In the News
for the Week of 8-26-08
- HPV vaccine may not be cost-effective in adult women
- Guidelines updated for infective endocarditis prophylaxis in valvular heart disease
- Statin therapy does not increase likelihood of cancer
- Bleeding complication rates lower with radial PCI vs. femoral PCI
- Preeclampsia may hint at increased risk for later end-stage renal disease
- First drug approved to treat chorea in Huntington's disease
- Six patient reactions trigger reissue of pancreatitis warning for exenatide
- MKSAP quiz: stroke prevention
ACP regulatory and insurer affairs
- Stricter rules set for Medicaid’s tamper-proof prescriptions
- CMS proposal for ICD-10 diagnosis codes would impose ‘extraordinary’ cost on internists
From ACP Hospitalist
- Latest issue of ACP Hospitalist online and in the mail
From ACP Internist
From the College
- College announces winners of free ACP memberships
Editorial note: ACP InternistWeekly will not be published on Tuesday, Sept. 2 due to the Labor Day holiday.
HPV vaccine may not be cost-effective in adult women
The cost of vaccinating 12-year-old girls against human papillomavirus (HPV) compares well to other preventive health measures, but vaccinating older women is substantially less cost-effective, researchers reported.
Researchers synthesized epidemiologic and demographic data to compare health and economic outcomes of vaccinating women at ages 12, 18, 21 or 26. Assuming that the vaccine provided lifelong immunity, the study found that vaccination of 12-year-olds cost $43,600 per quality-adjusted life-year gained (QALY) more than the current screening practice.
Catch-up vaccinations for older women passed the conventional $50,000 threshold for cost-effectiveness—18-year-olds were $97,300 per QALY; 21-year-olds were $120,400; 26-year-olds were $152,700. The study was published in the Aug. 21 New England Journal of Medicine.
Because the vaccination’s duration of efficacy is still under debate, researchers also calculated a model if HPV immunity waned 10 years after vaccination. The cost for even preadolescent girls exceeded $140,000 per QALY.
Other assumptions made in the model could also reduce the cost-effectiveness of vaccination, noted an accompanying editorial. Researchers assumed that the vaccine has the same effect on pre-adolescent girls as the older women on whom it was tested, that vaccinated women will continue to obtain screening, and that no other oncogenic strains of HPV will take the place of HPV-16 and -18, the editorial said.
Study authors concluded that cost-effectiveness of HPV vaccination in the U.S. would be optimized by achieving universal coverage in young adolescent girls and targeting catch-up efforts to women under 21. The editorial emphasized using caution when introducing large-scale vaccination programs before fully answering questions raised by this research..
Guidelines updated for infective endocarditis prophylaxis in valvular heart disease
The American College of Cardiology and American Heart Association have updated their joint guidelines for preventing infective endocarditis (IE) in valvular heart disease.
The update, published in the Aug. 19 Journal of the American College of Cardiology, is based on new evidence that has emerged since the 2006 ACC/AHA Guidelines for the Management of Valvular Heart Disease were published. Major changes include:
- There are now no Class I recommendations for IE prophylaxis in patients with valvular heart disease;
- Antibiotic IE prophylaxis is no longer indicated in patients with aortic stenosis, mitral stenosis, or symptomatic or asymptomatic mitral valve prolapse. It is also not indicated in adolescents and young adults with native heart valve disease;
- It's not recommended to administer antibiotics solely to prevent IE in patients undergoing a genitourinary (GU) and gastrointestinal (GI) tract procedure. Nor is it recommended solely on the basis of an increased lifetime risk of IE; and
- IE prophylaxis for dental procedures should only be used in patients with underlying cardiac conditions associated with the highest risk for adverse outcomes, such as prosthetic valves or prior IE. In those cases, prophylaxis is reasonable for procedures that involve manipulating gingival tissue or the periapical region of teeth, or perforating oral mucosa.
