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Published on 8 March 2007

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ROLE trial finds ranolazine “well tolerated” in severe chronic stable angina

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Researchers have found that long-term therapy with ranolazine seems well tolerated in high-risk coronary heart disease (CHD) patients, and survival analyses suggest that symptomatic improvements attributable to ranolazine are not offset by increased mortality.

Writing in the Journal of the American College of Cardiology, the researchers described safety and tolerability data from 746 chronic angina patients in the ROLE (Ranolazine Open-Label Experience) programme.

The study involved patients with severe functional impairment due to angina – with a mean Duke Treadmill Score (DTS) of -14.4 – who completed one of two randomised treadmill trials. Ranolazine was titrated to optimal dosages of 500–1,000mg twice daily. Physical examination, laboratory tests and adverse-event reporting were performed periodically. Additionally, the ROLE programme’s mortality was compared against the DTS predictive model and other contemporary cohorts of high-risk CHD patients. The mean follow-up period was 2.82 years.

The researchers said that two years after initial dosing, 571 patients (76.7%) remained on therapy and 72 patients (9.7%) discontinued ranolazine due to adverse events.

The investigators also reported the following results:

• Age ≥64 years predicted for higher withdrawal rates.

• Patients with a history of CHF had lower withdrawal rates.

• Mean QTc interval was prolonged by 2.4msec. No treatment discontinuations occurred due to QTc prolongation, and no torsade de pointes (very rapid ventricular tachycardia) was reported.

• During a total of 2,102 patient-years over the ROLE programme, 64 deaths occurred (3.0% annually).

J Am Coll Cardiol 2007;49:1027-34



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