In the News
for the Week of 9-29-09
- Trial vaccine partially effective against HIV
- 8.3 million adults seriously considered suicide last year
- MKSAP Quiz: atrioventricular nodal reentrant tachycardia
- WHI analysis finds that HRT may increase women’s risk of aggressive lung cancer
- Inactivated more effective than live vaccine during 2007-08 flu season
- New recommendations focus on self-care for heart failure
- Statins may be comparable to other primary prevention therapies in those with high CRP and low LDL
- Tamiflu dosing warning issued for mix-ups between milligrams and milliliters
- ACP calls for increased role for FDA
Health care reform
- ACP Advocate highlights Baucus bill, liability reform
From ACP Internist
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From the College
Cartoon caption contest
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Physician editor: Darren Taichman, ACP Member
Trial vaccine partially effective against HIV
For the first time, a vaccine has shown effectiveness in preventing HIV, government researchers reported last week.
The phase III trial used two previously developed vaccines, which had individually had no effect, in a prime-boost regimen. More than 16,000 adults ages 18 to 30 years participated in the randomized, controlled trial in Thailand. Participants received either placebo or ALVAX HIV vaccine, a modified canary pox vaccine, at enrollment and again at one month, three months and six months. At three and six months, participants in the placebo group again received placebo and those in the vaccine group received the AIDSVAX B/E vaccine, a glycoprotein 120 vaccine. The participants were tested for HIV infection every six months for three years.
At the conclusion of the study, 74 of the 8,198 patients in the placebo group had caught HIV, compared with 51 of the 8,197 in the vaccine group, a reduction of 31%. Patients who tested HIV-positive were provided free antiretroviral medications. The statistically significant, although modest, benefit shown by the trial permits cautious optimism about the possibility of developing a more effective vaccine, experts told the Sept. 24 New York Times.
The study also found that patients who became infected despite receiving the vaccine did not have lower levels of the virus in their blood than those who got the placebo. This finding is significant because it indicates that the markers researchers have been using to gauge vaccine effectiveness may be inaccurate, experts said. The discovery also demonstrates the importance of testing vaccines in patients, noted an NIH press release.
The trial was sponsored by the U.S. Army in collaboration with the National Institute of Allergy and Infectious Diseases, the government of Thailand, and Sanofi Pasteur and Global Solutions for Infectious Diseases (the manufacturers of the vaccines). The study partners are currently working to determine the next steps in research on this and other HIV vaccine candidates..
8.3 million adults seriously considered suicide last year
Nearly 8.3 million U.S. adults (3.7%) had serious thoughts of committing suicide in the past year, reported the Substance Abuse and Mental Health Services Administration, a division of the Department of Health and Human Services.
The report is based on 2008 data drawn from the National Survey on Drug Use and Health, which obtained responses from 46,190 persons aged 18 years or older. The study also shows that:
- 2.3 million adults made a suicide plan,
- 1.1 million adults attempted suicide, and
- adult women had marginally higher levels of suicidal thoughts and behaviors than males.
The chart breaks down suicidal ideation by age:
People experiencing substance abuse disorders within the past year were more than three times as likely to have seriously considered suicide (11% vs. 3% of non-substance abusers). Substance abusers were also four times more likely to have planned a suicide than those without substance abuse disorders (3.4% vs. 0.8%), and nearly seven times more likely to have attempted suicide (2% vs. 0.3%).
Only 62.3% of adults who had attempted suicide in the past year received medical attention for their attempts, and 46% stayed in a hospital overnight or longer for treatment.
MKSAP Quiz: atrioventricular nodal reentrant tachycardia
A 35-year-old man is evaluated for atrioventricular nodal reentrant tachycardia. Over the past 6 weeks, he has visited the emergency department twice for tachycardia; both episodes were successfully terminated with adenosine. A third recurrence was terminated at home with vagal maneuvers.
Physical examination is unremarkable. A resting electrocardiogram demonstrates no abnormalities with the patient in normal sinus rhythm. An outpatient echocardiogram is normal.
Which of the following will most likely prevent future episodes of tachycardia?
A) Calcium-channel blocker therapy
B) Amiodarone therapy
C) Digoxin therapy
D) Radiofrequency catheter ablation
Click here or scroll to the bottom of the page for the answer and critique.
