In the News for the Week of 2-27-07
- AHA: All women should consider aspirin use to prevent stroke
- Health care spending slowed as drug spending rose
- Patches may be safer than pills in hormone therapy
- ACP Journal Club: Abnormal D-dimer test indicated that anticoagulation should be continued
- New evidence for COPD treatments
- High pulse pressure indicates risk of atrial fibrillation
- Several drug warnings, alerts and directives issued
- Avoid gadolinium MRI with kidney disease patients
- NFID campaign targets flu vaccination among diabetics
All women should consider using aspirin regularly to prevent strokes, the American Heart Association said last week in updated, evidence-based guidelines released online Feb. 19 by Circulation.
Healthy women under age 65 should consider taking 81 mg daily or 100 mg every other day of aspirin, as long as the benefit of preventing ischemic stroke seems to outweigh adverse effects like intestinal bleeding and hemorrhagic stroke, the guidelines said. The same recommendation applies to women 65 and older whose blood pressure is controlled, to prevent stroke and myocardial infarction.
Women should check with their doctors before starting an aspirin regimen, noted Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, in the Feb. 20 Philadelphia Inquirer.
Folic acid, antioxidant supplements, hormone therapy and selective estrogen-receptor modulators shouldn’t be used to prevent cardiovascular disease, the new guidelines said. The guidelines also advised doctors to look at several factors–in addition to the short-term absolute Framingham global risk score–when deciding on preventive therapy. Those include medical and lifestyle history, family history of CVD and genetic conditions.
Additional recommendations deal with exercise, diet, fat intake, alcohol and smoking, weight, dietary supplements and blood pressure. All recommendations include an indication of the strength of the recommendation and the level of evidence to support it.
Risk categories were changed to reflect the fact that the average lifetime risk for CVD in women is high-- nearly 1 in 2, and to place greater emphasis on lifetime risk than short-term risk. Last revised in 2004, the guidelines cover the primary and secondary prevention of chronic atherosclerotic vascular diseases. An evaluation and treatment algorithm is also included with the guidelines.
The Circulation article is online.
The Philadelphia Inquirer is online.
Growth in health care spending slowed in 2006, while prescription spending growth accelerated to 6.5%, according to a new government report. It marks the fourth consecutive year of a slowing trend for U.S. health spending growth.
The CMS report reflects projections by government economists and actuaries. The experts calculated that health spending grew 6.8% in 2006, compared with 6.9% in 2005, and that, as a share of gross domestic product, health care will hold steady before resuming an upward trend. By 2016, projections show that nearly 20 cents of every dollar of U.S. spending will go to health care.
Medicare Part D has dramatically redistributed drug spending from private payers to public although the net effect on overall spending is expected to be small, the report found. Private insurers’ ability to negotiate medication prices through Part D has helped to hold down prices even as more seniors are able to get drugs, report authors said in the Feb. 21 Washington Post. The report was published in the Feb. 21 issue of Health Affairs.
In the long term, the report predicted that public spending growth will outpace private health care spending. From 2008 to 2016, private spending is expected to grow at an average annual rate of 6.4%, compared with 7.5% in public spending. The statistics indicate that the U.S. is moving away from traditional sources of insurance, such as employer-based coverage, to a system comprising more federal and state-government provided health care, noted the report authors.
Health Affairs is online.
The Washington Post is online.
Hormone therapy administered through patches and gels may present less risk of blood clots, a new French study found. Researchers in the Estrogen and Thromboembolism Risk study found that route of delivery, type and dose of hormone therapy (HT) affect rates of venous thromboembolism (VTE).
The multicenter, case-control study took 271 consecutive cases of VTE in women and matched them to hospital and community controls. HT use was present in 46% of the VTE cases and 37% of controls. Compared to non-hormone patients, women who took oral HT had a four-fold risk of VTE, while the transdermal hormone users had no increased risk. The study was published in the Feb. 20 issue of the American Heart Association's journal, Circulation.
The data lends support to evidence that the route of estrogen administration matters, although similar data is not readily obtainable in the U.S., where transdermal HT is more unusual, noted an accompanying editorial. Large-scale clinical trials are needed but unlikely to be conducted in the near future, the editorial said. The Kronos Early Estrogen Prevention study will offer one investigation, randomizing women to micronized progesterone with either conjugated equine estrogen or transdermal estradiol.