The guidelines were revised for several reasons. IE is more likely to result from frequent exposure to random bacteremias associated with daily activities than from bacteremia caused by a dental, GI tract or GU procedure. As well, the number of IE cases preventable by prophylaxis in patients undergoing those procedures is "exceedingly small," the article said. Also, the risk of adverse effects caused by antibiotics exceeds any benefit from prophylactic antibiotics.
Physicians should be prepared to discuss the updated guidelines with patients as the changes may cause some concern, the article said. Some doctors and patients may still be more comfortable continuing with prophylaxis for IE in certain circumstances; in those cases, the doctor should ensure that the risks associated with antibiotics are minor before prescribing them.
Statin therapy does not increase likelihood of cancer
Statins are not associated with a higher incidence of cancer, according to a meta-analysis of randomized controlled trials involving more than 97,000 patients.
Previous research reported an association between on-treatment low-density lipoprotein cholesterol (LDL-C) levels and cancer in patients on statins. Authors reviewed data from 15 trials of 51,797 patients given statins and 45,043 given placebo. The patients were followed for an average of about 4.5 years, or 437,017 patient years of follow-up. There were 5,752 cancer cases. Researchers reported their findings in the Journal of the American College of Cardiology.
Meta-regression analysis of the treatment arms of the studies showed an inverse association between treating LDL-C levels with statins and cancer, with 2.2 (95% CI, 0.7 to 3.6) fewer cancers per 1,000 person-years for every 10 mg/dL decrease in treating LDL (P= 0.006). The difference among control arms was 1.2 (95% CI, –0.2 to 2.7; P= 0.09). Meta-regression analysis showed that statins did not affect cancer risk for any levels of treatment.
The study also found a relationship between on-treatment LDL-C levels and cancer in patients not treated with statins.
Researchers concluded that statin-treated patients lower their LDL-C with no extra cancer risk..
Bleeding complication rates lower with radial PCI vs. femoral PCI
The seldom-used radial approach to percutaneous coronary intervention (r-PCI) results in lower rates of bleeding and vascular complications than the popular femoral approach (f-PCI), though both are equally effective at unclogging arteries, a new study found.
Researchers analyzed data from 593,094 procedures in the National Cardiovascular Data Registry on the use and outcomes of r-PCI. They used logistic regression to evaluate the adjusted association between r-PCI and procedural success, bleeding complications, and vascular complications, looking especially at high-risk-of-bleeding patients like the elderly, women, and those with acute coronary syndrome. The results appear in the August Journal of the American College of Cardiology: Cardiovascular Interventions.
R-PCI procedures only accounted for 1.3% of total procedures, yet were associated with a similar rate of procedural success (adjusted odds ratio [OR], 1.02 [95% CI, 0.93 to 1.12]) and a significantly lower risk for bleeding complications (OR, 0.42 [95% CI, 0.31 to 0.56]) after multivariable adjustment. The reduction in bleeding complications was more pronounced among women, patients younger than 75 years old, and patients undergoing PCI for acute coronary syndrome.
R-PCI may be used infrequently because of the learning curve associated with the technique, doctors' unwillingness to adopt a new approach, and concerns over long fluoroscopy times, the study's authors said. Still, the results of the current study suggest that wider adoption of radial PCI in clinical practice could improve the safety of the procedure, especially for higher-risk patients.
Preeclampsia may hint at increased risk for later end-stage renal disease
Preeclampsia may hint at developing end-stage renal disease (ESRD), a Norwegian study said, although no causal link is known and the overall incidence is low.
Women with preeclampsia during their first pregnancy were nearly five times as likely to develop ESRD as those without preeclampsia, and risk was even higher when the preeclamptic pregnancy resulted in a low-birth-weight or preterm infant, researchers reported in the New England Journal of Medicine.
To unravel the issues, researchers linked data from the Medical Birth Registry of Norway, which has recorded all births in Norway since 1967, with data from the Norwegian Renal Registry, which follows all patients diagnosed with ESRD since 1980.
They arrived at a study population of 570,433 women with a first singleton birth between 1967 and 1991. Researchers included data for women with up to three pregnancies.
