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Comparison of risk-assessment strategies favors "statins for all"

Chicago, IL - Treating all persons regardless of low-density-lipoprotein (LDL)-cholesterol levels with high-dose statins appears more cost-effective than any of the well-known coronary disease risk-stratification strategies, according to Dr Benjamin Z Galper (Columbia University, New York, NY).

At the American College of Cardiology (ACC) 2012 Scientific Sessions, Galper presented the results of an analysis of five strategies for identifying and treating coronary disease risk factors in men age 35 to 80 years women age 45 to 80:

· "Treat all." Prescribe the entire population high-dose statins and low-dose aspirin regardless of Framingham risk score (FRS) or baseline LDL level.

· Screening based on the Adult Treatment Panel (ATP) III recommendations of the National Cholesterol Education Program with statins dosed according to both baseline Framingham score and LDL levels.

· Screening based on the guidelines developed by the Society for Heart Attack and Prevention and Eradication (SHAPE), which determines risk based on coronary artery calcium (CAC) computed-tomography (CT) scanning.

· The modified SHAPE approach mandated by law in Texas, in which patients with a >10% risk of coronary artery disease based on the Framingham score undergo CAC scans to further stratify their risk.

· A strategy based on the results of the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial. Everyone with LDL >130 mg/dl and a C-reactive protein (CRP) >2 mg/L receives 40 mg of rosuvastatin.

Galper et al performed a Markov-chain Monte Carlo statistical analysis of 30 years based on the costs of testing and statins and the expected number of patients classified as moderate or high risk shown in the trials of the screening strategies. The study also accounted for the risk of cancer attributed to the radiation from imaging but did not account for the possible increased risk of diabetes with statins, Galper said, because "it's still not clear how clinically relevant that might be."

For every strategy except "treat all," patients with a Framingham risk >10% were assumed to be on low-dose aspirin.

"Our simulation suggests that treating all men and women with high-dose generic atorvastatin and all men with low-dose aspirin appears to be the most effective approach for the primary prevention of coronary disease," he said. Compared with the actual figures on statin prescription and coronary disease for 2011, all of the strategies analyzed were more effective and cheaper than the status quo, Galper said. The treat-all approach turned out to be the most effective strategy for both men and women, adding 187 860 and 68 350 quality-adjusted life-years (QALYs), respectively, compared with the status quo. In men, the treat-all strategy prevented 160 000 MIs. At the other end of the list, the Texas approach would only prevent 75 000 MIs in men, according to the statistical model. For men, the treat-all approach was the least expensive overall and most cost-effective.

In women, the MIs prevented ranged from 5848 with the JUPITER-guided approach to 39 400 with the treat-all strategy. The SHAPE strategy was cheapest in women, but applying the treat-all approach in women would cost only $2425 per QALY compared with SHAPE, so it would be more cost-effective, Galper said.

The SHAPE strategy would prevent more MIs than the ATP III approach but would cause about 206 radiation-related malignancies, and the ATP III-based approach would result in the fewest number of patients taking statins (28%).

"It's possible that the treat-all was more effective because the majority of people who die from sudden death in this country have no overt history of CHD," Galper said. "Perhaps calcium score, Framingham risk, or CRP level were unable to identify many of these individuals and thus those people, of course, wouldn't be normally be treated with statins [outside of the treat-all strategy]."

"From a public-health standpoint, you could argue that it may be difficult to implement a strategy in which the bulk of the US adult population is placed on a high-dose atorvastatin," he said, noting that statin-therapy compliance rates are often as low as 20% to 40%. But even if that is true, the study identifies other strategies for men and women that are still better than "the hybrid approach" in the Texas legislation, Galper pointed out.

Galper said that this analysis makes a strong case for allowing statins to be sold over the counter. "The actual rates of true adverse events [with statins], even looking at millions of people treated, are relatively low. So it does mean that perhaps we should be making them available at the drugstore." However, in a conversation with heartwire, he acknowledged that the comparisons made in his group's statistical simulation should be confirmed by a large randomized trial.