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[Safety of ciprofibrate. Open study in a Portuguese population]
M C Branco1, J P de Moura, M Pereira
1Centro Hospitalar de Coimbra (CHC), Serviço de Medicina Interna.
Study Objective:
To determine the safety of ciprofibrate in portuguese patients with dyslipidaemia.
Design:
Open-label study with 6-month therapy.
Participants:
Sequential sample of 40 patients, 20 from each hospital, 37 patients (92.5%) completed the study.
Methods:
After at least one month of diet or washout period, all participants were given 100 mg/day of ciprofibrate, taken after the evening meal. Analysis and clinical examinations were performed at weeks (-4), (0), (+8), (+16) and (+24). Glycemia, uric acid, creatine kinase, creatinine and transaminases were determined.
Main Results:
Thirty-seven patients ended the study (92.5%), three abandoned because of gastrointestinal adverse effects, six other patients also complaint of gastrointestinal side effects. The creatinine and creatine kinase levels increased 9.7% and 19.2%, although kept in the normal range. There were no statistically significant changes in glycemia, uric acid and transaminases levels.
Conclusions:
These results confirm the high safety of ciprofibrate in patients with dislipidaemia. The short term of this study does not allows taking conclusions about long term use of this drug.