In the News for the Week of 12-18-07
- Average cholesterol level of Americans falls to 199
- Statins increase risk of second hemorrhagic stroke
- Legislation needed to halt Medicare's scheduled physician pay cut
- Annals: Drug-eluting stents in patients undergoing PCI
- Thiazolidinediones increase risk of heart trouble, death for older diabetics
- Hypertension management falls short for adults at high risk for heart disease
- System errors are 30% of settled malpractice claims
- Proton pump inhibitors unlikely to carry heart risk
- Genetic tests advised for people with Asian ancestry before using carbamazepine
ACP publishing news
- Vote online for your favorite cartoon caption
- Guidance on changes to Medicare pay-for-reporting program
- New patient education DVD on bipolar disorder
Editorial Note: Due to the winter holidays, ACP Observer Weekly will take a two-week hiatus. We will return under our new name, ACP Internist Weekly, on Jan. 8, 2008.
The average cholesterol level of American adults dropped below 200 last year, falling into the ideal range for the first time in 50 years, according to a new report from the National Center for Health Statistics.
The decrease was mainly observed in men age 40 or older and women age 60 and older, the report found. Although there was little change in other sex or age groups, the change in older men and women was sufficient to reduce the overall average from 204 mg/dL in 1999-2000 to 199 mg/dL in 2005-06. The mean serum cholesterol of men ages 40 to 59 dropped from 214 in 1999-2000 to 205 last year, while men over age 60 decreased from 206 to 189. The average for women over age 60 dropped from 224 to 209 in the same time period.
The report, which included about 4,500 Americans age 20 and older, also found that the percentage of adults with high total cholesterol (240 or higher) decreased from 20% in 1988-1994 to 16% in 2005-06, meeting the Healthy People 2010 objective for high cholesterol reductions. However, about half of those with levels of 240 or higher had never been told by a health care professional that their cholesterol was high. According to the report, about 65% of men and 70% of women have been screened for high cholesterol in the past five years, with older age groups more like to receive screening.
Researchers attributed the report’s findings to increasing use of cholesterol-lowering medications, and a study author noted that the age groups with decreases were also those most likely to be treated with medication, according to the Dec. 13 Washington Post. High total cholesterol continues to be a significant public health problem in the U.S. and further research into LDL and HDL levels are needed to better assess the clinical risk, the NCHS report concluded.
The National Center for Health Statistics data brief is online.
The Washington Post is online.
Statins may increase the risk of hemorrhagic stroke, especially in patients who have had a previous brain hemorrhage, according to a new study.
Researchers conducted a post-hoc analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels study (SPARCL), which randomized 4,731 patients who had recent strokes to receive either 80 mg/day of atorvastatin or placebo. Overall, the SPARCL study found that atorvastatin reduced the risk of stroke in patients by about 16%.
However, the analysis found an increase in the number of patients who had a hemorrhagic stroke among the active treatment group (55 patients had hemorrhagic strokes vs. 33 in the placebo group.) Further analysis found that patients who had hemorrhagic stroke previously were at significantly higher risk for another hemorrhage (hazard ratio: 5.65).
Study patients with stage 2 hypertension also had much higher risk of hemorrhagic stroke—six times that of the normal blood pressure patients, the researchers found. Other factors that increased risk included being male and older age. The study was published online ahead of print in Neurology on Dec. 12.
Based on the study findings, clinicians should be very cautious about starting a statin for patients who have had a brain hemorrhage in the past one to six months, the study’s lead author told the Dec. 12 Washington Post. He described the findings as indicative of a small but significantly increased risk. Other experts quoted in the Washington Post noted that the SPARCL patients took higher doses of the statin than most patients receive.
Neurology is online.
The Washington Post is online.
ACP is encouraging its members to contact their Congressional representatives about the importance of averting a 10.1% Medicare payment cut scheduled to take effect on Jan. 1. Congress must act now by passing legislation to stop the cut, which is mandated under the Physician Fee Schedule for 2008 that CMS released earlier this year.
The payment cut is a result of Medicare’s flawed ‘sustainable growth rate,’ or SGR, formula, which unfairly ties Medicare payments to an arbitrary budget target that does not take patient needs into account. As a result, Medicare payments for physician services keep decreasing while the cost for doctors to provide care keeps climbing.
