JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives 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.
When warranted, JAMA releases studies with an embargo time that is different than the standard Tuesdays at 3 pm US Central time because of scientific presentations at medical meetings or because of public health implications.
THIS WEEK'S CONTENT
JAMA EARLY NEWS RELEASE
(Embargoed for Early Release: 8:00 a.m. CT, Monday, November 13, 2006)
JAMA EARLY NEWS RELEASE
DIABETES MEDICATION MAY HELP SLOW PROGRESSION OF ARTERY WALL THICKENING
PHARMACY CARE PROGRAM HELPS ELDERLY PATIENTS TAKE ALL THEIR MEDICATIONS
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Embargoed for Early Release: 8:00 a.m. CT, Monday, November 13, 2006
Media Advisory: To contact Theodore Mazzone, M.D., call Sherri McGinnis González at 312-996-8277.
DIABETES MEDICATION MAY HELP SLOW PROGRESSION OF ARTERY WALL THICKENING
CHICAGOA medication given to diabetics to improve their body’s sensitivity to insulin also appears to slow the thickening of their artery walls, according to a study posted online today by JAMA. The study is being released early to coincide with its presentation at the American Heart Association Scientific Session. It will be published in the December 6 print issue of JAMA.
Individuals with diabetes, who cannot produce sufficient amounts of insulin or respond to the insulin needed to turn glucose into energy, have a higher risk for myocardial infarction (heart attack), according to background information in the article. Controlling blood pressure and low-density lipoprotein (LDL, or “bad”) cholesterol has been shown to reduce some of this excess risk. “However, even with optimal control of these potent cardiovascular risk factors, incremental risk for cardiovascular events remains high compared with individuals without diabetes,” the authors write. “New approaches are, therefore, needed to further reduce cardiovascular risk in patients with diabetes.”
Theodore Mazzone, M.D., of the University of Illinois College of Medicine, Chicago, and colleagues studied the effects of a potential new approach, using a drug known as pioglitazone, in 462 adults with type 2 diabetes in the Chicago metropolitan area between 2003 and 2006. Study participants had an average age of 60 and included 289 men and 173 women; they were randomly assigned to receive a daily dose of either pioglitazone (15 to 45 milligrams) or of glimepiride (1 to 4 milligrams), another diabetes medication that works through different mechanisms. At the beginning of the study and again 24, 48 and 72 weeks later, ultrasound was used to measure the thickness of the middle layers of the carotid arteries (which are located in the neck and carry blood to the brain). The measurements are called carotid artery intima-media thickness, or CIMT. Using this measurement, other studies have suggested that thicker artery walls, and changes in artery wall thickness over time, are associated with a higher risk for heart events. Glycosolated hemoglobin (HbA1c) levels, a measure of blood glucose control over an extended period, were also monitored throughout the study, as were blood pressure, blood cholesterol levels and adverse events.
A total of 158 (68 percent) of the pioglitazone group and 165 (72 percent) of the glimepiride group completed the 72-week trial; 175 (76 percent) of those in the pioglitazone group and 186 (81 percent) in the glimepiride group had at least one ultrasound of the carotid artery and were included in the artery wall thickness analysis. At baseline, the average CIMT was comparable in the pioglitazone group than among and the glimepiride group (.771 millimeters vs. .779 millimeters). At the 72-week follow-up period, the CIMT of patients in the glimepiride group increased by an average of .012 millimeters from the beginning of the study, while the average CIMT in the pioglitazone group decreased by .001 millimeters. “A pre-specified subgroup analysis based on age, sex, systolic blood pressure, duration of type 2 diabetes mellitus, body mass index, HbA1c value and statin use showed a uniform beneficial effect of pioglitazone treatment,” the authors write.
Over the course of the study, blood pressure changes were not significantly different between the two groups. HbA1c levels were also similar until week 48, when those in the pioglitazone group became significantly lower than those in the glimepiride group. High-density lipoprotein (HDL or “good”) cholesterol levels increased in those taking pioglitazone by week 24 and remained higher through 72 weeks compared with those taking glimepiride. These measures represent potential mechanisms by which pioglitazone reduced artery thickness, the authors write. “It also remains possible that thiazolidinediones [the class of drug that includes pioglitazone] can have a directly beneficial effect on the vessel wall,” they continue.
“Additional data will be needed to determine the clinical significance of these findings; specifically, whether a strategy of routine use of pioglitazone instead of glimepiride substantially reduces major cardiovascular events,” they conclude.
