In the News
for the Week of 2-12-08
- NIH halts diabetes trial of intensive blood sugar treatment
- ACS patients at risk for adverse events soon after stopping clopidogrel, study finds
- Domestic violence associated with chronic disease, risky behaviors
- Cardiac rehab rates remain low in survivors of heart attack
- Suction of artery blockages shows promise in new study
- ACP Journal Club: In-home palliative care increases patient satisfaction, lowers costs
- Neurologists issue guidelines to assess risk for falls
- Varenicline gets warning for possible neuropsychiatric symptoms
- Class I recall of Medtronic drug pump
ACP publishing news
- Cartoon caption contest: Put words in our mouth
- Deadline for "Internists as Artists" program entries
NIH halts diabetes trial of intensive blood sugar treatment.
A large government trial of diabetes treatments was halted last week after it was found that intensive efforts to lower patients’ blood sugar were associated with higher mortality rates.
The ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial included more than 10,000 patients who had diabetes and at least two other risk factors for heart disease. The patients were randomized to either intensively low blood sugar goals (A1c of less than 6%) or standard goals and treatment (A1c between 7% and 7.9%). Over the almost four-year study period, 257 patients in the intensive group had died, compared with 203 patients in the standard group, NIH officials announced last week. Based on that survival difference (which works out to 3 deaths per 1,000 participants per year), officials decided to halt the intensive treatment arm of the trial.
The researchers have not uncovered an explanation for the difference in survival, although an investigation is ongoing. Overall, death rates in both groups were lower than in similar populations in other studies. Because of recent concerns, the researchers specifically looked at rosiglitazone for a link to the increased deaths, but they found no association. The standard treatment arm of the ACCORD study, as well as related trials of blood pressure and lipid treatment, will continue until the planned conclusion date of June 2009.
The trial was inspired by previous research that had found a potential link between lower blood sugar and lowered risk of cardiovascular disease. During the ACCORD study, half of the intensive group participants achieved an A1c of less than 6.4% and half of the standard group had an A1c of less than 7.5%. Average blood sugar levels for both groups were lower than when they entered the study.
The findings on survival difference should have little impact on clinical practice, because few high-risk patients are currently treated to such low blood sugar goals, NIH experts said. They also urged patients not to adjust their treatment plans without consulting a health care provider. The results do raise broad questions about appropriate targets and intensity of treatment, which will require further research, experts told the Feb. 7 Washington Post.
The NIH press release is online.
The Washington Post is online.
ACS patients at risk for adverse events soon after stopping clopidogrel, study finds.
Patients with acute coronary syndrome (ACS) who are prescribed clopidogrel after medical or surgical treatment are at increased risk for adverse events soon after stopping the drug, according to a new study.
Researchers used data from the Veterans Affairs Veterans Health Administration Cardiac Care Follow-up Clinical Study to determine when and how often ACS patients died or had acute myocardial infarction (MI) after stopping post-treatment clopidogrel. The study looked at 1,568 patients with ACS who had received medical therapy and 1,569 patients with ACS who had received percutaneous coronary intervention (PCI). Patients were mostly male veterans (98.2%) discharged from 127 hospitals between Oct. 1, 2003, and March 31, 2005 with prescriptions for clopidogrel. The results appear in the Feb. 6 Journal of the American Medical Association.
After clopidogrel treatment was stopped, medical patients and PCI patients were followed for a mean of 196 and 203 days, respectively. Death or acute MI occurred in 268 (17.1%) medical patients and 124 (7.9%) PCI patients after stopping clopidogrel, with 163 (60.8%) events and 73 (58.9%) events, respectively, occurring from 0 to 90 days after the drug was stopped. When the authors performed multivariable analysis that adjusted for length of clopidogrel treatment, they found a significantly higher risk in the 0- to 90-day period after stopping clopidogrel in both medical and PCI patients (incidence rate ratio, 1.98 [95% CI, 1.46 to 2.69] and 1.82 [CI, 1.17 to 2.83], respectively, compared with 91 to 180 days).
