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1.
Standard vs. double dose of intravenous nicorandil in preventing contrast-induced nephropathy in patients with coronary heart disease undergoing elective coronary procedures.
Zeng, Z, Zhang, H, Zhang, P, Li, Y, Fu, N
Coronary artery disease. 2021;(3):256-257
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2.
Comparison of double-dose vs. usual dose of nicorandil for the prevention of contrast-induced nephropathy after cardiac catheterization.
Zeng, Z, Fu, X, Zhang, X, Fu, N
International urology and nephrology. 2019;(11):1999-2004
Abstract
PURPOSE Contrast-associated nephropathy (CIN), the third main reason of the acute kidney injury (AKI) in inpatients, is a potentially severe side effect of angiography and the preventive role of nicorandil on CIN is still controversal. The aim of this clinical trial was to evaluate the preventive role of different doses of nicorandil on CIN in patients experiencing cardiac catheterization compared with hydration. METHODS We recorded outcomes from 330 patients who were randomly divided to either a double-dose (30 mg/day) nicorandil group or to a usual-dose (15 mg/day) nicorandil group or a control group (hydration only). The primary endpoint of the current research was the occurrence of CIN, which is defined as a relative elevation of SCr level of 25% above the baseline or an absolute increment of SCr of more than 44.2 µmol/L (0.5 mg/dL) within 48 or 72 h after contrast medium exposure. Additional endpoints were the changes in BUN, SCr, Cys-C, eGFR, and CRP level within 48 h after contrast agent exposure and major adverse events occurring during hospitalization and 14 days of follow-up. RESULTS 6 out of 111 patients (5.4%) had contrast-induced nephropathy in the double-dose group and it occured 11 out of 107 patients (10.3%) in the usual-dose group, 16 out of 112 patients (14.3%) in the control group. There was a significant difference in the occurrence of CIN between the double-dose group and the control group at 48 h after taking the radiocontrast medium (p = 0.026) while no such significant difference observed in the usual-dose group and the control group (p = 0.367), the double-dose group and usual-dose group (p = 0.180) as well. CONCLUSIONS Daily peri-procedural usual-dose nicorandil could just relieve contrast-induced renal injury, only double-dose nicorandil was associated with a reduced incidence of CI-AKI compared with hydration.
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3.
Effects of Nicorandil Versus Nitroglycerin on Arterial Oxygenation During Two-Lung Ventilation and One-Lung Ventilation in Patients With Risk Factors for Myocardial Ischemia: A Prospective, Randomized, Double-Blind Study.
Murakami, C, Kawano, H, Kinoshita, M, Kondo, A, Inoue, M
Journal of cardiothoracic and vascular anesthesia. 2019;(3):702-709
Abstract
OBJECTIVES To compare the effects of nicorandil and nitroglycerin on arterial oxygenation during two-lung ventilation (TLV) and one-lung ventilation (OLV) in patients with risk factors for myocardial ischemia. DESIGN A prospective, randomized, double-blind study. SETTING A tertiary care hospital. PARTICIPANTS Fifty-six patients scheduled for elective video-assisted thoracic surgery were assigned randomly to either the nicorandil group or the nitroglycerin group. INTERVENTIONS Patients in the nicorandil group received a bolus dose of nicorandil, 0.08 mg/kg during induction of anesthesia, followed by a continuous infusion at a rate of 0.08 mg/kg/h. Patients in the nitroglycerin group received a continuous infusion of nitroglycerin at a rate of 1 µg/kg/min from the induction of anesthesia. MEASUREMENTS AND MAIN RESULTS Arterial blood gas analysis was performed at the following points: before induction of anesthesia; during TLV; at 5, 10, 20, and 30 minutes after the initiation of OLV. PaO2 at TLV (479.7 ± 57.1 v 408.2 ± 70.9 mmHg, p < 0.001); and at 5 minutes (344.8 ± 85.1 v 282.6 ± 85.8 mmHg, p = 0.012), 20 minutes (215.7 ± 103.0 v 158.2 ± 74.5 mmHg, p = 0.027), and 30 minutes (198.8 ± 103.5 v 147.5 ± 64.1 mmHg, p = 0.039) after OLV was significantly higher in the nicorandil group than in the nitroglycerin group. CONCLUSION This study demonstrated that oxygenation during TLV and OLV was significantly higher in patients receiving nicorandil than in those receiving nitroglycerin.
