In the News for the Week of 5-22-07
- Vitamins linked to fatal prostate cancer
- Diabetes, antipsychotic drug use rises sharply in girls
- CV, diabetes management better for men than women, African-Americans
- ACP Journal Club: Fenoldopam reduces acute kidney injury and death in critical illness
- Mild asthma controlled with less medication, studies find
- Anxiety increases chances of heart attack, death in CAD patients
- Stroke patients slow to reach hospital
- Record Leadership Day attendance for introduction of new Health CARE Act
- ACP applauds geriatric and chronic care coordination legislation
- 2007 National Abstract Winners now online
Please note: ACP Observer Weekly will not be published the week of May 27 due to the Memorial Day holiday.
Multivitamin use does not increase the risk of early or localized prostate cancer, but it does appear to be linked to advanced and fatal cancers, a new study found.
Using data from almost 300,000 men enrolled in the NIH-AARP Diet and Health Study, researchers compared men’s vitamin-taking habits with development of prostate cancer. About a third of study participants took a multivitamin, and about 5% were heavy users who took multivitamins or other supplements more than seven times per week. Over the five-year study, 10,241 men were diagnosed with prostate cancer and 179 died.
The researchers found no association between vitamin use and the risk of localized prostate cancer. However, heavy vitamin users were almost twice as likely to have advanced and fatal prostate cancer as non-users. That association was strongest in men who had a family history of prostate cancer or who took individual micronutrient supplements, including selenium, beta carotene or zinc.
One possible explanation for the findings is that the vitamins have little effect until a cancer appears and then spur tumor growth, study authors told the May 15 Washington Post. However, because the study participants were not randomized and voluntarily took the vitamins, the results could show that men who were at the highest risk of prostate cancer because of family history or other factors took vitamins as a preventive measure.
In any case, the finding of an increase in prostate cancer in multivitamin users is of concern and warrants further research, said study authors. The next research on the subject will come from the Physicians’ Health Study II, scheduled to conclude in December 2007. This study was published in the May 16 Journal of the National Cancer Institute.
The study is online.
The Washington Post is online.
The number of adolescent girls taking prescription drugs for diabetes, insomnia, psychotic behavior and attention deficit/hyperactivity disorder (ADHD) has grown significantly in recent years, and outpaces growth among boys, a new study found.
The analysis by Medco Health Solutions, Inc., the nation's largest prescription drug manager, reviewed prescription drug claims between 2001 and 2006 of 370,000 insured children aged 10 to 19. It found the number of girls on type 2 diabetes medication rose 167% in that time period, compared with a 33% increase for boys. For all diabetes medication, the rise was 59% for girls and 14% for boys.
Antipsychotic drug use rose 117% among girls and 71% among boys, while 46% more girls than boys took sleep medications in 2006, with girls increasing their use by more than 80% since 2001. The increase in prevalence of girls taking ADHD drugs was double that of boys, showing a 74% jump in the last five years. Though rates are still rising, growth of drug use did slow between 2005 and 2006 among girls for most drugs, except sleep medications.
The findings question the appropriateness of prescribing medicines mostly intended for adults for young people, said experts quoted in the May 16 New York Times. Experts suggested focusing instead on counseling and lifestyle changes before turning to medications for adolescent patients.
The Medco release is online.
The New York Times is online.
Cardiovascular and diabetes disease screening and management are better for white men than women and African Americans, particularly where cholesterol is concerned, four new studies found.
Following are summaries of the studies, which were published in the May/June issue of Women’s Health Issues:
Using patient data from 31 health plans, researchers found women had worse outcomes than men on 6 of 7 quality indicators, including LDL control at <100 mg/dL in those with diabetes (OR = 0.81) or a history of CVD (OR=0.72). Women did achieve higher performance than men in controlling blood pressure (OR= 1.12). Most differences were small and varied at least as much by race/ethnicity or socioeconomic status as gender.
In evaluating six diabetes management measures by gender and race/ethnicity, authors found women were slightly more likely to have received HbA1c screening or eye exams, but only 0.75 as likely to have LDL control at <100 mg/dL compared with men. African Americans were less likely than whites to have received HbA1c screening (OR=0.77), eye exams (OR=0.94), cholesterol screening (OR=0.66), or achieve adequate HbA1c control or LDL control at <100 mg/dL (OR=0.69).
