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[Tolerance and effectiveness of transdermal nitroglycerin in angina pectoris. A multicenter study. Adesitrin Italian
A Strano1, C Luca, F Pamparana
1Dipartimento Medicina Interna, Università degli Studi Tor Vergata, Roma.
Insights
This study shows a new nitroglycerin transdermal system effectively reduced angina attacks by 88% and improved exercise tolerance in patients with coronary artery disease. The treatment was well-tolerated, with most side effects being mild and temporary.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Angina pectoris significantly impacts patient quality of life and requires effective management.
- Existing antianginal therapies may have limitations in efficacy or tolerability for some patients.
- Nitroglycerin is a cornerstone therapy for angina, with transdermal delivery offering sustained release.
Purpose of the Study:
- To evaluate the antianginal efficacy and tolerability of a novel nitroglycerin multilayer transdermal system.
- To assess the impact of the transdermal system on anginal attack frequency and exercise capacity.
- To determine the safety profile and patient acceptance of the new nitroglycerin delivery method.
Main Methods:
- A multicenter, open-label study involving 506 outpatients with inadequately controlled angina.
- Patients received 5 or 10 mg/day of the nitroglycerin transdermal system for 10 weeks.
- Efficacy was assessed by anginal attack frequency and ergometer testing; tolerability was monitored for adverse events.
Main Results:
- Weekly anginal attacks decreased by 88%; 60% of patients became angina-free.
- Ergometer test showed a 31% increase in exercise time and a 63% decrease in ST depression (p<0.001).
- Treatment discontinuation occurred in 9.1% of patients due to adverse effects (headache, local intolerance) or other reasons. Mild to moderate side effects were reported in 18.4%.
Conclusions:
- The nitroglycerin multilayer transdermal system demonstrates significant clinical and ergometer efficacy in managing angina.
- The system is well-tolerated and accepted by patients, with manageable side effects primarily occurring early in treatment.
- This novel transdermal delivery offers a promising therapeutic option for patients with chronic angina.
Abstract:
A multicenter open study was carried out in order to evaluate the tolerability and antianginal efficacy of the nitroglycerin "multilayer transdermal system". Forty eight cardiologic centers enrolled 506 outpatients (123 females and 383 males), mean age: 61 +/- 8 (SD) years, with effort angina (43%), angina at rest (17%) and mixed angina (40%), not well controlled by their previous antianginal therapy (greater than or equal to 2 anginal attacks a weeks). The duration of the treatment with 5 or 10 mg/die was 10 weeks with a control every 2 weeks. At the end of the study, the weekly frequency of anginal attacks was reduced by 88%, and 60% of the patients were free from anginal attacks. In 117 patients, studied by ergometer test, the exercise time increased by 31% (p less than 0.001) and the ST depression decreased by 63% (p less than 0.001). The treatment was interrupted in 9.1% of the patients: in 4.55% for unwanted effects (headache and/or local intolerance) and in 4.55% for other reasons. The same unwanted effects, but of mild or moderate severity, were observed in 18.4% of the patients, most of them during the first 2 weeks of the treatment. In conclusion, the "multilayer system" for delivering transdermal nitroglycerin showed a good clinical and ergometer efficacy and was well tolerated and accepted by the anginal patients in study.