| pathology | Demonstrated benefit and harm | k | | | |
|---|
| acute coronary syndrome | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| MERLIN TIMI 36, 2007 | ranolazine vs placebo | Recurrent ischemia 0.87 [0.77; 0.98] | | Death from any cause 0.98 [0.80; 1.20] cardiovascular death 0.99 [0.80; 1.24] MI 0.97 [0.82; 1.16] |
| Trial | Treatments | Patients | Method |
|---|
| MERLIN TIMI 36, 2007 | ranolazine 1000 mg twice daily for the duration of the trial (intitialy 200 mg intravenously for 1 hour, followed by an 80 mg/h intravenous infusion) (n=3279) vs. placebo (n=3281) | Hospitalized with NSTE-ACS; ischemic symptoms at rest within 48 hours; and at least one indicator of moderate to high risk, defined as elevated troponin or creatine kinase-myocardial band, ST-depression >0.1 mV, diabetes, or TIMI risk score for unstable angina/NSTEMI >=3 | Double blind Parallel groups Sample size: 3279/3281 Primary endpoint: CV death, MI, or recurrent ischemia FU duration: median 11.4 months |
|
| coronary artery disease | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ERICA, 2006 | ranolazine 1000mg + amlodipine vs placebo + amlodipine | | | | | MARIZA, 2004 | ranolazine 1000mg vs placebo | | | | | RAN080, 2005 | ranolazine 1000mg vs placebo | | | | | CARISA 1000mg, 2004 | ranolazine 1000mg vs placebo (on top standard treatment) | | | Death from any cause 0.33 [0.03; 3.12] |
| Trial | Treatments | Patients | Method |
|---|
| ERICA, 2006 | ranolazine 1000 mg twice a day for 6 weeks + amlodipine (10 mg/d) (n=281) vs. placebo + amlodipine (10 mg/d) (n=284) | patients with stable chronic angina already treated with the maximal dose of amlodipine (10mg/d) | double blind Parallel groups Sample size: 281/284 Primary endpoint: angina frequency FU duration: 6 weeks | | MARIZA, 2004 | ranolazine 500 mg twice daily (sustained-release ranolazine 500, 1,000, or 1,500 mg) (n=191) vs. placebo (n=191) cross over 4 period with Ranolazine ER 500,1,000, or 1,500 mg or placebo twice a day as monotherapy
for 1 week each | Patients with angina-limited exercise | double blind Cross over Sample size: 191/191 Primary endpoint: Exercise duration FU duration: 1 week | | RAN080, 2005 | ranolazine IR 400mg TID (n=158) vs. placebo (n=158) cross over 3 periods with Ranolazine IR 400 mg
TID, atenolol 100 mg
QD and placebo for 1
week each | patients who had symptom-limited exercise | double blind Cross over Sample size: 158/158 Primary endpoint: Time to onset of angina during exercise testing FU duration: 1 week | | CARISA 1000mg, 2004 | ranozaline 1000mg (in combination with beta-blockers or calcium antagonists) (n=261) vs. placebo (n=258) 3rd arm receiving ranolazine 1000mg twice daily
| patients with severe chronic angina who have symptoms of chronic angina and who experience angina and ischemia at low workloads despite taking standard doses of atenolol, amlodipine, or diltiazem
| double blind Parallel groups Sample size: 261/258 Primary endpoint: exercise tolerance and angina frequency FU duration: 12 weeks
|
|
| stable angina | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ERICA, 2006 | ranolazine 1000mg + amlodipine vs placebo + amlodipine | | | | | MARIZA, 2004 | ranolazine 1000mg vs placebo | | | | | RAN080, 2005 | ranolazine 1000mg vs placebo | | | | | CARISA 1000mg, 2004 | ranolazine 1000mg vs placebo (on top standard treatment) | | | Death from any cause 0.33 [0.03; 3.12] |
| Trial | Treatments | Patients | Method |
|---|
| ERICA, 2006 | ranolazine 1000 mg twice a day for 6 weeks + amlodipine (10 mg/d) (n=281) vs. placebo + amlodipine (10 mg/d) (n=284) | patients with stable chronic angina already treated with the maximal dose of amlodipine (10mg/d) | double blind Parallel groups Sample size: 281/284 Primary endpoint: angina frequency FU duration: 6 weeks | | MARIZA, 2004 | ranolazine 500 mg twice daily (sustained-release ranolazine 500, 1,000, or 1,500 mg) (n=191) vs. placebo (n=191) cross over 4 period with Ranolazine ER 500,1,000, or 1,500 mg or placebo twice a day as monotherapy
for 1 week each | Patients with angina-limited exercise | double blind Cross over Sample size: 191/191 Primary endpoint: Exercise duration FU duration: 1 week | | RAN080, 2005 | ranolazine IR 400mg TID (n=158) vs. placebo (n=158) cross over 3 periods with Ranolazine IR 400 mg
TID, atenolol 100 mg
QD and placebo for 1
week each | patients who had symptom-limited exercise | double blind Cross over Sample size: 158/158 Primary endpoint: Time to onset of angina during exercise testing FU duration: 1 week | | CARISA 1000mg, 2004 | ranozaline 1000mg (in combination with beta-blockers or calcium antagonists) (n=261) vs. placebo (n=258) 3rd arm receiving ranolazine 1000mg twice daily
| patients with severe chronic angina who have symptoms of chronic angina and who experience angina and ischemia at low workloads despite taking standard doses of atenolol, amlodipine, or diltiazem
| double blind Parallel groups Sample size: 261/258 Primary endpoint: exercise tolerance and angina frequency FU duration: 12 weeks
|
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