American College of Physicians: Internal Medicine — Doctors for Adults ®

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In the News
for the Week of 7-29-08

Highlights

Statins

  • Vytorin does not prevent progression of aortic valve disease, researchers report
  • Statins may protect against dementia

Women’s health

  • Antidepressant-related sexual dysfunction improves with sildenafil
  • Topiramate may cause congenital malformations if taken in first trimester of pregnancy

Obesity

  • No need to deny obese patients knee replacements

FDA news

  • New test can identify patients with warfarin sensitivity

Test yourself

  • MKSAP quiz: Screening tests

Impact of Medicare legislation

  • E-prescribing incentives included in new Medicare legislation
  • Medicare will waive retroactive beneficiary cost sharing due to new legislation
  • ACP tells Congress financial incentives are necessary to encourage adoption of health IT

From the College

  • Recruitment opens for ACP’s free, online QI programs
  • Steven Weinberger receives Thoracic Society's educator award

From ACP Internist

  • Discuss pre-diabetes treatment on our blog
  • Put words in our mouth: vote for your favorite cartoon caption entry

Highlights

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Group issues first clinical guidelines on pre-diabetes

The American College of Endocrinology last week issued its first guidelines[PDF] on managing patients with pre-diabetes to assist physicians in identifying those at high risk and developing specific treatment plans aimed at preventing the full-blown disease.

The guidelines recommend intensive lifestyle control as the first line of defense against the development of diabetes, including reducing weight by 5%-10%; engaging in moderate exercise for 30-60 minutes a day, five days a week; and following a low-fat diet low in sodium. The authors define pre-diabetes as having a fasting glucose of 100-125 mg/dL or a two-hour post-glucose challenge of 140-199 mg/dL.

While there are no drugs approved specifically for the treatment of pre-diabetes, evidence suggests that metformin and acarbose may be effective for high-risk patients, such as those with cardiovascular disease or worsening glycemia, the guidelines state. The authors noted safety concerns with using thiazolidinediones and said there is insufficient evidence to recommend new agents such as GLP-1 receptor agonists, DPP3 inhibitors or meglitinides.

Other recommendations include:

  • Statins are recommended to achieve LDL cholesterol, non-HDL cholesterol or apoB treatment goals of 100 mg/dL, 130 mg/dL and 90 mg/dL;
  • Target blood pressure should be systolic <130 mm Hg and diastolic 80 mm Hg;
  • Use ACE inhibitors/ARBs as first-line agents;
  • Aspirin is recommended for all with pre-diabetes unless there is excess risk of gastrointestinal, intracranial or other hemorrhagic condition;
  • Test glucose tolerance and microalbuminuria annually; and
  • Test fasting plasma glucose, hemoglobin A1C and lipids every six months.

How are you managing the treatment of patients with pre-diabetes? Post your comments on ACP Internist's blog.

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Antidepressant prescriptions increase from 2002 to 2005

Antidepressant prescriptions are on the rise, with more written by primary care doctors than psychiatrists or internal medicine specialists, a new report[PDF] found.

Filled outpatient prescriptions rose to 170 million in 2005 from 154 million in 2002, according to the Agency for Healthcare Research and Quality. In 2005, psychiatrists wrote 29% of those prescriptions, general practitioners (including internists) wrote 23%, family practitioners wrote 21% and internal medicine specialists wrote 10%, the study found. The prescriptions were written after in-person or phone visits; refills weren’t included in the report.

Roughly the same percentage of general practice and internal medicine specialists wrote antidepressant prescriptions in 2005 compared to 2002, but those written by psychiatrists declined by four percentage points, while those written by family doctors increased by nearly three percentage points.

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Statins

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Vytorin does not prevent progression of aortic valve disease, researchers report

A new clinical trial concluded that aggressive cholesterol lowering with simvastatin plus ezetimibe (Vytorin) in patients with mild to moderate aortic stenosis reduces the risk of coronary artery disease events but does not affect the progression of aortic valve disease.

The so-called SEAS study included 1,873 patients with mild to moderate aortic stenosis without symptoms who were randomly assigned to receive either a combination of simvastatin (40 mg daily) and ezetimibe (10 mg daily) or placebo. After four years of follow-up, there was no significant difference between the groups for major cardiovascular events or aortic valve disease events alone, but the treatment group had a 22% reduction in atherosclerotic events alone compared with the placebo group. There were slightly more cancer incidences and deaths in the treatment group, although researchers cautioned that this could have been due to chance.

The SEAS findings were reported in a June 21 news release and have not yet been published in a journal.

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Statins may protect against dementia

Statin users were half as likely to develop dementia or cognitive impairment as non-users, according to a study published in the July 29 issue of Neurology.

