Efficacy and Safety of a Novel Triple Single-Pill for Uncontrolled Hypertension

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BACKGROUND: Novel single-pill combinations with blood pressure (BP)-lowering agents are needed to increase treatment options for hypertension. OBJECTIVES: The purpose of this study was to assess the efficacy and safety of a novel single pill (candesartan cilexetil, amlodipine, and chlorthalidone) compared with an active control (valsartan, amlodipine, and hydrochlorothiazide) for uncontrolled hypertension. METHODS: OPTION TREAT (Efficacy and Safety of a Novel Triple Single-Pill Combination Therapy Compared with an Active Control in Patients with Uncontrolled Hypertension) was a randomized, double-blind, double-dummy, noninferiority trial conducted across 19 sites in Brazil. Participants with an office systolic BP of 140 to 180 mm Hg and a diastolic BP of 90 to 110 mm Hg despite dual therapy were randomized in a 1:1 ratio to receive either the experimental treatment or the active control for 12 weeks. The primary outcome was the mean change in office systolic BP from baseline to week 12. The prespecified noninferiority margin was 3 mm Hg. Secondary outcomes included mean changes in diastolic BP and adverse events. RESULTS: Overall, 703 participants were included (mean age 57.8 years, 62.7% women, baseline office BP of 153.0/95.6 mm Hg). At 12 weeks, the least square mean change in systolic BP was -22.6 mm Hg in the experimental group vs -18.2 mm Hg in the control group (between-group difference -4.4 mm Hg; 90% CI -6.3 to -2.5 mm Hg; P < 0.001). Diastolic BP was also reduced in both groups, with greater reductions in the experimental group (-13.8 mm Hg vs -12.0 mm Hg; P = 0.008). Adherence was high, and serious adverse events were rare. CONCLUSIONS: In patients with uncontrolled hypertension, a novel triple single-pill containing candesartan cilexetil, amlodipine, and chlorthalidone improved BP control at 12 weeks and had a reasonable safety profile. (Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT for Systemic Arterial Hypertension [OPTION TREAT]; NCT05920005).

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