Shahnaz Shahinfar, M.D., led the design and execution of a worldwide outcomes trial with Cozaar for more than 1,500 patients around the world with Type 2 diabetes, hypertension and kidney disease. She and her team were dedicated to ensuring that the trial–RENAAL (Reduction of Endpoints in Non-Insulin Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan)–was conducted in the most rigorous, disciplined and scientifically valid manner possible. In the end, what meant the most to Dr. Shahinfar and her colleagues was how their work ultimately paid off for patients. “When we first learned the results of the study–that Cozaar significantly reduced the rate of progression of nephropathy (kidney disease) in patients with Type 2 diabetes, hypertension and nephropathy, delaying their need for dialysis or kidney transplant–we knew then that this finding could be of great importance to these patients and their families.”      Large-scale clinical outcomes trials that help change the way diseases are treated have become a hallmark of Merck science. “We pioneered long-term outcomes trials that today form the backbone of medical guidelines worldwide for several therapeutic areas–from cholesterol management to osteoporosis,” Dr. Shahinfar says.      Major outcomes trials with Merck medicines can also lead to wider access to formularies. Such is the case with Vioxx. In 2002, the medicine achieved exclusive formulary status in the United States covering an additional 15 million lives after data from the landmark 8,000-patient Vioxx Gastrointestinal Outcomes Research (VIGOR) study were added to its label. Vioxx, which selectively inhibits the COX-2 enzyme, is the first and only medicine clinically proven to reduce the risk of clinically significant gastrointestinal side effects versus naproxen.      The results of two other outcomes studies also have the potential to change medical practice: the Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) trial and Oxford University’s Heart Protection Study (HPS). In the LIFE study, Cozaar significantly reduced the combined risk of cardiovascular morbidity and mortality, most notably stroke, in patients with hypertension and left ventricular hypertrophy (a thickening of the heart’s main pumping chamber) compared to the beta-blocker atenolol. Black patients in the study, however, had a lower risk of cardiovascular morbidity and mortality on atenolol than on Cozaar. HPS, the largest study ever conducted with a cholesterol-modifying medicine, found that Zocor 40 mg saved lives by significantly reducing the risk of heart attack and stroke in a broad range of high-risk patients. Even more important, Zocor 40 mg demonstrated life-saving benefits for high-risk patients with normal cholesterol levels.      Merck has long understood that it is not enough to develop a medicine. Rather, we continue to seek further evidence of its value. Through outcomes trials we often uncover insights on how our medicines improve health and lives.