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Cost-effectiveness of Gemfibrozil for Coronary Heart Disease Patients With Low Levels of High-Density Lipoprotein Cholesterol
The Department of Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial
John A. Nyman, PhD;
Melissa S. Martinson, PhD;
David Nelson, PhD;
Sean Nugent, BA;
Dorothea Collins, ScD;
Janet Wittes, PhD;
Carol L. Fye, RPh;
Timothy J. Wilt, MD, MPH;
Sander J. Robins, MD;
Hanna Bloomfield Rubins, MD, MPH;
for the VA-HIT Study Group
Arch Intern Med. 2002;162:177-182.
Background Although numerous clinical trials and economic analyses have established
the efficacy and cost-effectiveness of lowering cholesterol for the prevention
of coronary heart disease, there are few data on the role of raising high-density
lipoprotein cholesterol (HDL-C) levels and lowering triglyceride levels. The
US Department of Veterans Affairs (VA) Cooperative Studies Program HDL-C Intervention
Trial (VA-HIT) was a multicenter, randomized trial of gemfibrozil, an agent
that raised HDL-C levels and lowered triglyceride levels, yet had no effect
on low-density lipoprotein cholesterol (LDL-C) levels. The study showed that
gemfibrozil therapy significantly reduced major cardiovascular events (cardiovascular
death, myocardial infarction, and stroke) in patients with coronary heart
disease, low HDL-C levels, and low LDL-C levels.
Objective To report the results of a cost-effectiveness study based on the results
of the VA-HIT.
Methods The cost per year of life gained with gemfibrozil therapy was calculated.
Hazard functions were estimated, and the resulting probabilities were used
in a Markov model simulation to estimate the effect of gemfibrozil on life
expectancy and costs over a simulated lifetime. Sensitivity analyses were
used to account for uncertainty.
Results Using the prices of gemfibrozil that were negotiated by the VA, gemfibrozil
was cost saving. Using drug prices found outside the VA, a quality-adjusted
life-year saved by gemfibrozil therapy cost between $6300 and $17 100.
Conclusions Gemfibrozil reduces major cardiovascular events in male coronary heart
disease patients with low levels of HDL-C and low levels of LDL-C and would
result in cost saving at annual drug costs of $100 or less in 1998 dollars.
Even at the higher drug prices represented by the average wholesale price
in the United States, the cost of a life-year saved is well below the threshold
that would be deemed cost-effective. To our knowledge, this is the first economic
analysis based on clinical trial data to assess the cost-effectiveness of
raising HDL-C levels and lowering triglyceride levels in a setting in which
LDL-C levels were not lowered.
From the School of Public Health, Division of Health Services Research
and Policy, University of Minnesota (Drs Nyman and Martinson), and Center
for Chronic Disease Outcomes Research, Department of Veterans Affairs Medical
Center, Minneapolis, Minn (Drs Nelson, Wilt, and Rubins and Mr Nugent); Department
of Veterans Affairs Cooperative Studies Program Coordinating Center, West
Haven, Conn (Dr Collins); Statistics Collaborative, Washington, DC (Dr Wittes);
Department of Veterans Affairs Clinical Research Pharmacy Coordinating Center,
Albuquerque, NM (Ms Fye); and Department of Medicine, Boston University School
of Medicine, Boston, Mass (Dr Robins). A list of the members of the VA-HIT
study group was published previously (N Engl J Med.
1999;341:410-418).
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