treat patients with uncontrolled blood pressure.

[10:46] Let's talk about why we believe that is so critical. So this approach to titrating a single medication, which typically happens over months or even years has not worked. I'll go as far as saying, it's not only not an effective strategy to achieve blood pressure control in most people with hypertension, I'm going to say that it's a failed strategy. It just has not worked for decades. And here's why I think that is: that when we increase the dose of an antihypertensive medication, we're going to lower blood pressure about two to three millimeters on average. And that's true whether you increase it incrementally or whether you double the dose, you're only going to get to that same two to three millimeter drop in systolic blood pressure. On the other hand, if you add a new blood pressure medication class, even at low dose, you're gonna see three times the blood pressure lowering effect compared to increasing the dose of that medication. And I'm gonna sit at one more time, even though it's already on the slide: that adding a new blood pressure medication has three times the blood pressure lowering effect as increasing or doubling the dose of an existing medication. So when you add a new medication, even at low dose, you'll see approximately 7 millimeter reduction in systolic blood pressure—that's at low dose. If you add a medication at standard dose, you'll see a 9 to 10 millimeter reduction, and if you add a drug at high dose, you'll see a 10 to 12 millimeter reduction in systolic blood pressure. So that is substantial.

[12:11] We know that most people with hypertension need more than one medication to get to goal, and that's why we need to consider using more combinations of medications. And when we use two or more medications, combination therapy, single pill combinations—what some people call fixed-dose combination, two medications in a single tablet or capsule—are a very practical way to do that because you're prescribing two medication classes or more without increasing the number of pills, or the number of refills required for the patient. And we go into much more detail about this in the pre-work video and we can discuss more in the Q&A, but basically, the bottom line is we need to move away from prescribing a single medication class and increasing the dose over long periods of time, and move towards prescribing multiple medications more quickly, ideal as fixed dose or single pill combinations.

[13:03] Now, this is a shift that's way overdue, but as Neha said, and I'm going to acknowledge, I've been personally focused on this training, teaching, working with students, residents, and attending physicians for more than 20 years. This is a challenge, but we've got to sort of break through to speed up the process. And the reason for that, as Neha said is that we're rapidly increasing the number of people with hypertension. We've been doing that for a while, that trend has been there, but we're literally heading towards over 160 million people with hypertension. We have to get better at treating it.

Meador: [13:39] So if you go to the next slide, I mean, this is just astounding. It has three times the blood pressure lowering effect, it comes in a single pill, it just seems like it would be almost low hanging fruit. But obviously there are some significant barriers to doing this, to prescribing combination therapy. What are some of those common barriers that you hear or common questions you get about using combination therapy?

Sachdev: [14:04] Yeah, and I'll say I think it's good when we get these questions because it means people are thinking about the change and what it means and how to do it. So I think of it as two kind of types of questions. One I'll say…and barriers, concerns that are raised. One I'll say is the clinical use type of questions. So what are the indications? What are the recommendations? Who is this appropriate for who is it not appropriate for? I think the big one we hear almost all the time is side effects. What are the side effects? And then is it safe? Are my patients going to tolerate this? And that's a very valid and real question because it's something that both clinicians think about but also patients will think about and ask about.

Sachdev: [14:50] The other type of question I think I hear a lot is the practical use questions. So what are formularies like for this? Are single pill combinations available on formularies? What's the cost? Is it covered? Is it available? Will patients have access to it? How do I talk to patients about these medications? More focused on how to actually do it. And then there's the clinical use, which is a little more about what should I be doing and does it make sense for my patients?

Meador: [15:24] And, Mike, do you have anything to add that? There's actually a nice question in the question area that fits right in with this conversation: What about cost and adherence for the patient? Insurance coverage, formularies are often a challenge.

Rakotz: [15:37] Yeah, I mean, we'll get into that in a little more detail, but these are extremely common questions and we think there are some pretty good resources and tools to use. And just knowing what's available, that most of hypertensive medications are generic, including most combination therapies that are available with no prior authorization. And it really comes down to understanding formularies, which change frequently, making that information available. Million Hearts and NAC have created a really great new tool for that, that we can go into more detail. But yeah, go ahead.