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4.
Additive value of nicorandil on ATP for further inducing hyperemia in patients with an intermediate coronary artery stenosis.
Kobayashi, Y, Okura, H, Neishi, Y, Higa, T, Kobayashi, Y, Uemura, S, Yoshida, K
Coronary artery disease. 2017;(2):104-109
Abstract
BACKGROUND The induction of hyperemia is of importance to precisely assess the functional significance of coronary artery lesions with fractional flow reserve (FFR). Adenosine or ATP alone is used widely in this setting; however, little is known about the additive value of nicorandil, which acts as a nitrate and a K-ATP channel opener, to induce further hyperemia. PATIENTS AND METHODS A total of 183 intermediate native coronary artery lesions from 112 patients were prospectively enrolled into this study. FFR was measured using a coronary pressure wire during an intravenous ATP infusion alone (150 mcg/kg/min) (FFRATP) and repeated after an adjunctive intracoronary nicorandil injection (2.0 mg) (FFRATP+Nico). RESULTS Physiologic measurements were completed without any severe adverse effects from ATP and nicorandil in all patients. FFRATP and FFRATP+Nico had a strong linear correlation (R=0.79, P<0.001). The FFR value became significantly lower with an adjunctive intracoronary nicorandil injection compared with ATP alone [FFRATP vs. FFRATP+Nico, 0.87 (interquartile range: 0.81-0.92) vs. 0.85 (0.79-0.90), P<0.001]. A total of 18 lesions out of 183 (9.8%) were reclassified after a nicorandil injection (12 from FFR>0.80 to ≤0.80 vs. six from FFR≤0.80 to >0.80, P=0.26). The adjunctive effect of nicorandil was accentuated with each increment of FFRATP strata (per 0.05 increase, P for trend<0.001), but with minimal effect around the borderline FFR zone. CONCLUSION An adjunctive intracoronary nicorandil injection is safe, but appears to have little effect in inducing further hyperemia. Therefore, its effect on the clinical scenario is limited.
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5.
Impacts of nicorandil on infarct myocardium in comparison with nitrate: assessed by cardiac magnetic resonance imaging.
Yamada, K, Isobe, S, Ishii, H, Yokouchi, K, Iwata, H, Sawada, K, Murohara, T
Heart and vessels. 2016;(9):1430-7
Abstract
In this pilot study, we compared the infarct and edema size in acute myocardial infarction (MI) patients treated by nicorandil with those treated by nitrate, using cardiac magnetic resonance (CMR) imaging. Fifty-two acute MI patients who underwent emergency percutaneous coronary intervention (PCI) were enrolled, and were assigned to receive nicorandil or nitrate at random just before reperfusion. For the assessment of infarct and edema areas, short-axis delayed enhancement (DE) and T2-weight (T2w) CMR images were acquired 6.1 ± 2.4 days after the onset of MI. A significant correlation was observed between the peak creatinine kinase (CK) level and the infarct size on DE CMR (r = 0.62, p < 0.05), as well as the edema size on T2w CMR (r = 0.70, p < 0.05) in patients treated by nicorandil (28 patients). A similar correlation was seen between the peak CK level and the infarct size on DE CMR (r = 0.84, p < 0.05), as well as the edema size on T2w CMR (r = 0.84, p < 0.05) in patients treated by nitrate (24 patients). The maximum CK level was significantly lower in patients treated by nicorandil rather than nitrate (1991 ± 1402, 2785 ± 2121 IU/L, respectively, p = 0.03). Both the edema size on T2w CMR and the infarct size on DE CMR were significantly smaller in patients treated by nicorandil rather than nitrate (17.7 ± 9.9, 21.9 ± 13.7 %; p = 0.03, 10.3 ± 6.0, 12.7 ± 6.9 %, p = 0.03, respectively). The presence and amount of microvascular obstruction were significantly smaller in patients treated by nicorandil rather than nitrate (39.2, 64.7 %; p = 0.03; 2.2 ± 1.3, 3.4 ± 1.5 cm(2); p = 0.02, respectively). Using CMR imaging, we demonstrated that the complementary use of intravenously and intracoronary administered nicorandil during PCI favorably acts more on the damaged myocardium after MI than nitrate. We need a further powered prospective study on the use of nicorandil.
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6.
RETRACTED: Nicorandil vs nifedipine for the treatment of preterm labour: a randomized clinical trial.
