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

During weeks 2-8, average weekly angina frequency was significantly lower with ranolazine versus placebo (3.8 [3.6-4.1] versus 4.3 [4.0-4.5] episodes, P=0.008), as was weekly sublingual nitroglycerin use (1.7 [1.6-1.9] versus 2.1 [1.9-2.3] doses, P=0.003).

The rate of serious adverse events and the rate of discontinuations due to adverse events were similar between the ranolazine and placebo groups. 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; see below for important safety information.

About the TERISA Study

TERISA was a randomized, double-blind, placebo-controlled, parallel study designed to evaluate the efficacy of ranolazine in chronic stable angina patients with concurrent type 2 diabetes who remain symptomatic for angina despite receiving a stable dose of one or two concomitant antianginal agents, including beta-blockers, calcium channel blockers or long-acting nitrates.

A total of 949 patients were randomized (1:1, 473 and 476 in the ranolazine and placebo arms, respectively), 22 of whom either never initiated or discontinued treatment during the first two weeks (11 in each treatment arm), leaving 927 evaluable patients (462 and 465 in the ranolazine and placebo arms, respectively). Their mean age was 64 and 61 percent were male. The patients had a mean diabetes duration of 7.5 years and a mean baseline hemoglobin A1c (HbA1c, a laboratory measure of blood glucose) level of 7.3 percent. At randomization, 56 percent of patients were receiving one antianginal agent and 44 percent were receiving two antianginal agents.

The primary efficacy endpoint was average angina frequency during weeks 2-8, with the effect of ranolazine treatment estimated as a ratio of ranolazine to placebo frequency. During the four-week, single-blind, placebo run-in phase, average weekly angina frequency was similar between the ranolazine and placebo groups (6.6 [6.3-7.0] versus 6.8 [6.4-7.2]; ratio 0.98 [0.91-1.05]). During weeks 2-8, weekly angina frequency was significantly lower in the ranolazine group than in the placebo group (3.8 [3.6-4.1] versus 4.3 [4.0-4.5] episodes; ratio 0.89 [0.82-0.97] P=0.008).

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