Comparative efficacy and safety of calcium carbasalate plus metoclopramideversus ergotamine tartrate plus caffeine in the treatment of acute migraine attacks

This randomized, double-blind, double-dummy, multicenter, parallel-group st udy aimed at comparing the efficacy and safety of calcium carbasalate (equi valent to 900 mg aspirin) plus metoclopramide 10 mg (CM) with ergotamine ta rtrate 1 mg plus caffeine 100 mg (EC) administered in the treatment of 2 ac ute migraine attacks. A total of 296 patients fulfilling the International Headache Society diagnostic criteria for migraine were enrolled. In total, one or two migraine attacks were treated in 268 and 235 patients, respectiv ely. The primary endpoint for the first treated attack was headache relief, with intensity decreasing from moderate or severe to mild or absent 2 h af ter drug intake. Usual secondary efficacy endpoints were assessed. A superi ority of CM over EC was observed for both treated attacks for the main endp oint: success in 54 versus 36%, p = 0.003 for the first attack and 60 versu s 44%, p = 0.02 for the second attack. CM was also significantly superior t o EC during the first attack for complete headache relief (20 vs. 8%, p = 0 .006), nausea (42 vs. 63%, p = 0.007) and willingness to take the drug agai n (90 vs. 80%, p = 0.043). The global efficacy evaluation, rated by the inv estigators, was significantly more favorable to CM for both attacks (p = 0. 001 for the first attack and p = 0.02 for the second). The patients' evalua tion was significant for the first attack (p = 0.002), The global incidence of adverse events was 45% higher with EC, though not significant (32 vs, 2 2%, p = 0.075). They were most often unspecific and mild to moderate in int ensity. Gastrointestinal side effects were significantly less frequent with CM than EC (7 vs. 21%, p = 0.001). Thus, CM is more effective and has a be tter gastrointestinal safety than EC in the acute treatment of migraine att acks.