U of S part of drug safety network that discovers risk in potent cholesterol-lowering drugs

EMBARGOED RELEASE - 6:00 am CST - March 20, 2013 2013-03-22-CGSR A Canada-wide network formed to ferret out rare and serious side effects of drugs has borne its first fruit: high potency statins, used to control cholesterol, appear to pose a small increased risk of acute kidney injury.

Statins are among the most widely used prescription drugs, and are proven life-savers for patients with high cholesterol who have heart disease. They are also often prescribed to patients with high cholesterol who have no history of heart disease.
"This is the most comprehensive study of its kind, and demonstrates the power of the CNODES approach," said Gary Teare who leads the Saskatchewan arm of the Canadian Network for Observational Drug Effect Studies (CNODES), which conducted the work.
"This new knowledge will help doctors recommend safer treatment options to regulate cholesterol levels in patients who may not need a high potency statin," said Teare, with the University of Saskatchewan School of Public Health and Saskatchewan's Health Quality Council.
The research, published in the latest issue of the British Medical Journal (BMJ), found a 34 per cent relative increase in risk of hospitalization for acute kidney injury within 120 days of starting treatment with high potency statins as compared with low potency statins.
"Although the absolute risk of kidney damage with these drugs is low, our findings put into question the common approach of using higher doses to push cholesterol levels lower and lower," said lead author Colin Dormuth from the University of British Columbia. "In some cases, patients may be exposed to unnecessary risk of kidney damage for small gains in cardiovascular health."
About one in 500 patients in the study were hospitalized for acute kidney injury within a period of up to two years after starting on lower strength statin therapy. For patients on therapy for one to two years, those on the higher strength medications were at 15 per cent greater relative risk of kidney injury.
"Based on these findings, it will be important for patients and doctors to carefully consider the risks and benefits of higher strength statin therapy." said co-author Matthew James, assistant professor at the University of Calgary. "This is particularly important for patients with no known history of cardiovascular disease, where the benefit of statin therapy is usually smaller."
About one in three patients considered in this study started statin therapy over an 11-year period and were prescribed a higher strength statin. Statins considered to be high potency were rosuvastatin (e.g.,Crestor) at doses of 10mg or higher, atorvastatin (e.g.,Lipitor) at doses of 20mg or higher, and simvastatin (e.g., Zocor) at doses of 40mg or more. All other statins were considered low potency.
The researchers examined health records of two million patients in Canada, the United States, and the United Kingdom. CNODES analyzes vast amounts of anonymous patient data to assess questions of drug safety more reliably than would otherwise be possible in smaller trials or epidemiological studies.
"This study from the CNODES team demonstrates the importance of pan-Canadian collaboration in addressing questions of prescription drug safety," said Dr. Samy Suissa, principal investigator of CNODES, based at the Jewish General Hospital in Montreal. "The cutting-edge approach and the speed with which this study was completed provide more efficient and effective protection of the health of Canadians."
CNODES is part of the Drug Safety and Effectiveness Network (DSEN), which is funded by Health Canada, and the Canadian Institutes of Health Research (CIHR). Learn more at www.cnodes.ca.
For more information, contact:
Greg Basky
Health Quality Council
(306) 668-8810 x 111
Cell: 306-370-9446
Todd Hoffman
Jewish General Hospital, Montreal
(514) 340-8222 x 8661
Cell: 514-433-3500

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