Telmisartan-chlorthalidone fixed-dose combination at 2 chlorthalidone dose levels versus telmisartan in uncontrolled hypertension: a Phase III trial

초록

Background: Evidence comparing different diuretic doses within fixed-dose combinations (FDCs) remains limited. We evaluated telmisartan/chlorthalidone FDCs according to chlorthalidone dose in patients with blood pressure (BP) inadequately controlled on telmisartan monotherapy. Methods: In this randomized, double-blind trial, 254 patients with uncontrolled BP [sitting systolic blood pressure (SBP) >= 140 and <180 mm Hg; sitting diastolic blood pressure (DBP) <110 mm Hg] after a telmisartan run-in period were randomized (1:1:1) to receive either telmisartan/chlorthalidone FDCs (40/12.5 or 40/6.25 mg), or telmisartan 40 mg for 8 weeks. The primary endpoint was the change in sitting SBP from baseline to Week 8. Results: At Week 8, telmisartan/chlorthalidone FDCs demonstrated greater reductions in sitting SBP compared with telmisartan monotherapy: least-squares mean differences were -9.5 mm Hg [95% CI, -13.5 to -5.6] for the 40/12.5 mg and -6.1 mm Hg [95% CI, -10.4 to -1.9] for the 40/6.25 mg. BP control rates (target BP: SBP/DBP <140/90 mm Hg, or <130/80 mm Hg in patients with albuminuric chronic kidney disease or established cardiovascular disease) at Week 8 also favored telmisartan/chlorthalidone FDCs over telmisartan monotherapy (53.2% for the 40/12.5 mg and 43.0% for the 40/6.25 mg vs 32.9% for telmisartan 40 mg). Safety profiles were comparable among treatment groups. Conclusions: In patients inadequately controlled on telmisartan alone, FDCs of telmisartan with 2 different doses of chlorthalidone provided greater BP reduction than telmisartan monotherapy without increased safety risk, supporting its role as an effective and well-tolerated treatment option.

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