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November 23, 2009 — Embargoed ContentJAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives of Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases. ARCHIVES OF INTERNAL MEDICINE NEWS RELEASES
Complete Table of Contents
(Embargoed Until: 3 P.M. (CT), Monday, November 23, 2009)
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED. JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ON-LINE. Go to www.jamamedia.org for more information and to apply for access. Please Note: The FOR THE MEDIA website now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, November 23, 2009
Psychotropic Medications Associated With Risk of Falls in Older Adults
CHICAGO—Older adults who take several types of psychotropic medications—such as antidepressants or sedatives—appear more likely to experience falls, according to an analysis of previous studies reported in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. More than 30 percent of individuals older than 65 will fall at least once a year, and falls and their complications are the fifth-leading cause of death in the developed world, according to background information in the article. Each year, 85 percent of all injury-related hospital admissions and more than 40 percent of nursing home admissions are related to falls, and the annual costs related to falls and their complications are estimated to be in the billions of dollars worldwide. Both internal and external risk factors contribute to falls, and medications have previously been implicated in the probability of falling and in the risk of sustaining a fracture. John C. Woolcott, M.A., of the University of British Columbia and Centre for Health Evaluation and Outcomes Sciences, Vancouver, Canada, and colleagues conducted a meta-analysis of 22 previously published studies conducted between 1996 and 2007. The studies involved 79,081 participants older than 60 years and evaluated nine drug classes: antihypertensive agents; diuretics; beta-blockers; sedatives and hypnotics; neuroleptics and antipsychotics; antidepressants; benzodiazepines; narcotics; and non-steroidal anti-inflammatory drugs. When the data were pooled and results adjusted for other factors, the use of sedatives and hypnotics, antidepressants and benzodiazepines were significantly associated with the risk of falling in older adults.
"Given the divergent results shown by some observational assessments within specific medication classes, the results of our meta-analysis reiterate the need for caution when prescribing these medications to seniors," the authors write. "It is hoped that future research in this area can be completed with larger sample sizes in both community and long-term care facility settings and thus improve the quality of information about fall risks that is available to physicians and pharmacists when they are deciding which types of pharmacotherapy to provide."
Editor's Note: This research was supported in part by the Canadian Institutes of Health Research, the Michael Smith Foundation for Health Services Research and the Government of Canada Research Chair in Pharmaceutical Outcomes. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, November 23, 2009
Direct-to-Consumer Pharmaceutical Advertising May Be Associated With Increased Medicaid Pharmacy Expenses
CHICAGO—Direct-to-consumer advertising (DTCA) for a commonly prescribed antiplatelet drug does not appear associated with increased use, but may be associated with increased drug costs and Medicaid pharmacy expenditures, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. "The cost of drugs to public and private health insurance programs has been a long-standing source of concern among policy markers," the authors write as background information in the article. Millions of Americans are enrolled in publicly funded Medicare Part D programs. In addition, prescription drugs are cited as one of the three top reasons for Medicaid expenditure growth, and prescription drug costs have increased by an average of 15.4 percent per year between 1994 and 2004. Meanwhile, spending for DTCA has increased more than 330 percent in the last 10 years. Michael R. Law, Ph.D., of Centre for Health Services and Policy Research, The University of British Columbia, Vancouver, Canada, and colleagues studied the association between DTCA and the use and cost of clopidogrel, a commonly used and heavily marketed (as Plavix) antiplatelet agent. Researchers examined pharmacy data from 27 state Medicaid programs from 1999 to 2005. Changes in the amount of units sold, costs per unit and total pharmacy expenditures after DTCA initiation were noted. There was no DTCA for clopidogrel from 1999 to 2000. From 2001 to 2005, U.S. spending on DTCA for clopidogrel exceeded $350 million, an average of $70 million per year. Clopidogrel use in the 27 Medicaid programs did not change after DTCA. However, cost per unit per quarter increased by $0.40 (12 percent) after DTCA for the drug began, leading to an added $40.58 in pharmacy costs per 1,000 Medicaid enrollees per quarter. "Overall, this change resulted in an additional $207 million in total pharmacy expenditures," the authors write.
