Re: Statins for Secondary Prevention in Elderly Patients: A Hierarchical Bayesian Meta-Analysis
- From: Marilyn Mann <mannm@xxxxxxxxxxx>
- Date: Fri, 4 Jan 2008 12:09:36 -0800 (PST)
Meta-analysis shows statins reduce all-cause mortality 22% in elderly
CHD patients
January 3, 2008 Michael O'Riordan
Montreal, QC - 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 [1].
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-prevention 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)
Revascularization
0.70 (0.53-0.83)
Stroke
0.75 (0.56-0.94)
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.
Evidence-based reimbursement
In an editorial accompanying the published study [2], 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'."
Sources
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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