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Gilead’s Ranexa® Reduces Angina Frequency In Study Of Chronic Angina Patients With Type 2 Diabetes

Similarly, at baseline, average weekly sublingual nitroglycerin use was similar between treatment arms (4.1 [3.7-4.6] versus 4.5 [4.1-5.0]; ratio 0.92 [0.80-1.06]). During weeks 2-8, the average weekly number of sublingual nitroglycerin doses was significantly lower in patients receiving ranolazine compared to placebo (1.7 [1.6-1.9] versus 2.1 [1.9-2.3] doses; ratio 0.83 [0.73-0.94] P=0.003).

In prespecified subgroup analyses, the efficacy of ranolazine was consistent irrespective of baseline average weekly angina episodes (<3 versus ≥3), number of concomitant antianginal medications (one versus two), age (<65 versus ≥65) and sex. There was, however, a significant difference in the effect of ranolazine versus placebo on the primary endpoint by the geographic region of enrollment (Russia, Ukraine and Belarus versus other countries; P interaction=0.016): The average number of weekly angina episodes between the ranolazine and placebo arms among patients enrolled in Russia, Ukraine and Belarus was not statistically significantly different (4.1 [3.9-4.4] versus 4.3 [4.1-4.6]; ratio 0.95 [0.87-1.05] P=0.31). Among patients enrolled in other countries, there was a significant reduction in average weekly angina episodes in the ranolazine group versus placebo (3.1 [2.8-3.5] versus 4.1 [3.7-4.6]; ratio 0.77 [0.65-0.90] P=0.002).

Serious adverse events with onset during the treatment phase were reported in 16 of the 470 ranolazine patients and 20 of the 474 placebo patients who took at least one dose. Five patients died during the treatment phase, including three patients in the ranolazine group (two myocardial infarctions and one sudden cardiac death) and two patients in the placebo group (one patient with acute cardiac failure and one with pulmonary embolism). The discontinuation rate due to adverse events was also comparable between both treatment groups (nine and 11 in the ranolazine and placebo groups, respectively). Notable non-serious adverse events included nausea, reported in 17 ranolazine and two placebo patients; dizziness, reported in 17 ranolazine and six placebo patients; and constipation, reported in eight ranolazine and two placebo patients.

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