Congress needs to act before Christmas, when it is scheduled to adjourn for the year, in order to stop the payment cut from going into effect. If Congress does not act before year-end, it could still choose to pass legislation when it resumes session in late January. In that case, however, the cuts would still be in effect until the legislation is passed and signed into law.
Members can find information on how to call or email their representatives in Congress through ACP’s Legislative Action Center.
ACP will notify its members of any change in the legislative situation as soon as it occurs.
The following articles will appear in the Dec. 18, 2007, online edition of Annals of Internal Medicine. This issue also includes a recommendation against screening for carotid artery stenosis and a review of the use of vitamin D for chronic kidney disease. The full text is available to College members and subscribers online.
Balancing efficacy and safety of drug-eluting stents in PCI. Experts say current clinical evidence implies that benefits of drug-eluting stents probably outweigh risks, even for patients with complex lesions; but “larger prospective studies with adequate power to detect small differences in stent thrombosis, MI and mortality rates are required.” Meanwhile all patients should be screened before any coronary intervention to be sure they can tolerate uninterrupted dual anti-platelet therapy for a minimum of three to six months and preferably one year.
Organ donation. An article argues that the laws about organ donation need revising to insure that doctors can give first priority to the end-of-life care for the potential donor rather than to preserving their organs for donation.
Osteoporosis treatment. This major study finds insufficient evidence to decide the most effective treatment to prevent fractures in men and women with low bone density or osteoporosis. Note: This paper is being released early online by Annals of Internal Medicine. It will appear in the Feb. 5, 2008, print edition of the journal.
Thiazolidinediones, primarily rosiglitazone (Avandia), increase the risk of congestive heart failure, acute myocardial infarction and death for older patients with diabetes, a new study found.
The retrospective cohort study used health care databases in Ontario to examine 159,026 diabetes patients age 66 years and older who had been treated with at least one hypoglycemic agent between 2002 and 2005. Follow up was for a median of 3.8 years. The study was published in the Dec. 12 Journal of the American Medical Association.
Patients treated with thiazolidinedione monotherapy had a 60% higher risk of congestive heart failure, a 40% higher risk of acute myocardial infarction and a 29% higher risk of death compared with people taking other hypoglycemic agent combination therapies. Patients treated with thiazolidinedione combination therapy had a 31% higher risk of congestive heart failure, and a 24% higher risk of death, but no higher risk of heart attack, compared with those taking other therapies. The association between thiazolidinedione treatment and cardiac events appears limited to rosiglitazone, the authors said.
Past research has indicated that rosiglitazone and pioglitazone may increase the risk of congestive heart failure, while two meta-analyses have suggested rosiglitazone may increase the risk of acute myocardial infarction. The FDA recently added boxed warnings to the drugs’ labels to reflect these risks, but has stopped short of recommending that the drugs be pulled from the market.
“These findings provide evidence from a real-world setting and support data from clinical trials that the harms of thiazolidinediones may outweigh their benefits,” though further studies are needed, the authors said. For now, clinicians need to weigh the potential benefits and harms of treatment on an individual basis, especially with high-risk elderly populations, they said.
The Journal of the American Medical Association is online.
Hypertension is significantly more prevalent and less adequately treated in adults with one or more major risk factors for cardiovascular disease than among the general population, a new study reported.
Researchers examined data from the 2003-04 National Health and Nutrition Examination Survey, comparing the prevalence, treatment and control rates of hypertension in patients with cardiovascular comorbidities to those without one or more of the following conditions: coronary artery disease, congestive heart failure, chronic kidney disease, peripheral artery disease, diabetes mellitus, dyslipidemia, and the metabolic syndrome. The prevalence of hypertension in adults with comorbidities ranged from 51.8% to 81.8% compared with 23.1% for those without multiple risk factors.
Even though the majority of adults with comorbidities in the study were being treated for hypertension, only one-third to one-half of these patients reached blood pressure goals, said the authors. The control rate would be even lower, they noted, if the study had applied recent recommendations by the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure to reduce blood pressure to less than 130/80 mm Hg in high-risk patients. The study appears in the Dec. 10 issue of Archives of Internal Medicine.
Two thirds of adults with coronary artery disease and 78.5% of patients with diabetes, chronic kidney disease, congestive heart failure and peripheral artery disease had isolated systolic hypertension, researchers found. That finding is significant, noted an accompanying editorial, considering that systolic hypertension is a stronger predictor of heart disease than diastolic pressure in adults older than age 50.
