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Extended-Release Carvedilol in the Treatment of Hypertension: A Double-Blind, Randomized, Placebo-Controlled Trial
Kang-Ling Wang1,2, Chih-Yuan Fang3, Wen-Ter Lai4
1General Clinical Research Center, Taipei Veterans General Hospital.
Insights
Extended-release carvedilol (carvedilol ER) was evaluated for hypertension treatment. While well-tolerated, carvedilol ER did not significantly lower systolic or diastolic blood pressure compared to placebo in this trial.
Area of Science:
- Cardiovascular medicine
- Pharmacology
- Clinical trials
Background:
- Immediate-release carvedilol necessitates twice-daily dosing, potentially impacting patient compliance.
- A novel once-daily extended-release formulation of carvedilol (carvedilol ER) was developed to address dosing frequency.
- Hypertension management remains a critical area in cardiovascular health.
Purpose of the Study:
- To evaluate the efficacy of once-daily extended-release carvedilol (carvedilol ER) in reducing systolic blood pressure (SBP) and diastolic blood pressure (DBP).
- To compare the effectiveness of carvedilol ER against a placebo in patients with hypertension.
- To assess the safety profile of carvedilol ER in the studied population.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 134 patients with hypertension.
- Participants were assigned to placebo, low-dose carvedilol ER, or high-dose carvedilol ER for 8 weeks.
- Primary endpoint: reduction in office SBP; Secondary endpoints: reduction in office DBP and BP control rates.
Main Results:
- In the intention-to-treat analysis, neither low-dose nor high-dose carvedilol ER showed significant placebo-adjusted reductions in SBP or DBP.
- The per-protocol analysis indicated a significant reduction in DBP with high-dose carvedilol ER (placebo-adjusted difference, -4.7 mm Hg; p = 0.026).
- A dose-dependent improvement in blood pressure control was observed, with 48% of patients on high-dose carvedilol ER achieving target BP.
Conclusions:
- Extended-release carvedilol (carvedilol ER) was found to be well-tolerated in patients with hypertension.
- The study concluded that carvedilol ER did not demonstrate a statistically significant greater reduction in SBP or DBP compared to placebo.
- Further research may be needed to clarify the clinical utility of carvedilol ER in hypertension management.
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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