Nitroglycerin transdermal patches are designed to prevent angina episodes in coronary artery disease patients by delivering controlled doses of nitroglycerin through the skin. A key study on these patches was structured as a randomized, double-blind, placebo-controlled trial involving 291 acute myocardial infarction (AMI) survivors. Participants were divided into groups receiving either placebo or active patches with varying nitroglycerin doses (0.4, 0.8, or 1.6 mg/h). This design ensured rigorous evaluation of efficacy and safety while minimizing bias.
Key Points Explained:
1. Study Design: Randomized, Double-Blind, Placebo-Controlled
- Randomization: Patients were randomly assigned to treatment groups to eliminate selection bias and ensure comparable baseline characteristics.
- Double-Blind: Neither participants nor researchers knew who received the active nitro transdermal patch or placebo, reducing observer and participant bias.
- Placebo-Controlled: The placebo group provided a baseline to measure the true therapeutic effect of nitroglycerin patches.
2. Participant Profile
- The study enrolled 291 AMI survivors, a population at high risk for recurrent angina, making the findings clinically relevant for preventive therapy.
- Coronary artery disease patients were targeted, as nitroglycerin’s vasodilatory effects address their narrowed blood vessels and oxygen demand.
3. Dosage Variations
- Patches delivered 0.4, 0.8, or 1.6 mg/h of nitroglycerin, allowing researchers to:
- Compare dose-dependent efficacy.
- Identify optimal dosing for angina prevention while minimizing side effects (e.g., headaches or hypotension).
4. Outcome Measures
- Primary Endpoint: Likely angina episode frequency or time to first recurrence, though specific metrics weren’t detailed in the provided references.
- Safety Monitoring: Adverse effects (e.g., skin irritation or systemic hypotension) were tracked across dosage groups.
5. Clinical Implications
- The design ensured reliable data on whether nitroglycerin patches could reduce angina recurrence post-AMI.
- Findings would guide dosing recommendations for long-term prophylaxis in high-risk patients.
This structured approach highlights how robust trial design can validate the therapeutic role of transdermal nitroglycerin in managing chronic cardiovascular conditions.
Summary Table:
| Study Design Aspect | Details |
|---|---|
| Type of Study | Randomized, double-blind, placebo-controlled trial |
| Participants | 291 acute myocardial infarction (AMI) survivors |
| Treatment Groups | Placebo, 0.4 mg/h, 0.8 mg/h, and 1.6 mg/h nitroglycerin patches |
| Key Objectives | Evaluate efficacy and safety of nitroglycerin patches in preventing angina |
| Primary Endpoint | Likely angina episode frequency or time to first recurrence |
| Safety Monitoring | Tracked adverse effects like skin irritation and hypotension |
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