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Title: Health Canada Approves Avapro (Irbesartan) for the Treatment of Diabetic Renal Disease

"Health Canada Approves Avapro (Irbesartan) for the Treatment of Diabetic Renal Disease"

In time for National Diabetes Month, Avapro is the First and Only Drug Approved by Health Canada for the Treatment of Early and Late Stage Renal (Kidney) Disease in Patients with High Blood Pressure and Type 2 Diabetes. TORONTO, ON -- November 12, 2002 -- There is good news for Canadians with high blood pressure and type 2 diabetes. Bristol-Myers Squibb and Sanofi-Synthelabo today announced that Health Canada has approved AvaproŽ (irbesartan) for a new and unique indication: the treatment of early and late stage renal disease in patients with high blood pressure and type 2 diabetes mellitus. In Canada, approximately 8 million people suffer from high blood pressure(i) and approximately 2 million from diabetes.(ii) An estimated one-third of patients with diabetes will develop chronic kidney failure which requires dialysis or a kidney transplant.(i) The economic burden of diabetes and its complications is expected to reach $14 billion annually in health care costs and projections reveal an exponential increase in the number of deaths due to diabetes into the year 2016.(iii) Avapro, an angiotensin II receptor blocker (ARB), was originally approved by Health Canada in 1998 for the treatment of essential (mild, moderate and severe) hypertension. "This new indication is particularly important because in Canada about 50 per cent of patients that end up on dialysis treatment for kidney failure are due to complications related to their diabetes." said Dr. Daniel Cattran, Nephrologist, Toronto General Hospital, University Health Network. "Avapro has been shown to slow down and in some cases reverse the kidney disease and hence is an important new therapy." Avapro's new indication is based on the results of two landmark studies recently published in the New England Journal of Medicine -- IRMA-2 (IRbesartan MicroAlbuminuria Type 2 Diabetes Mellitus in Hypertensive Patients) and IDNT (Irbesartan Diabetic Nephropathy Trial). These two studies evaluated hypertensive type 2 diabetic patients across the broad spectrum of early (IRMA-2) and late stage (IDNT) kidney disease. The two studies included 2,305 patients worldwide with participation of key centres across Canada.(iv),(v) The IRMA-2 study showed that patients receiving 300 milligrams of Avapro (irbesartan) daily for approximately two years, significantly reduced their risk of progression of type 2 diabetic renal disease by 70 per cent versus the control group (placebo plus other allowed medications to lower blood pressure).(iv) In addition, one in three patients (34%) on Avapro (irbesartan) 300 mg actually reverted to normoalbuminuria. The IDNT study demonstrated that treatment with Avapro (irbesartan) slows the progression of diabetic renal disease or death by 23 per cent versus Norvasc (amlodipine), an anti- hypertensive drug, in patients with high blood pressure, type 2 diabetes and evidence of renal disease.(v) A major challenge to successfully managing renal disease is noncompliance with anti-hypertensive therapy. A recent study demonstrated that Avapro (irbesartan) had improved compliance over other antihypertensives because of both its efficacy at lowering blood pressure and its improved tolerability profile.(vi) This was confirmed in the June 2002 issue of the Canadian Journal of Cardiology which revealed that angiotensin II receptor blockers (ARB's) such as Avapro (irbesartan) have improved compliance in comparison with other anti-hypertensive drug classes.(vii) "Avapro is amazingly well tolerated." adds Dr. Cattran. "In some studies, where it's compared to an inactive medication called placebo it actually has less side effects than the placebo. In other drug studies where it is compared to drugs commonly used for the control of blood pressure, Avapro has fewer side effects. This is important because of the compliance issue. Patients are more likely to take their medication when they don't get any or very few side effects." Taking into account the results of clinical trials such as IRMA-2 and IDNT, the American Diabetes Association (ADA) issued guidelines in January 2002 that recommend angiotension II receptor blockers, such as Avapro, as the initial agent of choice in the treatment of high blood pressure patients with type 2 diabetes and evidence of renal disease.