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

Abstract

Background: Single-pill combination (SPC) antihypertensive products improve blood pressure control and medication adherence among patients with hypertension. It is unknown to what degree commercially available SPC products could be used to target an intensive systolic blood pressure goal of <120 mm Hg.

Methods: This cross-sectional analysis included participants randomized to the intensive treatment arm (goal systolic blood pressure <120 mm Hg) of the Systolic Blood Pressure Intervention Trial (SPRINT) using ≥2 antihypertensive medication classes at the 12-month postrandomization visit. Antihypertensive medication data were collected using pill bottle review by research coordinators, and regimens were categorized by the unique combinations of antihypertensive classes. We calculated the proportion of regimens used, which are commercially available as one of the 7 SPC class combinations in the United States as of January 2023.

Results: Among the 3833 SPRINT intensive arm participants included (median age, 67.0 years; 35.5% female), participants were using 219 unique antihypertensive regimens. The 7 regimens for which there are class-equivalent SPC products were used by 40.3% of participants. Only 3.2% of all medication class regimens used are available as a class-equivalent SPC product (7/219). There are no SPC products available with 4 or more medication classes, which were used by 1060 participants (27.7%).

Conclusions: Most SPRINT participants in the intensive arm used an antihypertensive medication regimen, which is not commercially available as a class equivalent SPC product. To achieve the SPRINT results in real-world settings, maximize the potential benefit of SPCs, and reduce pill burden, improvements in the product landscape are needed.

Registration: URL: https://www.

Clinicaltrials: gov/ct2/show/NCT01206062; Unique identifier: NCT01206062.

Keywords: antihypertensive; cardiovascular diseases; drug combinations; goal; hypertension.

Figure 1.. Flow Diagram for Inclusion and Exclusion

SPRINT: Systolic Blood Pressure Intervention Trial

Figure 2.. Relative popularity of antihypertensive medication regimens and SPC product availability, by the number of medication classes in the regimen.

Tree-map of all antihypertensive medication regimens with at least 2 classes combined which were used by participants in the intensive group at the 12-month visit. Each box represents a unique combination of antihypertensive medication classes. Box sizes are proportional to the frequency of use, with larger boxes representing more popular regimens. Solid color boxes represent regimens which are commercially available as an SPC product; white colored boxes are not. Only regimens that were used by more than 0.5% of the population are labeled.