Ranolazine After Incomplete Percutaneous Coronary Revascularization in Patients With Versus Without Diabetes Mellitus

Abstract

BACKGROUND Chronic angina is more common in diabetes mellitus (DM) patients with poor glucose control. Ranolazine both treats chronic angina and improves glucose control. OBJECTIVES This study sought to examine ranolazine’s antianginal effect in relation to glucose control. METHODS We performed a secondary analysis of RIVER-PCI, a clinical trial in which 2,604 patients with chronic angina and incomplete revascularization following percutaneous coronary intervention (PCI) were randomized to ranolazine versus placebo. Mixed-effects models were used to compare the effects of ranolazine versus placebo on hemoglobin A1c (HbA1c) at 6 and 12 months of follow-up. Interaction between baseline HbA1c and ranolazine’s effect on Seattle Angina Questionnaire (SAQ) angina frequency at 6 and 12 months was tested. RESULTS Overall, 961 (36.9%) had DM at baseline. Compared with placebo, ranolazine significantly decreased HbA1c by 0.42±0.08% (adjusted mean difference ± standard error) and 0.44±0.08% from baseline to 6 and 12 months, respectively, in DM patients, and by 0.19±0.02% and 0.20±0.02% at 6 and 12 months, respectively, in non-DM patients. Compared with placebo, ranolazine significantly reduced SAQ angina frequency at 6 months among DM patients, but not at 12 months. The reductions in angina frequency were numerically greater among patients with baseline HbA1c ≥7.5% than those with HbA1c <7.5% (interaction p=0.07). CONCLUSIONS In patients with DM and chronic angina with incomplete revascularization after PCI, ranolazine’s effect on glucose control and angina at 6 months was proportionate to baseline HbA1C, but the effect on angina dissipated by 12 months.

Efficacy and Safety of Ranolazine in Diabetic Patients: A Systematic Review and Meta-analysis

“…As primary efficacy outcome, change in A1C level from baseline was reported in 6 studies. [14][15][16][17]28,29 Compared with the placebo group, the combined results indicated that ranolazine significantly reduced the A1C level in patients with diabetes (WMD = −0.49%; 95% CI = −0.58 to −0.40; P < 0.00001; I 2 = 0%). In the subgroup analysis, the 2 predefined characteristics for stratifying the included studies had the same grouped result.…”

“…However, selection bias was unclear in 3 trials, 16,17,29 and detection bias was classified as unclear in 2 trials 17,29 because of absence of detailed information. Overall, 1 trial 29 had a high risk of bias, 4 trials 14,15,28,30 had a low risk of bias, and the others 16,17 had an unclear risk of bias. No clinically significant cardiovascular events, including myocardial infarction, acute coronary syndrome, recent revascularization (including coronary artery bypass graft procedures or percutaneous coronary intervention), transient ischemic attack, or ischemic stroke ≤3 months prior to screening.…”

Glyco-metabolic Effects of Ranolazine: A truly Multifaceted Drug?

“…Interestingly, R reduced the incidence of new fasting glucose >110 mg/dl in patients without T2DM at baseline compared to placebo (31.8% versus 41.2%; p = 0.003). In a secondary analysis of RIVER-PCI trial, Faranoff et al [22] reported the efficacy of R in lowering HbA1c especially in patients with poor glucose control and that this efficacy was greater at 6 months than at 12 months.…”

Therapy of Stable Angina of Effort by Triple Combinations of Antianginal Drugs in Geriatric Practice

“…По данным субанализа этого исследования, у пациентов с сахарным диабетом (n = 961) ранолазин снижал уровень гемоглоби-на А1с, но не уменьшал тяжесть стенокардии через 12 мес. терапии [29]. Ранее X. Xu et al применяли триметазидин после ЧКВ у больных с сочетанием многососудистой ИБС и сахарного диабета [30].…”