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Pharmaceutical Research

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AHRQ-funded Centers for Education and Research on Therapeutics examine the safety and effectiveness of several popular medications

The Centers for Education and Research on Therapeutics (CERTs) demonstration program consists of seven centers and a coordinating center. The CERTs conduct research and provide education that advances the optimal use of therapeutics (that is, drugs, medical devices, and biological products). The goal is to increase awareness of both the use and risks of new therapeutics and ways to improve their safe and effective use; provide clinical information to patients, providers, insurers, health care administrators, and government agencies; and improve quality while reducing costs by focusing on the appropriate use of therapeutics.

The CERTs program is a national initiative that is administered as a cooperative agreement by the Agency for Healthcare Research and Quality in consultation with the Food and Drug Administration. The seven CERTs centers are: Duke University, the HMO Research Network, the University of Alabama, Birmingham, the University of Arizona, the University of North Carolina, the University of Pennsylvania, and Vanderbilt University.

Researchers at the Vanderbilt CERT (HS10384), which is led by Wayne A. Ray, Ph.D., focus on prescription drug use among Medicaid enrollees. They recently published three articles, which are summarized here.

Hartert, T.V., Speroff, T., Togias, A., and others (2002, November). "Risk factors for recurrent asthma hospital visits and death among a population of indigent older adults with asthma." Annals of Allergy, Asthma, & Immunology 89, pp. 467-473.

Asthma is a common cause of hospitalization among the elderly, particularly women and indigent patients. Regular use of inhaled corticosteroids (CCS) protects individuals from acute worsening of asthma that can lead to hospitalization and death. According to this study, inhaled CCS are underprescribed for elderly asthma patients who are poor. Only 10 percent of indigent elderly asthma patients in this study were current users of inhaled CCS, whereas 31 percent had required rescue with systemic CCS in the year before their initial hospitalization. Furthermore, the hospital visit for asthma did not prompt more appropriate prescribing of asthma medication.

The researchers studied 510 Medicaid-insured elderly patients who survived a single hospital visit for asthma in 1992. They examined recurrent hospital visits for asthma and death from all causes during the year after the initial hospital visit. Overall, 10 percent of the study patients were on inhaled CCS at admission and only 11 percent at discharge. Also, 23 percent of the patients had recurrent asthma hospital visits, and 12 percent died during the 1-year followup.

Asthma severity was the strongest independent risk factor for both a recurrent hospital visit and death. Moderate to severe asthma nearly doubled the relative risk (RR) of recurrent hospital visit (RR 1.92) and tripled the risk of death (RR 2.99). Near-fatal asthma more than doubled the risk of recurrent hospital visit (RR 2.28) and quadrupled the risk of death (RR 4.44). Among those with near-fatal asthma, only 39 percent had filled a prescription for oral CCS at hospital discharge, and only 20 percent had inhaled CCS prescribed and filled.

Ray, W.A., Stein, M., Daugherty, J.R., and others (2002, October). "COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease." Lancet 360, pp. 1071-1073.

People typically take nonsteroidal antiinflammatory drugs (NSAIDs) to alleviate the pain and inflammation associated with conditions such as rheumatoid arthritis. Premarketing and postmarketing trials have raised doubts about the cardiovascular safety of the NSAID rofecoxib, especially at doses greater than 25 mg. The study from the Vanderbilt CERT shows there is reason for concern. The researchers found that adults who use high-dose (more than 25 mg) rofecoxib are nearly twice as likely to be hospitalized with a heart attack or die from serious coronary heart disease (CHD) than users of other NSAIDs, such as ibuprofen, naproxen, or celecoxib. However, those who use rofecoxib at a dose of 25 mg or less have no greater risk of serious CHD than other NSAID users.

Since there is no evidence of greater long-term (more than 5 days) efficacy for the higher doses, long-term use of high-dose rofecoxib should be avoided, suggest the researchers. They retrospectively examined the occurrence of serious CHD in 202,916 non-users of NSAIDs, 24,132 users of rofecoxib, and 151,728 users of other NSAIDs among individuals enrolled in the Tennessee Medicaid program (TennCare). These adults (aged 50 to 84 years) lived in the community and did not have life-threatening non-cardiovascular illness.

Users of high-dose rofecoxib were 1.70 times as likely as non-users to have CHD; among new users this rate increased to 1.93. Thus, risk of serious CHD increased by 70 percent relative to non-users of NSAIDs, and new users had a nearly doubled risk. By contrast, there was no evidence of elevated risk of CHD among users of rofecoxib at doses of 25 mg or less or among users of other NSAIDs.

Ray, W.A., Daugherty, J.R., and Griffin, M.R. (2002). "Lipid-lowering agents and the risk of hip fracture in a Medicaid population." Injury Prevention 8, pp. 276-279.

According to several recent studies, patients taking the widely used and well-tolerated lipid-lowering statin drugs have half the rate of osteoporotic fractures of people taking no lipid-lowering drugs. These reports led many to wonder about the bone-sparing potential of statins. However, these researchers caution that it is premature to use statins to prevent osteoporotic fractures. Other factors may be the source of fewer fractures among users of statins and other lipid-lowering medications. For example, these patients tend to have higher body mass index, since overweight people are more likely to have high lipid levels, and higher body mass usually correlates with stronger bones.

The researchers compared hip fracture rates among Tennessee Medicaid patients who were new users of statins with new users of other lipid-lowering drugs, primarily gemfibrozil. They used Medicaid data from 1989 through 1998 to identify all new users of lipid-lowering drugs and randomly selected non-user controls. None of those selected (50 years of age and older) had been diagnosed with osteoporosis or had a life-threatening illness.

Overall, there were 12,505 new users of statins, 4,798 new users of other lipid-lowering drugs, and 17,380 non-user controls. Among the study group, there were 186 hip fractures (2.8 per 1,000). Statin users had a 38 percent lower rate of hip fracture, and users of other lipid-lowering medications had a 56 percent lower rate of hip fracture, compared with non-users of lipid-lowering medications. The difference between statins and other lipid-lowering medications was not significant. Larger observational studies or meta-analysis may be needed to quantify differences in fracture rates between specific types of lipid-lowering agents.

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