Search

To compare the efficacy and safety of fixed-dose combination (FDC) of simvastatin and ezetimibe vs simvastatin monotherapy in Indian patients with primary hypercholesterolemia.This multicentric, double-blind, comparative, study conducted in India enrolled 230 patients with hypercholesterolemia (baseline low-density lipoprotein cholesterol [LDL-C]120 mg/dL for patients on previous hypolipidemic drugs or135 mg/dL for naïve subjects) were randomly assigned to receive either simvastatin (10 mg/day) or simvastatin (10 mg) plus ezetimibe (10 mg) FDC for 12 weeks. The primary efficacy endpoint was the mean percentage change in LDL-C from baseline to 12 weeks of therapy for simvastatin monotherapy vs simvastatin plus ezetimibe FDC. Secondary efficacy endpoints were mean percentage of changes in total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) from baseline to end of treatment, as well as proportion of patients achieving National Cholesterol Education Program Adult Treatment Panel III target LDL-C levels in each risk category.At the end of 12 weeks, the mean percentage reduction from baseline in LDL-C (-33.7%) was significantly greater with simvastatin and ezetimibe FDC compared to simvastatin alone (-26.28%, P0.05). Significantly greater percentage of patients (88%, P0.001) attained National Cholesterol Education Program Adult Treatment Panel III LDL-C target levels following ezetimibe/simvastatin treatment compared to simvastatin monotherapy (71%). Reductions in TG were significantly greater with ezetimibe/simvastatin than simvastatin (P0.001). Increases in HDL-C, and reduction in TC were similar between treatment groups. Safety and tolerability profiles were comparable for both treatments.Fixed-dose combination of simvastatin and ezetimibe provides a more effective means for reducing LDL cholesterol levels in Indian patients with hypercholesterolemia than simvastatin monotherapy without compromising the safety and tolerability profile.

Varenicline, a partial agonist of α4β2 nicotinic acetylcholine receptor (nAChR), is the most recently approved drug for smoking cessation. Despite the availability of effective treatments for smoking cessation, such as nicotine replacement therapy and Bupropion sustained-release, abstinence rates remain less than optimal. As a nAChR partial agonist, Varenicline attenuates the craving and withdrawal symptoms that occur with abstinence from nicotine and also reduces the rewarding effects of nicotine obtained from smoking in patients who lapse. Clinical trials have demonstrated superior efficacy of this drug over Bupropion-SR for achieving abstinence from smoking, and Varenicline has also been shown to significantly delay smoking relapse. As the latest agent approved for smoking cessation, the mechanism of action, efficacy, and safety of Varenicline has been reviewed in this paper. Key words: α4β2 nicotinic acetylcholine receptor; Varenicline; smoking cessation; partial agonist. DOI: 10.3126/kumj.v7i2.2714 Kathmandu University Medical Journal (2009) Vol.7, No.2 Issue 26, 162-164