2011-175
December 22, 2011
For immediate release

OTTAWA - In light of the recent company decision (Novartis press release) to stop a multi-national clinical trial known as the ALTITUDE study, Health Canada is informing Canadians that it is reviewing the safety of the prescription blood-pressure drug Rasilez (the brand name for aliskiren).

The ALTITUDE study (ALiskiren Trial In Type 2 diabetes Using cardio-renal Disease Endpoints) was investigating if Rasilez could reduce the risk of cardiovascular (heart-related) and renal (kidney) events when added to conventional therapies in patients with diabetes and kidney impairment. In the study, Rasilez was given in addition to other blood-pressure lowering drugs.

Novartis terminated the study after interim data suggested that Rasilez was unlikely to benefit these patients participating in the clinical trial and could potentially lead to harm.

Specifically, when used in combination with other blood pressure -lowering drugs known as angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), Rasilez was associated with an increased risk of non-fatal stroke, kidney complications, hyperkalemia (high levels of potassium in the blood) and low blood pressure.

Rasilez is currently authorized in Canada for use either alone or in combination with other drugs including ACE-inhibitors and ARBs to control high blood pressure.

Health Canada is currently evaluating available safety data, including information from Novartis along with other regulators internationally, to determine the impact of this new information on the risk-benefit profile of Rasilez when used as currently authorized in Canada. Novartis is also assessing the implication of the safety findings from the ALTITUDE study in their other ongoing trials.

Health Canada will take appropriate regulatory action as necessary. This could include strengthening and updating the drug labelling information with new safety information, based on review findings. Health professionals and the public will be informed of new safety recommendations coming out of the review as appropriate.

As a precautionary measure, Novartis has indicated that it is no longer promoting Rasilez use in combination with an ACE-inhibitor or ARB drug.

Patients taking Rasilez either alone or in combination with other blood-pressure reducing drugs who have questions or concerns should talk to their health professional. Patients should not stop treatment without consulting their healthcare professional. If untreated, high blood pressure can cause serious health effects over time.

ALTITUDE involved 8,606 patients from 36 countries worldwide. Novartis has confirmed to Health Canada 329 patients are from Canada. Novartis, in consultation with Health Canada, is taking appropriate steps to mitigate any risks to the trial participants. Novartis is informing Canadian investigators of the decision to terminate the study and of appropriate steps for patient care. As noted in the Novartis press release, participants in the ALTITUDE study should contact their study site for guidance on medication and should not stop treatment until they have seen their physician in view of the importance of controlling high blood pressure.

More information is available on the Novartis website.

How to report side effects to health products

To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• Internet: MedEffect Canada
• Mail: Canada Vigilance Program
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