In the Phase 3 CARISA trial
Ranexa®: Superior clinical effects in treating chronic angina
Ranexa 1000 mg BID,* when added to a beta-blocker or a calcium channel blocker, was superior to those treatments plus placebo at:
*Limit the dose of Ranexa to 500 mg BID when coadministered with diltiazem, verapamil, or other moderate CYP3A inhibitors.
- Increasing exercise duration
- Increasing the time to onset of ischemia during exercise testing at peak plasma concentrations
- Decreasing angina frequency
- Decreasing nitroglycerin use
Well-studied safety profile
The most common adverse reactions (> 4% and more common than with placebo) during treatment with Ranexa were dizziness, headache, constipation, and nausea.
See below for CARISA trial design and baseline characteristics.
CARISA TRIAL DESIGN1
- 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 BID (n = 272), Ranexa 1000 mg BID (n = 261), or placebo (n = 258) for 12 weeks (note: 750 mg is not an approved dose)
- At the physician's discretion, patients received either atenolol 50 mg, amlodipine 5 mg, or diltiazem 180 mg once daily as required background antianginal therapy. Sublingual nitrates were used as needed
- Primary endpoint was exercise duration at trough drug levels at 12 weeks (modified Bruce treadmill test). Secondary endpoints included exercise duration at peak drug levels, time to angina and 1-mm ST-segment depression at peak and trough levels (modified Bruce treadmill test) and weekly angina attacks and weekly nitroglycerin use as reported in patient diaries
CARISA BASELINE CHARACTERISTICS
†Treatment comparison P values for continuous variables are from an analysis of variance with effects fitted for treatment and background therapy. Treatment comparison P values for categorical variables are based on a Cochran-Mantel-Haenszel test stratified by background therapy.
‡Without pathologic Q waves.
Note: 750 mg is not an approved dose.