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The ERICA Trial

The Efficacy of Ranolazine in Chronic Angina Trial. The ERICA Trial. Peter H. Stone, MD, FACC, Nikolay A. Gratsiansky, MD, Alexey Blokhin, MD, I-Zu Huang, MD, Lixin Meng, MS, MPH, for the ERICA Investigators Journal of The American College of Cardiology. ERICA Trial: Background.

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The ERICA Trial

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  1. The Efficacy of Ranolazine in Chronic Angina Trial The ERICA Trial Peter H. Stone, MD, FACC, Nikolay A. Gratsiansky, MD, Alexey Blokhin, MD, I-Zu Huang, MD, Lixin Meng, MS, MPH, for the ERICA Investigators Journal of The American College of Cardiology

  2. ERICA Trial: Background • Ranolazine is a unique antianginal agent that has been effective in stable angina, but it has not been studied in the setting of maximum recommended doses of conventional antianginal agents. • The purpose of this study was to determine if ranolazine improves angina in stable coronary patients with persisting symptoms despite maximum recommended dose of amlodipine. JACC Vol. 48 No. 3, 2006

  3. ERICA Trial: Study Design 565 patients, age ≥18 years, documented history of CAD, chronic stable angina ≥3 months, and ≥ 3 episodes of angina per week during a ≥ 2-week qualification period despite treatment with 10 mg/day amlodipine. Placebo Controlled. Randomized. Blinded 27% Female, Mean age 62 years, Mean follow up 6 weeks 10mg/d AmlodipineandPlacebo twice a day for 6 weeks n=284 10 mg/d Amlodipine and 1,000 mg Ranolazine twice a day for 6 weeks n=281 • Primary Endpoint: Weekly average frequency of self-reported angina episodes during the 6-week treatment phase • Secondary Endpoint: Weekly average nitroglycerin consumption during the 6-week treatment phase; change from baseline of the 5 dimensions of the Seattle Angina Questionnaire (SAQ) JACC Vol. 48 No. 3, 2006

  4. ERICA Trial: Primary Endpoint Primary Endpoint of Mean Anginal Attacks per week p=0.028 • At 6 weeks follow-up, the mean number of anginal attacks/week was lower in the ranolazine group compared with the placebo group (2.88 vs 3.31, p=0.028). JACC Vol. 48 No. 3, 2006

  5. ERICA Trial: Secondary Endpoint Average weekly nitroglycerin consumption p=0.014 • The average weekly nitroglycerin consumption was lower in the ranolazine group (2.03 vs 2.68, p=0.014). JACC Vol. 48 No. 3, 2006

  6. ERICA Trial: SAQ Angina Frequency Frequency of SAQ Angina p=0.008 • SAQ angina frequency was significantly improved in the ranolazine group vs placebo (18.5 vs 22.5, p=0.008) but there was no difference in the other SAQ components. JACC Vol. 48 No. 3, 2006

  7. ERICA Trial: Adverse Events Frequency of Adverse Events • The frequency of adverse events was similar between groups (39.9% for ranolazine and 35.3% for placebo), with constipation the most frequently reported AE (8.9% for ranolazine and 1.8% for placebo). JACC Vol. 48 No. 3, 2006

  8. ERICA Trial: Summary • Among patients with stable chronic angina already treated with the maximal dose of amlodipine, the addition of ranolazine was associated with a reduction in the average frequency of weekly anginal episodes at 6 weeks compared with placebo. • Prior studies have demonstrated improvements in exercise tolerance with ranolazine alone or with standard doses of anginal medications, but the present trial extends these findings to patients with persistent angina despite maximal dosing of amlodipine. • Results were consistent in the subgroups shown, including those on long-acting nitrates and by degree of angina symptoms at baseline. JACC Vol. 48 No. 3, 2006

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