Long‐term safety and tolerability profile of ezetimibe and atorvastatin coadministration therapy in patients with primary hypercholesterolaemia

摘要: Summary Long-term safety and tolerability of ezetimibe plus atorvastatin (EZE + ATV) coadministration therapy were compared to those ATV monotherapy in patients with primary hypercholesterolaemia. Upon completion a 12 week randomised, double-blind, placebo-controlled study comparing EZE 10 mg; 10, 20, 40 or 80 mg; EZE + ATV 80 mg placebo, 246 enrolled 12-month extension, reassignment double-blind 10 mg (n = 201) matching placebo (n = 45) coadministered daily open-label 10 mg. At intervals 6 weeks, not at National Cholesterol Education Program Adult Treatment Panel II LDL-C goals titrated the next higher dose. Safety evaluations included adverse event (AE) reports laboratory test results. groups similar regard incidence all AEs (71 vs. 67%), treatment-related (22 27%) discontinuations due (9 7%) (6 7%), respectively. Neither clinically significant elevations hepatic transaminases creatine kinase nor any cases myopathy rhabdomyolysis observed either group during extension study. After produced greater reductions low-density lipoprotein cholesterol (LDL-C; −53 −37%), total (TC; −38.8 −26.0%) triglycerides (TG; −28 −12%) increases high-density (4.6 4.5%) 10 mg, respectively, these changes maintained 1 year (p < 0.01 for LDL-C, TC TG). More achieved goal than endpoint (91 78%, respectively; p = 0.02). Thus, months was well tolerated more efficacious monotherapy.