For the study, researchers enrolled 1,674 dementia-free patients via the Sacramento Area Latino Study on Aging (SALSA), a prospective cohort study of Latinos older than 60 from the Sacramento, Calif. area.

During the five-year study, 452 patients (27%) took a statin drug at some point. Of the participants who used statins, 263 (58%) used them for two or more years. Enrollees in this group were slightly younger, more educated, more likely to be born in the U.S., more likely to have medical insurance and more likely to have diabetes at enrollment.

Enrollees were evaluated for cognitive and clinical function every 12 to 15 months. A total of 130 people developed dementia or cognitive impairment.

Scientists controlled for a number of other dementia risk factors, such as education, smoking, diabetes, stroke and a gene associated with dementia, the APOE ε4 allele. Statin users were about half as likely as those who did not use statins to develop dementia or cognitive impairment without dementia (hazard ratio=0.52; 95% CI 0.34, 0.80).

Authors wrote in the study that their results may have detected more of an effect than other examinations of statins and cognitive impairment because it was a prospective study, it included clinical evaluation of dementia, and the large number of diabetics in the population led to more statin use. Also, researchers noted the use of statins increased overall during the study period of 2000 to 2006, following the 2001 Adult Treatment Panel III guidelines.

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Women’s health

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Antidepressant-related sexual dysfunction improves with sildenafil

Sildenafil (Viagra) appears to reduce sexual dysfunction in women whose antidepressants cause adverse sexual side effects, a new study found.

Researchers studied 98 women, with an average age of 37 years, who were taking selective or nonselective serotonin reuptake inhibitors, had major depression in remission, and had sexual dysfunction (such as lack of arousal or orgasm delay). Half were randomly assigned placebo and half sildenafil at a flexible dose starting at 50 mg and adjustable to 100 mg. Patients were instructed to take the pills one to two hours before anticipated sexual activity for eight weeks.

About 72% of women taking sildenafil reported improvement with treatment, compared to 27% of women taking placebo. Women in the sildenafil group also showed greater improvement in sexual function on a clinician-rated severity improvement scale compared to the placebo group. Baseline endocrine levels were within normal limits and didn’t differ between groups, and depression scores remained about the same. Headache, flushing and dyspepsia were often reported during treatment with sildenafil. The study was published in the July 23/30 issue of the Journal of the American Medical Association.

The results are important because sexual dysfunction is a very common side effect of taking antidepressants, and is a major reason why people stop taking the drugs and relapse into depression, the authors wrote. Women experience major depressive disorder at almost double the rate of men, and therefore experience greater sexual dysfunction; by addressing this side effect, fewer patients may stop taking the medication and treatment outcomes could improve, they said.

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Topiramate may cause congenital malformations if taken in first trimester of pregnancy

Pregnant women who take topiramate (Topamax) in the first trimester are more likely to have children with congenital malformations, a new study found.

For the prospective study, researchers followed 203 pregnant epileptic women who had become pregnant while taking topiramate alone or with other antiepileptic drugs. The main outcome measure was the major congenital malformation (MCM) rate, with secondary outcomes including the risk of specific MCM, minor malformation rate, birthweight and gestational age at delivery. The study was published in the July 22 Neurology.

The MCM rate was 5% for women taking topiramate alone and 11.2% for those taking topiramate as part of polytherapy. Four of the MCMs were oral clefts, and four cases of hypospadias were reported. Overall, the rate of oral clefts observed was 11 times the background rate.

While the authors acknowledged the study had a small sample size, and, on the whole, the number of outcomes of pregnancies exposed to topiramate is low, the MCM rate for topiramate polytherapy still raises concerns, they said. Physicians should monitor pregnancies of women on the drug, which is also prescribed to prevent migraines, the authors said.

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Obesity

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No need to deny obese patients knee replacements

Obese patients benefit almost as much from knee replacement surgery as patients with lower BMIs, according to an observational study that will be published online in Annals of the Rheumatic Diseases.

In some parts of England, total knee arthroplasty (TKA) is only offered to those with a BMI less than 30 kg/m2 because higher BMIs are thought to be a risk factor for knee osteoarthritis.

Researchers in England followed 325 patients from three health districts approximately six years after surgery, along with 363 age- and sex-matched controls from the general population. Between baseline and follow-up, in an analysis restricted to the 108 obese patients, median physical function score on a self-administered questionnaire increased from 17 to 20 points (P=0.002), whereas among the 36 obese patients in the control group, the median score decreased from 61 to 25 points (P=0.001).

