AI Article Synopsis
- A study was conducted to evaluate the effectiveness of a new once-daily extended-release carvedilol (carvedilol ER) formulation in lowering blood pressure among patients with hypertension, as opposed to the traditional twice-daily dosing.
- A total of 134 patients were randomly assigned to receive either placebo, low-dose carvedilol ER, or high-dose carvedilol ER for 8 weeks, with the main goal of measuring systolic and diastolic blood pressure changes.
- Results showed that while carvedilol ER was generally well tolerated, it did not lead to significant reductions in blood pressure compared to placebo, although higher doses showed some gradational improvement in blood pressure control.
Article Abstract
Background: Immediate-release carvedilol requires twice-daily dosing and may have low treatment compliance. We assessed the efficacy of a new formulation of once-daily extended-release carvedilol (carvedilol ER) on systolic blood pressure (SBP) and diastolic blood pressure (DBP) among patients with hypertension in this double-blind, randomized, placebo-controlled trial.
Methods: A total of 134 patients with untreated or uncontrolled hypertension were randomly assigned in a 1:1:1 ratio to receive placebo, low-dose carvedilol ER, or high-dose carvedilol ER for 8 weeks. The primary endpoint was the reduction in office SBP at 8 weeks. Secondary endpoints included the reduction in office DBP and the proportion of patients with blood pressure (BP) < 140/90 mm Hg.
Results: In the intention-to-treat population, placebo-adjusted changes in SBP/DBP were -2.9 mm Hg [95% confidence interval (CI), -9.6 to 3.7]/-1.7 mm Hg (95% CI, -5.6 to 2.3) and -4.9 mm Hg (95% CI, -11.5 to 1.7)/-3.4 mm Hg (95% CI, -7.3 to 0.5) for low-dose carvedilol ER and high-dose carvedilol ER, respectively. In the per-protocol population, high-dose carvedilol ER was associated with a significant DBP reduction [placebo-adjusted difference, -4.7 mm Hg (95% CI, -8.8 to -0.5); adjusted p = 0.026]. There was a gradational improvement in BP control with carvedilol ER (25%, 37%, and 48% for placebo, low-dose carvedilol ER, and high-dose carvedilol ER, respectively; linear-by-linear association p = 0.028). There were no differences in safety among the three groups.
Conclusions: Carvedilol ER, though well tolerated, did not result in a greater reduction in either SBP or DBP compared with placebo.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7953114 | PMC |
| http://dx.doi.org/10.6515/ACS.202103_37(2).20200914B | DOI Listing |
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