Preventive Effect of Pretreatment with Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Angiography (PRINCIPLE Study)

PURPOSE: To investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy (CIN) in patients with renal dysfunction undergoing coronary angiography. MATERIALS AND METHODS: This randomized controlled multicenter study enrolled a total of 166 patients (nicorandil n=81; control n=85) with an estimated glomerular filtration rate 0.5 mg/dL increase or >25% rise in serum creatinine (SCr) concentration within 48 hours of contrast exposure compared to baseline. RESULTS: The final analysis included 149 patients (nicorandil n=73; control n=76). The baseline characteristics and the total volume of the used contrast (Iodixanol, 125.6+/-69.1 mL vs. 126.9+/-74.6 mL, p=0.916) were similar between the two groups. The incidence of CIN also did not differ between the nicorandil and control groups (6.8% vs. 6.6%, p=0.794). There was no difference between the two groups in the relative change in SCr from baseline to peak level within 48 hours after coronary angiography (-1.58+/-24.07% vs. 0.96+/-17.49%, p=0.464), although the nicorandil group showed less absolute change in SCr than the control group (-0.01+/-0.43 mg/mL vs. 0.02+/-0.31 mg/mL, p=0.005). CONCLUSION: Prophylactic intravenous infusion of nicorandil did not decrease the incidence of CIN in patients with renal dysfunction undergoing coronary angiography.

Acute hemodynamic effects of nicorandil in patients with primary pulmonary arterial hypertension.

BACKGROUND: Pulmonary arterial hypertension is managed with vasodilators, and till date no specific drug has been identified with sufficient degree of success. Potassium channels have been implicated in the pathogenesis of primary pulmonary arterial hypertension. We undertook this study to assess the acute effect of oral nicorandil in patients of pulmonary arterial hypertension. METHODS AND RESULTS: We studied acute hemodymanic response of 40 mg oral nicorandil in 10 patients with primary pulmonary arterial hypertension aged between 15 and 39 years (mean age 27.2 +/- 6.7 years). Responders (Group I) were defined as those with > or =20% reduction of pulmonary vascular resistance index and no change or increase in cardiac index; and non-responders (Group II) were those with < 20% reduction of pulmonary vascular resistance index. There were 7 responders (pulmonary vascular resistance index decreased from 22.8 +/- 9.3 to 17.9 +/- 6.5 Wood units) and 2 non-responders (pulmonary vascular resistance index decreased from 26 +/- 3.5 to 25 +/- 1.0 Wood units). The maximum reduction in pulmonary vascular resistance index from baseline was 29.77 +/- 6.53% (23.7-40.5%) in responders and 7.3 +/- 4.2% (4.3-10.3%) in non-responders. The study was halted prematurely in one patient who developed hypotension, requiring intravenous inotropes. CONCLUSIONS: Our results suggest that nicorandil significantly decreases pulmonary artery pressure in primary pulmonary arterial hypertension acutely and can be cautiously tried for the therapeutic use in primary pulmonary arterial hypertension. Further studies are warranted.