Meador: [16:12] I was going to say we're moving into solutions, which is definitely what we want to go into next. [crosstalk]

Rakotz: [16:16] [crosstalk] Yeah, if we can go to the next slide, I can start and I'll tackle what Neha bucketed as sort of the clinical use types of questions. And first, I want to say that as far as initiating treatment with multiple medications and combination therapy, both the 2017 ACC AHA Guideline on Hypertension and the 2018 European Society of Cardiology and European Society of Hypertension Guidelines, both have very strong evidence and recommendations to support the use of combination therapy, and many instances for initiating treatment for those with a diagnosis of hypertension and their blood pressure is uncontrolled. Now, typically, if you look at the 2017 guideline… What the guideline says, if I was to translate that into something very simple: if someone's blood pressure is 150 over 90 or greater, the recommendation is to consider using, initiating two medications if they're not on any medications, initially, to treat their hypertension. In the European Society Guideline, they actually come out with really an even stronger statement where they believe that while 150 over 90 they think is a good cutoff for initiating with two medications in the form of single pill combination therapy, they believe that almost everybody, unless there's a contraindication, should be placed on single-pill combination therapy. And their whole strategy, which interestingly is getting their population from 40% control to 80% control, is to use single-pill combination therapy. And as I said earlier, when I was using those statistics, that's about what you'd see if you increased the frequency that we increase therapy. So I think it's very interesting, and it's very consistent across those two guidelines.

[18:05] You know, we hear a lot of questions about using clinical judgment and the truth is, that's absolutely a given in all patients. We're not telling people that every single person should go on this combination this time. But we need to be careful not to blanketly use this as a reason for not intensifying when it's indicated. You know, we hear a lot that patients don't want to take more medications, but we hear even more that prescribers don't want to use more medications because they're concerned about the costs, the side effects, and other things. I think it's important to use things like biologic age and not chronological age when you're considering treatment. We've all seen patients who looked like they're 50-year-old athletes, and we've also seen patients, many patients who are in their 50s and 60s that for whatever reason, due to chronic conditions, they may be more frail, and they may be more at risk for receiving two medications. So things like frailty scores, getting a really good analysis of the situation, getting more data inputs to make those decisions, is really important.

[19:08] And I think it's important to mention, don't forget to weigh the risks and benefits of treatment, but I think it's also important to weigh the risks and benefits of not treating. We have to keep in mind that hypertension is the leading risk factor for death and disability in the world—that includes the United States. So while we have to have, you know, very good thoughtful consideration for treating, we need to use the same amount of thoughtful consideration due to the risks of not treating people with uncontrolled high blood pressure at any age. So I think that those things are really important.

[19:43] Two more quick things I want to point out. One is that we see a lot of questions about the safety and tolerability of combination therapy and particularly single-pill combination therapy. And there is evidence to strongly support that using single-pill combination therapies is safe and well tolerated for most people, and in fact, there's really good data to support that when single-pill combinations are used, they're no more likely to be discontinued than single agents. But they're much more effective at lowering blood pressure and getting people to goal blood pressure. They've been shown to get more people to goal than single-pill combination therapy, they've been shown to get people to goal more quickly, which is really important at reducing risk and preventing heart attacks and strokes than single drug therapy. And perhaps the most important is that when you initiate treatment with single-pill combinations, there is good evidence to show that you will reduce heart attacks, heart disease, heart failure, premature death, more than if you initiate a treatment with a single medication. So there are many compelling reasons to consider initiating single-pill combination therapy compared to monotherapy, when it's indicated with that systolic blood pressure, greater than or equal to 150 over 90 diastolic.

Rakotz: [20:57] And finally, I just want to briefly say a few words about the importance of treatment protocols. We could talk more about this in the Q&A, but they're a great strategy for improving blood pressure control within and across organizations and they make it very easy to know what medications are available, what their costs of those medications are, which are much more likely to make them get prescribed if prescribers know this information. It's absolutely critical. And I think, just as important as what to prescribe for treatment protocols, it will help us understand…or I should say, every member of the team understand who needs treatment and when follow up should occur. And you know, we all know how busy things are right now, you better than I. Things are very difficult in primary care. So the fact that it's easy to make a misstep—possibly not schedule a follow-up appointment, not recommend a follow-up appointment—but when every member on the team understands when to follow up and do, when somebody needs to come back, that their blood pressure's controlled, you've got a whole team working to take care of patients that need a follow up, you're much less likely to make a mistake that's going to impact quality and safety. So I just want to say that there are many benefits to using treatment protocols.