The study had several limitations, including the homogeneous study cohort and the lack of information on patients’ reasons for stopping clopidogrel treatment. However, the authors wrote that their results, if replicated in other populations, could have clinical implications. They stressed that their findings do not necessarily indicate that the potential risk outweighs the benefit of clopidogrel after ACS, but called for more studies to confirm the presence of a cluster effect after clopidogrel cessation. If their findings are confirmed, the authors wrote, clinical guideline recommendations regarding clopidogrel therapy might need to be reconsidered.
The Journal of the American Medical Association is online.
Domestic violence associated with chronic disease, risky behaviors.
The results of the largest study to date on intimate partner violence (IPV) in the U.S. add to mounting evidence that victims of domestic violence are prone to a host of serious chronic diseases and risky behaviors.
Results from the CDC's 2005 Behavioral Risk Factor Surveillance System telephone survey, which included 70,000 adults, revealed that 10,243 (24%) of female and 3,035 (12%) of male respondents had a lifetime history of IPV. Men and women with a history of domestic violence had significantly higher rates than other respondents of arthritis, asthma, activity limitations and stroke, as well as risky behaviors including heavy drinking, smoking and high-risk sexual behaviors. Women with a history of IPV also were more likely to have heart attacks, hypertension and heart disease.
The results underscore the need for primary care physicians to assess for IPV, especially when patients show signs or symptoms of ongoing stress, said the report. They also suggest that secondary intervention strategies are needed to address the health-related needs of IPV victims.
While the survey cannot infer a causal relationship, said an editorial accompanying the article in the CDC's Feb. 8 Morbidity and Mortality Weekly Report (MMWR), evidence from other studies suggests that the biologic response to long-term stress might be an underlying factor. For example, said the editorialist, a link has been found between violence, stress and somatic disorders, such as fibromyalgia, and stress has been linked to chronic diseases such as cardiovascular disease and asthma.
The MMWR report is online.
The CDC's "Intimate Partner Violence and Sexual Violence Victimization Assessment Instruments for Use in Healthcare Settings" is online.
Cardiac rehab rates remain low in survivors of heart attack.
Only about one-third of heart attack survivors participate in outpatient cardiac rehabilitation, despite evidence that it reduces morbidity and mortality and improves outcomes, according to a new CDC survey.
As part of the CDC's 2005 Behavioral Risk Factor Surveillance System telephone survey, 129,416 people from 21 states and the District of Columbia responded to questions about heart attack history and cardiac rehab. Overall, 4.2% reported having had a heart attack and, of those, 34.7% said they had received cardiac rehab on an outpatient basis. Current guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation note that rehab reduces morbidity and mortality, improves clinical outcomes, enhances psychological recovery and decreases the risk for secondary cardiac events.
Cardiac rehab prevalence was 25.3% for patients younger than age 50 and ranged from 35.5% to 37.0% in older patients. Age-adjusted rehab prevalence was higher in men than in women and Hispanics reported a higher prevalence than non-Hispanic whites. Rehab was also more prevalent among patients living in urban areas and with higher levels of education and higher incomes. The results appear in the Feb. 1 Morbidity and Mortality Weekly Report.
An accompanying editorial reiterated the importance of cardiac rehabilitation in patients who have had a heart attack and noted that the rate of receipt reported in this survey, approximately one-third, is consistent with that seen in other studies. Many factors could explain these low rates, the author wrote, including cost and lack of access. Future studies should examine barriers to rehab participation and ways to improve referral to these services, the editorialist concluded.
The MMWR article is online.
Suction of artery blockages shows promise in new study.
Vacuuming out artery blockages during a myocardial infarction (MI) results in better outcomes than standard primary percutaneous coronary intervention (PCI), according to a new study.
