JACC Publishes Long-Term Safety and Tolerability Data from,Ranolazine Open Label Experience (ROLE) Program ( PALO ALTO Calif. March 14 2007 /PRN...)

JACC Publishes Long-Term Safety and Tolerability Data from,Ranolazine Open Label Experience (ROLE) Program

PALO ALTO, Calif., March 14, 2007 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. announced today that the Journal of the of Cardiology (JACC) has published data from the Ranolazine Open Label Experience (ROLE) program, which showed long-term therapy with Ranexa(R) (ranolazine extended-release tablets) to be safe and well tolerated in patients with chronic stable angina who completed one of two phase 3 clinical trials, and enrolled in the ROLE program.

These data also suggest no evidence of increased mortality attributable to Ranexa based on two year survival rates of ROLE participants compared with published outcomes of similar cohorts used as a reference population.

Because ROLE was an open label study, and not a placebo controlled clinical trial with a comparator group, it does not allow for a rigorous analysis for mortality and it is difficult to fully characterize the implications of the deaths reported in the study.

The ROLE program evaluated 746 patients with chronic angina who chose to receive Ranexa(R) following their participation in the phase 3 Monotherapy Assessment of Ranolazine In Stable Angina (MARISA) or the phase 3 Combination Assessment of Ranolazine In Stable Angina (CARISA) clinical studies with Ranexa. More than 85 percent of eligible MARISA patients and more than 80 percent of eligible CARISA patients chose to receive Ranexa in the ROLE program.

The mean duration of follow-up was 2.82 years and more than 75 percent of ROLE patients completed at least two years of Ranexa therapy. Two years after initial dosing, 9.7 percent of patients had discontinued Ranexa due to adverse events.

No treatment discontinuations occurred due to QT prolongation and no cases of torsades de pointes were reported. The most commonly reported adverse events, other than angina, were dizziness (11.8 percent) and constipation (10.9 percent).

"The high rate of patients choosing
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