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ERICA

ERICA. E fficacy of R anolazine I n C hronic A ngina trial. Background and hypothesis. Incidence of symptomatic angina in stable CAD patients remains high despite the use of conventional agents and/or revascularization

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ERICA

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  1. ERICA Efficacy of Ranolazine In Chronic Angina trial

  2. Background and hypothesis • Incidence of symptomatic angina in stable CAD patients remains high despite the use of conventional agents and/or revascularization • Traditional pharmacologic therapies determinants of MVO2(heart rate, myocardial contractility, wall stress) • Combinations of these therapies may provide incremental antianginal efficacy but may also produce side effects • Ranolazine is a new antianginal agent with a novel mechanism of action that does not significantly affect HR or wall stress Does ranolazine reduce angina in CAD patientsdespite treatment with the maximum dose of a conventional antianginal agent (amlodipine)? MVO2 = Myocardial oxygen consumption Stone PH et al. J Am Coll Cardiol. 2006;48:566-75.

  3. ERICA: Study design Evaluation of Ranolazine In Chronic Angina History of CAD* Stable angina (≥3 angina episodes/week)Amlodipine 10 mg/dayN = 565 Ranolazine extended-release 500 mg bid (1 week) then 1000 mg bidn = 281 Placebon = 284 RandomizedDouble-blind 7 weeks Primary efficacy variable:Angina frequency (weekly average) *≥60% stenosis, previous MI, and/or stress-induced perfusion defect Stone PH et al. J Am Coll Cardiol. 2006;48:566-75.

  4. ERICA: Concomitant medications N = 564 on amlodipine 10 mg/day *All other antianginals were proscribed Stone PH et al. J Am Coll Cardiol. 2006;48:566-75.

  5. ERICA: Ranolazine reduces angina frequency and nitrate consumption N = 564 on amlodipine 10 mg/day 6 5 P = 0.028 4 Mean number per week P = 0.014 3 2 1 0 Baseline Week 7 Baseline Week 7 Angina episodes Nitroglycerin use Placebo Ranolazine 1000 mg bid Stone PH et al. J Am Coll Cardiol. 2006;48:566-75.

  6. ERICA: Consistent treatment effect regardless of gender, age, and concomitant long-acting nitrates N = 564 on amlodipine 10 mg/day; week 7 4 3.5 3 Meanangina episodes per week 2.5 2 1.5 1 0.5 0 Women Men <65 years ≥65 years LAN use No LAN Placebo Ranolazine 1000 mg bid LAN = long-acting nitrates Stone PH et al. J Am Coll Cardiol. 2006;48:566-75.

  7. ERICA subgroup analyses: Frequency of angina N = 564 on amlodipine 10 mg/day Angina episodes per week >4.5 ≤4.5 >4.5 ≤4.5 6 P= 0.029 30 P= 0.57 5 P< 0.001 P< 0.001 4 20 Number/week SAQ score( baseline) 3 P= 0.036 P= 0.28 2 10 1 0 0 Angina frequency NTG use Angina frequency NTG use Seattle Angina Questionnaire(angina frequency domain) Placebo Ranolazine 1000 mg bid Stone PH et al. J Am Coll Cardiol. 2006;48:566-75.

  8. ERICA: No significant effect on heart rate or BP N = 564 on amlodipine 10 mg/day; Supine measurement Stone PH et al. J Am Coll Cardiol. 2006;48:566-75.

  9. ERICA: Safety and tolerability N = 564 on amlodipine 10 mg/day Stone PH et al. J Am Coll Cardiol. 2006;48:566-75.

  10. ERICA: Summary • Added to maximum-dose amlodipine, ranolazine extended-release 1000 mg bid for 6 weeks significantly reduced angina frequency and nitroglycerin use • Treatment effect appeared to be greater in patients with >4.5 angina episodes weekly • No significant change in HR or BP; no cases of torsades de pointes reported • Low withdrawal rate due to adverse events in both groups • 1.1% ranolazine • 1.4% placebo Stone PH et al. J Am Coll Cardiol. 2006;48:566-75.

  11. Implications • ERICA efficacy parameters are in agreement with previous studies using antianginal agents • SAQ* provides an appealing feature to assess disease-specific measures of quality of life • Because ranolazine can prolong QTc, the daily dose should not exceed 1000 mg/day; use should be limited to patients unresponsive to other antianginal agents Ranolazine provides additional, well-tolerated antianginal efficacy in patients who remain symptomatic despite maximal CCB therapy Cairns JA. J Am Coll Cardiol. 2006;48:576-8. Stone PH et al. J Am Coll Cardiol. 2006;48:566-75. *Seattle Angina Questionnaire

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