| Summary: | 碩士 === 臺北醫學大學 === 藥學系 === 94 === Objective: Therapeutic interchange of HMG-CoA reductase inhibitors was implemented since June 6th, 2005. Atorvastatin (Lipitor®), simvastatin (Zocor®), pravastatin (Mevalotin®) and fluvastatin (Lescol®) were substituted with simvastatin (Zolotin®) and atorvastatin (Lipitor®). The purpose of this study was to evaluate the efficacy and safety of statin
therapeutic interchange in patients with dyslipidemia.
Method: This is a non-randomized, open-labeled and self-controlled study. Patients met the inclusion and exclusion criteria were eligible for the study and followed for seven months. Electronic prescription records and laboratory data of the subjects were collected one year before and seven months after interchange. The efficacy endpoints included changes in lipid profiles, including total cholesterol(TC), low-density lipoprotein cholesterol(LDL-C), high-density lipoprotein cholesterol(HDL-C) and triglyceride(TG), as well as the percentage of subjects attaining LDL-C goal according to National Cholesterol Education Program-Adult Treatment Panal III before and after interchange. Safety endpoints included aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatine kinase (CK), other statin-related adverse effects recorded in charts, and major drug interactions.
Result: A total of 292 patients in the group of Zolotin® and 97 patients in the group of Lipitor® were eligible for the evaluation. TC, LDL-C and HDL-C values all improved after interchange. The percentage of patients achieving LDL-C goal significantly increased after converting to Zolotin® (8.3% VS 33.6%, p<0.05), while in Lipitor® users, the percentage increased from 5.8% to 29.4% (p<0.05). Although AST of one patient and ALT of four patients increased to three folds of upper limit of normal (ULN), none developed overt symptoms. Statin treatment were discontinued in these patients subsequently. During the 7 months after conversion, only a small number of people showed a slight increase in creatine kinase, but none developed clinical signs or symptoms. There were eight cases of muscle symptoms after converting to Zolotin®, seven of whom discontinued Zolotin® immediately. In the group of Lipitor® users, only one patient developed muscle cramping and discontinued treatment subsequently. There were no significant changes in any other adverse reactions. No major drug interaction was identified either before or after the interchange.
Conclusion: Implementation of therapeutic interchange in statin improved the lipid profiles and increased the percentage of patients achieving LDL-C goal. Therefore, therapeutic interchange of statin may achieve better efficacy without causing severe adverse effects.
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