Comparison of reports from patients and health professionals: statins and muscle disorders

BACKGROUND AND METHODS: Statin- and especially cerivastatin-induced muscle effects reported by patients and doctors to the Limoges centre of pharmacovigilance during the years 2000 and 2001 were compared. In both instances, only reports with complaints of muscle pain or modification of creatine phospokinase (CPK) values and cases with one statin or one statin-fibrate association were selected. RESULTS: In the reports of 28 patients (21 involving cerivastatin), 80 % of the patients complained of diffuse myalgia. The dose was normal. The CPK value (six cases) was 1.7 +/- 0.9 N (upper limit of normal) [1-3.2 N]. Thirteen medical reports were received at the pharmacovigilance centre during the years 2000 and 2001: eight myalgias and five increases in CPK without muscle pain (9 +/- 9 N [1-20 N]). No common cases were identified among patients' and doctors' reports. Doctors tended to declare more severe effects, not necessarily associated with clinical signs. Patients' reports were at times inaccurate. CONCLUSION: Before including patients' reports in the present pharmacovigilance database, a thorough reconsideration is necessary.