(JAMA. 2006;296:(doi:10.1001/jama.296.21.joc60158). Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Embargoed for Early Release: 8:00 a.m. CT, Monday, November 13, 2006
Media Advisory: To contact corresponding author Allen J. Taylor, M.D., call Walter Reed Army Medical Center public affairs at 202-782-7177. To contact editorial author Ross J. Simpson, Jr., M.D., Ph.D., call Stephanie Crayton at 919-966-2860.
PHARMACY CARE PROGRAM HELPS ELDERLY PATIENTS TAKE ALL THEIR MEDICATIONS
CHICAGOA pharmacy care program for elderly patients increases medication adherence, which results in improved health outcomes, according to a study posted online today by JAMA. The study is being released early to coincide with its presentation at the American Heart Association Scientific Session. It will be published in the December 6 print issue of JAMA.
“Adherence to chronic pharmacological therapies is poor, leading to worsening disease severity and increased costs associated with higher hospital admission rates,” the authors provide as background information. “Barriers to medication adherence are numerous, but include the prescription of complex medication regimens, treatment of asymptomatic conditions and convenience factors. These factors are particularly prevalent among the elderly population, placing them at increased risk for medication nonadherence.”
Jeannie K. Lee, Pharm.D., and colleagues from Walter Reed Army Medical Center, Washington, D.C., report the results from the Federal Study of Adherence to Medications in the Elderly (FAME), a multi-phase investigation that included 200 community-based patients age 65 years or older taking at least four chronic medications. The FAME study, which was conducted from June 2004 to August 2006 consisted of three phases. First, all 200 patients entered a two-month run-in phase that provided a baseline for medication adherence using pill counts, and for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) readings. Of these patients, 174 then entered a six-month intervention phase that included standardized medication education, regular follow-up by pharmacists and all medications dispensed in time-specified blister packs. Following the intervention phase, 159 patients were randomized to continue the pharmacy care program or return to their usual care for an additional six months.
The average age of the study patients was 78 years. Cardiovascular risk factors were prevalent and included drug-treated hypertension in 184 patients (91.5 percent) and drug-treated hyperlipidemia in 162 patients (80.6 percent). The patients took an average of nine different chronic daily medications. At the beginning of the first phase of the study, the researchers found the average medication adherence was 61.2 percent. “After six months of intervention, medication adherence increased to 96.9 percent and was associated with significant improvements in systolic blood pressure (133.2 to 129.9 millimeters of mercury) and LDL-C (91.7 to 86.8 milligrams per deciliter),” the researchers report. “Six months after randomization, the persistence of medication adherence decreased to 69.1 percent among those patients assigned to usual care, whereas it was sustained at 95.5 percent in pharmacy care.” The pharmacy care group also had significant reductions in systolic blood pressure compared to the usual care group, but no significant differences between the groups in LDL-C levels or reductions.
“In this study, a comprehensive pharmacy program composed of patient education and custom blister-packed medications was associated with substantial and sustained improvements in medication adherence among elderly patients receiving complex medication regimens. The association of improved medication adherence with reduced levels of BP and LDL-C suggests that such a program could lead to meaningful improvements in health outcomes. The results of the FAME study call for greater emphasis within health care delivery systems and policy organizations on the development and promotion of clinical programs to enhance medication adherence particularly among the at-risk elderly population,” the authors conclude.
(JAMA. 2006;296:(doi.10.1001/JAMA.296.21.joc60162). Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: CHALLENGES FOR IMPROVING MEDICATION ADHERENCE
In a related editorial, Ross J. Simpson Jr., M.D., Ph.D., from the University of North Carolina at Chapel Hill writes “for chronic medical conditions, such as hypercholesterolemia and hypertension, a wide and persistent separation exists between evidence-based recommendations and the actual care patients receive.”
“Patient characteristics that may lead to poor adherence include advanced age, cognitive impairment and depression as well as attitudes and beliefs about the importance of the medication, the disease being treated and the potential for adverse effects.”
“…the study by Lee and colleagues adds important information about improving medication adherence in elderly patients and also highlights the challenges inherent in designing and conducting high-quality research in this critically important area. Multifaceted interventions that incorporate structural and counseling components and include appropriately skilled and motivated pharmacists appear useful to promote medication adherence and persistence. Future studies are needed to confirm that interventions incorporating these components will result in increased and sustained patient adherence and, better yet, will improve outcomes.”
(JAMA. 2006;296:(doi:10.1001/jama.296.21.jed60074). Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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