- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Research Looks Into Lessening the Danger of Statin Drugs
Personalized DNA tests identify patients at risk for adverse events (August 6)
Cholesterol-lowering statins are among the best-selling drugs in North America and around the world. However, statin myopathy is a common side effect, affecting up to 10 percent of statin users. A recent study conducted by U.S. and Canadian researchers found that common variations in a person’s genes could put them at risk for statin-related muscle injury.
“Currently, we do not fully understand the drug exposure necessary for optimal statin therapy, making it difficult to predict an individual’s dose requirement while minimizing the risk of side effects,” said lead investigator Dr. Richard Kim. In the new study, Kim set out to quantify patient’s blood levels of statins and to decipher the role genes play in statin uptake and absorption.
“We found that commonly occurring genetic variations in the genes that help to clear the drugs from the body, widely referred to as drug transporters, are key predictors of patients who will likely have high statin blood levels,” Kim said. “We think those patients with high levels of statins in their blood are at a much greater risk for statin-associated muscle injury.”
Currently, physicians cannot readily identify at-risk patients using the available clinical tests. However, Kim proposes that using the pharmacogenetic tests presently available, in addition to the clinical variables he and his research team have outlined in their paper, would help to identify these patients and prevent serious side effects. “This seems to be very relevant, especially for the many elderly patients who take these medications,” Kim observed.
As part of their personalized medicine program, Kim plans to use pharmacogenetic tests and the algorithm they created, and to apply them in a hospital. In addition, a larger clinical trial is being planned to compare the researchers’ genomics-guided approach versus standard care in terms of better outcomes, cost-effectiveness, and prevention of adverse drug reactions.
The study was published in Circulation Cardiovascular Genetics.
Source: Lawson Health Research Institute; August 6, 2013.