The findings should have a significant impact on current thinking about HT, much of which is based on the Women’s Health Initiative findings, a co-author of the editorial told the Feb. 20 Wall Street Journal. The findings in the WHI (in which 44% of adverse events were related to VTE) might have been dramatically different if patches had been used, particularly for women who are recently menopausal, the author said.
The Circulation article is online.
The Wall Street Journal is online (subscription required).
A new trial found that an abnormal D-dimer test result indicates that anticoagulation should be continued to prevent venous thromboembolism (VTE) recurrence.
In the randomized controlled trial, researchers followed 619 Italian patients who had a first episode of symptomatic, unprovoked VTE, had received a vitamin-K antagonist or acenocoumarol for three months or more, and had D-dimer testing 30 days after anticoagulation was discontinued. Of the patients with abnormal D-dimer levels, 122 were assigned to remain off coagulation and 105 resumed anticoagulation with vitamin-K antagonists.
In a follow-period of up to 18 months, 15% of the patients with abnormal levels who remained off anticoagulation had recurrent VTE or major bleeding events, compared with 2.9% of those who resumed the therapy (number needed to treat = 12). The rate of recurrent VTE in patients with normal D-dimer levels following initial anti-coagulation did not differ from patients who had abnormal D-dimer levels following initial anticoagulation and resumed anticoagulation. The study is abstracted in the March/April ACP Journal Club.
The study is an important step in the refinement of anticoagulation care for patients with VTE, but should not establish a practice standard, said Journal Club reviewer Mark Crowther, MD, of McMaster University in Hamilton, Ontario. Further studies are needed to develop a risk-stratification system to identify risk factors (such as biomarker levels and the degree of residual venous obstruction) for recurrence before anticoagulation is stopped. Dr. Crowther also noted that the study used a qualitative D-dimer test, although growing numbers of laboratories use quantitative tests.
Peer ratings for this review: Internal Medicine, Hematologists/Thrombosis: 7/7 stars.
ACP Journal Club is online.
Combination therapy for chronic obstructive pulmonary disease (COPD) shows significant benefits over monotherapy options but does not significantly affect mortality rates, a new study found.
In the randomized double-blind trial, researchers treated 6,112 patients with salmeterol plus fluticasone propionate (combination therapy), placebo, salmeterol alone or fluticasone alone for a period of three years. The primary outcome was death from any cause, although the frequency of exacerbations, health status and spirometric values were also assessed. The study was published in the Feb. 22 New England Journal of Medicine.
All-cause mortality rates were 12.6% in the combination therapy group, 15.2% for placebo, 13.5% for salmeterol, and 16.0% for fluticasone. Although combination therapy had the best result, the differences in mortality did not meet the study’s standard for statistical significance. However, study authors did conclude that the combination regime showed significant benefits in all other outcomes, including reducing the annual rate of exacerbations from 1.13 to 0.85.
One weakness of the study was that 40% or more of the enrolled subjects dropped out, noted an accompanying editorial. Patients in the placebo group may have left because their symptoms became intolerable, thus explaining why the trial failed to demonstrate the expected mortality rate in the placebo group.
Overall, the study indicates that monotherapy with corticosteroids should not be advocated for patients with COPD and that monotherapy with a long-acting bronchodilator appears to be safe, the editorial suggested. Caution in the use of combination therapy is urged because of the increased rate of pneumonia among all study patients receiving inhaled corticosteroids, a finding that requires further investigation, the editorial said.
Another recent study, released online last week by the Annals of Internal Medicine, compared treatments in 449 Canadians with COPD. In the randomized controlled trial, researchers tested tiotropium in combination with either salmerterol, futicasone-salmeterol or a placebo. The study found that the addition of fluticasone–salmeterol to tiotropium therapy did not statistically influence rates of COPD exacerbation but did improve lung function, quality of life, and hospitalization rates in patients with moderate to severe COPD. The article will be published in the April 17 print issue of Annals.
Annals of Internal Medicine is online.
Pulse pressure is an important risk factor for incident atrial fibrillation, a study in the Feb. 21 issue of the Journal of the American Medical Association found.
