European Heart Journal Advance Access originally published online on September 21, 2005
European Heart Journal 2006 27(1):42-48; doi:10.1093/eurheartj/ehi495
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Effects of ranolazine on exercise tolerance and HbA1c in patients with chronic angina and diabetes
1Department of Cardiology, London Chest Hospital, Bonner Road, London E2 9JX, UK
2St Louis University Health Services Center, St Louis, MO, USA
3CV Therapeutics Inc., Palo Alto, CA, USA
Received 31 January 2005; revised 19 July 2005; accepted 19 August 2005; online publish-ahead-of-print 21 September 2005.
* Corresponding author. Tel: +44 20 8983 2413; fax: +44 20 8983 2290. E-mail address: timmis{at}1ch.demon.co.uk
See page 5 for the editorial comment on this article (doi:10.1093/eurheartj/ehi624)
Aims The anti-anginal efficacy and safety of ranolazine in diabetic and non-diabetic patients included in the Combination Assessment of Ranolazine In Stable Angina (CARISA) trial (JAMA 2004;291:309) were studied. Glycaemic control was also assessed in CARISA and its long-term open-label extension study.
Methods and results Patients with chronic angina enrolled in CARISA (189 with diabetes, 634 without diabetes) on background atenolol, diltiazem, or amlodipine therapy were randomized to placebo, ranolazine 750 or 1000 mg twice daily for 12 weeks, during which exercise tolerance, angina frequency, nitroglycerin usage, glucose, HbA1c, and lipids were measured. Patients completing the randomized study could enroll in an ongoing open-label extension study and were evaluated every 3 months. Ranolazine produced similar improvements in exercise parameters, nitroglycerin use, and angina frequency in diabetic and non-diabetic patients. Adverse events were similar between groups. Fasting glucose and lipids remained unaltered in diabetic patients after 12 weeks of therapy. In a post hoc analysis, ranolazine 750 and 1000 mg reduced HbA1c vs. placebo by 0.48±0.18% (P=0.008) and 0.70±0.18% (P=0.0002), respectively; the HbA1c levels appeared to remain unchanged over time during long-term therapy.
Conclusion Anti-anginal efficacy and safety of ranolazine for angina were similar between diabetic and non-diabetic patients. Ranolazine significantly improved glycaemic control in diabetic patients.
Key Words: Ranolazine • Diabetes • CARISA • Chronic stable angina • HbA1c
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