ESRD occurred in 477 women at a mean age of 41 and a mean of 17 years after the first pregnancy. Preeclampsia during the first pregnancy was associated with a relative risk of ESRD of 4.7 (95% CI, 3.6 to 6.1).
Among women pregnant twice or more, preeclampsia during the first pregnancy was associated with a relative risk of ESRD of 3.2 (95% CI, 2.2 to 4.9), during the second pregnancy with a relative risk of 6.7 (95% CI, 4.3 to 10.6), and during both pregnancies with a relative risk of 6.4 (95% CI, 3.0 to 13.5).
Among women who had been pregnant three or more times, preeclampsia during one pregnancy was associated with a relative risk of ESRD of 6.3 (95% CI, 4.1 to 9.9), and during two or three pregnancies with a relative risk of 15.5 (95% CI, 7.8 to 30.8).
Results were similar after adjustment for possible confounders and after exclusion of women who had kidney disease, rheumatic disease, essential hypertension, or diabetes mellitus before pregnancy.
First drug approved to treat chorea in Huntington's disease
Tetrabenazine (Xenazine) just became the first drug in the U.S. with FDA approval to treat chorea in patients with Huntington’s disease, according to an FDA release issued last week.
The drug decreases the amount of dopamine available to interact with certain nerve cells, thereby decreasing involuntary movements. Reported side effects include depression and suicidal thoughts and actions, so tetrabenazine shouldn't be used in patients who are actively suicidal or who have untreated depression. Other common side effects include insomnia, drowsiness, restlessness and nausea.
Tetrabenazine has been approved with a required Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of the drug outweigh its risks. The REMS includes educational materials and a medication guide..
Six patient reactions trigger reissue of pancreatitis warning for exenatide
Physicians should discontinue exenatide (Byetta) in patients whom they suspect have pancreatitis, and the drug shouldn't be restarted in those patients later, an FDA update said.
Six cases of hemorrhagic or necrotizing pancreatitis in patients taking exenatide have been reported since the FDA issued a warning about a link between the drug and the condition last October. All patients had to be hospitalized, and two of them died.
There aren't any signs or symptoms to distinguish acute hemorrhagic or necrotizing pancreatitis associated with exenatide from the less severe form of pancreatitis, the FDA said. For patients with a history of pancreatitis, clinicians should consider prescribing alternative antidiabetic therapies.
FDA is working with Amylin Pharmaceuticals, Inc., which manufactures Byetta, to add stronger and more prominent warnings to the product label about the risk of acute hemorrhagic or necrotizing pancreatitis, the agency said.
MKSAP quiz: stroke prevention
A 76-year-old man is evaluated for new-onset atrial fibrillation. He reports fatigue and decreased exercise tolerance for approximately six weeks, but otherwise feels well with no chest pain or palpitations. His medical history is pertinent for a 10-year history of hypertension treated with hydrochlorothiazide and type 2 diabetes mellitus. He takes glyburide and pravastatin.
His physical examination demonstrates a heart rate of 98/min and a blood pressure of 162/88 mm Hg. The cardiac examination reveals an irregular rate with no murmur and an S1 of variable intensity. The lungs are clear to auscultation.
The echocardiogram demonstrates left ventricular hypertrophy with normal left ventricular function and left atrial enlargement.
What is the most effective way to prevent stroke in this patient?
A) Aspirin therapy
B) Warfarin therapy with target international normalized ratio (INR) of 2 to 3
C) Cardioversion and antiarrhythmic drugs for maintenance of sinus rhythm
D) Aspirin combined with clopidogrel
Click here or scroll to the bottom of the page for the correct answer.
ACP regulatory and insurer affairs.
Stricter rules set for Medicaid’s tamper-proof prescriptions
Medicaid prescriptions that are hand-written or printed from a computer application must contain at least one feature from each of three different categories of tamper-resistance, according to new Centers for Medicare and Medicaid Services (CMS) rules effective Oct. 1, 2008.
Previously (as of April 2008), paper prescriptions only needed to contain one tamper-resistant feature. The new regulations require paper prescriptions to use at least one feature designed to prevent each of the following:
- unauthorized copying of a completed or blank prescription;
- the erasure or modification of information written on the prescription by the prescriber; and
- the use of counterfeit prescription.