Meador: [20:58] So Mike, this is a hugely helpful response, really laying out a strong case for the clinical use of combination therapy. I do you want to give Neha a minute to add anything, any thoughts about this, and then move on to sort of the practical use.

Sachdev: [22:32] Yeah, I think I'll go ahead and talk about the practical use, because I think that's just very top of mind for a lot of people. And so to repeat, again, what Mike said, many of these medications are available as generics. So just recognizing that and being able to look for the generic versions can be helpful if you're looking at cost and accessibility, availability. The other thing that can be helpful is to really get an assessment of your local availability. And so knowing what's on your formularies for the patient populations you serve, or your most common formularies. We know they change. We know that sometimes medications change, but just having a good idea of what's available, so that you know what you can prescribe right in the moment. For some patients….for some organizations, if you have an in-house pharmacy, like the 340B, for example, we've seen some organizations work to increase availability and stock medications that weren't previously there. So that's another way to make things more available for people and to know what's there.

[23:44] And then when you have that, it makes it a lot easier at the point of care for people to prescribe. So Mike talked about treatment protocols. It's also really important to keep in mind that when you're making that treatment protocol, you want to have medications that you can actually use for patients. So again, just taking a look at what's available, making a list or integrating it into your treatment protocol. I've even seen some places put…be able to link this into the EHR, just to say, when you've got someone in front of you, again, knowing how busy you are, it makes it a lot easier to use these medications and to take this approach.

[24:25] The last thing I just want to touch on is making shared decisions with patients. And I just want to point out that the medication classes that are in single-pill combinations are the same ones that you would use individually as a monotherapy. So the medications you're using are the same. And so that doesn't…that should help in terms of thinking about your approach to talking with patients. And then of course with adherence, like anything else when you're making a prescription for a patient or making a treatment decision, you want to have that conversation and make it a collaborative and shared decision of what's the best treatment for that person. So I will stop there and see if Mike has anything to add.

Rakotz: [25:13] No, I think for the sake of time, let's keep moving forward. I think that's great.

Meador: [25:18] Super. So on the next slide. So you talked a little bit about…Mike, you mentioned this in your remarks. How can the entire team, the entire care team really increase and improve treatment intensification by working together?

Sachdev: [25:32] Yeah, so everyone has a role. I'll jump in first, just because I think it's so important to say, you know, everyone has a role. I started this out by saying we want everyone listening to know what they can do personally. And I really do believe everybody's got a role here. So patients are at the center, but for prescribers and teams, taking a look at your own practice, I think, what are you doing currently? Doing that self assessment, self diagnosis, at really looking at your patient encounters to see, are you treating patients with uncontrolled blood pressure? How are you treating them and what needs to change? I think data can be very helpful here. It can help you see where you need to…identify where you need to improve and make a plan for that. I also think, if you're not a prescriber, a team member who's providing direct clinical care, you're a champion. And so what can you do to help support that happening? So are you someone who can help make that data more accessible? Are you able to help make resources available for direct care providers? Really, everybody's got a role, and it's going to take a team to help move the needle here. Mike?

Rakotz: [26:44] Yeah, I mean, I couldn't agree more on all of those fronts. And I think that, you know, as prescribers and for those of us who primarily manage hypertension, I think—we may have mentioned this briefly—but I think there's sort of this underlying feeling that we're really good at this already. But we're not, and sometimes data is the only way to bring that forward. We all tend to overestimate how good we are at hypertension. It stands out from many other chronic conditions, where we just feel like we know how to do this, there's only a handful of medications we feel like we need to use and we can get everybody to goal. But the data really tells a much different picture in that there may be a lot of reasons why we haven't gotten people to goal blood pressure, but those risks are substantial. And this is why heart attacks and strokes continue to be the leading cause of death.