Rezk, M, Sayyed, T, Masood, A, Dawood, R
European journal of obstetrics, gynecology, and reproductive biology. 2015;:27-30
Abstract
This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy). This article has been retracted at the request of the Editor-in-Chief. The editors were alerted to the following concerning features of this trial: The submission date is impossible. Patients were recruited at 24 to 34 weeks (mean 31 w). 18% of participants delivered after 37 weeks. Average recruitment 26 per month. Recruitment ended September 2014 but the paper was received by journal on 23 October 2014. The second author, Sayyed T, is co-author of related retracted papers in BJOG. In view of these concerns we wrote to Dr Rezk who had no satisfactory explanation and declined to share the data. We have therefore decided to retract.
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7.
Nicorandil Versus Nitroglycerin for Symptomatic Relief of Angina in Patients With Slow Coronary Flow Phenomenon: A Randomized Clinical Trial.
Sani, HD, Eshraghi, A, Nezafati, MH, Vojdanparast, M, Shahri, B, Nezafati, P
Journal of cardiovascular pharmacology and therapeutics. 2015;(4):401-6
Abstract
OBJECTIVE Patients with the coronary slow flow phenomenon frequently experience angina episodes. The present study aimed to compare the efficacy of nicorandil versus nitroglycerin for alleviation of angina symptoms in slow flow patients. METHODS In a single-center, single-blind, parallel-design, comparator-controlled, randomized clinical trial (NCT02254252), 54 patients with slow flow and normal or near-normal coronary angiography who presented with frequent angina episodes were randomly assigned to 1-month treatment with nicorandil 10 mg, 2 times a day (n = 27) or sustained-release glyceryltrinitrate 6.4 mg 2 times a day (n =27). Frequency of angina episodes, pain intensity, and the Canadian Cardiovascular Society (CCS) grading of angina pectoris were assessed at baseline and after 1 month of treatment. RESULTS In all, 25 patients in the nicorandil arm and 24 patients in the nitroglycerin arm were analyzed. After 1 month, patients treated with nicorandil had fewer angina episodes (adjusted mean number of episodes per week, nicorandil versus nitroglycerin; 1.68 ± 0.15 vs 2.29 ± 0.15, P = .007, effect size = 14.6%). Patients also reported greater reductions in pain intensity with nicorandil versus nitroglycerin (adjusted mean of self-reported pain score; 3.03 ± 0.29 vs 3.89 ± 0.30, P = .046, effect size = 8.4%). A significantly higher proportion of patients in the nicorandil arm were categorized in CCS class I (76% vs 33.3%, P = .004) or class II (16.0% vs 45.8%, P = .032). CONCLUSION In slow flow patients, nicorandil provides better symptomatic relief of angina than nitroglycerin.
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8.
Differences in hemodynamic responses between intravenous carperitide and nicorandil in patients with acute heart failure syndromes.
Hattori, H, Minami, Y, Mizuno, M, Yumino, D, Hoshi, H, Arashi, H, Nuki, T, Sashida, Y, Higashitani, M, Serizawa, N, et al
Heart and vessels. 2013;(3):345-51
Abstract
While recent guidelines for the treatment of acute heart failure syndromes (AHFS) recommend pharmacotherapy with vasodilators in patients without excessively low blood pressure (BP), few reports have compared the relative efficiency of vasodilators on hemodynamics in AHFS patients. The present study aimed to assess the differences in hemodynamic responses between intravenous carperitide and nicorandil in patients with AHFS. Thirty-eight consecutive patients were assigned to receive 48-h continuous infusion of carperitide (n = 19; 0.0125-0.05 μg/kg/min) or nicorandil (n = 19; 0.05-0.2 mg/kg/h). Hemodynamic parameters were estimated at baseline, and 2, 24, and 48 h after drug administration using echocardiography. After 48 h of infusion, systolic BP was significantly more decreased in the carperitide group compared with that in the nicorandil group (22.1 ± 20.0 % vs 5.3 ± 10.4 %, P = 0.003). While both carperitide and nicorandil significantly improved hemodynamic parameters, improvement of estimated pulmonary capillary wedge pressure was greater in the carperitide group (38.2 ± 14.5 % vs 26.5 ± 18.3 %, P = 0.036), and improvement of estimated cardiac output was superior in the nicorandil group (52.1 ± 33.5 % vs 11.4 ± 36.9 %, P = 0.001). Urine output for 48 h was greater in the carperitide group, but not to a statistically significant degree (4203 ± 1542 vs 3627 ± 1074 ml, P = 0.189). Carperitide and nicorandil were differentially effective in improving hemodynamics in AHFS patients. This knowledge may enable physicians in emergency wards to treat and manage patients with AHFS more effectively and safely.
