Effects of ranolazine on exercise tolerance and HbA1c in patients with chronic angina and diabetes.
OBJECTIVE
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.


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, HbA(1c), 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 HbA(1c) vs. placebo by 0.48+/-0.18% (P=0.008) and 0.70+/-0.18% (P=0.0002), respectively; the HbA(1c) levels appeared to remain unchanged over time during long-term therapy.


CONCLUSIONS
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.
Timmis
Adam D
AD
Department of Cardiology, London Chest Hospital, Bonner Road, London E2 9JX, UK. timmis@1ch.demon.co.uk
Chaitman
Bernard R
BR
Crager
Michael
M
D000083:Acetanilides; D000368:Aged; D000787:Angina Pectoris / Q000097:blood / Q000188:drug therapy*; D002908:Chronic Disease; D003925:Diabetic Angiopathies / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D017079:Exercise Tolerance; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008297:Male; D005996:Nitroglycerin / Q000627:therapeutic use; D010879:Piperazines / Q000627:therapeutic use*; D000069458:Ranolazine; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*
D000083:Acetanilides; D004791:Enzyme Inhibitors; D006442:Glycated Hemoglobin; D005996:Nitroglycerin; D010879:Piperazines; D000069458:Ranolazine; D014665:Vasodilator Agents