Improvement in physical function was smaller in patients who were obese, but was still better than physical function of patients in the obese control group. Researchers concluded, "The improvement in physical function following TKA was apparent in patients who were obese as well as non-obese, whereas obese controls experienced a marked decline in physical function over the follow-up period. This differential from controls may in part reflect judicious selection for surgery, with a tendency to operate preferentially on patients who do not suffer from other concurrent disease. However, it suggests that if appropriate selection criteria are applied, TKA can be worthwhile in patients who are obese."

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FDA news

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New test can identify patients with warfarin sensitivity

The FDA last week approved a test to identify patients who may be sensitive to warfarin (Coumadin).

Osmetech’s eSensor Warfarin Sensitivity Test detects the three genetic markers known to play a critical role in metabolism of warfarin, which in turn can help physicians decide on a dosage level for patients, the manufacturer said in a news release. The test is available now.

Warfarin is the second-most-likely drug to cause adverse events requiring hospitalization. Last year, the FDA approved updated labeling for warfarin that required manufacturers to explain that a person’s genetic makeup may influence their response to the drug.

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Test yourself

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MKSAP quiz

Case Study:
A 67-year-old man is evaluated during an annual check-up. His medical history is significant for hypertension and hyperlipidemia, both of which are treated. He has an active retirement, walks daily, and plays golf at least three times per week. He was a heavy smoker (two to three packs per day) for nearly 30 years, but quit at age 48 years. He drinks alcohol only moderately—no more than two drinks daily, and his CAGE screening score is 0/4. He reports no chest pressure or dyspnea during his daily walk. He denies cough. He denies any problems with initiating urine stream or with polyuria or nocturia. He gets an annual flu shot, received a pneumococcal vaccine last year, and had a normal colonoscopy two years ago. His current medications include lisinopril, chlorthalidone and simvastatin.

On physical examination, his pulse is 72/min, his blood pressure is 132/75 mm Hg, and his BMI is 27. His cardiovascular examination including peripheral pulses, lung examination, and abdominal examination are all normal.

Which one of the following screening tests is most appropriate for this patient based on evidence of benefit?

A. Abdominal ultrasound
B. Chest CT
C. Electron-beam CT of the heart
D. Prostate serum antigen level
E. Serum thyroid-stimulating hormone

Click here or scroll to the bottom of the page for the correct answer.

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Impact of Medicare legislation

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E-prescribing incentives included in new Medicare legislation

In addition to stopping cuts in Medicare physician payments, H.R. 6331, the Medicare Improvements for Patients and Providers Act of 2008, contains other provisions of importance to internists. The legislation also contains a program that would provide voluntary incentives for e-prescribing that would later transition to a mandate by 2012. The program was pushed by members of Congress, patient advocacy groups, and employers who believe that e-prescribing can reduce medical errors and lead to overall quality improvements.

The e-prescribing transition would start with incentive payments to physicians who successfully use e-prescribing programs from 2009 to 2013. In 2009 and 2010 the payment would be up to 2% of total Medicare allowable charges that each physician generated during that calendar year. In 2011 and 2012 the payment would be 1% for eligible physicians; and 0.5% in 2013.

Starting in 2012 providers who fail to implement e-prescribing would be subject to a reduction in payments of up to 2% unless they fall under a "hardship exemption." The bill also calls on the Government Accountability Office to use this time to study the effectiveness of e-prescribing and issue a report by September 2012.

ACP will communicate more information about the new e-prescribing regulations as it becomes available.

ACP, has supported providing adequate incentives for the adoption of e-prescribing but has expressed concern about a mandate. For more information about the College's policy please visit the Advocacy Web site.

Many internists don't use e-prescribing and say they aren't ready to start, while others have either successfully incorporated e-prescribing or are taking a "wait and see" approach. Read their comments on the ACP Internist blog.

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Medicare will waive retroactive beneficiary cost sharing due to new legislation

Physicians will not be subject to administrative sanctions if they do not retroactively ask their patients for the difference in the patients’ portion of cost-sharing for claims for services provided from July 1 to 15, according to a guidance statement from Medicare[PDF].

CMS offered additional guidance on the effects of H.R. 6331 last week after passage of the Medicare Improvements for Patients and Providers Act of 2008, which reversed the 10.6% cut in Medicare payments to physicians.

The payment cut had been in effect for the first 15 days of July. CMS had previously announced that they were instructing contractors to automatically reprocess any claims that had been affected by the 10.6% cut, retroactive to July 1.

The new guidance came as a policy statement from the Department of Health and Human Services, Office of the Inspector General (OIG), and said that it will allow physicians to waive any increases in Medicare beneficiary cost-sharing that result from the retroactive payments. This means that physicians will not be subject to OIG administrative sanctions if they choose not to retroactively ask their patients for the difference in the patients' portion of cost-sharing for claims for services provided from July 1 to 15.

