A RANDOMIZED ACTIVE CONTROLLED CLINICAL STUDY TO EVALUATE EFFICACY AND SAFETY OF RESVERATROL AS AN ADJUVANT THERAPY IN PATIENTS WITH HYPERTENSION
Objectives: No long-term clinical efficacy and safety study of resveratrol as adjuvant therapy along with gold standard therapy has been conducted in patients with essential hypertension. The aim of this study was to investigate the efficacy and safety of resveratrol as an adjuvant therapy in newly diagnosed hypertensive patients.
Methods: In this randomized active-controlled study, hypertensive patients (male/female) of 20-65 years aged were randomized (1:1) to receive telmisartan 20 mg or telmisartan 20 mg plus resveratrol 1 g daily for 12 months. Efficacy variables included a change in systolic and diastolic blood pressure (DBP) from baseline and were followed up for every 3 months. Treatment-emergent adverse events were assessed.
Results: A total of 60 hypertensive patients were analyzed (telmisartan [n=30] and telmisartan plus resveratrol [n=30]). Resveratrol as an adjuvant with telmisartan significantly reduced in systolic (p<0.001) and DBP (p<0.001) as compared to telmisartan monotherapy. Change in systolic and DBP from baseline was significantly higher in telmisartan plus resveratrol group than telmisartan (p<0.001) at all followed visits. Both the study drugs have similar safety profile and found well tolerable.
Conclusions: Resveratrol plus Telmisartan was found to be superior over telmisartan monotherapy in reducing systolic and DBP in newly diagnosed hypertensive patients. Both the study drugs were effective with comparable safety profile. Our study supports the long-term clinical efficacy and safety study of resveratrol along with gold standard therapy in essential hypertension.
Keywords: Essential hypertension, Resveratrol, Systolic and diastolic blood pressure, Telmisartan
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