In the News
for the Week of 8-31-10
- Pioglitazone poses same risk as rosiglitazone in insurer’s study
- Statin beneficial to intermediate-risk patients, says new JUPITER analysis
- MKSAP Quiz: generalized, intensely pruritic eruption
Abdominal aortic aneurysm
- Additional screening criteria suggested for abdominal aortic aneurysm
- Annual PSA follow-ups not needed in low-risk cases
- Comorbid illnesses still more likely to kill prostate cancer survivors
- Medicare expands tobacco cessation coverage
- Veterans Affairs solicits applications for centers of excellence
From the College
- ACP announces new Division of Medical Practice, Professionalism & Quality
- ACP Chapter meetings coming up
For the record
- Clarification to a previous issue
Cartoon caption contest
- And the winner is …
Physician editor: Darren Taichman, FACP
Editorial note: ACP InternistWeekly will not be published next week due to the Labor Day holiday.
Pioglitazone poses same risk as rosiglitazone in insurer’s study
Patients faced the same risk of death or cardiac events whether they took rosiglitazone or pioglitazone, according to a new retrospective analysis.
The study included more than 36,000 patients and used information from the database of one insurer (WellPoint). All of the patients began taking either rosiglitazone or pioglitazone between 2001 and 2005, and had no reported prior use of insulin. Propensity scoring was used to control for confounding differences between patients taking the different drugs. The primary outcome was time to acute myocardial infarction (AMI), acute heart failure (AHF) or all-cause mortality. The results were published online last week by Circulation: Cardiovascular Quality and Outcomes.
Of the rosiglitazone patients, 4.16% (602 patients) suffered an AMI, AHF or death compared to 4.14% (599 patients) of the pioglitazone patients. There were no significant differences in risk between the groups for any of the endpoints. The study also looked at the subpopulation of patients who were at least 65 years of age, and found that 355 (13.88%) of the rosiglitazone patients had an event compared with 393 (13.94%) of the pioglitazone patients. The study authors concluded that no significant differences were found between the death and cardiac event risk associated with the two drugs in this study population.
Previous research has found inconsistent results on this question, some of which conflicts with these findings, the authors said. They noted that some other studies which found an increased risk with rosiglitazone included only elderly patients. The current study did include elderly patients, but only ones that had full health coverage, and therefore might still be employed, possibly indicating that they are healthier than other elderly study populations.
That difference is one possible explanation for the failure to find an elevated risk with rosiglitazone, the authors concluded. Another explanation is that both rosiglitazone and pioglitazone confer an additional cardiovascular risk, they said. Further research to refine study methodology, identify at-risk populations and validate events and exposure are needed, especially in light of ongoing legislative and FDA review of rosiglitazone, the authors concluded..
Statin beneficial to intermediate-risk patients, says new JUPITER analysis
Rosuvastatin is beneficial as primary prevention for patients who are at intermediate risk of a cardiac event and have elevated C-reactive protein (CRP), according to the latest analysis of JUPITER.
JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) included more than 17,000 patients who had cholesterol under 130 mg/dL and CRP of 2 mg/L or above. Evaluation of those patients using the Framingham risk score indicated that about 6,000 had a 10-year risk of a cardiac event of 5% to 10%. Another 7,340 patients had a Framingham risk of 11% to 20%. This new analysis assessed the effect of rosuvastatin, 20 mg, versus placebo on these intermediate-risk patients. The results were published online last week by Circulation: Cardiovascular Quality and Outcomes.
Patients with a 5% to 10% Framingham risk were 45% less likely to have an event if they took the drug (P=0.005) and those with a 10% to 20% risk had a 49% reduction in events (P<0.0001). That worked out to a 5-year number needed to treat of 40 for the 5% to 10% group and 18 for the 10% to 20% group. The researchers also tried stratifying the study population based on the Reynolds Risk score (which includes family history and CRP) and found similar results, except that more patients were considered lower or higher risk.
The results support the recommendations of the American Heart Association and the Centers for Disease Control and Prevention that CRP is best used in patients with a 10-year risk between 5% and 20%, the study authors said. If these patients are found to have elevated CRP, they might well be considered candidates for statin therapy, the authors suggested, noting that this group is currently outside treatment guidelines. Patients with even lower risk (less than 5% over 10 years) were found to receive only small benefit from statin treatment.
Recent Canadian guidelines have called for prophylactic statins for older patients with elevated CRP and Framingham scores above 10%. This approach is supported by the new findings, but it is limited by its exclusion of patients with a risk between 5% and 10%, the study authors said. Their analysis found that most women in JUPITER who benefited from taking a statin were in this 5% to 10% group, so they advocated expanding the definition of intermediate risk to include these patients.
