January 3, 2008 (Montreal, QC, Canada) - In elderly patients with documented coronary heart disease (CHD), statins reduce all-cause mortality, as well as CHD mortality, nonfatal myocardial infarction, the need for revascularization, and stroke, a new review has shown . Investigators say that the magnitude of benefit, with statins reducing all-cause mortality 22%, is larger than previously estimated.
"Despite having as many positive statin trials as we do, concerns have been raised about a lack of hard evidence with statins in elderly patients, mainly because there have been limited data showing a reduction in all-cause mortality," said lead investigator Dr Jonathan Afilalo (McGill University, Montreal, QC). "We hope that this study will reawaken an awareness in clinicians that this is a proven therapy that is being significantly underutilized in our highest-risk patients."
The results of the study are published in the January 1, 2008 issue of the Journal of the American College of Cardiology.
Some Doubt About the Benefits of Statins in Elderly
Speaking with heartwire , Afilalo said that despite the recommendations of the National Cholesterol Education Program Adult Treatment Program (NCEP ATP III) to lower LDL cholesterol levels in elderly CHD patients, the use of statins in these patients remains low, hovering between 40% and 60%.
"As much as statins have garnered a good reputation in cardiology, we still see in the literature that the prescription rates, even among elderly patients who have had a recent myocardial infarction, are low," said Afilalo. "We're talking about half of these high-risk patients with active coronary heart disease not receiving statins."
The underutilization, he said, stems from inconsistencies in the data showing the effectiveness of statins to reduce mortality in elderly patients. Specifically, concerns were raised after the publication of the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER) trial, a study that failed to show an effect of statin therapy on all-cause mortality in patients 70 to 82 years old with cardiovascular risk factors or documented cardiovascular disease. The published PROSPER data, however, did not present results stratified by the primary and secondary cohorts, leaving questions about the possible benefits of statins in the secondary-prevention patients.
With these inconsistencies in mind, the investigators performed a meta-analysis to determine if statins reduce all-cause mortality in elderly CHD patients, and to quantify the treatment effect. The group included nine studies, consisting of 19 569 patients between 65 and 82 years of age. In addition to studies publishing data on elderly subgroups, including the 4S, CARE, LIPID, and HPS studies, the investigators obtained unpublished data on elderly subgroups and on the secondary-prevention subgroup in the PROSPER trial.
Overall, the review showed that the use of statins for secondary prevention in elderly patients with documented CHD reduced all-cause mortality 22% and reduced CHD mortality 30%. Nonfatal myocardial infarction was reduced 26%, the need for revascularization 30%, and stroke 25%.Pooled Five-Year Relative Risk of All-Cause Mortality and Cardiovascular Events
|Event||Relative Risk (95% CI)|
|All-cause mortality||0.78 (0.65-0.89)|
|Coronary heart disease mortality||0.70 (0.53-0.83)|
|Nonfatal myocardial infarction||0.74 (0.60-0.89)|
Afilalo said the benefit is larger than expected, mainly because two meta-analyses of young and elderly patients showed that the number needed to treat to save one patient was 56 and 61, respectively. In this meta-analysis focused on elderly patients, the number needed to treat to save one patient was 28.
The investigators did not pool rates of adverse events in their meta-analysis, mainly because the different studies used different definitions of adverse events and reported these events differently. Afilalo told heartwire , however, that elderly patients do not experience higher rates of serious adverse events than younger patients. There are higher rates of myalgia typically reported in the elderly, both in the placebo and statin arms, partly because the elderly have more aches and pains, he noted.
In an editorial accompanying the published study , Drs George Diamond and Sanjay Kaul (University of California Los Angeles) write that two practical problems continue to plague statin therapy in clinical practice: long-term adherence remains poor; and the treatment gap, especially among the elderly, remains large.
"Meanwhile, the use of PCI continues to increase despite the lack of equivalent evidence of outcomes benefit," write the editorialists. "Current reimbursement policy actually encourages such misuse. Once drugs and devices are approved for marketing, physicians often use them in unapproved ways, and payers reimburse such 'off-label' use to the same degree as 'on-label' use. Fine tuning these financial incentives might help to close the treatment gap and increase adherence to statin therapy."
Diamond and Kaul propose that the Centers for Medicare and Medicaid discount a drug's price not by some fixed amount, but rather in direct proportion to its proven therapeutic benefit. With various incentives in place, the patient could receive better access to proven drugs at more affordable prices. They even suggest empowering the US Food and Drug Administration advisory panels with additional authority to discount the drug's cost on the basis of the scientific evidence they are already reviewing.
The statin treatment gap, Diamond and Kaul argue, is an example of the disconnect between what the providers of care should do, according to the evidence, and what they are paid to do, according to reimbursement policies.
"This situation will not change unless and until we realign the financial and scientific incentives and begin rewarding caregivers, not for the prodigal provision of products and services, but for the enlightened provision of therapeutic benefit," they write. "Evidence-based reimbursement can be the bridge to [a] 'far, far better thing'."
Afilalo J, Duque G, Steele R, et al. Statins for secondary prevention in elderly patients. J Am Coll Cardiol 2008; 51:37-45.
Diamond GA, Kaul S. Prevention and treatment: a tale of two strategies. J Am Coll Cardiol 2008; 51:46-48
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Cite this: Michael O'Riordan . Meta-Analysis Shows Statins Reduce All-Cause Mortality 22% in Elderly CHD Patients - Medscape - Jan 03, 2008.