The randomized trial included 1,071 Dutch patients who received either conventional PCI or thrombus aspiration, in which, instead of opening the artery with a balloon, a small catheter is advanced into the occluded segment. Direct aspiration of the occluding thrombus was then performed, followed by stenting, usually without balloon dilation. The goal of the new procedure was to avoid the microvascular obstruction that can be caused by atherothrombotic debris from conventional PCI.
Using coronary angiography, the researchers found that 26% of the conventional treatment group had little or no blood reaching the heart through the artery (myocardial blush grade 0 or 1) compared with 17% of the aspiration group. The aspiration group also had better rates of complete resolution of ST-segment elevation (57% resolved compared with 44%). After 30 days of follow-up, the study also found that patients with the lowest blood flow had the highest rates of mortality and adverse events (5% death rate for blush grades 0 and 1 compared with a 1% rate for blush grade 3). The study was published in the Feb. 7 New England Journal of Medicine.
Study authors concluded that thrombus aspiration is applicable in a large majority of patients with myocardial infarction with ST-segment elevation, and that it results in better reperfusion and clinical outcomes than conventional treatment. The authors are now using the technique in their hospital and expect others to adopt it soon, according to the Feb. 7 Washington Post.
An accompanying editorial called the study results encouraging, but expressed concern about whether the results of this single-center trial could be repeated on a larger scale as well as the possibility of catheter-caused damage to the arterial segment. The editorialist also noted that current quality guidelines in the U.S. are focused on door-to-balloon time, and would have to be revised if the technique were to be adopted.
The Washington Post is online.
ACP Journal Club: In-home palliative care increases patient satisfaction, lowers costs.
A study found that adding in-home palliative care to usual care increased patient satisfaction and reduced use and costs of medical services.
The randomized controlled trial involved 310 patients with a mean age of 74 who had a primary diagnosis of congestive heart failure, chronic obstructive pulmonary disease or cancer, and a life expectancy of 12 months or less. Half were assigned to usual care (per Medicare guidelines) alone, and half to in-home palliative care (IHPC) plus usual care. IHPC involved a team of health professionals who coordinated and assessed care across settings.
More patients in the IHPC group than the usual care group were “very satisfied” with patient care at 30 and 90 days, but the groups did not differ at 60 days. Fewer patients in the IHPC group visited the emergency department or were hospitalized, and IHPC resulted in lower mean costs of care ($12,670 vs $20,222, 95% CI of the difference ˙$12,411 to ˙$780) and lower mean daily costs ($95 vs $213 per day). Mean survival time was shorter in the IHPC group (196 days vs 242 days), and more patients in the IHPC group died at home. The study is abstracted in the January/February ACP Journal Club.
The IHPC model used in the study limits the generalizability of the results--especially the costs and care utilization--because the composition of palliative care teams has not been standardized and may vary across settings, wrote Journal Club reviewer Jennifer Chambers, MD, of the Milton S. Hershey Medical Center. Such standardization, as well as further examination of the survival difference between groups, should occur before IHPC is widely implemented, she added, although primary care physicians may wish to suggest IHPC to patients with life-limiting illness who are not eligible for or interested in hospice care.
Peer ratings for this review: Internal Medicine/Family Practice, Geriatrics: 6/7 stars. Cardiology, Oncology, Pulmonology: 5/7 stars.
ACP Journal Club is online.
Neurologists issue guidelines to assess risk for falls.
The American Academy of Neurology issued new guidelines last week to assist physicians in deciding which patients to screen for fall risks.
The guidelines are based on a review of literature from 1980-2005, and conclude:
- People who have been diagnosed with stroke, dementia and gait and balance disorders, and who use assistive devices to ambulate, have an established higher risk of falls;
- Those with Parkinson disease, peripheral neuropathy, lower extremity weakness or sensory loss, and substantial vision loss have a probable higher risk of falls;
- A history of falling in the last year strongly predicts the likelihood of future falls;
- General risk factors for falls included advanced age, age-associated frailty, arthritis, impairments in activities of daily living, depression, and the use of psychoactive medications like antidepressants, sedatives and neuroleptics.