The study is further evidence of the gap between treatment guidelines and actual practice, continued the editorial. One reason for this may be the difficulty of achieving aggressive target goals, which requires intensive interventions and close monitoring by physicians, the editorial noted. Patients and physicians also may be wary of adverse events, skeptical about the validity of official guidelines, or constrained by limited access to care and cost of medications.
System errors contributed to nearly 30% of settled claims between 2004 and 2006, according to a closed claims analysis by one malpractice insurer.
In an effort to determine what impact health system errors have on medical malpractice claims, The Doctors Company analyzed 363 of its closed claims that were settled for between $100,000 and $500,000 from 2004 to 2006.
Of these 363 claims, 63%, (228 claims) showed provider error only, largely due to the nature of settled claims that generally occur when there is some caregiver responsibility for the adverse event that caused the patient injury. Another 28.7% (104 claims) involved both provider and system error while just 1% of total claims (four claims) involved only system error.
The most common type of system errors included: medication-related errors (32%), communication errors (27%), health care-associated infections (18%), medical record errors (13%), and wrong-site surgery (5%). These five types of system errors accounted for 95% of all system errors in The Doctors Company’s analysis.
Internal medicine, family practice and psychiatry are involved in nearly half of all medication-related errors in the analysis. Medication monitoring (43%) and dosage errors (26%) accounted for 69% of medication-related errors. Of the medication monitoring errors, one-third involved failing to properly monitor warfarin.
Other key findings include:
- More than one-third of errors involving medical records resulted from the absence of a written informed consent. Another 35% were associated with medication-related errors.
- Internal medicine accounted for 11.4% of the 35 communications errors studied and 12.5% of the 24 health care associated infections that occurred.
The press release is online.
Long-term use of omeprazole (Prilosec) and esomeprazole (Nexium) isn’t likely to be associated with a higher risk of heart problems, the FDA said last week.
The FDA began reviewing research on the proton pump inhibitors after receiving results of studies last May that compared the drugs’ effectiveness with surgery in treating severe gastroesophageal reflux disease (GERD). Cardiovascular events that occurred during the studies raised a question of whether long-term use of the drugs might increase the risk of heart attacks, heart failure and heart-related sudden death.
After a comprehensive review, the FDA said that it appears the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of studies doesn’t indicate the presence of a true effect. The agency recommends health care providers continue to prescribe, and patients continue to use, the drugs as advised by the labeling.
The FDA news release is online.
Before taking carbamazepine (Carbatrol, Tegretol, Equetro), patients with Asian ancestry should get a genetic test that can identify a higher risk of developing a rare, but serious, skin reaction, the FDA said last week.
The prescribing information for carbamazepine, which is used to treat epilepsy, bipolar disorder and neuropathic pain, already includes a warning for all patients that rare but severe skin reactions can occur, including toxic epidermal necrolysis and Stevens-Johnson syndrome. In countries with mostly white populations, the risk of these reactions is estimated at about 1 to 6 per 10,000 new users of the drug, but it is thought to be about 10 times higher in some Asian countries.
The skin reaction warnings will be moved to the current boxed warning section of the labeling, as will the recommendation for genetic testing for those with Asian ancestry. Studies have found a strong association between certain serious skin reactions and an inherited variant of the immune system gene HLA-B* 1502, usually found in people with Asian ancestry. Anyone who has already taken carbamazepine for more than a few months is unlikely to experience a skin reaction if he or she hasn’t already, the FDA added.
The FDA news release is online.
The American College of Cardiology/American Heart Association Task Force on Practice Guidelines has updated its guidelines on treatment for ST-segment elevation myocardial infarction (STEMI). The update, published online Dec. 10 by the Journal of the American College of Cardiology, is a focused update of the Task Force's 2004 recommendations on this topic.
The updated recommendations include the following:
- Patients with STEMI should receive PCI within 90 minutes if they present at a hospital with PCI capability or can be transferred to a hospital with PCI capability and treated within that time window. Patients who present to a hospital without PCI capability and cannot be transferred and treated within 90 minutes should instead receive fibrinolytic therapy within 30 minutes unless contraindicated.
