Adalat XL Plus approved in Canada

Aug 12 2008

Bayer Inc. announced that Health Canada has granted a Notice of Compliance (NOC) for Adalat XL Plus, a co-packaging of Adalat XL and Aspirin 81mg.

Adalat XL Plus (nifedipine extended-release tablets and acetylsalicylic acid delayed-release tablets) is indicated for patients for whom treatment with both Adalat XL and Aspirin 81mg is appropriate. Adalat XL Plus is not indicated for initial therapy. The dose of nifedipine should be determined by titration before the switch to Adalat XL Plus. Once the dose of nifedipine has been established, patients should take one tablet of Adalat XL (nifedipine extended-release tablets) and one tablet of Aspirin 81mg (acetylsalicylic acid delayed-release tablets) daily.

"Hypertension is a significant risk factor for cardiovascular events," said Dr. Akbar Panju, Professor of Medicine and Vice Chair (Clinical) at McMaster University and former Chief of Medicine at Hamilton Health Sciences. "Packaging Adalat XL and Aspirin 81mg together offers patients the convenience of receiving the daily preventative therapy as well as the antihypertensive benefits of Adalat XL."

"As a leader in cardiovascular care, Bayer is committed to providing solutions that will help to improve the cardiovascular health of Canadians," said Philip Blake, President and CEO, Bayer Inc. "The release of Adalat XL Plus responds directly to patients' needs by improving ease of use, enabling better patient compliance and, most important, resulting in better healthcare outcomes."

Adalat XL, an antianginal and antihypertensive, received its initial NOC in 1992, and is indicated for the treatment of chronic stable angina and mild to moderate hypertension. Aspirin received NOC for a low-dose 81-mg formulation in 1998 for use as a physician-supervised daily preventative therapy.

In Canada, hypertension results in more patient visits to a physician than any other diagnosis, with over 20 million visits per year. Hypertension is a risk factor for cerebrovascular disease, coronary artery disease, congestive heart failure, renal failure, peripheral vascular disease, dementia and atrial fibrillation. It has been shown that 90 per cent of hypertensive Canadians have additional cardiovascular risk factors.

According to a survey of Canadian patients taking both Adalat XL and low dose acetylsalicylic acid (ASA), 93 per cent of patients indicated a preference for a dual prescription of Adalat XL and ASA and 80 per cent indicated they would take their medication more regularly if offered in this format.

Adalat XL Plus is available in cartons containing 28 Aspirin 81 mg tablets packed with 28 (either 20 mg, 30 mg, or 60 mg) Adalat XL tablets. The tablets are packaged in clear blisters and are arranged side by side. Due to the clear nature of the blister package and the difference in colour of the two products, they are readily distinguishable from each other.

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