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| |  Canada Approves Once-A-Day Oral Diabetic Drug, Actos (Pioglitazone) TORONTO, ON -- September 14, 2000 -- Eli Lilly Canada Inc. announced Health Canada's approval of Actos™ (pioglitazone hydrochloride), a new oral treatment that effectively manages glycemic control in patients with type 2 diabetes. Health Canada also recognized that many patients with diabetes, treated with Actos in clinical trials, exhibited improved lipid levels. Current research has proven that effective management of lipid levels in this patient group can significantly reduce the risk of heart disease - the leading cause of death among people with type 2 diabetes. "Eighty percent of people with diabetes die of some form of heart or blood vessel disease," said Dr. Amir Hanna, Staff Endocrinologist at St. Michael's Hospital in Toronto, and Assistant Professor of Medicine at the University of Toronto. "That is why a novel drug such as Actos that not only effectively treats type 2 diabetes, but may also reduce the risk of heart disease in this high-risk population, is such a powerful tool." Actos' effect on the blood-lipid profile is unique in that it is the only oral medication for type 2 diabetes that not only effectively lowers blood glucose but also raises the good cholesterol (HDL), while lowering triglycerides and not increasing the bad cholesterol levels (LDL). Specifically, Actos raises HDL by up to 13 percent, lowers tryglicerides by up to 23 percent and has no statistically significant effect on LDL. This is particularly important given that Health Canada states that adults with diabetes are more likely than those without to have risk factors for heart disease, especially low levels of HDL cholesterol and high levels of triglycerides. Actos is the newest addition to a class of diabetes medicines known as insulin sensitizers or thiazolidinediones (TZDs). Unlike conventional diabetes therapies that work by increasing insulin production, or lowering glucose production in the liver, TZDs help sensitize the fat and muscle cells to the action of the body's own natural insulin. "In the management of type 2 diabetes, it is now recognized that each individual risk factor must be assessed, treated and monitored," said Dr. Greg Curnew, Cardiologist and Director of the Coronary Care Unit at the Hamilton Health Sciences Centre. "So while glucose levels are clearly important and Actos will manage these, there are other factors that must be managed as well. It is also important that people living with diabetes keep their lipid levels in check to reduce the risk of heart disease." The need for monitoring lipid levels was further highlighted in a national Canadian survey of physicians conducted by the research firm Pollara, which was also released today. The survey noted that, on average, physicians said that less than half (47 percent) of their patients achieved the Canadian Diabetes Association (CDA) guidelines for lipid control. Target lipid levels are assessed in relation to a patient's level of risk. According to the most recent lipid guidelines, patients over the age of 30 who have diabetes are now classified as being at "very high risk" for coronary artery disease. This is equivalent to the risk level for non- diabetics who have already had a heart attack. (Report of the Working Group on Hypercholesterolemia and Other Dyslipidemias, Recommendations for the management and treatment of dyslipidemia, CMAJ, May 15, 2000). The first step in the treatment of diabetes still remains lifestyle changes. Relevant diet and exercise changes should be implemented before moving onto pharmaceutical therapies. A patient should be sure to speak to his or her physician with respect to a complete diabetes management plan. The impact of Actos on glucose and lipid levels has been well demonstrated in many studies including one that was presented earlier this year at the American Diabetes Association annual meeting. In that study, the effects of Actos in subjects with type 2 diabetes were evaluated during a 26- week, multicentre, double-blind, fixed-dose, placebo-controlled trial. A total of 408 subjects with HbA1c levels (a measure of average blood sugar levels during the last three months) greater than or equal to 8 percent were randomized to receive placebo, 7.5 mg, 15 mg, 30 mg or 45 mg of Actos once daily for 26 weeks. Participants in the study demonstrated improved glycemic control when taking Actos 45 mg once daily with mean HbA1c levels decreasing by 1.6 percentage points versus placebo and mean fasting blood glucose levels decreasing by 3.6 mmol/L versus placebo. In addition, mean HDL cholesterol levels increased by 19.1 percent from baseline on a dose of 45 mg of Actos. The study also evaluated participants' triglyceride levels, believed to increase the risk of coronary heart disease, which showed a mean decrease of as much as 9.3 percent from baseline at the 45 mg dose. The conclusion was that Actos monotherapy improved glycemic control and lipid profiles in patients with type 2 diabetes. "The Canadian Diabetes Association welcomes any new treatment options, including drugs Actos, that may assist the person with diabetes in managing diabetes and/or related complications. This is especially important given that the prevalence of diabetes in Canada, especially type 2 diabetes, is expected to double over the next decade," said Donna Lillie, Director, Research and Professional Education, Canadian Diabetes Association. "The Canadian Diabetes Association encourages individuals with diabetes who are interested in new treatment opportunities to discuss them with their physician to determine the appropriateness of particular treatments in their individual situation." Related Links: Actos (pioglitazone hydrochloride) and Eli Lilly Canada Inc.
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