Authors assessed 11 screening, treatment and intermediate outcome measures of quality care for more than 2 million patients with cardiovascular disease and diabetes in 19 Medicare and commercial plans. After adjustment for age, race/ethnicity and socioeconomic status, more than 75% of observed differences favored men. Female diabetic Medicare plan enrollees were 19% less likely than men to have LDL-C controlled (RR=0.81); female commercial enrollees were 16% less likely (RR=0.84).
Researchers examined the feasibility of collecting gender-stratified results of CVD-related performance measures from health plans. While reporting quality data by gender is feasible, it appears to be a low priority for the plans, the authors said. They found gender disparities in plans were common, and usually favored men, with greater gender differences in intermediate outcomes like lipid control than in risk identification (e.g., lipid screening).
The Women’s Health Issues studies are online.
A review found that fenoldopam reduced acute renal failure (ARF) requiring renal replacement therapy and all-cause mortality in critically ill patients.
Researchers conducted a meta-analysis of 16 randomized controlled trials that evaluated fenoldopam in critically ill patients in surgical or intensive care units. Control group treatments included placebo or best available treatment (usually low-dose dopamine). The review’s primary outcomes were ARF requiring one or more episodes of renal replacement therapy (RRT) and all-cause hospital mortality, with secondary outcomes of ICU length of stay (LOS), hospital LOS, peak serum creatinine level and hypotension.
The review found that the fenoldopam reduced risk for ARF, requirement for RRT, and all-cause mortality. The intervention group also had shorter ICU stays, borderline shorter hospital LOS and lower peak serum creatinine levels, and the groups did not differ significantly for hypotensive episodes. The fenoldopam patients had 43% less ARF requiring RRT (number needed to treat (NNT) = 23) and 31% lower mortality (NNT = 17). The study is abstracted in the May/June ACP Journal Club.
The review, published earlier this year in the American Journal of Kidney Diseases (2007;49:56-68) suggests that fenoldopam provides patient-important benefits, although the small size of the included trials may limit the impact of the findings, said Journal Club reviewers Neill Adhikari, MD, and Jan Friedrich, MD, of the University of Toronto. Considering the trials’ sizes, methodological quality and the possibility of industry funding bias, the estimates of treatment may be overly optimistic. Fenoldopam is a promising therapy for ARF, the reviewers commented, but a larger, multicentered RCT is needed to further evaluate the therapy.
Peer ratings for this review: Intensivist/Critical Care, Nephrology, Cardiac Surgery: 6/7 stars. Vascular Surgery: 5/7 stars.
ACP Journal Club is online.
Step-down and as-needed therapies are effective treatment options for patients with mild, persistent asthma, according to two new studies.
In the first study, researchers randomly assigned 500 patients with well-controlled asthma to continue taking fluticasone twice daily, take montelukast nightly or take fluticasone plus salmeterol once daily. They found that about 20% of the fluticasone and fluticasone plus salmeterol groups had treatment failure, compared with approximately 30% of the patients taking montelukast. All three groups had similar numbers of symptom-free days.
Based on the findings, the use of once-daily fluticasone plus salmeterol or once-daily montelukast can be considered for patients whose asthma is well-controlled with twice-daily corticosteroids, study authors concluded. Although montelukast had a higher failure rate, considerations of convenience and cost may offset that factor for some patients and physicians, and no single approach is best for all asthma patients, the authors said.
In the other randomized, controlled trial of 455 patients, researchers compared regular use of inhaled beclomethasone with symptom-driven use of inhaled beclomethasone and albuterol. As measured by the primary outcome of morning peak expiratory flow rate, the study found that symptom-driven use of the combined drugs in a single inhaler was as effective as twice-daily use of beclomethasone alone. As-needed treatment also resulted in lower six-month cumulative doses of the inhaled corticosteroid.
The authors noted previous studies showing that regular therapy with inhaled corticosteroids for mild asthma reduces the frequency of exacerbations and may reduce the rate of decline in lung function. However, they said, those studies looked at patients with mild or moderate asthma, where as this study included only those with mild persistent asthma. The six-month duration of the study was too short, however to determine whether as-needed therapy affects the natural history of asthma, and longer-term studies are needed to resolve this question.
The study’s findings on the effectiveness of symptom-driven use could help answer the problem of poor compliance, a major issue in the treatment of asthma, said study authors. They also noted that the lower cumulative doses in the as-needed treatment could alleviate concerns about the safety of prolonged intake of inhaled corticosteroids.