(viii) The Quebec Society of Hypertension also included this recommendation in its most recent guidelines(ix) and the Canadian Hypertension Society has recently recommended that angiotensin II receptor blockers such as Avapro should move to first line in patients with hypertension and diabetes and also first line in general hypertension.(*) "The really frightening thing about the complications of hypertension and diabetes is that although both diseases are associated with heart, kidney, and head complications individually, when you put the two diseases together the risk skyrockets." said Dr. Ross Feldman, Executive Member, Canadian Hypertension Education Program. "The other part people should know is that we now have very effective therapies. In combination with changes in lifestyle, effective therapy of blood pressure and of blood sugar can significantly reduce a patient's overall risk of having a stroke, heart attack and kidney failure." In earlier clinical hypertension trials with Avapro, there were no significant differences in overall adverse events between Avapro and placebo. Adverse events that occurred in at least one percent of patients treated with Avapro and at a higher rate versus placebo included diarrhea, dyspepsia/heartburn and fatigue. In addition, as soon as pregnancy is detected, patients should discontinue Avapro therapy.(xi) "We're pleased that Health Canada has recognized Avapro as the first medication to effectively treat patients with high blood pressure and diabetic renal disease," said Dr. Nacia Faure, Medical Director Bristol-Myers Squibb. "It is good news for a growing number of Canadians who are at increased health risks. With Health Canada's approval, they can now take one medication to effectively treat a complication relating to two diseases." Available in Canada for five years, Irbesartan is marketed worldwide by Bristol-Myers Squibb and Sanofi-Synthelabo under the brand names of AvaproŽ, Aprovel™, and Karvea™. Irbesartan is also marketed in combination with hydrochlorothiazide under the brand names AvalideŽ, CoAprovel™ and Karvezide™. Irbesartan, discovered by Sanofi-Synthelabo research teams, is part of a co-development and marketing agreement initiated in 1993 between Bristol-Myers Squibb and Sanofi-Synthelabo. References: ---------------------- (i)Health Canada. How to Control Blood Pressure and Reduce Your Risk of Heart Disease. Available online at www.hc-c.gc.ca/hppb/ahi/hypertension. Accessed on September 20, 2002. (ii) Canadian Diabetes Association. Diabetes Facts. Available online at www.diabetes.ca/Section_About/thefacts.asp. (iii) Health Protection Branch, Health Canada. Diabetes in Canada: National Statistics and Opportunities for Improved Surveillance, Prevention and Control. 1999, page 4. (iv) Parving, H.H., Lehnert, H., Mortensen, J.B., et al. The Effect of Irbesartan on the Development of Diabetic Nephropathy in Patients with Type 2 Diabetes. New England J of Medicine, 2001, 345:12. (v)Lewis, E.J., Hunsicker, L.G., Clarke, W.R., et al. Renoprotective Effect of the Angiotensin Receptor Antagonist Irbesartan in Patients with Nephrology Due to Type 2 Diabetes. New England J of Medicine, 2001, 345:12. (vi) Hasford, J. Minram, A., Simons, WR., A population based European cohort study of persistence in newly diagnosed hypertensive patients. Journal of Human Hypertension, 2002, 16: 569. (vii) Marenette, M.A., Gerth, W.C., Billings, D.K., and Zarnke, K.B. Antihypertensive persistence and drug class. Can J of Cardiology, 2002, 18:8. (viii) American Diabetes Association Position Statement, Diabetic Nephropathy. Diabetes Care, 2002, 25: S85. (ix) Quebec Society of Hypertension: Treatment Guidelines, Hypertension arterielle et diabete, 2002, 133. (*)Canadian Hypertension Society: Treatment Guidelines, Draft Recommendations presented at Canadian Cardiovascular Congress, Edmonton, Oct 2002. (xi) Avapro Product Monograph, 2002, Sanofi-Inc. SOURCE: Bristol-Myers Squibb and Sanofi-Synthelabo

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