A Randomized Open-Label Parallel-Group Study Evaluating the Efficacy and Safety of Candesartan Cilexetil and Amlodipine in Mild to Moderate Essential Hypertensives in a Tertiary Care Hospital in Chennai
Abstract
Objective: This research compared the effectiveness of combining amlodipine and candesartan in treating mild to moderate hypertensive patients. It suggests using drugs from different groups to achieve target blood pressure levels, as per contemporary evidence-based medicine. Hypertension is a leading global health threat, causing early deaths and other health conditions.
Materials and Methods: Newly diagnosed essential hypertensives with BP ≥140/90 to <180/110 mmHg were screened for this randomized, prospective, open-label, 3-arm, interventional, phase IV study. Eligible patients were divided into 3 groups, with amlodipine or candesartan cilexetil as monotherapy in 2 arms and the third arm with amlodipine + candesartan for 12 weeks. All the efficacy parameters will be presented as a percentage change in the mean of blood pressure from baseline and were compared using ANOVA with p-value<0.05 to be statistically significant.
Results: Out of 90 patients randomized, 83 were included for analysis. While the reduction in systolic blood pressure by amlodipine, candesartan, and amlodipine + candesartan from baseline was 11.7, 13.1, and 19mm Hg, the reduction in diastolic blood pressure by amlodipine, candesartan, and amlodipine + candesartan was 6.2, 10.7 and 11.9 mmHg at the end of 12 weeks (p-value<0.0001). Out of a total of 90 participants in the 3 groups, the incidence of adverse events was reported by 7 participants.
Conclusion: The study found that combining a calcium channel blocker and an angiotensin receptor blocker was more effective and tolerable in treating mild to moderate essential hypertensives.
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