Despite the studies’ findings, twice-daily therapy is still the best option for most patients, as long as they are doing well and don’t mind taking the medication, an author told the May 16 Washington Post. Both studies were funded by asthma medication manufacturers and published in the May 17 New England Journal of Medicine.
The Washington Post is online.
A high level of anxiety heightens the risk of heart attack or death in coronary artery disease patients, a new study found.
The study followed 516 CAD patients at an outpatient cardiology clinic for an average of 3.4 years. Patients completed weekly questionnaires with items such as whether they felt peaceful, took a long time to fall asleep at night, or had upset bowels or stomach, the May 14 Washington Post said.
Those who scored in the upper third for anxiety on the Kellner Symptom Questionnaire had almost twice the risk of nonfatal myocardial infarction or death compared with the lowest third (age-adjusted hazard ratio 1.97, 95% CI 1.03 to 3.78, p=0.04), the study found. After adjusting for many factors including age, smoking and hypertension, it found that each one-point increase in the anxiety score was associated with a 6% increased risk of nonfatal MI or death (HR = 1.06, 95% CI 1.01 to 1.12, p=0.02). The study was published in the May 22 issue of the Journal of the American College of Cardiology.
A next step for research is to discover whether an intervention like medication or counseling can change a patient’s prognosis, said one study author in the Washington Post. Referring highly anxious patients to a psychiatrist or psychologist might be appropriate, he added.
The Journal of the American College of Cardiology abstract is online.
The Washington Post is online.
Medicare would limit coverage of erythropoiesis stimulating agents (ESA) for treatment of certain cancers under a new rule proposed last week. The proposed coverage change is a response to recent actions taken by the FDA to highlight the risks of ESAs.
Based on studies showing that ESAs could cause serious adverse events or increase tumor growth in cancer patients, the FDA had added a black box warning to the drugs. Two weeks ago, a panel of FDA advisors also proposed limited the drugs’ use in oncology treatment.
CMS officials have drawn up a proposed list of instances in which ESA treatment is reasonable and necessary. The list, which specifies certain cancers and conditions, is available for public review and comment for the next 30 days. The agency is also closely reviewing the use of ESA in the treatment of end-stage renal disease, and may offer further rule changes on the drugs in the future, officials said.
The proposed rule is online.
The Physicians Quality Reporting Initiative (PQRI) is set to begin on July 1, 2007. The PQRI is a new program that allows physicians to be paid for reporting certain quality measures on Medicare claims.
This is a voluntary program and physicians may still continue to participate in Medicare as they do now if they choose not to participate in PQRI. CMS will pay physicians a bonus payment if they report on quality measures on a limited number of patients to whom the measures apply.
In anticipation of the upcoming start date of the PQRI, CMS has designated a test code (G8300) for reporting before July 1. The code may be used to test system readiness for the submission of these new quality reporting measures, but will expire when the PQRI program starts on July 1. This new code, G8300, may be attached to any claim submitted by the physician to Medicare. However, CMS is requesting that if possible providers submit some claims with the PQRI test code before May 30, 2007.
Beginning May 23, CMS also will ask providers to begin using their National Provider Identifier (NPI) number to submit claims. The NPI will be used by all payers to identify health care providers, eliminating the current need for multiple identifiers for the same provider. CMS encourages health care providers that have not yet obtained NPIs to do so immediately. However, as previously announced, CMS will not penalize covered entities that fail to meet the deadline if they show a good-faith effort to use the NPI.
Details about how to use the new test code can be found on the CMS Web site.
Further information on the PQRI is available from CMS online.
Assistance tools and updates from ACP are online.
More than half of stroke patients arrive at a hospital more than two hours after the onset of symptoms, found a new report from the CDC. Such delays in treatment make patients less likely to receive tissue plasminogen activator (tPA) therapy and increase the risk of stroke-related disability.
The study, conducted in 142 hospitals in 2005 and 2006, found that patients who call an ambulance are more likely to arrive at the emergency department within two hours of symptom onset. Patients who arrive by ambulance also experience fewer delays at the hospital—69.2% of them receive imaging within an hour compared with 56.3% of patients who arrive on their own.