The study involved 5,331 subjects age 35 and older who had no prior or current AF. Researchers measured baseline pulse pressures and monitored patients for incident atrial fibrillation for a mean period of 16 years.
AF developed in 13.1% of subjects about 12 years after baseline pulse pressure was assessed. Cumulative 20-year AF incidence rates were 5.6% for pulse pressure of 40 mm Hg or less and 23.3% for pulse pressure greater than 61 mm Hg. In models adjusted for age, sex, baseline and time-dependent change in mean arterial pressure, and for clinical risk factors for AF, pulse pressure was associated with increased risk for AF (adjusted HR, 1.26 per 20-mm Hg increment; 95% CI). Mean arterial pressure was unrelated to incident AF (adjusted HR, 0.96 per 10-mm Hg increment; 95% CI).
Results indicate that arterial stiffness, as evidenced by elevated pulse pressure, “represent a potentially modifiable risk factor for AF,” the authors said. “These findings underscore a potential weakness of simply concentrating on systolic pressure and ignoring diastolic and pulse pressure.”
Study limitations include the fact that echocardiographic measures were evaluated at a single examination rather than over time. Also, the cohort was mostly white, middle-aged to elderly, with normal or moderate blood pressure elevations, which might limit generalizability. Given our aging society and the fact that pulse pressure often increases with age, future research should examine whether interventions that alter pulse pressure will also alter AF risk, the authors said.
The Journal of the American Medical Association is online.
The FDA issued alerts, warnings and directives last week for several drugs:
Consumers who ordered Ambien (zolpidem), Xanax (alprazolam), Lexapro (escitalopram) and Ativan (lorazepam) online may have received haloperidol (Haldol) instead, the FDA warned. Several people who ordered the brand drugs used for depression, anxiety and insomnia over the Internet reported receiving the generic antipsychotic instead, and some wound up in the emergency department with breathing difficulty, muscle spasms and stiffness, the FDA said.
Consumers reported receiving the pills through various Internet sites. The origin of the false tablets is still unknown, but packages were postmarked in Greece. Photos of the tablets and packaging are online (see URL below), and consumers who received such products are urged not to take them and to report them to the FDA and their health care providers.
The FDA release is online.
Photographs of the haloperidol tablets and their packaging are online.
Information on buying medicines is online.
Manufacturers of all drugs for Attention Deficit Hyperactivity Disorder (ADHD) were directed to develop Patient Medication Guides to alert patients to the drugs’ possible cardiovascular and psychiatric risks, and to advise precautions be taken. Risks include sudden death, stroke, and heart attack in certain patient populations, as well as hearing voices, becoming suspicious for no reason, and mania in patients without previous psychiatric problems.
Physicians should work with those being considered for treatment with ADHD drug products to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems, the FDA said.
The FDA release is online.
The draft patient medication guides are online.
Genentech was asked to add a boxed warning to the omalizumab (Xolair) label warning that the allergy-based asthma medicine may cause anaphylaxis. The FDA also requested that the existing warning for anaphylaxis be strengthened in the patient medication guide to include the possibility of a patient developing anaphylaxis after any dose–even if there was no reaction to the first dose–and that anaphylaxis after administration of the drug may be delayed up to 24 hours after a dose is taken.
Health care providers should observe patients for at least two hours after an omalizumab injection and be ready to manage life-threatening anaphylaxis, the FDA said. Patients also should carry and know how to initiate emergency self-treatment for anaphylaxis.
The FDA release is online.
Based on new study results, healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone (Avandia), the FDA said in a Medwatch safety alert.
Avandia manufacturer GlaxoSmithKline found women with type 2 diabetes mellitus who took rosiglitazone suffered more fractures of the upper arm, hand or foot than women who took metformin (Glucophage) or glyburide (Diabeta), the FDA said. An independent safety committee reviewed an interim analysis in a separate study and found consistent results.
The FDA alert is online.
MRI contrast agents containing gadolinium are potentially dangerous to people with advanced kidney disease and should be avoided in these patients except when medically necessary, according to a new recommendation from the CDC and a recent FDA advisory.
The CDC recently conducted an investigation of nephrogenic systemic fibrosis (also known as nephrogenic fibrosing dermopathy), a condition that is characterized by thickening and hardening of the skin and can lead to joint immobility and significant disability in affected persons. The investigation confirmed earlier studies finding an association of gadolinium exposure to development of NSF.
