The ALTITUDE study was trying to determine whether Rasilez (aliskiren) could reduce the risk of cardiovascular and kidney problems in patients with diabetes and renal impairment when taken with other blood pressure-lowering drugs.
Novartis terminated the multinational clinical trial after interim data suggested Rasilez was unlikely to benefit those patients and could potentially cause harm.
Specifically, when used in combination with drugs known as ACE-inhibitors or angiotensin receptor blockers (ARBs), Rasilez was associated with an increased risk of non-fatal stroke, kidney complications, 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 said Thursday it is evaluating available safety data, including information from Novartis and international regulatory bodies, to determine if prescribing changes are needed.
As a precautionary measure, Novartis has said it is no longer promoting Rasilez use in combination with an ACE-inhibitor or ARB drugs.
Consumers taking Rasilez either alone or in combination with other blood pressure-reducing drugs who have questions or concerns should talk to their health professional. They should not stop treatment without consulting their health-care professional. If untreated, high blood pressure can cause serious health effects over time.
The ALTITUDE study involved 8,606 participants from 36 countries, including 329 in Canada. Participants should contact their study site for guidance on medication and should not stop treatment until they have seen their physician, Health Canada said.