In the News
for the Week of 3-10-09
- PPIs may weaken benefits of clopidogrel after acute coronary syndrome
- FDA warnings don't protect drug company from liability, Supreme Court rules
- MKSAP quiz: ischemic cardiomyopathy
- New score to identify those at risk of atrial fibrillation
- Kidney disease may predict ischemic stroke in patients with AF
- Some skin patches can cause burns during MRI
From ACP Internist
- March ACP Internist is online and coming to your mailbox
- Your thoughts exactly: direct-to-consumer genetic tests
- ACP Advocate covers developments in health care reform
From the College
- ACP Medicine names new editor
- Join Annals of Internal Medicine's discussion forum
- Internal Medicine 2009 virtual exhibit hall opens
- AAMC and AMWA awards: call for nominations
Cartoon caption contest
- Put words in our mouth
Physician editor: Darren Taichman, ACP Member
PPIs may weaken benefits of clopidogrel after acute coronary syndrome
Proton pump inhibitors (PPIs) combined with clopidogrel after an acute coronary syndrome (ACS) may increase risk of death or readmission, leading some to suggest that the combination not be used for prophylaxis.
PPIs are frequently prescribed to reduce the risk of gastrointestinal tract bleeding from taking clopidogrel and aspirin. But studies have reported that omeprazole decreases clopidogrel's platelet inhibitory effect. Researchers did a retrospective cohort study of 8,205 ACS patients taking clopidogrel after discharge from 127 Veterans Affairs hospitals between Oct. 1, 2003, and Jan. 31, 2006. They reported results in the Journal of the American Medical Association.
Of the 8,205 patients, 63.9% were prescribed PPI in addition to clopidogrel at discharge, during follow-up, or both and 36.1% were prescribed clopidogrel only. Death or rehospitalization for ACS occurred in 20.8% (615) of patients taking clopidogrel without PPI and 29.8% (1,561) of patients combining them. The combination was associated with increased risk of death or rehospitalization for ACS compared with use of clopidogrel only and a higher risk for revascularization procedures, but no higher risk for all-cause mortality. The increased risk of adverse events observed with the concomitant use of clopidogrel and PPI was seen even after controlling for the use of aspirin, as well as after excluding patients with a history of gastrointestinal bleeding.
Because this was an observational study, no conclusion can be drawn as to whether the adverse events seen were caused by the combination of PPI and clopidogrel. Randomized, controlled trials are needed, researchers wrote, because the "modest" risk seen in the study translates to a considerable number of people due to how frequently PPIs are prescribed to patients receiving dual-antiplatelet therapy. They added that PPIs should be used only for patients with a clear indication, such as a history of gastrointestinal tract bleeding, rather than for routine prophylaxis..
FDA warnings don't protect drug company from liability, Supreme Court rules
The Supreme Court ruled last week that drug manufacturer Wyeth was liable for a patient losing her arm after an improper injection of anti-nausea drug promethazine (Phenergan).
In 2000, the patient, Diana Levine, visited a clinic for treatment of a migraine, reported the March 5 New York Times. A physician's assistant administered Phenergan by IV push, rather than the more common and less risky methods of intramuscular injection or intravenous drip. The drug hit an artery and gangrene set in, requiring the amputation of her arm. Ms. Levine settled a claim against the clinic for the improper injection but also sued Wyeth for not having a strong enough warning about the risks of IV-push administration.
Ms. Levine's lawsuit contended that the drugmaker should have strengthened the drug's warnings, while the defense argued that the manufacturer could not change the warning without FDA involvement. The court decision in her favor reversed an FDA policy, established in 2006, that agency approval of a drug and its warnings protected drugmakers from liability.
Last year, the court decided a similar case about a medical device in favor of the manufacturer because of a difference in the wording of a federal law. Democratic lawmakers have announced plans to change that law to allow such claims against device manufacturers, the March 4 Washington Post reported. Consumer advocates lauded the court's decision, while opponents expressed concern that the ruling could deter pharmaceutical research and innovation. Wyeth's defense attorney told the Washington Post that as a result of the decision, physicians would likely exercise much greater caution in choosing a method of drug administration.