- Intravenous beta-blockers should be avoided in STEMI patients with signs of heart failure or low output state, increased cardiogenic shock risk, or other contraindications.
- Clopidogrel should be added to aspirin and continued for at least 14 days in STEMI patients regardless of whether they receive reperfusion with fibrinolytic therapy or do not receive reperfusion.
- Routine use of nonsteroidal anti-inflammatory drugs (NSAIDs), except aspirin, should be discontinued at presentation with STEMI, and NSAIDs other than aspirin should be avoided during hospitalization for STEMI.
The guidelines also include new recommendations for transitioning patients to the catheterization laboratory after they have received fibrinolytic treatment and for using anticoagulants in patients receiving reperfusion with fibrinolytics.
The Journal of the American College of Cardiology is online.
A press release from the American Heart Association is online.
Baseline screening should start at age 40 for adults with no signs or risk factors for eye disease in order to intervene before diseases take hold, according to updated guidelines from the American Academy of Ophthalmology.
Baseline screening can reveal serious visual problems, such as ocular tumors, as well as evidence of systemic diseases that affect the eyes, such as hypertension and diabetes, according to the Academy's EyeSmart public awareness campaign Web site. Early treatment of conditions such as glaucoma, cataract and diabetic retinopathy often can save patients from eventual blindness.
The guidelines note that patients of any age with eye disease risk factors, such as high blood pressure, family history or diabetes, should consult with their ophthalmologist about frequency of eye exams.
Many adults age 40 and older are unaware that they have the beginning signs of eye disease, according to the EyeSmart site. For example, about half of the estimated 2.22 million people with primary open-angle glaucoma in 2000 were unaware that they had the disease at the time of diagnosis. In addition, many people with diabetic retinopathy, a leading cause of blindness, do not receive evaluation and treatment in time to minimize vision loss.
More information on the EyeSmart campaign is online.
ACP publishing news
Weekly'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.
Go online to view the cartoon and then pick the winner, who receives a $50 gift certificate good for any ACP product, program or service. The winning caption will appear in the Jan. 8, 2008 issue.
The CMS has announced that its pay-for-reporting program, the Physician Quality Reporting Initiative (PQRI), will continue through 2008. The College’s Practice Management Center has posted frequently asked questions on its Web site to help guide members through changes to the program.
The PQRI, which began in July 2007, is a voluntary pay-for-reporting program that allows physicians to earn a bonus for reporting on quality measures that apply to their patients. The 2008 program will have the same reporting standards. In order to successfully meet the requirements of the program, physicians must report on at least three quality measures on 80% of their appropriate claims.
Physicians can participate in the 2008 program even if they did not participate this year. There is no registration process required. Physicians who wish to participate should begin reporting the appropriate quality measures on Jan. 1, 2008.
Physicians who successfully completed the requirements of the program during the second half of 2007 are scheduled to receive a bonus payment of 1.5% of their allowed charges from the Medicare physician fee schedule. The payments are expected to arrive some time in the second quarter of 2008.
It is important to note that there may be changes to the bonus payments for the 2008 PQRI program. Congress is currently considering options for how to address the 10.1% cut in Medicare payments that is scheduled to take effect in 2008. It is possible that the legislation passed to fix the payment cut could affect the funding for the PQRI bonus payment. ACP will notify members if a change occurs that will affect PQRI funding or any other aspect of the program.
The College’s FAQs and further information about the PQRI are online.
ACP has released a new patient education DVD and guidebook on bipolar disorder. Once referred to as “manic depression,” bipolar disorder is now believed to be caused by a chemical imbalance in the brain and affects more than 8 million Americans.
The College’s A Guide to Bipolar Disorder guidebook and DVD offer comprehensive information about the illness, including signs of the disease, how to treat it, how to cope with it and associated risk factors. A Guide to Bipolar Disorder is free for all members.
A version of the guide can be downloaded online.
Other patient education materials on a variety of topics are available on the Doctors for Adults Web site and can be ordered by calling 866-439-9857 Monday through Friday from 9am to 8pm.
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A 66-year-old man is evaluated for vague abdominal pain of several months' duration and a 10-kg (22-lb) weight loss. He drinks alcohol socially but does not smoke. The patient is otherwise well, has good performance status, and takes no medications. Following a physical exam, lab studies, and a CT scan, what is the most appropriate initial management of this patient?
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