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Plavix(R) Plus Aspirin More Effective Than Aspirin Alone In Preventing Major Vascular Events In Patients With Atrial Fibrillation

August 27, 2017

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today new findings from a landmark investigational study that demonstrated that, for patients with atrial fibrillation who were at increased risk for stroke and could not take an oral anticoagulant (OAC) medication, taking Plavix® (clopidogrel bisulfate) in addition to aspirin significantly reduced major vascular events by 11% over aspirin alone, at a median of 3.6 years of follow-up (6.8% vs. 7.6% per year, p=0.01). The greatest benefit was seen in the reduction of stroke, by 28% (2.4% vs. 3.3% per year, p "Sanofi-aventis and Bristol-Myers Squibb Company sponsored ACTIVE A as part of our ongoing commitment to investigate the full potential of Plavix® through major clinical trials, covering a broad spectrum of patients at risk of cardiovascular events early and long-term," said Brian Daniels, Senior Vice President, Global Development and Medical Affairs, Bristol-Myers Squibb.

"These results are of major interest for people with atrial fibrillation and at increased risk for vascular events, particularly stroke, who cannot take OACs," said Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis.

Study and Findings

ACTIVE A was a Phase III, double-blind, placebo-controlled trial designed to compare the combination of Plavix® 75mg once daily plus aspirin (75-100mg daily recommended dose) to aspirin alone (75-100mg daily recommended dose) for preventing the first occurrence of a major vascular event, the primary endpoint, during the trial, with a median of 3.6 years of follow-up. Major vascular events included stroke, non-central nervous system (non-CNS) systemic embolism, heart attack, or vascular death. The trial included 7,554 patients with atrial fibrillation who could not take OACs and had at least one major risk factor for stroke (risk factors included: 75 years of age or older; on treatment for systemic hypertension; prior stroke, transient ischemic attack, or non-CNS systemic embolus; left ventricular dysfunction; documented peripheral vascular disease; and age 55 to 74 years with either diabetes requiring drug therapy or with documented previous heart attack or coronary artery disease). Patients were determined unsuitable for OAC by the physician for the following reasons: specific risk of bleeding, physician judgment that OACs were inappropriate for the patient, or the patient's desire to avoid OAC therapy.

Plavix plus aspirin therapy compared to aspirin alone, respectively, also resulted in:

- A non-statistically significant reduction in heart attacks of 22% (0.7% vs. 0.9% per year, p=0.08)

- No statistically significant reductions in the other components of the primary endpoint, including non-CNS systemic embolism (0.4% vs. 0.4% per year, RR=0.96, p=0.84), vascular death (4.7% vs. 4.7% per year, RR=1.00, p=0.97), or total death (6.4% vs. 6.6% per year, RR=0.98, p=0.69)

- Statistically significant increases, as expected, in the rate of major bleeding (2.0% vs. 1.3% per year, RR=1.57, p