Efficacy and Safety of Resveratrol as an Adjuvant Therapy in Patients with Dyslipidemia: Result of a Randomized Active Controlled Clinical Study
Rakesh Ojha1*, Pranesh Kulkarni 2, Bhavin Vyas 1
1Department of Pharmacology, Maliba College of Pharmacy, Uka Tarsadia University,
Bardoli, Surat, Gujarat, India.
2Vikas Hospital, Rambaug, Kalyan (West), Maharashtra, India
The aim of this study was to investigate the efficacy and safety of resveratrol as an adjuvant therapy in newly diagnosed dyslipidemic patients. In this randomized active-controlled study, dyslipidemic patients(male/female) aged 20-65 years were randomized to receive atorvastatin 10 mg or atorvastatin 10 mg plus resveratrol 1 gram daily for 12 months. Efficacy variables included change inlipid profile (total
cholesterol [TC], serum triglycerides [TGA], low-density lipoprotein [LDL] and high-density lipoprotein [HDL]) from baseline and were
followed-up for every 3 months. Treatment-emergent adverse events (TEAEs) were assessed. A total of 60 dyslipidemicpatients were analyzed (atorvastatin [n=30] andatorvastatin plus resveratrol [n=30]). Resveratrol as an adjuvant withatorvastatin significantly reduced plasma TC, TGA and LDL as compared to atorvastatin monotherapy (p<0.001 for
eachparametre). Meanlevels of HDL were significantly higherin atorvastatin plus resveratrol group than atorvastatin (p<0.001). Both the study drugs have similar safety profile, and found well tolerable.
Keywords: Dyslipidemia; Resveratrol; Lipid profile; Atorvastatin
[Full Text Article]