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Published on 26 April 2007

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Ranolazine in ACS: safe, but not very useful

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Ranolazine, a novel anti-anginal drug in late-stage development inEurope, is not beneficial in acute non-ST-elevation coronary syndromes(ACS), according to the results of a controlled trial just – althoughthe drug does seem to be safe.

Ranolazine hasanti-ischaemic actions and has been launched in the USA for chronicangina; this trial (MERLIN TIMI-26) aimed to determine whether it hasany benefit in ACS.

The study involved patients with signsof myocardial ischaemia lasting at least ten minutes and having a highrisk of further severe myocardial events, enrolled within 48 hours ofonset. In addition to standard therapy, they were randomised totreatment with ranolazine (IV initially then oral) or placebo, andfollowed up until the end of the study. Primary outcome was a compositeof cardiovascular death, myocardial infarction (MI), or recurrentischaemia; study duration was event-driven, requiring at least 310deaths and 730 major cardiovascular events.

A total of6,560 patients were randomised to ranolazine (n=3,279) or placebo(n=3,281), of whom 19 (ranolazine n=11, placebo n=8) did not receiveany study drug; median duration of treatment was 348 days. At the endof the study, there was no significant difference between the twogroups in the rate of primary endpoint events, which had occurred in696 patients (21.8%) in the ranolazine group and 753 patients (23.5%)in the placebo group (hazard ratio 0.92; 95% CI, 0.83–1.02; p=0.11).There were also no differences in the major secondary endpoints ofcardiovascular death or MI, although there were trends favouringranolazine in some longer-term outcomes. More patients in theranolazine group required dose reduction due to QTc prolongation (0.9%vs 0.3%), although there were no differences in symptomatic arrhythmiasor total mortality. More patients stopped ranolazine due to adverseeffects (8.8% vs 4.7%).

The authors conclude thatranolazine was no better than placebo for reducing major cardiovascularevents in patients with ACS, although it did not significantly increasemajor adverse events. Secondary outcomes provided support for efficacyin chronic angina. An accompanying editorial discusses the study.

JAMA 2007;297:1775-83;1823-5

 



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