[Safety of ciprofibrate. Open study in a Portuguese population].
OBJECTIVE
To determine the safety of ciprofibrate in portuguese patients with dyslipidaemia.


METHODS
Open-label study with 6-month therapy.


METHODS
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.


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.
Branco
M C
MC
Centro Hospitalar de Coimbra (CHC), Serviço de Medicina Interna.
de Moura
J P
JP
Pereira
M
M
Jesus
L C
LC
Ferraz
A
A
Silva
J M
JM
Ferreira
M R
MR
Serra e Silva
P
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D002995:Clofibric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D058607:Fibric Acids; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011174:Portugal
D058607:Fibric Acids; D000960:Hypolipidemic Agents; D002995:Clofibric Acid; C019304:ciprofibrate
Segurança do ciprofibrato. Estudo aberto numa população portuguesa.