In the most comprehensive study of its kind, researchers found that patients taking higher strength statins face a small increase in the risk of acute kidney injury. Published in the latest issue of the British Medical Journal (BMJ), the research was conducted by the Canadian Network for Observational Drug Effect Studies (CNODES).
The study 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, Assistant Professor of Anesthesiology, Pharmacology and Therapeutics at 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 1 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 1 to 2 years, those on the higher strength medications were at 15 per cent greater relative risk of kidney injury.
“The consequences of rapid loss of kidney function experienced in acute kidney injury can be profound and long-lasting,” advised co-author Dr. Matthew James, Assistant Professor at the University of Calgary. “Based on these findings, it will be important for patients and doctors to carefully consider the risks and benefits of higher strength statin therapy. This is particularly important for patients with no known history of cardiovascular disease, where the benefit of statin therapy is usually smaller.”
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.
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.
To conduct the study, CNODES researchers from across Canada examined health records of 2 million patients in Canada, the United States, and the United Kingdom. As is its mandate, the network has the ability to analyze a large amount 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, the Principal Investigator of CNODES and Director of the Centre for Clinical Epidemiology at the Lady Davis Institute 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). This research was conducted by CNODES, which the Institute for Clinical Evaluative Sciences(ICES) is a member of.
Authors: Dormuth CR, Hemmelgarn BR, Paterson JM, James MT, Teare GF, Raymond CB, Lafrance JP, Levy A, Garg AX, Ernst P and the Canadian Network for Observational Drug Effect Studies (CNODES).
The study "High Potency Statins and Acute Kidney Injury: A Multicenter Retrospective Observational Analysis of Administrative Databases," was published online at www.bmj.com
CNODES Investigators: Samy Suissa (Principal Investigator, McGill University); David Henry and Michael Paterson (Ontario); Colin Dormuth (British Columbia); Brenda Hemmelgarn (Alberta); Gary Teare (Saskatchewan); Patricia Martens and Patricia Caetano (Manitoba); Pierre Ernst, Jacques LeLorier, and Robert Platt (Québec); and Adrian Levy and Ingrid Sketris (Nova Scotia).For more about CNODES: www.cnodes.ca.
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