Antihypertensive Medication Regimens Used in the Systolic Blood Pressure Intervention Trial

Abstract

BACKGROUND: Describing the antihypertensive medication regimens used in the SPRINT (Systolic Blood Pressure Intervention Trial) would contextualize the standard and intensive systolic blood pressure (SBP) interventions and may inform future implementation efforts to achieve population-wide intensive SBP goals. METHODS: We included SPRINT participants with complete medication data at the prerandomization and 12-month visits. Regimens were categorized by antihypertensive medication class. Analyses were stratified by treatment group (standard goal SBP <140 mm Hg versus intensive goal SBP <120 mm Hg). RESULTS: Among 7860 participants (83.7% of 9361 randomized), the median number of classes used at the prerandomization visit was 2.0 and 2.0 in the standard and intensive groups ( P =0.559). At 12-months, the median number of classes used was 3.0 and 2.0 in the intensive and standard groups ( P <0.001). Prerandomization, angiotensin-converting enzyme inhibitor (ACE), or angiotensin-II receptor blocker (ARB) monotherapy was the most common regimen in the intensive and standard groups (12.6% versus 12.2%). At 12-months, ACE/ARB monotherapy was still the most common regimen among standard group participants (14.7%) and was used by 5.3% of intensive group participants. Multidrug regimens used by the intensive and standard participants at 12 months were as follows: an ACE/ARB with thiazide (12.2% and 7.9%); an ACE/ARB with calcium channel blocker (6.2% and 6.8%); an ACE/ARB, thiazide, and calcium channel blocker (11.4% and 4.3%); and an ACE/ARB, thiazide, calcium channel blocker, and beta-blocker (6.5% and 1.2%). CONCLUSIONS: SPRINT investigators favored combining ACEs or ARBs, thiazide diuretics, and calcium channel blockers to target SBP <120 mm Hg, compared to ACE/ARB monotherapy to target SBP <140 mm Hg. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT01206062.

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

“…While a class equivalent SPC product may exist for a patient’s regimen, it may not be clinically appropriate to use it. Similarly, to truly replicate the regimens employed by SPRINT investigators, 14 SPC products would be needed that align with the SPRINT protocol. For example, chlorthalidone was the recommended thiazide diuretic of choice (and was used by 88% of SPRINT participants taking a thiazide diuretic 2 ), but the current SPC market in the US only hosts 2 products with chlorthalidone: azilsartan/chlorthalidone and atenolol/chlorthalidone.…”

“…Detailed treatment algorithms are available in Cushman et al 2 The current analysis assessed medication regimens used by the intensive group participants at the 12-month visit, by which point most medication changes had occurred. 14 We included intensive group participants who were alive, attended the 12-month visit, had complete medication data at the 12-month visit, and who were taking 2 or more antihypertensive medications (N=3833; 90.2% of intensive arm participants with complete 12-month visit data; Figure 1).…”

“…Details regarding how antihypertensive medication data were collected and analyzed have been previously described. 14…”

“…2,13 For intensive group participants, the SPRINT investigators favored regimens with angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin-II receptor blockers (ARBs), thiazide diuretics, and calcium channel blockers (CCBs), used at an average of two-thirds the maximum recommended doses. 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.…”

“…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.…”