WHI analysis finds that HRT may increase women’s risk of aggressive lung cancer
Combined hormone replacement therapy may increase a woman’s risk of developing more aggressive lung cancers, adding to the debate about whether the risks of hormone therapy outweigh its benefits.
Researchers analyzing the Women’s Health Initiative study performed a post hoc analysis of lung cancers diagnosed in the trial. This included more than 16,500 postmenopausal women randomly assigned to receive either combined hormone (oestrogen and progesterone) replacement therapy (HRT) or placebo.
After a mean of five to six years of treatment and two to four years of follow-up, there was no significant difference between the two groups in diagnosis of lung cancers. But more women in the HRT group died from lung cancer (73 vs. 40 deaths; 0.11% vs. 0.06%; HR 1.71, 95% CI, 1.16-2.52, P=0.01) compared with those taking placebo. The results were published online Sept. 20 in The Lancet.
While the follow-up period did not reveal a significant increase in incidence of non-small-cell lung cancer, the result should be interpreted with caution, the authors said. They noted that non-small-cell lung cancers, as well as poorly differentiated cancers and cancers with metastatic spread, were diagnosed more frequently in the HRT group. Considering the findings on increased mortality, these results suggest that HRT might stimulate the growth of already established non-small-cell cancers, they said.
The results, taken together with previous analyses, justify recommending discontinuation of HRT after lung cancer is diagnosed, said an accompanying editorial. HRT should be avoided in women at high risk for lung cancer, especially those with a history of smoking, the editorial added.
Combined with previous findings that HRT does not protect against heart disease, the current analysis should lead physicians to question whether HRT should be used at all, the editorialist said. The benefits of routine use of HRT may not outweigh the risks of mortality, the editorial concluded, especially if there is no improvement in quality of life.
Inactivated more effective than live vaccine during 2007-08 flu season
Inactivated influenza vaccine is more effective than live attenuated vaccine in preventing symptomatic influenza in healthy adults, a recent trial concluded.
Researchers conducted a randomized, double-blind, placebo-controlled trial of licensed inactivated and live attenuated flu vaccines in 1,952 healthy adults during the 2007-08 season. Absolute efficacy against types A and B was 68% for the inactivated vaccine compared with 36% for the live vaccine, a relative efficacy of 50%. The difference in efficacy against type A virus was 72% for the inactivated vaccine versus 29% for the live vaccine with a relative efficacy of 60% for the inactivated vaccine. The results appear in the Sept. 24 New England Journal of Medicine.
The trial, part of a multi-year study of flu vaccines that began in 2004-05, provides clear evidence of the superiority of the inactivated vaccine, the authors said. However, researchers still do not have conclusive evidence of the efficacy of vaccines for the type B virus because circulating type B virus strains were not included in the 2007-08 vaccine.
The authors also noted that a small proportion of participants who received the inactivated vaccine, but not those who received the live vaccine, had antibody responses to the novel type A (H1N1) virus. They anticipated that issues might arise related to which type A strain to include in licensed vaccines if the H1N1 virus continues to circulate along with other type A viruses.
New recommendations focus on self-care for heart failure
A new statement on heart failure from the American Heart Association summarizes current evidence on patient self-care and recommends specific steps that physicians should take to promote self-care by their heart failure patients.
Specific self-care behaviors outlined in the statement include medication adherence, symptom monitoring, dietary adherence, fluid and alcohol restriction, weight loss, exercise and smoking cessation. Recommendations for patients include, among others, maintaining current immunizations, developing medication adherence systems and monitoring body weight. The paper appears in the Sept. 22 Circulation.
The paper calls for better assessment of patients by physicians, such as routine, repeated and ongoing assessment of anxiety, depression, cognition, sleep quality, finances and availability of a family caregiver. Some of the paper’s specific recommendations for physicians include:
- Provide structured and individually reinforced education during all clinical encounters. Teach skills rather than simply providing information.
- Simplify the medication regimen whenever possible. Use once-daily medicines and fixed-dose combinations whenever possible.
- Assess for use of OTC medications and herbal remedies.
- Treat comorbid conditions aggressively.
- Screen routinely for barriers to self-care (e.g., inability to afford medicines).
