‘Quadpill’ strategy effective, safe, tolerable vs. monotherapy for BP lowering
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Use of a “quadpill” capsule containing quarter doses of four antihypertensive medications conferred greater BP reductions compared with monotherapy, with similar safety and tolerability, a speaker reported.
“The main barriers to blood pressure control are the need for multiple medicines, treatment inertia, the failure to uptitrate the treatment despite blood pressure not being at target and concerns regarding adverse events,” Clara K. Chow, PhD, professor at the Westmead Applied Research Center at University of Sydney, Australia, said during a presentation at the European Society of Cardiology Congress. “In the SPRINT trial, the majority of patients in both the intervention and control arms needed multiple medicines to achieve BP target. The main goal of our study was to examine whether simplified strategies using low-dose single-pill combinations could overcome these barriers to blood pressure control.”
Researchers enrolled 591 patients with hypertension, half of whom were already on monotherapy at baseline, and randomly assigned them to BP management with initial quadpill or monotherapy with irbesartan 150 mg. The study was simultaneously published in The Lancet.
The quadpill capsule contained bisoprolol 2.5 mg, irbesartan 37.5 mg, indapamide 0.625 mg and amlodipine 1.25 mg.
The primary outcome was change in mean automated unattended office systolic BP at 12 weeks. Secondary outcomes included change in mean automated unattended office BP at 52 weeks, change in mean 24-hour BP at 12 and 52 weeks, percentage of patients requiring uptitration of BP management therapies (addition of amlodipine 5 mg), BP control (BP < 140/90 mm Hg) and drug safety and tolerability.
By 12 weeks, additional hypertension therapies were being used in 15% of participants in the quadpill cohort and 40% of the monotherapy control group, at which time, the mean change in BP was 6.9 mm Hg lower in the quadpill arm compared with the control group (95% CI, –4.9 to –8.9; P < .001).
After 12 weeks of the intervention, 76% of patients in the quadpill group achieved a BP of less than 140/90 mm Hg compared with 58% of the control arm (RR = 1.3; 95% CI, 1.2-1.5; P < .0001).
A total of 70.6% of participants elected to continue trial participation up to 1 year. By that time, the mean BP in the quadpill group was 7.7 mm Hg lower compared with the control group (95% CI, –5.2 to –10.3; P < .0001).
According to the presentation, BP control was achieved in 81% of the quadpill group compared with 62% of the control group (RR = 1.32; 95% CI, 1.16-1.5).
Chow stated that despite uptitration at weeks 6, 12, 26 and 52 in the monotherapy arm, rates of successful BP management were higher in the quadpill arm.
Among participants in the quadpill arm, mean 24-hour ambulatory systolic BP was 8.5 mm Hg lower during the daytime and 7.5 mm Hg lower during the nighttime by week 12 (P for both < .001).
Seven serious adverse events occurred in the quadpill arm and three in the control arm, and the rate of treatment-related withdrawals between groups was similar (4% vs. 2.4%; P = .27).
Adverse effects were similar between groups.
“This study demonstrates the simplicity and efficacy of a quadpill-based strategy to achieve and maintain blood pressure control, that is, blood pressure control in a single step,” Chow said during the presentation.
Reference:
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Chow C, et al. Late Breaking Trials in Hypertension. Presented at: European Society of Cardiology Congress; Aug. 27-30, 2021 (virtual meeting).
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