Another recent study found gadolinium levels in the tissue of patients with NSF that are 35- to 150-fold higher than the level of gadolinium retained in the bone of healthy volunteers with normal kidney function. Many academic medical centers, including Yale and Johns Hopkins, have recently drawn up guidelines regarding the use of gadolinium in patients with kidney disease.
The CDC study, published in the Feb. 23 Morbidity and Mortality Weekly Report, traced 33 NSF patients in St. Louis and found an association with gadolinium. As of Dec. 25, 2006, the FDA MedWatch system had received 90 reports of NSF possibly related to gadolinium-containing contrast agents. Clinicians should be aware of the potential for NSF and when possible avoid use of gadolinium-contrast agents in patients with advanced kidney disease, the CDC said.
The Morbidity and Mortality Weekly Report is online.
The FDA advisory is online.
The National Foundation for Infectious Diseases launched a campaign last week to increase flu vaccination rates among diabetics, less than half of whom are immunized each season.
Diabetics aged six months and older, as well as their close contacts (including household members and healthcare workers), should get annual flu vaccinations, the CDC and American Diabetes Association said. A new NFID report, “Improving Influenza Vaccination Rates in Adults and Children with Diabetes: Overcoming Immunization Barriers in this High-risk Population," identifies tactics that clinical practices can use to encourage vaccinations. They include:
- Increasing flu vaccine access and demand via influenza vaccine-only clinics, extended office hours and consumer education.
- Overcoming practice-related barriers by, for example, updating standing orders and adding flu vaccination to quality care checklists
- Recommending flu vaccination to patients via posters, postcards and emails.
Diabetics may have impaired immune function that can lead to increased morbidity and mortality from influenza infection, the NFID noted. Influenza may also interfere with blood glucose management, putting diabetics at increased risk of high glucose levels and diabetic coma.
Studies have found more than 70% reduction in hospitalization and death among diabetic adults who received flu vaccines, the release said. Several medical groups, including ACP, support the goals of the NFID initiative.
The NFID release is online.
The NFID campaign brochure is online.
William A. Bailey, the man who illegally downloaded information about 80,000 ACP members from the College’s Web site, has been sentenced to three months in prison, followed by three months probation under electronic surveillance and three years of supervised release, according to the U.S. Attorney’s Office in Philadelphia.
Mr. Bailey, of Charlotte, N.C., pled guilty to computer intrusion in October of 2006 and was subsequently convicted. Mr. Bailey downloaded contact information between January and May 2005 for the benefit of a company he owned called dr-411.com, which sold contact information for doctors. He has since paid $150,000 in civil damages to ACP and was fined an additional $10,000 at his sentencing.
The U.S Attorney's Office said Mr. Bailey stole only contact information from ACP, which did not include Social Security numbers or credit-card information.
The case began when ACP noticed increased activity on the ACP Web site and notified the FBI. After the College recognized the incursion, members reported receiving mail and email from unfamiliar sources.
Douglas K. Owens, ACP Member, Chair of ACP's Clinical Efficacy Assessment Subcommittee, won this year's VA Under Secretary's Award for outstanding achievement in health services research.
Dr. Owens is a senior investigator for the Center for Health Care Evaluation at the VA Palo Alto Health Care System in Palo Alto, Calif., as well as a professor of medicine and health research and policy at Stanford University. The award was presented to him by the VA on Feb. 22nd.
Dr. Owens was nominated by his medical center for his research focusing on evaluating the effectiveness and cost effectiveness of medical technologies, clinical decision making, and the development of clinical practice guidelines. The award comes with a one-time $5,000 cash prize and $50,000 a year in research support for three years.
More information is online.
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Copyright 2007 by the American College of Physicians.
A 68-year-old woman undergoes upper endoscopy for evaluation of dyspepsia. She has a history of pernicious anemia. She has no other medical problems and her only medication is oral vitamin B12. Upper endoscopy discloses a 6-mm polyp in the body of the stomach, which is removed by polypectomy. Pathologic examination of the polyp confirms a well-differentiated neuroendocrine tumor. What is the most appropriate management?
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