In CARISA, Ranexa increased time to onset of ischemia during exercise testing, significantly improved exercise duration, and significantly increased time to angina during exercise for patients with chronic angina.
CARISA: In addition to Ranexa, patients were on either atenolol 50 mg, amlodipine 5 mg, or diltiazem* CD 180 mg as standard treatments per protocol; sublingual nitrates were used as needed.1
Ranexa increased time to onset of ischemia during exercise testing
At peak plasma concentrations, Ranexa showed a 35-second placebo-corrected increase (58%) in time to 1-mm ST-segment depression during exercise (P ≤ .005 at 12 weeks).1
- At trough plasma concentrations, the placebo-corrected difference between treatment groups was not significant at 17% (21 seconds).2
Significantly improved exercise duration in patients with chronic angina
At peak plasma concentrations, Ranexa produced a 26-second placebo-corrected increase in exercise duration (P ≤ .05).1
Effects on exercise tolerance were considerably smaller in women than in men. The improvement in exercise duration in women was about 33% of that in men at the 1000-mg twice-daily dose level.1
Significantly increased time to angina during exercise
At peak plasma concentrations, Ranexa produced a 43% placebo-corrected increase in time to angina (P = .003).2
At baseline, patients in the placebo group and the Ranexa group experienced angina after a mean of 327 seconds on the treadmill.1
Trial Description
CARISA (Combination Assessment of Ranolazine In Stable Angina) was a double-blind, randomized, placebo-controlled clinical trial of 823 patients with chronic angina who received Ranexa 750 mg twice daily, Ranexa 1000 mg twice daily, or placebo for 12 weeks. Patients also received daily doses of atenolol 50 mg, amlodipine 5 mg, or diltiazem CD 180 mg as standard treatment. The primary endpoint was exercise duration on the modified Bruce treadmill test at trough drug levels. Secondary endpoints included exercise duration at peak drug levels, time to angina, time to 1-mm ST-segment depression, angina frequency, and weekly nitroglycerin use.1
*Limit dose of Ranexa to 500 mg twice daily in patients on moderate CYP3A inhibitors (eg, diltiazem, verapamil, aprepitant, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products).1 Read more on Simple Dosing and Usage.