CMS also clarified how to handle prescriptions printed from computers. Tamper-resistant paper is not necessary, as long as appropriate software and printer modifications are used.
The tamper-resistant regulation does not apply to prescriptions electronically transmitted to pharmacies via e-prescribing, prescriptions faxed to pharmacies, or prescriptions communicated to a pharmacy by telephone. The regulation also does not apply to beneficiaries who are enrolled in both Medicare and Medicaid, prescriptions to individuals in nursing and similar facilities, or state Medicaid programs which employ a managed care entity to pay for the prescription.
This Medicaid regulation stipulates the minimum standards for compliance and allows states to require more stringent standards. As these standards currently vary greatly by state, ACP recommends that members contact their respective states’ Medicaid director for more information. Contact information for state directors is online..
CMS proposal for ICD-10 diagnosis codes would impose ‘extraordinary’ cost on internists
Switching to ICD-10 diagnosis codes by 2011 could result in disruptions and costs not worth the benefits, ACP cautioned the Centers for Medicare and Medicaid Services (CMS).
CMS has proposed replacing ICD-9 codes with an expanded ICD-10 code set that would be effective Oct. 1, 2011, as well as updates to several other electronic transactions standards. The codes need replaced because the ICD-9 lacks specificity and detail, uses terminology inconsistently, doesn't capture new technology, and lacks codes for preventive services, among other reasons, CMS has said.
ACP told CMS of its concerns with moving forward to the ICD-10 codes, believing the disruption and cost are not worth the benefits. Physician practices would have to completely retrain their coding and billing staff, “a costly prospect” that would cause a significant loss in productivity during the transition. Some practices would have to buy a completely new practice management system, which could cost between $5,000 to $30,000.
ACP will submit comments to CMS on its proposal. The newly proposed regulations can be viewed on the CMS Web site.
From ACP Hospitalist.
Latest issue of ACP Hospitalist online and in the mail
The next issue of ACP Hospitalist is online and in the mail. This month's cover story addresses cardiac defibrillation, finding ways to deliver a shock in two minutes or less. Also in this issue, five MKSAP quiz questions on sepsis, an article on preventing falls and an expert analysis of Lewy body dementia.
For a free subscription to ACP Hospitalist contact ACP Customer Service at 800-523-1546 or send an e-mail to email@example.com.
From ACP Internist.
On the blog: quality reporting hits some kinks
Quality reporting has hit some kinks, as internists decide whether Medicare bonus payments are worth the effort. Also, how will news about the dangers of mixing juice and drugs change the way internists prescribe medication? Find these stories and a new edition of Medical News of the Obvious on ACP Internist's blog..
Cartoon caption contest: August's winning entry
ACP InternistWeekly has compiled the results from its latest cartoon contest, where readers are invited to match wits against their peers to provide the most original and amusing caption.
This issue's winning cartoon caption was submitted by William Riesen, FACP, of Mason City, Iowa. He will receive a copy of "Medicine in Quotations," ACP Press' comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history. Readers cast 211 ballots online to choose the winning entry. Thanks to all who voted!
The winning entry:
"Do you want me to speak, or just murmur?"
The winning caption received 43.1% of the votes cast. The runners-up were:
"Dr. Smith found his work as a judge for Friday Bedside Karaoke Rounds most rewarding." (30.8%)
"Lub-dub, lub-dub, lub-dub. Now give me my Viagra, please." (26.1%)
The cartoon contest continues in the Sept. 9 issue of ACP InternistWeekly.
From the College.
College announces winners of free ACP memberships
New this year, as a thank you for early payment of 2008-2009 membership dues, all members who paid their dues in full using ACP Online by April 30 were entered into a drawing to win one of 10 free ACP memberships for the 2009-2010 membership year. In addition, all members who paid their dues in full by June 30 were entered into a drawing to win one of 50 ACP vouchers worth $100.
