| |
|
|
|
|
| Slide Lecture Programs |
| 2007 Core Curriculum |
| Myocardial Ischemia Redefined: Optimal Care in CAD |
October 9, 2007
|
| III: |
Clinical Trial Update |
Slide 45 |
|
Download PowerPoint
|
ROLE: Long-term safety and tolerability in stable CAD patients
- The ROLE trial involved >80% of the patients who completed the MARISA or CARISA trials and voluntarily agreed to participate in an open-label extension program.
- The average exposure to the drug was 2.82 years. Of the 746 patients participating in the study, 571 (76.7%) completed 2 years of open-label therapy; only 9.7% of the 23.3% who did not complete 2 years of therapy stopped the study drug due to adverse effects.
- Aside from angina, the most common adverse effects were dizziness (11.8%) and constipation (10.9%). Adverse events rates were similar in patients who received ranolazine for the first time (n = 197 formerly in the placebo group), and 549 patients who had previously taken the drug.
- Electrophysiological complications were not a major determinant of study drug discontinuation.
|
|
|
Resources
