Long-term efficacy of pitavastatin versus simvastatin

• Published in: Advances in therapy 2011-09, Vol.28 (9), p.799-810
• Main Authors: Eriksson, Mats, Budinski, Dragos, Hounslow, Neil
• Format: Article
• Language: English
• Subjects: Aged; Cardiology; Cholesterol, LDL - blood; Coronary Artery Disease - etiology; Coronary Artery Disease - prevention & control; Double-Blind Method; Dyslipidemias - blood; Dyslipidemias - drug therapy; Endocrinology; Female; Health technology assessment; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Research; Pharmacology/Toxicology; Quinolines - adverse effects; Quinolines - therapeutic use; Rheumatology; Simvastatin - adverse effects; Simvastatin - therapeutic use
• ISSN: 0741-238X; 1865-8652
• DOI: 10.1007/s12325-011-0057-6

Introduction Pitavastatin is a novel, potent, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. This study compared the long-term efficacy of pitavastatin and simvastatin in dyslipidemic patients at high risk of coronary heart disease. Methods A 44-week blinded extension study was conducted at 24 centers in five European countries for patients who had previously completed a 12-week randomized, double-blind core study in which they received pitavastatin 4 mg or simvastatin 40 mg once daily. Patients originally randomized to pitavastatin 4 mg continued at the same dose throughout the extension study ( n =121). In simvastatin-treated patients ( n =57), the dose was increased to 80 mg in five patients who had not attained the National Cholesterol Education Program (NCEP) target for low-density lipoprotein cholesterol (LDL-C) during the core study. Primary endpoints were the proportion of patients attaining the NCEP and European Atherosclerosis Society (EAS) LDL-C targets, and the NCEP target for non-high-density lipoprotein cholesterol (non-HDL-C) at weeks 16 and 44. Results Of the 178 patients who entered the extension study, 156 patients (109 in the pitavastatin group, 47 in the simvastatin groups) completed the 44-week treatment period. At week 44, NCEP and EAS targets were attained by 81.7% and 84.2%, respectively, of pitavastatin-treated patients, and 75.4% and 73.7%, respectively, of simvastatin-treated patients. NCEP targets for non-HDL-C were achieved by 79.2% of pitavastatin-treated patients and 70.2% of simvastatin-treated patients. Both treatments were generally well tolerated, but pitavastatin 4 mg was associated with a numerically lower incidence of discontinuations due to treatment-emergent adverse events (5.8% vs. 10.5% of patients) and a lower rate of myalgia (4.1% vs. 12.3%) compared with simvastatin 40–80 mg. Conclusion Pitavastatin 4 mg provides long-term efficacy similar to that of simvastatin 40–80 mg. Further studies should ascertain whether trends suggesting that pitavastatin may exhibit a more favorable long-term tolerability profile are statistically significant.