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9.
Beneficial effects of intracoronary nicorandil on microvascular dysfunction after primary percutaneous coronary intervention: demonstration of its superiority to nitroglycerin in a cross-over study.
Ito, N, Nanto, S, Doi, Y, Kurozumi, Y, Natsukawa, T, Shibata, H, Morita, M, Kawata, A, Tsuruoka, A, Sawano, H, et al
Cardiovascular drugs and therapy. 2013;(4):279-87
Abstract
PURPOSE In patients undergoing primary percutaneous coronary intervention (PCI) for the treatment of ST-segment elevation myocardial infarction (STEMI), coronary microvascular dysfunction is associated with poor prognosis. Coronary microvascular resistance is predominantly regulated by ATP-sensitive potassium (KATP) channels. The aim of this study was to clarify whether nicorandil, a hybrid KATP channel opener and nitric oxide donor, may be a good candidate for improving microvascular dysfunction even when administered after primary PCI. METHODS We compared the beneficial effects of nicorandil and nitroglycerin on microvascular function in 60 consecutive patients with STEMI. After primary PCI, all patients received single intracoronary administrations of nitroglycerin (250 μg) and nicorandil (2 mg) in a randomized order; 30 received nicorandil first, while the other 30 received nitroglycerin first. Microvascular dysfunction was evaluated with the index of microcirculatory resistance (IMR), defined as the distal coronary pressure multiplied by the hyperemic mean transit time. RESULTS As a first administration, nicorandil decreased IMR significantly more than did nitroglycerin (median [interquartile ranges]: 10.8[5.2-20.7] U vs. 2.1[1.0-6.0] U, p=0.0002).As a second administration, nicorandil further decreased IMR, while nitroglycerin did not (median [interquartile ranges]: 6.0[1.3-12.7] U vs. -1.4[-2.6 to 1.3] U, p<0.0001). The IMR after the second administration was significantly associated with myocardial blush grade, angiographic TIMI frame count after the procedure, and peak creatine kinase level. CONCLUSION Intracoronary nicorandil reduced microvascular dysfunction after primary PCI more effectively than did nitroglycerin in patients with STEMI, probably via its KATP channel-opening effect.
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10.
Cardioprotective effects of nicorandil in patients undergoing on-pump coronary artery bypass surgery.
Yamamoto, S, Yamada, T, Kotake, Y, Takeda, J
Journal of cardiothoracic and vascular anesthesia. 2008;(4):548-53
Abstract
OBJECTIVE The purpose of this study was to assess the cardioprotective effects of nicorandil in patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). DESIGN A prospective, double-blind, randomized clinical study. SETTING A university hospital. PARTICIPANTS Thirty-two patients undergoing elective CABG surgery. INTERVENTIONS Patients were randomized into 2 groups: the nicorandil and placebo groups. In the nicorandil group, intravenous nicorandil infusion was started after the induction of anesthesia by a loading dose of 0.1 mg/kg, followed by a continuous infusion of 0.1 mg/kg/h until 2 hours after CPB, then decreased to 0.05 mg/kg/h, and discontinued at the end of surgery. The placebo group received the same volume of saline. Arterial blood was sampled, and serum troponin T (TnT) and CK-MB were measured at the following 4 stages: after the induction of anesthesia (baseline), 2 hours after CPB, the first postoperative day (POD), and the third POD. MEASUREMENTS AND MAIN RESULTS TnT concentrations were similar at baseline and increased with a peak on the first POD in both groups. In the nicorandil group, TnT concentration returned to the baseline value at the third POD, and the time course of TnT showed significantly lower levels (p = 0.012). CK-MB concentrations were similar at baseline, increased and peaked at 2 hours after CPB, and returned to the baseline on the third POD in both groups. There were no significant differences between the groups with respect to the changes in CK-MB concentrations. CONCLUSIONS The nicorandil group showed lower concentrations of TnT, suggesting that intraoperative administration of nicorandil may provide a degree of myocardial protection in CABG surgery.