"Consequently, payers and policy makers should appropriately still be concerned about DTCA increasing total drug costs for publicly funded reimbursement programs such as Medicaid and Medicare. Future longitudinal studies should examine other drugs and settings because many other countries are currently considering whether to permit DTCA," the authors conclude.
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, November 23, 2009
Adverse Heart Effects of Rofecoxib May Have Been Identified Years Earlier
CHICAGO—Clinical trial data indicated an association between the anti-inflammatory medication rofecoxib and cardiovascular risk as early as December 2000, before the product was taken off the market in September 2004, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Rofecoxib was introduced to the market in May 1999 and quickly became a commercial success, with sales reaching $2 billion annually, according to background information in the article. The manufacturer marketed the product (with the brand name Vioxx) as a safer alternative to traditional nonsteroidal anti-inflammatory drugs. However, concerns about its cardiovascular adverse effects reportedly existed during the drug development process. In September 2004, the manufacturer voluntarily withdrew the product from the market after one large trial was terminated early due to an increased risk of cardiovascular events. In November 2004, the manufacturer's chief executive testified before a U.S. Senate committee that until the halted trial, combined data from all randomized controlled clinical trials showed no difference in the risk of confirmed heart events between patients taking rofecoxib and those taking placebo. To assess whether and when analysis of published and unpublished clinical trial data could have revealed the cardiovascular risks of rofecoxib, Joseph S. Ross, M.D., M.H.S., of Mount Sinai School of Medicine, New York, and colleagues conducted a pooled analysis of all such trials conducted by the manufacturer before September 2004. The researchers identified 30 randomized, placebo-controlled trials that enrolled a combined 20,152 individuals, lasted from four weeks to four years and assigned a range of 17 to 2,586 participants to take doses of rofecoxib ranging from 12.5 milligrams to 50 milligrams. The authors pooled the data from these studies and analyzed the cumulative results. "As of December 2000, 21 of these trials had been completed (70 percent) and the risk of a cardiovascular thromboembolic [heart- or blood clot-related] adverse event or death was greater among subjects assigned to the rofecoxib group, raising concerns from a safety standpoint," the authors write. "Subsequently collected data through June 2001 showed that rofecoxib was associated with a 35-percent increased risk of a cardiovascular thromboembolic adverse event or death." The association strengthened as additional data became available—as of April 2002 the pooled analysis showed a 39-percent increased risk, and as of September 2004, a 43-percent increased risk. The analyses provide a roadmap for how drug safety can be assessed after a product has been introduced into the market, the authors note. New legislation requiring the public disclosure of trial results in the ClinicalTrials.gov database will make available substantial data that has not previously been used to understand drug safety or efficacy. Independent investigators will now be able to conduct comprehensive meta-analyses that can complement and corroborate surveillance done by the U.S. Food and Drug Administration.
"Physicians and the public deserve to be in a position to make informed choices about risks and benefits, and the disclosure and dissemination of information about potential risk immediately after its recognition is absolutely essential. Our study provides insight into what should have been known about the risks of rofecoxib," the authors conclude. "If we are to detect harms early and protect the public's health, while ensuring the availability of new, clinically effective therapeutics, a system must be established that makes full use of all existing evidence."