ACP is pleased to announce the following randomly selected winners:
Free 2009-2010 ACP memberships:
Jasjit S. Ahluwalia, FACP – Minnesota
Richard Andraws, MD –New Jersey
Philip H. Fung, MD – Texas
Samuel A. Geller, MD – Connecticut
William J. Manns, MD – Georgia
Edward C. Oldfield, III, FACP – Virginia (United States Navy Chapter)
Yuhta Oyama, FACP – Japan
Tejas V. Patel, MD – Massachusetts
LT Austin L. Parker, MC, USN –Georgia (United States Navy Chapter)
Charles D. Pengelly, FACP – England
$100 ACP vouchers:
Vijay M. Abhyankar, MD – Maryland
Jacob K. Ahdoot, MD – California
Cyriacus U. Anaele, MBBS – New York
Mirza K. Baig, FACP – Massachusetts
Berge C. Bakamjian, DO – California
Roger J. Bedimo, FACP – Texas
Aaron R. Bowen, MD – California
Samantha J. Brown, MD – Minnesota
Prasad K. Chode, MD – California
Roseann C. Ciuffo, MD – New York
Marc S. Coan, MD – Georgia
Robert L. Cody, MD – Ohio
Sisir K. Dhar, FACP – Indiana
Aydin Olgun, FACP – New York
Ronen S. Dudaie, MD – New Jersey
William E. Dudley, MD – New Hampshire
G. A. Dzido, MD – Illinois
Johnny B. Franklin, MD – Mississippi
Matthew T. Gaines, MD – Mississippi
James R. Galyean, III, FACP – Tennessee
Celso A. Gangan, MD – Oregon
James F. Gigante, MD – South Carolina
Hilary A. Gleekman-Greenberg, MD – New York
Richard D. Goulah, FACP – Montana
Joe K. Gregory, DO – Arizona
Sameh R. Hanna, MBBch – South Carolina
Alan B. Haratz, MD – New Jersey
Lester L. Himmelreich, FACP – Pennsylvania
Mark A. Huftel, MD – Wisconsin
Eugene J. Kalmuk, Jr., FACP – New York
Linda M. Lang, MD – Maryland
Mark Keith Lee, MD – Tennessee
Brian J. Lenzkes, MD – California
Gerald H. Lewis, FACP – Illinois
Peter J. Mattina, Jr., MD – Florida
Umashankar Mishra, MBBS, MD – India
Bruce Kinosian, MD – Pennsylvania
Stephanie Hall, MD – Tennessee
Toshio Amano, FACP – Japan
Qiangjun Cai, MD – Texas
Madhavi Yarlagadda, MD – Pennsylvania
Michael V. O'Reilly, MD, FRCPI – Ireland
William J. Peterson, MD – Alabama
Elizabeth A. Prosser, FACP – Ohio
Ronald R. Reimer, MD – Washington
Nilo I. Rivera, MD – New Mexico
Christine A. Sinsky, FACP – Iowa
Marsha H. Tallman, MD – Colorado
Dang-Quang D. Tran, MD – Texas
Diego T. Yangco, Jr., MD – Florida
For questions about these special drawings, or to pay your ACP dues for 2008-2009, please contact ACP Customer Service at 800-523-1546, ext. 2600, direct at 215-351-2600 (M-F, 9:00 am – 5:00 pm ET), or via e-mail at firstname.lastname@example.org..
B) Warfarin therapy with target INR of 2 to 3
The complete MKSAP critique on this topic is available to subscribers in the Cardiovascular Medicine section, item 131.
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 to http://mksap.acponline.org.
Return to the rest of ACP InternistWeekly.
About ACP InternistWeekly
ACP InternistWeekly is a weekly newsletter produced by the staff of ACP Internist. It is automatically sent to all College members who have an e-mail address on file with ACP.
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Copyright 2008 by the American College of Physicians.
A 47-year-old man is evaluated during a routine examination. He has no symptoms. Medical history is significant for a bicuspid aortic valve. He is not taking any medications. Following a physical exam, cardiac exam, and echocardiogram, what is the most appropriate management?
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