MKSAP quiz: ischemic cardiomyopathy
A 50-year-old black man with ischemic cardiomyopathy presents for a routine follow-up. His medical history is significant for biventricular pacemaker/cardioverter-defibrillator placement and diabetes mellitus. He develops shortness of breath from ascending less than 1 flight of stairs or walking less than 1 block on level ground, a symptom that has been stable. His medications include aspirin, lisinopril, carvedilol, isosorbide mononitrate, furosemide, spironolactone, digoxin, atorvastatin, and insulin. His blood pressure is 105/78 mm Hg and his heart rate is 62/min.
Physical examination reveals clear lungs, a regular cardiac rhythm, grade 2/6 systolic murmur at the apex, and no peripheral edema. A recent echocardiogram showed left ventricular enlargement, severely decreased systolic function (left ventricular ejection fraction, 15%), and mild mitral regurgitation.
Which of the following medications should be added?
Click here for the answer and critique for this question.
New score to identify those at risk of atrial fibrillation
Researchers have designed a risk score to help identify an individual's likelihood of developing atrial fibrillation, a Feb. 28 Lancet article said.
To create the score, researchers selected 4,764 Framingham Heart Study subjects aged 45-95 years then monitored them for up to 10 years for a first atrial fibrillation event. They looked at characteristics like age, sex, alcohol consumption, body mass index (BMI), blood pressure, cholesterol levels, ECG features and indicators of heart disease, and performed a Cox regression analysis to assess which posed risks of atrial fibrillation.
During follow-up, 10% of participants developed atrial fibrillation. For men, there were 6.3 events per 1,000 age-adjusted person-years; for women, there were 3.3 events per 1,000 age-adjusted person-years. The predicted 10-year risk of atrial fibrillation was 2% for those with BMI at or greater than 30, 2% for those with systolic blood pressure at or greater than 160, and 2% for those being treated for hypertension. Also, the younger a person was when heart failure or significant cardiac murmur developed, the greater his or her risk of atrial fibrillation later.
The risk scoring system is based on clinical factors that are easy to measure in primary care, making it convenient for providers to use, the authors said. Those at high risk can be targeted for preventive measures. A limitation of the score, however, is that it was developed and validated with white, middle-aged-to-elderly subjects, so it may not generalize to young people or other ethnic groups, they said..
Kidney disease may predict ischemic stroke in patients with AF
Chronic kidney disease may be an independent risk factor for thromboembolism in patients with atrial fibrillation, a recent study concluded.
Researchers looked at data on 10,908 patients with reduced estimated glomerular filtration rate (eGFR) or proteinuria and atrial fibrillation (AF). During more than 33,000 person-years of follow up when the patients were off anticoagulation, 676 thromboembolic events occurred. After adjustment for known risk factors, proteinuria increased the risk of thromboembolism by 54%, and the risk of stroke increased with lower levels of estimated eGFR.
The findings suggest that knowing the level of kidney function and the presence of proteinuria may help physicians decide whether to use antithrombotic agents to prevent stroke in patients with AF.
Some skin patches can cause burns during MRI
Certain medicated skin patches contain metal in the backing that can overheat during MRI scans and cause burns, the FDA said in a safety alert.
Providers who refer patients to have MRI scans should check whether they are wearing a patch, advise them how to remove the patch before the scan, then tell them how to replace it after the scan. MRI facilities should follow published safe practice recommendations about patients wearing patches, the FDA said.
The FDA has gotten reports of patients getting burned, and was told in January that an MRI warning was missing on Teva Pharmaceutical's fentanyl transdermal system. The agency is in the process of reviewing the labeling and composition of other patches to make sure those containing metal have a warning about the burn risk. The affected products include nicotine patches, and may be brand name, generic or over-the-counter, the alert said.
From ACP Internist.
March ACP Internist is online and coming to your mailbox
The next issue of ACP Internist is online. Find all of our print and online content, including ACP InternistWeekly, our blog, and polls and surveys (including our cartoon caption contest). Go online for the following stories:
- Intimate partner violence. Unexplained bruising or injuries are red flags for intimate partner violence, but less obvious signs might include chronic pain, depression or anxiety. Experts advise how to help victims at risk.
- Sjögren's syndrome explained. Lack of awareness compounds a condition that is exceedingly difficult to diagnose. Experts offer signs and symptoms for ruling it out or diagnosing it more quickly.
- Mindful Medicine. Would you pass "the eyeball test" if a patient with chest pain presented in your hospital's emergency room? Find out how one physician pressed for a better answer on a patient who presented with cardiac pain but no evidence of a heart attack.
Your thoughts exactly: direct-to-consumer genetic tests
ACP Internist is assessing how often internists are asked by patients about direct-to-consumer genetic tests. Tell us about your experiences.
