As AstraZeneca prepares to unleash a marketing campaign for the new Crestor indication, some experts are raising their eyebrows. Is it really a good idea to prescribe the statin to older patients who don't have elevated cholesterol, even if their C-reactive protein is high and they smoke or have high blood pressure? Cardiologists and researchers debate the idea in a New York Times article today, raising questions that could deter doctors from extending Crestor use to the 6.5 million people who'd likely qualify under the drug's new labeling.
Like all drugs, including its sister statins, Crestor can have such side effects as muscle trouble and liver problems. But most worrisome to these critics is a link to increased diabetes risk, which just surfaced last month in The Lancet. That risk has been added to Crestor's label. All these side effects tend to be outweighed by Crestor's benefits in people with high cholesterol and at risk of heart disease, the Times points out.
Cardiologist Steven Seiden calls the reduction in cardiovascular events "statistically significant but not clinically significant," the Times reports. "It's a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this," Stanford professor Dr. Mark Hlatky tells the paper.
But the FDA points out that using Crestor in these patients isn't mandatory and notes that it's a good thing when doctors debate a drug's risks and benefits. And no less a pharma critic than Dr. Steven Nissen of the Cleveland Clinic says the risk-reduction is enough for him to prescribe the drug for the new use. "I don't understand the antipathy out there," he tells the Times. "If somebody ... meets the criteria, am I going to deny them a drug that reduces their chance of a heart attack or stroke by 40 or 50 percent?"
- see the Times analysis