Objective: To obtain data on local and systemic tolerability of three different doses (5 mg/24 h, 10 mg/24 h, and 15 mg/24 h) of a new model of nitroglycerin patch (Trinipatch, Sanofi-Synthelabo, S. A.) in patients with chronic stable angina.
Methods: A total of 954 patients were studied for a follow-up period of 12 weeks. Patients were distributed as follows: 132 to the 5 mg/24 h patch, 727 to the 10 mg/24 h patch, and 95 to the 15 mg/24 h patch. The local tolerability was evaluated by using the Draize scale and the systemic tolerability by recording the adverse reactions and assessing the effect on blood pressure. Furthermore, the efficiency of therapy was evaluated by means of the variations observed in the number and severity of angina crises, as well as the weekly use of sublingual nitroglycerine.
Results: Ninety-four patients (9.8%) showed signs of cutaneous irritation. Thirty-two patients (3.3%) showed erythema, and one patient (0.1%) showed erythema and induration. Thirty-nine patients (4.1%) had some type of systemic adverse reaction during the study. A total of 44 adverse reactions were recorded, headache being the most common (79.5%). Only one severe adverse reaction was observed (mild heart failure), which in the opinion of the researcher was not related to the medication. No dropouts were recorded on account of adverse reactions. The number of patients with angina crises and the number of weekly angina crises decreased significantly with therapy.
Conclusions: The transdermic nitroglycerin patch was demonstrated to be a safe and well tolerated therapy for chronic stable angina, both in terms of local and systemic tolerability. Moreover, its efficiency was demonstrated as the number of angina crises decreased significantly.