Patients with any of the above risk factors should be asked about falls in the past year and further examined for the presence of specific neurologic deficits that predict falls, said the article in the Feb. 5 issue of the journal Neurology. If a further assessment of fall risk is needed after a comprehensive neurologic exam, health professionals should consider using the Get-Up-and-Go Test or Timed Up-and-Go Test, and the Tinetti Mobility Scale.
Unintentional falls account for more than 16,000 deaths and 1.8 million emergency room visits every year, the authors noted. Since many patients who are at risk seek neurologic consultations, physicians have an opportunity to identify those at greatest risk and offer interventions that could prevent falls, like gait training, review and reduction of medications, and exercise programs, the authors said.
The Neurology article is online.
Varenicline gets warning for possible neuropsychiatric symptoms.
The prescribing information for varenicline (Chantix) is being revised to warn health professionals, patients and caregivers to monitor patients for changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior, the FDA said last week.
Nicotine withdrawal may have complicated some reports of neuropsychiatric symptoms, but other patients have experienced symptoms without having stopped smoking. Some patients with pre-existing psychiatric illness saw a worsening or recurrence of their conditions, as well, and physicians should inquire about any history of psychiatric illness before starting patients on varenicline. In most cases, symptoms developed during treatment, but in some cases they developed after withdrawal of therapy.
The FDA issued an early communication to health care providers last November saying it was reviewing adverse event reports related to varenicline. As the review has proceeded, “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms,” the FDA said in a release.
Class I recall of Medtronic drug pump.
The FDA last week issued a Class I recall of several models of the Medtronic SynchroMed EL Implantable Infusion Pump.
The recalled models are: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. They were recalled because some pump motors may stall, which would stop drug delivery suddenly and possibly lead to withdrawal. Drug withdrawal from Intrathecal Baclofen Therapy can be fatal if not treated quickly and effectively.
Medtronic sent a letter to health professionals in August warning of the potential for the motors to stall. About 52,000 patients currently have the device, and about 8,000 of them have the type that could fail, but no deaths or serious injuries related to the products have been reported, according to the Feb. 4 Minneapolis Star-Tribune.
The FDA safety alert is online.
The Minneapolis Star-Tribune is online.
ACP publishing news
Caption contest: Put words in our mouth.
InternistWeekly wants readers to create captions for this cartoon--and help choose the winner.
E-mail all entries to firstname.lastname@example.org by Feb. 14. ACP staff will choose three finalists and post them in the Feb. 19 issue of InternistWeekly for an online vote by readers. The winner will appear in the Feb. 26 issue.
Pen the winning caption and win a copy of "Medicine in Quotations," ACP's comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history.
Deadline for "Internists as Artists" program entries.
Entries for ACP's national "Internists as Artists" program at Internal Medicine 2008 are now being accepted. All entry application forms must be submitted by March 14.
Designed to showcase physicians' talents in the visual arts, the "Internists as Artists" exhibit will be located in the Exhibit Hall of the Walter E. Washington Convention Center in Washington, D.C., during Internal Medicine 2008. Submissions can include painting, sculpture, photography, mixed media, woodworking, jewelry, crafts and ceramics.
Members interested in submitting entries must complete an application form and send it along with either a photograph or an electronic image of their artwork. (Member artists may submit a maximum of two entries.) Entries will be judged by program jury members, and each piece must be completely display-ready when it is submitted for consideration in the exhibit.
"Internists as Artists" is modeled on an Evergreen Award-winning event established by ACP's Virginia Chapter.
Completed application forms and electronic or photographic images should be sent to: Helen Canavan, ACP Internists as Artists Program, 190 N. Independence Mall West, Philadelphia, PA 19106-1572. Ms. Canavan can also be reached via e-mail at email@example.com or by calling 800-523-1546, ext. 2663.
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Copyright 2008 by the American College of Physicians.
A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?
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