Efficacy and tolerability of pregabalin versus topiramate in the prophylaxis of chronic daily headache with analgesic overuse: an open-label prospective study.

OBJECTIVES: Medication-overuse headache is one of the most disabling headaches. Antiepileptic drugs have been considered a promising strategy as prophylactic treatment in these patients, even if their use often has been limited by low tolerability or safety. The objective of this study was to evaluate the efficacy and safety of pregabalin compared with topiramate for the prophylaxis of chronic daily headache with medication overuse using an open-label prospective study.

METHODS: After a 2-month baseline period (T0), 100 consecutive patients with medication overuse headache were assigned to receive 150 mg/d pregabalin or 100 mg/d topiramate. After a titration period of 4 weeks, a follow-up visit was scheduled every 2 months (T1 and T2) to evaluate headache frequency, the amount of rescue medication intake, and disability.

RESULTS: Of the 46 pregabalin-treated patients, the mean monthly headache frequency significantly decreased from 21.8 ± 4.8 (T0) to 5.1 ± 3.8 (T2), and the monthly number of days with medication intake decreased from 15.1 ± 4.8 (T0) to 2.9 ± 1.9 (T2). Similarly, of the 42 topiramate-treated patients, the mean monthly headache frequency decreased from 21.8 ± 4.9 (T0) to 5.3 ± 3.5 (T2), and the mean monthly number of days with medication intake decreased from 15.1 ± 3.7 (T0) to 2.6 ± 1.5 (T2). A significant improvement of disability score was reported in both groups.

CONCLUSIONS: Similar to topiramate, pregabalin seems to be an effective and well-tolerated preventive therapy in chronic headache and a new option in the management of withdrawal from abused drugs in patients with analgesic overuse, a difficult-to-treat population.