Antihypertensive Medication Regimens Used by US Adults With Hypertension and the Potential for Fixed‐Dose Combination Products: The National Health and Nutrition Examination Surveys 2015 to 2020

Abstract

Background Fixed‐dose combination (FDC) antihypertensive products improve blood pressure control and adherence among patients with hypertension. It is unknown to what degree commercially available FDC products meet the current hypertension management prescription patterns in the United States. Methods and Results This cross‐sectional analysis of the National Health and Nutrition Examination Surveys 2015 to March 2020 included participants with hypertension taking ≥2 antihypertensive medications (N=2451). After constructing each participant's regimen according to antihypertensive classes used, we estimated the extent to which the 7 class‐level FDC regimens available in the United States as of January 2023 would match the regimens used. Among a weighted population of 34.1 million US adults (mean age, 66.0 years; 52.8% women; 69.1% non‐Hispanic White race and ethnicity), the proportions using 2, 3, 4, and ≥5 antihypertensive classes were 60.6%, 28.2%, 9.1%, and 1.6%, respectively. The 7 FDC regimens were among 189 total regimens used (3.7%), and 39.2% of the population used one of the FDC regimens (95% CI, 35.5%–43.0%; 13.4 million US adults); 60.8% of the population (95% CI, 57.0%–64.5%; 20.7 million US adults) were using a regimen not available as a class‐equivalent FDC product. Conclusions Three in 5 US adults with hypertension taking ≥2 antihypertensive classes are using a regimen that is not commercially available as a class‐equivalent FDC product as of January 2023. To maximize the potential benefit of FDCs to improve medication adherence (and thus blood pressure control) among patients taking multiple antihypertensive medications, use of FDC‐compatible regimens and improvements in the product landscape are needed.

Process Evaluation of a Double‐Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra‐Low‐Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA)

“…For antihypertensive FDCs, a change in the product landscape may be needed to improve conversion of real‐world treatment patterns with FDC‐equivalent options. 13 Notably, this was not a barrier discussed by health care professionals in this study. In addition, overcoming therapeutic inertia with greater initial (ie, upfront) blood pressure lowering was not mentioned as a perceived benefit of LDQT (or antihypertensive FDCs) among clinicians in this study, although this is 1 of the main aims of an LDQT strategy.…”

“… 6 , 9 , 12 Qualitative data are needed to explore why FDC for hypertension control has had poor uptake despite strong evidence supporting its use, including elucidating any patient‐ and clinician‐specific hesitancies beyond simple availability (eg, cost and inflexible titration). 13 …”

Single-Pill Combination Product Availability of the Antihypertensive Regimens Used for Intensive Systolic Blood Pressure Treatment in the Systolic Blood Pressure Intervention Trial

“…24,25 Applying a similar methodology to the National Health and Nutrition Examination Surveys, we estimated that 20.7 million US adults with hypertension taking 2 or more medications are using a regimen that is not commercially available as a single class-equivalent SPC product. 15 Assuming that 12.3% of the 20.7 million are eligible for the SPRINT trial, 26 then over 2.5 million SPRINT-eligible US adults do not have access to a class-equivalent SPC product. An important consideration for antihypertensive pharmacoequity 27,28 (ie, the equitable provision of medication for all) is that, should new SPC products be developed and marketed to US patients, these products would likely be brand-name only and be associated with higher cost burdens to the patient (especially disadvantaged persons) and the health system, limiting their utility until they become generic.…”

“…14 Still, 255 unique antihypertensive medication class combinations were used by SPRINT participants, and no combination was used by >15% of participants. 14 We previously estimated that 20.7 million US adults with hypertension taking 2 or more medications are using a regimen that is not commercially available as a single class-equivalent SPC product; 15 however, the degree to which the regimens used in the intensive treatment arm of SPRINT are available as SPC products is unknown. We describe the degree to which currently available SPC products match the antihypertensive medication class regimens used by SPRINT investigators to target intensive systolic BP goals.…”

The Management of Elevated Blood Pressure in the Acute Care Setting: A Scientific Statement From the American Heart Association

“…2,46 Despite these advantages, the use of fixeddose or combination therapy remains low, with only 27% of US adults on ≥2 antihypertensive medications using fixed-dose or combination therapy. 47 High-quality medication counseling on discharge is critical; 1 in 7 patients experiences confusion about their medication, leading to a higher risk of readmission. 48 Clear communication about any changes made during the admission, along with the need for outpatient monitoring, including out-of-office BP monitoring, is essential.…”