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Pregabalin effectiveness and tolerability in the prophylactic treatment of chronic migraine

Objectives To evaluate the effectiveness and tolerability of pregabalin in the prophylaxis of chronic migraine. Methods 17 patients (11 women, 6 men), 25 to 69 years, diagnosed of chronic migraine according to IHS criteria, and most of them (88%) refractory to previous prophylactic drug therapies, received pregabalin during 12 weeks in a starting dose of 75 mg/day subsequently adjusted according to patients' clinical response. The main outcome measure was the decrease in attacks' frequency. Secondary outcome measures included changes in attacks' severity and in the Headache Impact Test (HIT-6) score. Emergent adverse reactions to drug were recorded. Results Pregabalin final dose ranged from 150 to 450 mg/day (303 ± 118). Monthly attacks = frequency decreased from 22.5 ± 5.8 to 18.5 ± 9.9 (P < 0.0001; Effect Size [ES]:0.69). The frequency of attacks of severe intensity decreased from 7.8 ± 6.3 to 4.6 ± 6.0 (P = 0.0042; ES:0.51) without relevant changes in the frequency of moderate and mild intensity attacks. HIT-6 scores decreased from 64.4 ± 5.8 to 55.5 ± 11.7 (P = 0.0002; ES:1,53). Eight cases of pregabalin-associated adverse reactions were reported: four cases of dizziness and four of sedation. Two patients withdraw the study due to side effects. Conclusions Pregabalin was effective and well tolerated in this sample of predominantly refractory chronic migraine, reducing markedly both the frequency and severity of attacks, and decreasing significantly the impact of their disease on daily activities. Controlled studies evaluating the efficacy of this drug in migraine prophylaxis seem warranted.