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CLINICAL RESEARCH: CORONARY ARTERY DISEASE

Efficacy of Ranolazine in Patients With Chronic Angina

Observations From the Randomized, Double-Blind, Placebo-Controlled MERLIN–TIMI (Metabolic Efficiency With Ranolazine for Less Ischemia in Non–ST-Segment Elevation Acute Coronary Syndromes) 36 Trial

Sean R. Wilson, MD^_*, Benjamin M. Scirica, MD, MPH^_*,, Eugene Braunwald, MD^_*,, Sabina A. Murphy, MPH^_*, Ewa Karwatowska-Prokopczuk, MD, PhD, Jacqueline L. Buros, BA^_*, Bernard R. Chaitman, MD and David A. Morrow, MD, MPH^_*,,_*

^_* TIMI Study Group, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
CV Therapeutics, Palo Alto, California
Saint Louis University School of Medicine, St. Louis, Missouri

Manuscript received November 20, 2008; revised manuscript received January 9, 2009, accepted January 20, 2009.

^_* Reprint requests and correspondence: Dr. David A. Morrow, TIMI Study Group/Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, Massachusetts 02115 (Email: dmorrow{at}partners.org).

Objectives: We aimed to evaluate the efficacy and safety of ranolazine in a larger and more diverse group of patients with angina than previously studied.

Background: Ranolazine is an antianginal shown to reduce angina and improve exercise performance in selected patients with early-positive exercise testing and those with frequent angina.

Methods: We investigated the antianginal effects of ranolazine in the subgroup of patients with prior chronic angina (n = 3,565, 54%) enrolled in the randomized, double-blind, placebo-controlled MERLIN–TIMI (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) 36 trial of patients with acute coronary syndrome. Follow-up was a median of 350 days.

Results: Patients with prior angina received evidence-based therapy (95% aspirin, 78% statins, 89% beta-blockers, average 2.9 antianginal agents). The primary end point (cardiovascular death, myocardial infarction, recurrent ischemia) was less frequent with ranolazine (hazard ratio [HR]: 0.86; 95% confidence interval [CI]: 0.75 to 0.97; p = 0.017), due entirely to a significant reduction in recurrent ischemia (HR: 0.78; 95% CI: 0.67 to 0.91; p = 0.002). Ranolazine also reduced worsening angina (HR: 0.77; 95% CI: 0.59 to 1.00; p = 0.048) and intensification of antianginal therapy (HR: 0.77; 95% CI: 0.64 to 0.92, p = 0.005). Exercise duration at 8 months was greater with ranolazine (514 s vs. 482 s, p = 0.002). Cardiovascular death or myocardial infarction did not differ between treatment groups (HR: 0.97; 95% CI: 0.80 to 1.16; p = 0.71). Symptomatic documented arrhythmias (2.9% vs. 2.9%, p = 0.92) and total mortality (6.2% vs. 6.4%, p = 0.96) were similar with ranolazine or placebo.

Conclusions: In this largest study of ranolazine in patients with established coronary artery disease, ranolazine was effective in reducing angina with favorable safety in a substantially broader group of patients with angina than previously studied. (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes; NCT00099788)

Key Words: angina • exercise tolerance • ranolazine • recurrent ischemia

Abbreviations and Acronyms   ACS = acute coronary syndrome   CAD = coronary artery disease   CCSC = Canadian Cardiovascular Society classification   CI = confidence interval   ETT = exercise tolerance test   HR = hazard ratio   MI = myocardial infarction   PCI = percutaneous coronary intervention

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