ACP Advocate covers developments in health care reform
The latest issue of ACP Advocate covers new developments in health care reform, including the Obama administration's efforts to create a government insurance plan; a look at the new nominee for secretary of HHS, Kansas Governor Kathleen Sebelius; and details of health care provisions in President Obama's budget.
From the College.
ACP Medicine names new editor
ACP Medicine announced Elizabeth G. Nabel, MD, as its new Editor-in-Chief. Dr. Nabel is Director of the National Heart, Lung, and Blood Institute, where she oversees an extensive portfolio of basic and clinical research to prevent, diagnose, and treat heart, lung, and blood diseases. Dr. Nabel has been the recipient of many awards of distinction and is renowned worldwide for her contributions to medicine. She has a long-standing interest in medical education and is a champion of the concept “from bench to bedside.”
Dr. Nabel is the third editor-in-chief of ACP Medicine since its inception 30 years ago.
“Under Dr. Nabel's leadership, ACP Medicine will continue to be an invaluable evidence-based internal medicine resource for busy physicians," said John Tooker, FACP, the College's Executive Vice President and Chief Executive Officer..
Join Annals of Internal Medicine's discussion forum
Join Annals of Internal Medicine's discussion forum on health care reform. Comment on health care reform perspectives that appear in Annals and offer ideas about reform..
Internal Medicine 2009 virtual exhibit hall opens
Participants attending Internal Medicine 2009 in Philadelphia this April can plan their visit ahead of time with a new Virtual Exhibit Hall. Users can search by exhibitor, product or trade name; a “My Show” feature allows you to tailor your visit specifically to exhibitors of your choice, and a “featured” section offers additional information about exhibiting companies. It’s a simple, effective way to organize your time and educate yourself before stepping foot on the exhibit hall floor..
AAMC and AMWA awards: call for nominations
ACP members and leaders are invited to nominate candidates for several outside awards of particular interest to internists, given by the Association of American Medical Colleges (AAMC) and the American Medical Women’s Association (AMWA). The awards include The Herbert W. Nickens Award, The David E. Rogers Award, The Distinguished Research in the Biomedical Sciences Award, The Elizabeth Blackwell Medal, and the The Woman in Science Award. Please contact the organizations directly through the AAMC and AMWA Web sites to submit your nominations and get more information.
Cartoon caption contest.
Put words in our mouth
ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner.
E-mail all entries by March 19. ACP staff will choose three finalists and post them in the March 24 issue of ACP InternistWeekly for an online vote by readers. The winner will appear in the March 31 issue. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service..
MKSAP Answer and Critique
The correct answer = C) Hydralazine
This item is available to MKSAP subscribers in the Cardiovascular Medicine section, Item 121
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.
The African-American Heart Failure Trial (AAHeFT) demonstrated a significant reduction in mortality with the addition of hydralazine and nitrates to standard heart failure therapy in black patients with severe (NYHA class III or IV) symptoms. This black patient is on standard heart failure therapy, and is already on a nitrate, so the next appropriate step would be to add hydralazine. There may be concern with starting a vasodilator in a patient with relatively low blood pressure, but decreasing afterload with hydralazine will increase his cardiac output and blood pressure will likely remain stable.
The first-line therapy for prevention of sudden death in patients with heart failure is an implantable cardioverter-defibrillator (ICD). For patients who have contraindications to ICD placement, or for those who have recurrent ventricular arrhythmias causing repeated ICD shocks, amiodarone can be used. Clopidogrel is indicated for treatment of acute coronary syndrome or to prevent restenosis after intracoronary stenting and does not have a role in treating heart failure outside of these conditions. Nesiritide is an intravenous vasodilator and natriuretic agent that can be used for acute heart failure decompensation for afterload reduction and assisting diuresis. This patient is not acutely decompensated, and no definitive data exist showing a benefit of routine outpatient nesiritide infusions.
- The addition of hydralazine and nitrates to standard heart failure therapy in blacks with severe heart failure improves mortality.
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Copyright 2008 by the American College of Physicians.
A 53-year-old woman is evaluated for a 3-month history of swelling of the face, hands, and feet. She has untreated hepatitis C virus infection. She takes lithium for bipolar disorder. She has no additional symptoms. After a physical exam, lab results and kidney biopsy, what is the most likely cause of this patient's nephrotic syndrome?
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