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2250364 
Technical Report 
Oral nitroglycerin as a prophylactic antianginal drug: clinical, physiologic, and statistical evidence of efficacy based on a three-phase experimental design 
Winsor, T; Berger, HJ 
1975 
IPA/77/238033 
Heart J 
REF 80 
611-626 
eng 
IPA COPYRIGHT: ASHP With the use of a 3-phase experimental design, the efficacy of oral controlled release nitroglycerin (Nitrong; I) was evaluated in a total of 53 patients with documented angina pectoris due to coronary artery disease. I, 2.6 mg tablets administered 3 times daily, and placebo were studied. Sixteen patients recorded a 6 month trial of randomly sequenced one month periods of drug or placebo. In 15 patients, ST segments were monitored with a Holter dynamic ECG for periods of 10 to 12 hr under normal life style and evaluated by matching activities during periods of drug and placebo. In 22 patients, a multistage treadmill exercise test was conducted to an endpoint of anginal pain. I reduced the incidence and severity of anginal attacks by 47.2 and 49.4%, respectively, and decreased the number of sublingual I tablets used by 51.1% in comparison to placebo (p |LT/ 0.001). Eleven of 16 patients decreased their need for sublingual I by over 50%. Based on a polynomial trend analysis over a period of 8 weeks, no tolerance to the therapeutic effects of the drug was found. The data demonstrate that I was absorbed from the GI tract in quantitites sufficient to provide statistically significant clinical improvement of angina pectoris.