ABSTRACT
OBJECTIVE: To compare the efficacy and safety of fixed-dose combination (FDC) of simvastatin and ezetimibe vs simvastatin monotherapy in Indian patients with primary hypercholesterolemia. METHODS: 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 or >135 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. RESULTS: 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%, P < 0.05). Significantly greater percentage of patients (88%, P < 0.001) 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 (P < 0.001). Increases in HDL-C, and reduction in TC were similar between treatment groups. Safety and tolerability profiles were comparable for both treatments. CONCLUSION: 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.
ABSTRACT
Several large scale clinical trials have demonstrated that angiotensin converting enzyme inhibitors offer cardiovascular and renal protection independent of their effects on systolic BP. Trandolapril is a new angiotensin converting enzyme inhibitor approved for the treatment of hypertension. The potential advantages of this drug are long duration of action and better tolerability. The objective of the study was to compare the efficacy and tolerability of trandolapril with that of enalapril in mild to moderate hypertension in Indian population. In this double blind, multicentric, parallel comparative clinical study, 120 patients with mild to moderate hypertension were randomly assigned to receive trandolapril 2 mg or enalapril 5 mg once daily for 8 weeks. The attainment of sitting diastolic blood pressure <90 mmHg at the end of 8th week was considered as primary outcome measure and attainment of diastolic blood pressure <90 mmHg or reduction of at least 10 mmHg diastolic blood pressure compared to baseline at any visit was considered as secondary outcome measures. 98.4% patients treated with trandolapril and 92.6% patients treated with enalapril fulfilled the primary outcome measure. 54, 72 and 62% patients on trandolapril and 52, 61 & 64% patients on enalapril fulfilled secondary outcome measure at the end of 2nd, 4th and 8th week respectively. Also trandolapril was better tolerated than enalapril with no significant abnormality in lab parameters.