Editor's Note: This project was not directly supported by any external grants or funds. However, Dr. Ross is currently supported by a National Institute on Aging grant and by the American Federation of Aging Research through the Paul B. Beeson Career Development Award Program. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, November 23, 2009
Team-Based Care Involving a Pharmacist Improves Blood Pressure Control
CHICAGO—Patients whose hypertension is managed by a physician-pharmacist team have lower blood pressure levels and are more likely to reach goals for blood pressure control than those treated without this collaborative approach, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Previous studies suggest that patients with hypertension (high blood pressure) that remains uncontrolled often do not receive additional blood pressure medications, according to background information in the article. One strategy to improve blood pressure control is team-based care, involving the assistance of a clinical pharmacist in patient management. Barry L. Carter, Pharm.D., of the University of Iowa and Iowa City Veterans Administration, Iowa City, and colleagues conducted a randomized, controlled clinical trial of a team-based approach in 402 patients (average age 58.3) with uncontrolled hypertension receiving care at one of six clinics. All of the clinics already employed pharmacists, but before the study the pharmacists spent more time educating pharmacy students, medical residents and staff physicians about drug therapy than they did in direct patient management. In three clinics treating 192 patients, physicians and pharmacists underwent team-building exercises. Pharmacists also completed additional training sessions, assessed patients' blood pressure and medications at the beginning of and throughout the study, and made face-to-face treatment recommendations to physicians that were consistent with national guidelines. In the other three clinics, 210 patients were informed of their blood pressure and the blood pressure goal they should achieve, were given written information about managing blood pressure and were treated by physicians who received educational sessions on strategies to improve blood pressure control. After six months, 29.9 percent of patients in the control group and 63.9 percent of patients in the intervention group achieved blood pressure control, defined as a blood pressure of less than 130/80 millimeters of mercury for patients with diabetes or kidney disease and 140/90 millimeters of mercury for the other patients. Average blood pressure decreased 6.8/4.5 millimeters of mercury in the control group and 20.7/9.7 millimeters of mercury in the intervention group. The pharmacists in the intervention group made 771 recommendations; 742 (96.2 percent) were implemented by physicians. Patients in the intervention group had an greater average increase in the number of antihypertensive medications taken and more changes in their medications (including starting new medications, discontinuing current medications or increasing or decreasing dosage).
"A physician and pharmacist collaborative intervention achieved significantly better mean [average] blood pressure and overall blood pressure control rates compared with a control group," the authors conclude. "The results of this study suggest that clinics or health systems with clinical pharmacists should consider reallocation of duties to provide more direct patient management to significantly improve blood pressure control. Future studies of this model should include more clinics with greater geographic, racial/ethnic and socioeconomic diversity because these populations are likely to respond differently to the intervention."
Editor's Note: This study was supported by a grant from the National Heart, Lung and Blood Institute. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. Editorial: Team-Based Care and Medical Homes May Improve Chronic Disease Management
"As the nation once again engages in discussions of health reform, issues of quality and cost containment are high on the agenda," writes Helene Levens Lipton, Ph.D., of the University of California, San Francisco, in an accompanying editorial. "One approach to addressing these challenges is team-based delivery of health care services, including physicians and allied health professionals working collaboratively." In addition to Carter et al's report on collaboration with pharmacists, two other reports in this issue investigate allied health providers' impact on patient care. A randomized clinical trial conducted by Jun Ma, M.D., Ph.D., of the Palo Alto Medical Foundation Research Institute, Calif., and colleagues assessed a county health care system program in which nurses and dieticians helped manage cases to reduce cardiovascular risk. In addition, Paul C. Walker, Pharm.D., of the University of Michigan, Ann Arbor, and colleagues evaluated the addition of a pharmacist to the team caring for patients discharged from general medical services of an academic medical center. "The results of the three articles in this issue of the Archives, in the context of available literature, make the case that team-based interventions enhance quality of care and improve clinical outcomes, with mixed effects on medical service use and costs," Dr. Lipton writes. "The medical home—a model of comprehensive health care delivery and payment reform that emphasizes the central role of primary care—offers opportunities to implement team-based care and systematically and rigorously evaluate its effects on quality and costs."
"The baby boomers—beneficiaries of medical and public health advances that have led to increased life expectancy, and concomitantly, chronic medical conditions—will be placing increased demands on our health delivery system," Dr. Lipton concludes. "Among the changes that are needed to improve the quality and cost-effectiveness of their care, and in fact, to keep them in their own homes longer, the medical home is a promising innovation that can fuel advancements in team-based chronic disease management."
Editor's Note: Please see the articles for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. |
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