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SYNOPSIS This 34‐week, placebo‐controlled, single crossover study with a double‐blind randomized treatment sequence evaluated the effects of propranolol as a prophylactic agent in individualized doses ranging from 60–320 mg/day given to 62 patients who had common and/or classic migraine. Variables reflecting efficacy were the frequency, severity, and persistency of acute migraine attacks expressed as Headache Unit Index (HUI) and the therapeutic medication required for acute attacks during the study expressed as the Relief Medication Unit Index (RMUI). Both HUI and RMUI were significantly reduced from baseline after the six weeks of propranolol titration (p<0.0001) reflecting fewer and/or less severe headaches. During the crossover treatment periods, propranolol, in comparison with placebo, was significantly more effective in the reduction of HUI (p<0.01) and RMUI (p<0.05). Data at the end of the dose finding (titration) period were analyzed separately for patients whose final prescribed doses were 60‐240 mg or 320 mg/day propranolol. Significant reductions in HUI and RMUI (p< 0.0001) were shown at this time at each dose level. At all dose levels, propranolol was well tolerated. This was the first study in which the propranolol dose for migraine extended above the usual recommended 240 mg/day, i.e., up to 320 mg/day. This higher dose was administered if the drug had been well tolerated, even if only one headache in 2 weeks occurred at lower doses. The data suggest that there is an option to prescribe propranolol at higher doses as a preventive measure, thus reducing the need for ancillary medications.

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The safety and efficacy of using continuous high-dose transcutaneous nitroglycerin in doses up to 100 mg/24 hours in chronic stable angina was assessed in 20 patients using serial treadmill testing. Patients had first to show a response to sublingual nitroglycerin with a 20% improvement in exercise time. All patients were then titrated with 20 mg (40 cm2), 60 mg (120 cm2), 80 mg (160 cm2) or 100 mg (200 cm2) patches, until intolerable headache in association with a 10 mmHg reduction in blood pressure and a ten-beat increment in heart rate. Drug was then discontinued for 2 days and patients underwent three repeat stress tests to reestablish a consistent drug-free baseline. Patients were then randomized in double-blind fashion to receive either active patch (N = 11) in previous titration dose or placebo patch (N = 9), with treadmill tests performed at 0 (1 hour after previous patch removal), 4, and 24 hours after patch application at baseline and at weeks 1 and 2. Venous blood was obtained for measurement of plasma nitroglycerin levels. After the first 24 hours of active patch therapy, there was a significant reduction in systolic blood pressure (P = .05), a significant increase in heart rate (P = .01), and a minor increase in exercise tolerance (P = .06) compared to placebo. At weeks 1 and 2, there was an attenuation of drug effect in all of these parameters. Plasma nitroglycerin levels demonstrated consistently high plasma levels over each 24-hour dosing interval, on day 1, week 1, and week 2.(ABSTRACT TRUNCATED AT 250 WORDS)