- Refer patients who report poor sleep, who are obese, and whose bed partner reports snoring for screening for sleep-disordered breathing. Strongly encourage use of CPAP in patients with sleep-disordered breathing.
- Assess cognitive abilities on an ongoing, routine basis using an approach that is sensitive to known defects in memory, executive function, and processing speed.
The authors point out factors that can interfere with implementing self-care, including depression, sleep problems, impaired cognition in older adults, and comorbid conditions. They also highlight numerous failures in the health care system that discourage self-care, such as lack of patient education, inadequacy of performance measures addressing self-care after hospital discharge and guidelines that do not account for the fact that most HF patients have multiple comorbid conditions.
Future research should focus on finding better ways to detect early fluid retention, such as implanted devices; establishing evidence-based guidelines for dietary restrictions and weight loss; and evaluating the role of depression and anxiety in self-care, the authors concluded..
Statins may be comparable to other primary prevention therapies in those with high CRP and low LDL
Statin therapy may be comparable to other therapies for primary prevention of cardiovascular events in patients with low low-density lipoprotein levels but high C-reactive protein levels, according to a new study.
Previous results from JUPITER, a large, randomized, double-blind, placebo-controlled trial, found that rosuvastatin yielded large reductions in relative risk for first cardiovascular events in men and women with low levels of low-density lipoprotein (LDL) but high levels of C-reactive protein (CRP). However, the absolute risk reduction and subsequent number needed to treat (NNT) were unknown. Researchers further examined data from JUPITER to determine whether these variables were sufficient to warrant wider use of statins for primary cardiovascular prevention. JUPITER was supported by AstraZeneca.
The authors determined that the five-year NNT was 20 (95% CI, 14-34) for prevention of myocardial infarction, stroke revascularization or death and 29 (95% CI, 19-29) for net vascular benefit, including venous thromboembolism. They also found a five-year NNT of 29 (95% CI, 19-56) for a restricted "hard" end point of myocardial infarction, stroke or death. In comparison, previously reported five-year NNTs for primary prevention in men with hyperlipidemia were 40 to 70 for statins, 80 to 160 for antihypertensive therapy and more than 300 for aspirin. The study results appear in the November Circulation: Cardiovascular Quality and Outcomes.
The authors noted that JUPITER was stopped early and that the observed benefit of statins might dissipate with longer-term follow-up. However, they concluded that the absolute risk reduction and NNT for use of statins in patients with low LDL and high CRP levels are comparable to those of several accepted therapies for primary prevention of cardiovascular events. "These data may be informative in policy discussions regarding new guidelines for the primary prevention of cardiovascular disease," the authors wrote.
Tamiflu dosing warning issued for mix-ups between milligrams and milliliters
The FDA alerted prescribers and pharmacists about potential dosing errors with oseltamivir (Tamiflu) for oral suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters or teaspoons, while Tamiflu is dosed in milligrams. The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser.
Health care providers should write doses in milligrams if the dosing dispenser with the drug is in milligrams. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug. If prescription instructions specify administration using milliliters, the dosing device accompanying the product should be replaced with a measuring device (such as a syringe) calibrated in milliliters.
Additional information, including Tamiflu dosing for children over one year of age, is available online..
ACP calls for increased role for FDA
A new ACP policy paper calls for broader authority and increased funding for the FDA. "Improving FDA Regulation of Prescription Drugs" offers a half-dozen recommendations about how to improve the agency's ability to approve and monitor new drugs.
Health care reform.
ACP Advocate highlights Baucus bill, liability reform
Health care reform coverage continues in the ACP Advocate newsletter, which details the comprehensive reform package that was released by the Senate Finance Committee Chairman, Sen. Max Baucus, and takes a look at how liability reform is finally becoming part of the health care reform debate.
From ACP Internist.
The next issue is online and coming to your mailbox
The October issue of ACP Internist highlights the following stories.
Hospitals again look to integrate doctors. A new incarnation of hospital integration has sprung up, leaving some internists leery about signing on and others eager to set aside the increasingly onerous responsibilities of practice ownership.
Coordination key to post-stroke follow-up. Patients being treated by specialists for post-stroke care should keep primary care physicians at the center of their follow-up regimen.
