Study of the general and topical tolerance of Trinipatch and its clinical efficacy in the therapy of chronic stable angina in 5078 coronary disease patients
Durand, E.; Blanchet, H.; De la Garoullaye, A.
Annales de Cardiologie et d'Angeiologie 47(10): 757-765
1998
ISSN/ISBN: 0003-3928 PMID: 9922856 Document Number: 496095
Nitrates still play an important role in the treatment of coronary heart disease after more than hundred years of use in this indication. Following oral administration, they undergo intense gastric hydrolysis, and are largery destroyed by the first-pass effect. The development of an attenuation phenomenon of the therapeutic effect has been frequently reported during continuous treatments at fixed doses. Percutaneous administration of nitroglycerin due to the development of transdermal devices palliates these various obstacles. Trinipatch is a small, transparent, matricial, monolayer patch with an absorption promoter, marketed in two dose-strengths (5 mg/24 h and 10 mg/24 h) by Laboratoires Synthelabo. Its systemic and local safety and clinical efficacy were studied by 383 private cardiologists and 2,294 general practitioners in 5,079 coronary patients, between the ages of 19 and 91 years, in two open, multicentre trials lasting 3 months. The systemic safety, assessed by adverse event reporting, was good. 2.7% of patients experienced adverse events, but only 0.3% of patients presented a serious adverse event. The effects most frequently encountered were vasodilator effects. A very good stability of cardiovascular parameters was observed, with no reflex tachycardia. The local safety, evaluated by the Draize scale, was also satisfactory; after 1 month and 3 months of treatment, 6.6% and 5.7% of patients presented erythema, usually isolated and moderate. The clinical efficacy was evaluated by subjective criteria in the 740 patients included by cardiologists. A significant reduction of the number of angina attacks and the numbers of doses of nitroglycerin was observed. The percentage of pain-free patients increased from 18.2% at the start of the study to 76% at the end of the trial. These two trials confirmed the good systemic and local safety and clinical efficacy of Trinipatch.