Women are also less likely than men to receive prompt imaging (62.9% vs. 67.6% within one hour). The study found no racial disparities in the wait for imaging, but did find that blacks are less likely to arrive at the ED within two hours of symptom onset. The findings highlight the need for greater public education about stroke symptoms and the importance of stroke patients calling for ambulance transport, the CDC said.
In a related report, the CDC found that stroke prevalence varies widely among U.S. states—ranging from 1.5% in Connecticut to 4.3% in Mississippi. Almost a quarter of states, all located in the South or Midwest, had stroke prevalence of 3% or above. American Indian/Alaska Natives had the highest rate and Asians the lowest. Prevalence was also more than twice as high in individuals with less than 12 years of education than in college graduates. Both studies were published in the May 17 Morbidity and Mortality Weekly Report.
The MMWR is online.
About 300 College members from 42 state Chapters and the District of Columbia took to Capitol Hill last week to talk with lawmakers about pressing health care policy issues as part of ACP’s annual Leadership Day, which broke records for attendance this year.
Chapter Governors organized delegations to learn about issues and receive advocacy training before meeting with their state’s Senators and Representatives. Top issues discussed were replacing sustained growth rate (SGR) cuts with two years of positive updates and a pathway for SGR appeal; supporting initiatives to create a Patient Centered Medical Home; and expanding and improving access to health care for lower income patients.
At a news conference during the event, Representatives Marcy Kaptur (D-OH) and Steven LaTourette (R-OH) introduced the Health Coverage, Affordability, Responsibility and Equity Act (the Health CARE Act H.R. 2351), noting that it is based largely on an ACP proposal.
The Act differs in philosophy and substance from past, failed reform efforts in that it relies on choices, competition and financial incentives for state, small employers, insurers and individuals to make affordable coverage available to all Americans. It is not a “one size fits all” plan of government mandates and price controls, Reps. Kaptur and LaTourette said.
ACP President David C. Dale, FACP, endorsed the bill on behalf of the College, saying it will “translate many of ACP’s policies and principles to provide health insurance coverage to all Americans.”
ACP’s press release on the Health CARE Act is online.
Sen. Blanche Lincoln (D-AR) recently introduced the “Geriatric Assessment and Chronic Care Coordination Act of 2007.”The legislation, introduced in conjunction with a Senate Special Committee on Aging hearing on the future of Medicare, would link eligible seniors suffering from chronic illnesses with a qualified health professional (defined as a physician or a practitioner under the supervision of a physician) to coordinate their care.
In a statement applauding the legislation, the College noted that it represented a marked departure from Medicare’s practice of paying physicians for episodic and acute care. “Ongoing care coordination for patients with multiple chronic diseases and/or dementia is critical,” said ACP President David C. Dale, FACP. “It is essential that the system incorporate several of the key elements of the patient-centered medical home.”
The bill would provide for high-cost Medicare beneficiaries, those with either multiple chronic conditions or dementia and at least one chronic condition, to receive a comprehensive review of their medical condition. This review would include functional and cognitive capacity, as well as environmental and psychosocial needs. Individuals who had been assessed and deemed eligible for care coordination services could elect to use this benefit and choose a chronic care manager.
ACP’s press release is online.
This year, more than 2,500 abstracts were submitted to the National Associates and Medical Students Abstract Competitions which concluded at Internal Medicine 2007. Members can now go online to view the Associate and Medical Student winners in all four categories: Research Paper, Research Poster, Clinical Vignette Paper and Clinical Vignette Poster.
Five winners are chosen in each category in the student competition, and 10 are awarded for each category in the Associate competition. Entries are judged by the hundreds of member volunteers who review abstracts both before and during the meeting. For the 2007 competitions, 313 judges volunteered their time.
ACP sponsors the abstract competitions for its Associate and Medical Student Members each year as an opportunity for younger members to sharpen their skills conducting and presenting original research. Of the poster abstracts, judges chose 400 of “the best of the best” to be featured in a poster showcase at the meeting. Oral presentations of the highest scoring abstracts from the national competition were also featured.
Information about submitting an abstract for next year’s competition and a complete list of poster winners and oral presenters for 2007 is online.
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Copyright 2007 by the American College of Physicians.
A 59-year-old woman is evaluated during a routine follow-up visit. She was recently diagnosed with type 2 diabetes mellitus and hyperlipidemia. She feels well. Medications are metformin, atorvastatin, and aspirin. Following a physical exam and lab results, what is the most appropriate diagnostic test to perform next?
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