Post-marketing cohort study comparing the safety and efficacy of flunarizine and propranolol in the prophylaxis of migraine.
A comparative post-marketing surveillance study of the safety and efficacy of flunarizine and propranolol in the treatment of migraine was carried out. General practitioners in Belgium and the Netherlands each recruited patients for whom they would prescribe one of the study medications in the normal course of their treatment and recorded all medical events on follow-up forms for up to 8 months. A total of 1601 migraine patients were enrolled; 838 in the flunarizine cohort and 763 in the propranolol cohort. Propranolol was somewhat better than flunarizine in reducing the severity of migraine attacks, although this may have been due to a selection bias. Discontinuations of therapy due to events considered likely to be treatment-related were mostly due to the recognized side effects of the two drugs. As regards the occurrence of depressions, a total of 58 patients had depressive events, 34 in the flunarizine cohort and 24 in the propranolol cohort. Whereas migraine itself appears to be associated with an increased risk of depression, the number of previous migraine treatments was shown to be an additional risk factor for the development of depression in patients receiving flunarizine as was a history of depression. Overall, there was no appreciable difference in the risk/benefit ratio between flunarizine and propranolol.
Verspeelt
J
J
Janssen Research Foundation, Beerse, Belgium.
De Locht
P
P
Amery
W K
WK
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001480:Basal Ganglia Diseases / Q000139:chemically induced / Q000453:epidemiology; D001530:Belgium; D002648:Child; D015331:Cohort Studies; D003863:Depression / Q000139:chemically induced / Q000453:epidemiology; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005444:Flunarizine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D009426:Netherlands; D011433:Propranolol / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012307:Risk Factors; D012449:Safety; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015430:Weight Gain / Q000187:drug effects
D014665:Vasodilator Agents; D011433:Propranolol; D005444:Flunarizine