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ACP tells Congress financial incentives needed to encourage health IT adoption

Medicare needs to develop financial incentives for physicians who acquire and use health information technology (HIT), the Chair of ACP’s Medical Services Committee told Congress in testimony before the House Committee on Ways and Means, Subcommittee on Health. “Without adequate financial incentives, small practices and their patients will be left behind the technological curve,” said Yul Ejnes, FACP.

“Acquisition costs can average up to $44,000 per physician. The average annual ongoing costs are about $8,500 per physician,” continued Dr. Ejnes. “For many of these practices, the ‘business case’ for making such a large investment simply doesn’t exist. Public and private payers, not the physicians, realize much of the savings from physician investment in acquiring the necessary HIT.”

ACP's recommendations to Congress include:

  • Build into the Medicare physician payment system an add-on code for office visits and other services when supported by certified HIT;
  • Continue to support the establishment of the standards needed to allow true interoperability;
  • Continue to advance the patient-centered medical home, or PCMH, model as a means of rapidly driving primary care practices to acquire the information systems and other capabilities needed to provide patient-centered and coordinated care; and
  • Require that Medicare cover specific services associated with patient-centered care, such as secure e-mail consultations and remote monitoring.

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From the College

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Recruitment opens for ACP’s free, online QI programs

ACP’s Quality Improvement Program, ACPNet, has launched two new Web-based Quality Improvement Programs for COPD and pain management. Both projects will offer CME; the COPD Initiative also will offer credit towards ABIM Part 4 MOC. Both projects will offer a Web-based education module that will consist of a coordinated set of tools to help implement the intervention and organize the practice to facilitate patient care related to COPD or pain.

  • The COPD Initiative is designed to evaluate how you manage patients with COPD and help you make improvements in your clinical management of patients with COPD. The educational toolkit will include: diagnosis and management of COPD, pharmacologic management of stable COPD, pharmacologic management of acute COPD exacerbation, non-pharmacologic management of COPD, management of non-pulmonary COPD complications, management of patient end-stage COPD and patient education resources.
  • The Pain Management Project is designed to evaluate how you manage patients with non-malignant pain. The educational module will cover quality improvement techniques/methods for practice improvement related to pain, including diagnosis and assessment of pain, general approaches to pain management, how to treat specific types of pain (neuropathic, low back pain, and pain in the elderly), evidence-based guidelines and patient education resources.

For more information, contact Meghan Gannon at 215-351-2847 or mgannon@acponline.org, or online.

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Steven Weinberger receives Thoracic Society's educator award

Steven Weinberger, FACP, was awarded the American Thoracic Society's fifth annual Clinical Problems Educator Award during the group's 2008 international conference in Toronto. Dr. Weinberger is ACP's Senior Vice President for Medical Education and Publishing as well as an adjunct professor of medicine at the University of Pennsylvania and senior lecturer on medicine at Harvard Medical School.

The award recognizes a physician who has been singled out by students and peers as an outstanding teacher, clinician and mentor, and who has made a significant contribution to clinical education and educational program development in pulmonary/critical care medicine.

Before assuming his current position at the ACP in March 2004, Dr. Weinberger served as executive director of the Carl J. Shapiro Institute for Education and Research at Harvard Medical School and Beth Israel Deaconess Medical Center, executive vice chair of the Department of Medicine at Beth Israel Deaconess Medical Center, and professor of medicine and faculty associate dean for medical education at Harvard Medical School. A graduate of Harvard Medical School, Dr. Weinberger completed his internal medicine residency at the University of California, San Francisco Medical Center, followed by clinical and research fellowship training in pulmonary medicine at the National Heart, Lung, and Blood Institute of the National Institutes of Health. The recipient of numerous other teaching awards, Dr. Weinberger also is the author of the popular textbook Principles of Pulmonary Medicine now in its 5th edition.

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From ACP Internist

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Discuss pre-diabetes treatment on our blog

The American College of Endocrinology last week issued its first guidelines on managing patients with pre-diabetes, suggesting aggressive lifestyle control as the first line of defense in warding off full-blown disease, followed by selective drug treatment and frequent monitoring of symptoms. What are you doing in your practice to control symptoms in patients at risk for diabetes? Post your comments on our blog.

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Put words in our mouth: 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.

Put words in our mouth

Go online to view the cartoon and pick the winner, who receives a $50 gift certificate good for any ACP product, program or service.

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MKSAP answer

A. Abdominal ultrasound, to screen for abdominal aortic aneurysm. To view the complete MKSAP syllabus and critique on this topic (subscribers only), go online at Update 2 General Internal Medicine Item 5.

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.

Return to the rest of ACP InternistWeekly.

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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.

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