A multicenter randomized double-blind study was conducted on 140 patients with classic and/or common migraine who received either nadolol (80 mg or 160 mg OD) or propranolol (80 mg bid). Admission into the 12-week active treatment period required at least 3 attacks per month during a placebo lead-in period. Abortive headache therapy was allowed at the patients' discretion, each keeping a diary of migraine attacks and use of medications. Clinical assessments were performed monthly.
Data from 42 patients were excluded from the evaluation of efficacy, mainly because of non-adherence to protocol requirements. Drug efficacy evaluation in the remaining 98 patients was based on 4 separate migraine indices: frequency of attacks, intensity of attacks, days of pain, and need for relief medication, with success being defined as a reduction in an index of at least 50% relative to baseline. A successful response in at least I index was found in 48% of patients on nadolol 80 mg (p=NS vs propranolol 160 mg) and in 69% of the patients on nadolol 160 mg compared with 54% on propranolol 160 mg (p<0.05). Success in all 4 indices was found in 21% of patients on nadolol 80 mg (p=NS vs propranolol 160 mg) and in 41% of patients on 160 mg nadolol as compared to 15% on propranolol 160 mg (p<0.05).
Adverse reactions required discontinuation from therapy in 2 of 48 patients on nadolol 80 mg (4.1%), 2 of 47 patients on nadolol 160 mg (4.3%), and 4 of 44 patients on propranolol 160 mg (9.1%).
This study indicates that, in the prophylaxis of migraine, 80 mg of nadolol administered once daily is equivalent in efficacy and safety to propranolol 80 mg administered twice daily. Furthermore, nadolol given as a single daily dose of 160 mg is superior to an equal total daily dose of propranolol administered twice daily.