ROCKVILLE, Md., Nov. 14 /PRNewswire/ -- Results from the CREST (Cilostazol for RESTenosis) study presented earlier this week at the American Heart Association's Scientific Sessions 2003 (November 9-12) showed that cilostazol reduced the relative risk of restenosis, the renarrowing of arteries following angioplasty, by 39.5 percent over standard therapy alone. Investigators also associated cilostazol treatment with reduced rates of coronary stent blockage in patients with diabetes by 54 percent, and in patients with small blood vessels by 36 percent. Patients with these conditions are inherently more difficult to treat. There was no difference in adverse events in patients treated with either cilostazol or placebo. Otsuka America Pharmaceutical, Inc. (OAPI) currently markets cilostazol in the United States as PLETAL(R) (cilostazol) Tablets.
CREST was a multicenter, randomized, double-blind, placebo-controlled trial with 705 patients enrolled at 19 clinical sites across the U.S. Patients received standard therapy of aspirin and clopidogrel plus a dose of cilostazol or placebo approximately six hours after successful coronary stent implantation. Treatment with cilostazol and aspirin was continued for six months after discharge. John S. Douglas, MD, Director of Interventional Cardiology at Emory University Hospital, William Weintraub, MD, Director of the Emory Center for Outcomes Research and David R. Holmes, MD, of the Mayo Clinic directed the study.
"The CREST results are encouraging. Otsuka continues to look closely at cilostazol for broader use in the cardiovascular therapeutic area," said Manuel Del Rio, MD, Vice President of Medical Affairs for OAPI.
Coronary artery disease affects 13,000,000 people in the U.S., and more than 500,000 die from the condition each year. Approximately 1,000,000 angioplasty procedures with coronary stent implants occur in the U.S. annually, and about 30 percent of those patients experience restenosis at the site of an angioplasty or stent implantation.
Coronary artery disease is the most common type of heart disease and is the leading cause of death among men and women in the U.S. This condition occurs when the arteries that supply blood to the heart become narrow due to plaque buildup on the inner walls or lining of the arteries. Blood flow is reduced, decreasing the amount of oxygen supplied to the heart and increasing the risk of heart attack. Over time, this disease can weaken the heart muscle, leading to heart failure. Coronary artery disease can be prevented. Leading risk factors include high blood pressure and cholesterol, smoking, diabetes, and being overweight or obese.
At present, treatments for coronary artery disease include lifestyle changes, medication and several surgical procedures. Most commonly, these procedures include angioplasty with and without stent implantation and coronary artery bypass surgery. Restenosis decreases the overall effectiveness of these treatment options and often leads to chest pain, shortness of breath, fatigue and may require use of other invasive procedures.
Funding for CREST was provided by Otsuka America Pharmaceutical, Inc. (OAPI) in the form of an unrestricted research grant.
Cilostazol is currently marketed in United States as PLETAL(R) (cilostazol) Tablets and is indicated solely for the treatment of intermittent claudication, as demonstrated by increased walking distance. Intermittent claudication is a common symptom of peripheral arterial disease. PLETAL is contraindicated in patients with congestive heart failure of any severity. The most commonly adverse events reported are headache, diarrhea, abnormal stools, increased heart rate, and palpitations.
OAPI is a successful, innovative, fast-growing health care company that commercializes Otsuka-discovered and other product opportunities in North America. The company is part of the Otsuka Pharmaceutical Group.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a diversified health care company guided by its philosophy: "Otsuka -- people creating new products for better health worldwide" and dedicated to the research and development of innovative medical, pharmaceutical, and nutritional consumer products. Otsuka has a diverse portfolio including central nervous system, cardiovascular, circulatory, gastro-intestinal, respiratory, dermatological, ophthalmologic, and anti-cancer therapies, and is pursuing research in genomics and protein function. The Otsuka Pharmaceutical Group is composed of 51 businesses around the world and 22,000 employees, earning total revenues of $4.3 billion annually.
PLETAL is a registered trademark of Otsuka Pharmaceutical Co. Ltd. For full prescribing information for PLETAL, please visit the website at http://www.pletal.com/.
Otsuka America Pharmaceutical, Inc.