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The following is a summary of “Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension,” published in the December 2024 issue of Cardiology by Rodgers et al.
Single-pill combinations of blood pressure (BP)–lowering medications may be effective for the initial or early treatment of hypertension.
Researchers conducted a prospective study to assess the efficacy and safety of a new low-dose triple-pill combination for treating hypertension.
They randomized adults with mild-to-moderate hypertension to receive either a low-dose triple-pill combination (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg or telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg) or a placebo. The primary efficacy outcome was the home systolic BP (SBP) change from baseline to week 4. The primary safety outcome was treatment discontinuation due to AEs.
The results showed a placebo-corrected reduction in home SBP of −7.3 mm Hg (95% CI: −4.5 to −10.2) for the lower-dose combination and −8.2 mm Hg (95% CI: −5.2 to −11.3) for the higher-dose combination at week 4. Clinic SBP control (<140/90 mm Hg) at week 4 was 37%, 65%, and 70% for placebo, low-dose, and high-dose, respectively (both doses P<0.001 vs placebo). The treatment discontinuation due to AEs was 1.6% for placebo, 0% for low-dose, and 5.1% for high-dose. Elevated sodium or potassium levels were observed in 6.3%, 10.6%, and 10.1% of participants, respectively, but no one had severe electrolyte disturbances. Serious AEs were reported by 2 participants in the placebo and higher-dose groups.
They concluded that the low-dose triple-pill combination provided effective BP reduction with reasonable safety and tolerability compared to placebo.