Key result
Nicorandil boosts angina symptom improvement ~24% in cardiac syndrome X.
Why the study?
The pathophysiological mechanism of cardiac syndrome X is limited and current treatments fail to satisfactorily suppress symptoms, necessitating evaluation of nicorandil's clinical effects and safety.
Does nicorandil improve angina symptoms and endothelial function in patients with cardiac syndrome X?
Meta-Analysis (n=2,323)
Does nicorandil improve angina symptoms and endothelial function in patients with cardiac syndrome X?
Relative Risk: 1.24 (95% CI 1.19–1.29)
p-value: p=< .00001
Nicorandil may improve angina symptoms and endothelial dysfunction in patients with cardiac syndrome X, though the evidence quality is very low.
May support nicorandil for angina relief in cardiac syndrome X; leaves open confirmation in rigorous trials given very low evidence quality.
BACKGROUND: The prevalence of cardiac syndrome X (CSX) is considerable. Some patients show recurrent angina attacks and have a poor prognosis. However, the knowledge of CSX pathophysiological mechanism is still limited, and the treatment fails to achieve a satisfactory suppression of symptoms. Nicorandil has a beneficial effect on improving coronary microvascular dysfunction (CMD). This study aims to evaluate the clinical effects and safety of nicorandil on CSX patients. METHODS: The Cochrane Library, Pubmed, EMBASE, ClinicalTrials.gov and 4 Chinese databases were searched to identify relevant studies. The Cochrane "Risk of bias" tool was used to assess the methodological quality of eligible studies. Meta-analysis was performed by RevMan 5.3 software. The Eggers test and meta-regression were performed by software Stata 14.0. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: Twenty four randomized controlled trials (RCTs) involving 2323 patients were included. Most of the included studies were classified as having an unclear risk of bias because of poor reported methodology. The main outcomes are angina symptoms improvement, resting electrocardiogram (ECG) improvement, treadmill test result, and endothelial function. Meta-analysis showed that nicorandil had some benefit on improving angina symptoms (RR 1.24, 95% CI 1.19 to 1.29, I = 20%, P < .00001), resting ECG (RR = 1.24, 95% IC: 1.15 to 1.33, I = 0%, P < .00001), and prolonged the time to 1 mm ST-segment depression in treadmill test result (WMD = 38.41, 95% IC: 18.46 to 58.36, I = 0%, P = .0002). Besides nicorandil could reduce the level of endothelin-1 (ET-1) (SMD = -2.22, 95% IC: -2.61 to -1.83, I = 77%, P < .00001) and increase the level of nitric oxide (NO) (WMD = 27.45, 95% IC: 125.65 to 29.24, I = 81%, P < .00001). No serious adverse drug event was reported. The Eggers test showed that significant statistical publication bias was detected (Eggers test P = .000). The quality of evidence ranged from very low to low. CONCLUSIONS: Nicorandil shows the potential of improving angina symptoms, ECG, and endothelial dysfunction in patients with CSX. However, there is insufficient evidence for the clinical benefits of nicorandil due to the very low-quality evidence.
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Jia et al. (2020) conducted a meta-analysis in cardiac syndrome X (n=2,323). Nicorandil vs. Control was evaluated on angina symptoms improvement (RR 1.24, 95% CI 1.19 to 1.29, p=< .00001). Nicorandil significantly improved angina symptoms in patients with cardiac syndrome X (RR 1.24; 95% CI 1.19 to 1.29; P < 0.00001), though the quality of evidence was very low.
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