[27:36] So you know, acknowledging that we can do better is important. Data helps do that, and leveraging the champions. I'm a huge believer that every single member of the care team can become very engaged in hypertension, the way that we are passionate about it. And this will make a difference every day. For people understanding that a high blood pressure is uncontrolled, it usually needs to be addressed in one way or another, whether that's promoting healthy lifestyles, whether that's rechecking using out of office measurements, and whole blood pressure monitoring, whether it's more treatment—everybody can play a role there and hopefully, you can create protocols that make sure that that happens. So I can't say enough that every member of the care team can play a critical role, from those that work in primary care settings to pharmacists, to community health workers, people in the community, as long as there's good communication flowing, we really like to see a team-based approach. And just to say what you all know is that the team-based approach care of people with hypertension has the strongest level of evidence to support its use. So it's not something that we can we can ignore; it's absolutely critical.

Meador: [28:44] So Mike and Neha, thank you both so much. You know, we took some time to really answer the questions that came in on the pre-work, but we've also got some good questions that have come in now and today. And so I wonder if we can transition over here. And I encourage everybody in the audience today, if you do have additional questions, now's a great time to put those into the Q&A. One of the questions that was asked is really, when you're considering combination medication, how do you measure its effectiveness?

Rakotz: [29:17] Yep, I can start with that one. You know, again, you know, we've tried to quantify what you can expect to see in blood pressure lowering when you're considering using combination medications, even if they're at really low dose. But the way to sort of track the effectiveness of these combinations, really, is to look at what happens to blood pressure. We talked about knowing that most people will need more than one medication to get to goal. What we find is that there was a substantial increase in the number of people that get to goal using the single-pill combination as opposed to mono therapy. And if we could just get two more combination therapy, single pool combination therapy, we think we'd be successful.

[29:59] And I point to Kaiser, who's one of the most successful medical groups in the world at treating hypertension. They hover around a 90% blood pressure control rate, and for more than 20 years now, their treatment protocol has started by recommending that everybody goes on single-pill combination therapy of lisinopril HCT that can tolerate it. They start at low dose, they quickly titrate it up and add a third medication, and they find that that does get most people to goal. So I think that's the best way to look at the effectiveness of these single-pill combinations: just take a look at the blood pressure. People tend to be more adherent to the regimen. The medications, you know, demonstrate better lowering of blood pressure and better outcomes over time.

Meador: [30:41] Appreciate that answer. And Neha, do you have anything to add?

Sachdev: [30:44] No, I think Mike covered it.

Meador: [30:45] Great. And I think there's sort of a related question here, which is, is it indicated for patients who have an intent to get pregnant in the next year? Would you still prescribe combination therapy for those patients?

Rakotz: [31:01] So Meg, just to be clear, the question is, if somebody is thinking about getting pregnant, would we use combination therapy in those patients?

Meador: [31:10] [crosstalk] Absolutely. Correct.

Rakotz: [31:10] [crosstalk] So it's important to know if they have primary hypertension, that they really need to have their blood pressure controlled, there are medications that are safe to use in pregnancy. And that's a very good scenario to consult with the person's OBGYN physician, to make sure that if you're not familiar, that you're using combinations that are safe and effective. But you know, there's an extremely high risk of carrying a pregnancy when you have primary hypertension that's uncontrolled. That risk extends to the fetus, and so controlling blood pressure is absolutely critical, even when thinking about conceiving. So getting an OBGYN involved early or maternal fetal medicine specialist to make sure that you are on safe medications that work is a really good first step.

But I wouldn't shy away from using combination therapy, if they're safe in pregnancy. So that's something to keep in mind. In many cases, you would need to separate those out from a combined pill to make sure that you've got two on board, if you need to, to control blood pressure that are both safe in pregnancy. It may be challenging to find single-pill combinations that are safe in pregnancy. And so again, I highly recommend working with an OBGYN and maternal fetal medicine specialist if you're not sure.

Meador: [32:20] Appreciate that so much. Anything to add there, Neha?

Sachdev: [32:24] No, again, I think Mike covered it really well.

