Monitoring statin safety in primary care

• Published in: Pharmacoepidemiology and drug safety Vol. 16; no. 6; pp. 652 - 657
• Main Authors: Tragni, Elena, Filippi, Alessandro, Mazzaglia, Giampiero, Sessa, Emiliano, Cricelli, Claudio, Catapano, Alberico L.
• Format: Journal Article
• Language: English
• Published: Chichester, UK John Wiley & Sons, Ltd 01.06.2007
• Subjects: Adult; Aged; Aged, 80 and over; Alanine Transaminase - blood; Aspartate Aminotransferases - blood; Creatine Kinase - blood; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; laboratory monitoring; Lipids - blood; Male; Middle Aged; primary care; Primary Health Care; safety; statins
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/pds.1361

Purpose To verify General Practitioners (GPs) compliance to the recommended laboratory monitoring for statin users. Methods A retrospective study was conducted collecting data from the database of Italian College of General Practitioners, named Health Search; all the participant physicians used an automatic pop‐up which reminds them to periodically check liver enzyme levels in statin‐users. We examined the patients who received their first statin prescription from 29 November 1999 to 28 November, 2002. CPK, ASL, AST, and creatinine values recorded before and after the first prescription were evaluated. The minimum and maximum observation time before and after prescription were 6 and 42 months, respectively. The prevalence of laboratory monitoring prescribed by GPs was calculated at baseline and during follow‐up for all patients and for the subgroup of high‐risk patients. Results We identified 14 120 first‐ever statin users (male 47.4%). CPK, AST, ALT and creatinine tests were prescribed at least once at baseline in 8.5%, 53.9%, 50.9%, and 64.0% of patients, respectively; during the follow‐up 37.8%, 64.4%, 60.3%, and 61.5% of patient received the same tests prescriptions, respectively. No difference between high‐risk and non‐high‐risk patients was observed. During the follow‐up enzyme levels greater than three times the upper normal limit were recorded in 0.4%, 0.1%, 0.1%, and 0.3% of subjects for CPK, AST, ALT and creatinine, respectively. Conclusion Adherence to the recommended laboratory monitoring for statin users is very low among Italian GPs, even for high‐risk patients. Automatic reminders which pop‐up whenever statins are prescribed are ineffective. Copyright © 2007 John Wiley & Sons, Ltd.