Study on Drug to Help Retinopathy in Diabetic Patients

WAYNE, Pa., Nov 1, 2000 /PRNewswire via COMTEX/ -- AstraZeneca and Takeda Chemical Industries, Ltd. today announced the initiation of a study examining the use of the angiotensin II receptor blocker candesartan cilexetil (Atacand(R)) in the prevention and slowing of the progression of diabetic retinopathy. The Diabetic Retinopathy Candesartan Trial (DIRECT) is a four-year, multicenter, clinical trial evaluating the effects of candesartan cilexetil in diabetic retinopathy. The trial will involve 4,500 subjects from approximately 20 countries. Participants in the DIRECT Trial will receive candesartan cilexetil or a placebo once daily.

      The DIRECT Trial consists of three arms. The first arm will examine the effects of candesartan cilexetil in the prevention of diabetic retinopathy in insulin-dependent diabetic subjects. The second arm will observe the effects of candesartan cilexetil in slowing the progression of diabetic retinopathy in insulin-dependent diabetic subjects. The third arm will look at the effects of candesartan cilexetil in slowing the progression of diabetic retinopathy in non-insulin dependent diabetic subjects. Candesartan cilexetil is not indicated for the treatment of diabetes or its complications.

      According to the American Diabetes Association, an estimated 15.7 million people in the United States have been diagnosed with diabetes. Among the diabetic population, a major complication is diabetic retinopathy. Diabetic retinopathy is a loss of vision due to changes in the vessels of the retina. In the United States, it is the leading cause of blindness and affects a majority of diabetic patients.

      Candesartan cilexetil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. As a drug that acts directly on the renin-angiotensin system, candesartan cilexetil should be discontinued as soon as possible when pregnancy is detected. Candesartan cilexetil was launched in the United States in October 1998 under the brand name Atacand and is available in 33 countries. The DIRECT Trial is being conducted and co-sponsored by AstraZeneca and Takeda Chemicals Industries, Ltd.

      AstraZeneca (NYSE: AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15 billion and leading positions in sales of cardiovascular, gastrointestinal, oncology, anesthesia including pain management, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is a $7.4 billion healthcare business with approximately 9,500 employees.

(C) 2000 PR Newswire. All Rights Reserved.