Meador: [32:27] So I want to share, I have another question for you both, but I want to share this comment from the Q&Q that I thought was really great. So one of our audience members said when putting in a combination pill—so when prescribing a combination pill—I say to the patient, "The pill you're on seems to be good, but not quite good enough for you. Can we swap that one out for one that might be a little better for you?" That's a great script. I just wanted to share that with everybody.

Sachdev: [32:51] Yeah, I completely agree. And just getting back to that point about making that shared decision, using… If patients have concerns about specific medications, I think it's always helpful to know why or where it's coming from. That also goes I think, for adherence—if you've got a patient who is perhaps, you're concerned is not adhering to their treatment, really finding out why and then being able to make a plan with them to address that. But yeah, I agree that that's a great approach and just sharing why they need the treatment. And why you're making that decision or recommending that. And then of course getting their agreement.

Rakotz: [33:35] Yeah, and I'll add one thing to that Meg, that I'm not sure if this was part of the question. But there are, although most of the main four classes of medications, recommended to treat hypertension work in most people, there are certain situations where based on the person's physiology, an ACE or an ARB may not work at all. Or a fireside like diuretic may not work at all. And you can add it and you can increase the dose, but if it doesn't work, it's not likely going to work very well in combination with something else. So the idea of swapping out a class of medications that is not doing anything, is something that some consider a strategy, which I think is fine. But it should also raise the issue of, are there other things going on in this person that a typical effective antihypertensive medication doesn't work? Like too much sodium on board, or maybe the adherence isn't where you want it to be. So those conversations need to happen with everybody in all scenarios.

[34:28] And I will just say really quickly, somebody made a comment about the Million Hearts Protocol on the website, recommending not to change medication for three months based on stage 1 hypertension. And I'll just say that that's a great protocol. It is a little bit…it predates the 2017 guidelines. And so a lot of, some of those recommendations there are based on prior to 2017. But the great thing about that protocol is that it's completely customizable, so you can [unintelligible]. But that's why recommendations.

Meador: [35:01] I appreciate you addressing that. Definitely. That was one of the questions in the in the Q&A, and I think you already addressed some of the inertia. I think, just to summarize some of the things that I heard too, is really the importance of shared decision making, and I think the importance of framing this not as some kind of failure on the patient's part. If they don't achieve control on one medication class, I think there's sometimes a perception that the patient did something wrong, but I think communicating the fact that most patients need two, and that this isn't good enough for you—I think I love that sort of positive spin or framing of needing two medications and that we need to do better for you. I think that's, those are great ways of sort of talking about this to a patient who may be reluctant. And I think, you know, you've also mentioned, one of the reasons people are reluctant is because of fear of side effects or fear of costs, and those kinds of other barriers that surfaced during these conversations. I do have a couple more. I think we have time for maybe one or two. I'm looking in the list here. So it says is combination therapy effective for the African American population? Definitely want to give both of you an opportunity to answer that question.

Rakotz: [36:21] Yeah, and I'm happy to start to say yes, absolutely, 100%, it is. Absolutely. Not only is it effective, it's actually recommended as a high-grade recommendation to consider initiating with combination therapy for people that are African American and Black adults in the United States. So you know that some of the issues around using certain classes of medications alone, that may not be effective in Black adults, as other medications, you know, there are recommendations about that, but those tend to go away when you start using combinations of medications. So you would never withhold, say, an ACE inhibitor in combination with any other medication, regardless of somebody's race or ethnicity if they're tolerating it. So that's absolutely something to consider, that the combination of therapy and hypertension tends to open up the door to using all of those four classes, regardless of race.

Meador: [37:20] Absolutely, super. So there are a couple other good questions. I know we're running a little short on time. One, I just want to acknowledge someone said that she's the medication therapy management pharmacist who's working with providers to optimize blood pressure management, and it's really a call to action to leverage your clinical pharmacist. Couldn't agree more, so thank you for that. And then last question here, and then we want to pose a question to you. So the question is, are low doses of lisinopril okay for many years? Their blood pressure is under control.

