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Oral nicorandil reduces ischemic attacks in patients with stable angina: A prospective, multicenter, open-label,
Jie Jiang1, Yuntian Li2, Yingling Zhou3
1First Hospital Peking University, Beijing, China.
Insights
Oral nicorandil effectively reduced myocardial ischemia attacks in coronary heart disease patients with stable angina. This treatment was well-tolerated and showed no new safety concerns when added to standard care.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Medicine
Background:
- Coronary heart disease (CHD) with stable angina remains a significant clinical challenge.
- Exploring novel therapeutic strategies to improve antianginal treatment efficacy is crucial.
- Nicorandil, a potassium channel activator, is investigated for its potential benefits.
Purpose of the Study:
- To assess the efficacy and safety of oral nicorandil as an add-on therapy for patients with stable angina.
- To determine the impact of nicorandil on myocardial ischemia and other clinical parameters.
Main Methods:
- A randomized controlled trial involving 402 adult patients with stable angina.
- Patients received standard antianginal treatment, with one group additionally receiving nicorandil (5mg thrice daily) for 12 weeks.
- Primary endpoint: reduction in myocardial ischemia events measured by 24-hour Holter monitoring.
Main Results:
- Nicorandil significantly decreased the number of myocardial ischemia attacks (adjusted ratio 0.503, P=0.0086).
- No significant differences were observed in other Holter indicators, 6-minute walking test, or ECG parameters.
- Adverse events were reported in 11.7% of the nicorandil group versus 6.3% in the control group.
Conclusions:
- Oral nicorandil is effective in reducing ischemic attacks in stable angina patients when added to standard treatment.
- Nicorandil demonstrates a favorable safety profile with no new safety signals identified.
- This study supports nicorandil as a valuable therapeutic option for managing stable angina.
Objective:
To evaluate the efficacy and safety of oral nicorandil in coronary heart disease (CHD) patients with stable angina.
Method:
Eligible patients were randomized 1:1 to the nicorandil or control group. Current standard antianginal treatment was continued in both groups, while the patients in the nicorandil group received an additional 12-week treatment of nicorandil (5mg thrice daily). Primary endpoint was the number of myocardial ischemia measured by 24h Holter after 12-week treatment. Secondary endpoints included various 24h Holter indicators, angina occurrence, 6-min walking test (6MWT), ECG QT dispersion (QTd), safety and compliance.
Clinical Trial Registration:
NCT01396395.
Results:
A total of 402 adult patients with stable angina were enrolled. Two hundred patients were randomized to standard therapy plus nicorandil and 202 patients to standard therapy only. The baseline characteristics of the two groups were comparable. The number of myocardial ischemia attacks after treatment was significantly lower in the nicorandil group (LSMEANS 0.896) than the control group (LSMEANS 1.782), with an adjusted ratio of 0.503 (95% CI: 0.301, 0.840; P=0.0086). No significant differences in total myocardial ischemic burden, maximum ST-depression, longest duration of ST-depression, 6MWT, or heart rate variability were noted between the two groups. Twenty three (11.7%) of nicorandil group and 13 (6.3%) patients of control group reported at least one treatment emergent adverse event, respectively.
Conclusion:
Nicorandil significantly reduced the number of ischemic attacks when added to standard antianginal treatment in CHD patients with stable angina. It was well tolerated with no new safety signal identified.
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