Sorting out the worst offenders among herbal supplements. Internists need to monitor the ever-expanding range of herbs and supplements their patients might be taking for their patients’ and their own benefit.
Readers respond: Town hall meetings on health care seen as failure. Readers responding to ACP Internist's survey on the summer's town hall meetings said they saw them as a failure in the effort to reform health care.
From the College.
ACP launches ethics series on MedscapeCME
CME credits based on ACP Ethics Case Studies are available on MedscapeCME. The series features cases with commentaries by the College's Ethics, Professionalism and Human Rights Committee and the College's Center for Ethics and Professionalism. The studies use hypothetical examples to elaborate on controversial or subtle aspects of issues not addressed in detail in ACP's Ethics Manual, the Physician Charter on Professionalism, and other ACP position statements..
ACP Foundation offers patient guide for COPD
The ACP Foundation is launching its second patient self-management guide: Living with COPD: An Everyday Guide for You and Your Family. The same team that developed the Foundation's diabetes guide led the development of the COPD guide, with the addition of a pulmonologist and a smoking cessation expert. This guide will teach practical self-management skills and will motivate patients to modify their lifestyles and stop smoking by providing them with:
- practical information to help manage COPD
- affirming and motivating messages about living better with COPD
- voices and pictures of people with COPD in their everyday lives
- links to videos of real patients being shown how to use their inhaler
- a focus on the patient, not the disease
- pictures to tell the story
- strategies for setting achievable goals
- encouragement for patients to get support from family and friends
To order free COPD guides, visit the ACP Foundation’s Web site, click on the ORDER HERE button and enter promotional code ACPF0910IW. If you have any questions or concerns, please contact the ACP Foundation at 1-877-208-4189.
Cartoon caption contest.
Vote for your favorite entry
ACP InternistWeekly's cartoon caption contest continues. ACP staff has selected three finalists for the latest contest and is now asking readers to vote for their favorite caption to determine the winner.
"Apparently, HIPAA now requires we keep personal health information from the patient as well."
"We always cover the ears of the patient whenever we need to ask the nurse how to do something."
"As you may have surmised, palpation of the ears of a patient who presented with topical epoxy exposure is ill-advised."
Go online to view the cartoon and pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service. Voting continues through Oct. 5, with the winner announced in the Oct. 6 issue..
MKSAP answer and critique
The correct answer is D) Radiofrequency catheter ablation. This item is available online to MKSAP subscribers in the Cardiology section, Item 93.
ACP's Medical Knowledge Self-Assessment Program (MKSAP) allows you to:
- Update your knowledge in all areas of internal medicine
- Prepare for ABIM certification or recertification
- Support your clinical decisions in practice
- Assess your medical knowledge with 1,200 multiple-choice questions
To order the latest edition of MKSAP, go online.
This patient has atrioventricular nodal reentrant tachycardia that has recurred frequently despite adenosine treatment. Radiofrequency catheter ablation has a success rate of 90% to 95% and is the first-line therapy when medical therapy fails or medication-related adverse effects are intolerable. The efficacy of medical treatment is only 30% to 50%; therefore, radiofrequency catheter ablation has a better likelihood of preventing a recurrence in this patient.
Severity of symptoms and patient preference should also be considered when discussing treatment options in patients with AVNRT. Radiofrequency catheter ablation carries a 1% chance of causing complete heart block, necessitating a permanent pacemaker. For this reason, medical therapy should always be offered initially despite its lower efficacy rate. If medical therapy is preferred, the drug of choice is a calcium-channel blocker.
Due to the adverse effects of amiodarone, this drug is not recommended in atrioventricular nodal reentrant tachycardia. Flecainide or propafenone may also be considered. A “pill-in-the-pocket” approach with a single dose of diltiazem or propranolol is successful in some cases and could be considered. Digoxin is not usually effective in preventing recurrent tachycardia episodes in atrioventricular nodal reentrant tachycardia and is rarely used.
- Radiofrequency catheter ablation is the most effective treatment for atrioventricular nodal reentrant tachycardia.
- Calcium-channel blockers may be used for prophylaxis of recurrent atrioventricular nodal reentrant tachycardia but are less effective than radiofrequency catheter ablation.
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