Sachdev: [37:50] I mean, I'm going to say yes, because, again, if your blood pressure is under control, then that's, to me, that's not a reason to make a change. The goal here is to get people under control, reach their target blood pressure. So if that's happening, you know, that's great. We're really focused is those patients whose blood pressure is uncontrolled and higher than the goal. So yes. And I also just want to say I see a couple notes here about the treatment protocols that are on the Million Hearts website. There's a few different ones, if I remember correctly, right?

Rakotz: [38:26] [crosstalk] Mmhmm. Yeah.

Sachdev: [38:27] [crosstalk] Yeah, so there's not…there are a few different options that you can look at. And for people who maybe are considering one, they're a good place to start, but you can also take them and adapt them for your own organization. It's another place you can really leverage a clinical pharmacist, if you have that resource, to help you create a customized protocol for your own organization.

Meador: [38:50] Thank you, Neha. And I think it was our follow-up materials that we share out after this call, we're definitely going to share a link to the AMA's medication treatment protocol that we like to use in our NAC Million Hearts project. It's an excellent one. But I'm going to transition. I think we have a great question that Neha, Mike, and I would like to ask all of you, which is: what will you do to improve treatment intensification? So if you haven't had a chance to drop that in the Q&A, we definitely want to hear your thoughts. What are you going to take away from today's call and put into action?

[39:32] Alright, so while you're offering your thoughts about what you could do, I do want to share some resources. So we I just mentioned the AMA hypertension medication treatment protocol. It is linked in the slide deck. And we also have a few other resources I want to highlight. So we have a roadmap that we're using in our current NAC Million Hearts project focused on improving blood pressure control for African Americans. It really highlights and features intervention strategies for intensification of medication. We also have an excellent case study. That's called 80% Control: A Three Pillar Practical Approach. And then we have a recent resource that the CDC worked on with a couple of national partners that's so great. I'm just going to call it out. It's an excellent resource that is called Fixed-dose Combination, Antihypertensive Medication Coverage, by State Medicaid and Medicaid Managed Care Organizations. And it really allows you to look at your own state and see which of those combination therapies are covered, what have Tier 1 status, and hopefully, you can use that to program into your decision support to educate your providers and to help make the right thing to do easy in your practice.

[40:48] So next slide. So want to just briefly say that there is CME credit available for clinicians and you can claim that by visiting the activity page. You can see the link here, we're going to share this slide deck afterwards so you'll have access to this link. Basically, you're going to sign into the AMA's Ed Hub using this and then from the activity page, you're going to click start, you're going to click Submit, you'll take a short quiz, and then you're going to select the appropriate amount of CME to claim which is 1 for this event. Importantly, there is the deadline, and that is November 9. And importantly—it's in here and I want to just call it out because it sort of blends in—but the session activity code is treatment. So that keyword is really important when you're filling out the CME application as you need to, it's going to ask you for that code word. It's right here in the slide deck and its treatment. Next slide. And basically how to access and download your certificate of participation. So once you've logged in and successfully completed the evaluation quiz, you can click on your name, located at the top righthand of the page and select transcript, find your completed activity, select certificate, and download it.

[42:05] All right, so just want to also mention that we do have a series this year that we're planning and we have another event coming up fairly soon. November 16th, we're going to be focusing on managing cholesterol through telehealth. And if you're interested in registering for this event or the series, the link is actually in the chat. And then in January, we have another event on patient messaging and conversations and motivational interviewing for medication adherence. But before we wrap we have, we're right on time, but I just want to thank our speakers so much. Thank you, Dr Rakotz. Thank you, Dr Sachdev. Really, really appreciate your expertise and your thoughts and your answers to questions. And I want to just give you a chance to say goodbye to everybody and offer any final words of wisdom or tips.

Rakotz: [42:57] Well, thank you again, Meg, for having us. We really appreciate being here. And it's always great for us to hear directly from people who are out there trying to improve health. Just know that we will try to be as accessible as possible if you have any additional questions. We'll try to make sure we get answers to all the questions in the chat, but please don't hesitate to reach out if you think that there's anything else we can do to help you and again, you're doing great work. It's great to be a part of it.

Sachdev: [43:27] I'll just say ditto and thank you.

Meador: [43:30] Thanks, everybody for joining us today.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;

1 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;

1 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program; and

1 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program;

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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