STUDIES TO ASSESS IF PIZOTIFEN PROPHYLAXIS IMPROVES MIGRAINE BEYOND THE BENEFIT OFFERED BY ACUTE SUMATRIPTAN THERAPY ALONE

Two multi-centre studies - one double-blind, placebo-controlled (study 1) and one open (study 2) - were set up to assess if pizotifen prophy laxis improved migraine beyond the benefit offered by acute sumatripta n therapy alone, Eighty-eight patients completed the blinded study and 63 patients completed the open study, Both studies were of crossover design with patients undertaking a 4 week run-in period prior to a 12- week treatment period. Following a 4-week washout period patients comm enced a second 12-week treatment period on the alternative treatment r egimen, All breakthrough attacks were treated with 100 mg oral sumatri ptan with an optional 2 doses available to treat any recurrence within 24 h of taking dose 1. Pizotifen was built up to a final daily dose o f 1.5 mg over a 2-week period and patients remained on this dose for a further 10 weeks, Patients in the blinded study were given matching p lacebo tablets for one of the two treatment periods, The efficacy : of sumatriptan was not affected by pizotifen, The median of the monthly attack rate experienced by patients was slightly lower whilst patients were on pizotifen and sumatriptan than while on placebo prophylaxis a nd sumatriptan or sumatriptan alone; study 1, 3.5 vs 3.9 attacks per m onth (p = 0.008); study 2, 2.9 vs, 3.2 attacks per month (p = 0.23). A lso, while on pizotifen and sumatriptan more patients had a greater pr oportion of their time in the study migraine-free, From the results of these studies it does not appear that pizotifen reduces migraine seve rity; regardless of the treatment regimen the initial headache severit y of most attacks was moderate, Weight gains experienced by patients w hile on pizotifen and sumatriptan were greater than the weight gains e xperienced while on placebo prophylaxis and sumatriptan or sumatriptan alone (period 1); study 1, 2.6 vs, 1.0 kg (p = 0.002); study 2, 1.6 v s, -0.8 kg (p < 0.0001), The combination of pizotifen and sumatriptan did not result in any additional adverse events other than those usual ly seen with each medication alone, In these studies, where the averag e number of migraine attacks was around 4 per month, the benefits conf erred by pizotifen were at the expense of the adverse events associate d with the drug, particularly weight gain. Therefore the clinical bene fit of treatment with pizotifen for patients who have less than 4 atta cks per month should be carefully reviewed as acute treatment with sum atriptan may be the most appropriate treatment. Pizotifen may be bette r reserved for those patients who have 4 of more attacks per month.