MKSAP Quiz: generalized, intensely pruritic eruption
A 65-year-old man is evaluated for a generalized, intensely pruritic eruption that has been slowly progressing over the last 6 months. He has been treated with topical corticosteroids for 4 months for widespread eczema without relief of pruritus or change in clinical appearance. He has never had a skin biopsy. He does not have a personal or family history of asthma, atopic dermatitis, allergic rhinitis, or psoriasis.
On physical examination, temperature is 37.5 °C (99.5 °F), blood pressure is 135/85 mm Hg, pulse rate is 84/min, and respiration rate is 14/min. Skin examination reveals erythema with scale affecting greater than 90% of the body surface area. Alopecia, nail dystrophy, and ectropion (turning inside out of the eyelid) are present. There are thickening and fissuring of the skin on the palms and soles. Bilateral axillary and inguinal lymphadenopathy are present. The mucous membranes are not involved.
Which of the following is the most appropriate next step in management?
A) Antinuclear antibody assay
D) Rapid plasma reagin test
E) Skin biopsy
Click here or scroll to the bottom of the page for the answer and critique.
Abdominal aortic aneurysm.
Additional screening criteria suggested for abdominal aortic aneurysm
A new study suggests using additional criteria to expand routine screening for abdominal aortic aneurysm (AAA).
Currently, the U.S. Preventive Services Task Force recommends screening for AAA in men 65 to 75 years of age who have a history of smoking and does not recommend it in women or nonsmokers. However, approximately 41% and 22% of AAA deaths, respectively, occur in the latter two groups. Researchers analyzed retrospective data obtained from Life Line Screening on 3.1 million patients who filled out a medical and lifestyle questionnaire and had ultrasound screening for AAA from 2003 to 2008. Patients were self-referred for screening and paid for the tests themselves. The aim of the study was to identify risk factors associated with AAA. The study results will appear in the September Journal of Vascular Surgery.
The data showed that smoking was associated with AAA, as was excess weight. People who exercised at least once a week and incorporated nuts, fruits and vegetables into their diets at least three times a week were at lower risk, as were blacks, Hispanics and Asians compared with whites and Native Americans. Male sex, age, cardiovascular disease and family history were reaffirmed as known risk factors.
Based on these findings, the authors created a predictive scoring system to identify AAA in a population including women, nonsmokers and those less than 65 years old. They applied their scoring system to data from the National Health and Nutrition Examination Survey and thereby estimated a prevalence of 1.1 million AAAs in the U.S., 569,000 in the latter three lower-risk groups not included in current screening recommendations.
The authors noted that expanding the screening criteria for AAA will increase ultrasound costs, and that the threshold score used with their system must be chosen carefully. In addition, they acknowledged that their study was limited by its self-referred population and its reliance on self-reporting of medical and lifestyle factors. Nonetheless, they concluded that their findings provide new information on risk factors for AAA and could offer a way for primary care physicians to stratify an individual patient's risk. However, they wrote, "Before being considered useful in clinical practice, the scoring system will need to be tested and validated in other well-defined populations."
Annual PSA follow-ups not needed in low-risk cases
Patients with surgically treated low-risk prostate cancer may not need annual prostate-specific antigen (PSA) measurements, especially after three years of normal results.
Researchers at the Mayo Clinic in Rochester, Minn., looked at 2,219 patients who underwent radical prostatectomy between 1994 and 2004 for localized prostate cancer. They reported results in the September 2010 Journal of Urology.
They defined low risk as preoperative PSA levels less than 10 ng/mL, pathological stage pT2c or less, Gleason score 6 or less, negative lymph nodes and negative surgical margins. They excluded patients taking neoadjuvant or adjuvant therapy. Biochemical failure was defined as a PSA level above 0.4 ng/mL at any follow-up. PSA levels less than 0.15 ng/mL were defined as undetectable.
One hundred forty-two (6.4%) patients experienced biochemical failure during the study, and the risk decreased with longer PSA-free intervals. Of 2,193 men with undetectable PSA at one year, 84 (3.8%) later had biochemical failure. Of 2,117 patients with undetectable PSA two years postoperatively, 59 (2.8%) experienced biochemical failure. The rate continued to fall at three years (33 of 1,851; 1.8%), four years (22 of 1,567; 1.4%) and five years (19 of 1,351; 1.4%).
Biochemical failure one year after an undetectable PSA level is uncommon, especially after a PSA-free period of three years, researchers noted. Prostate-specific antigen measurements every two years should capture the majority of low-risk patients who experience progression, researchers suggested.
"A benefit to an upfront, aggressive surgical approach to localized prostate cancer should be that postoperative surveillance is less necessary and less intensive," the authors wrote. "It only makes sense that men undergoing [radical prostatectomy] for pathologically proven low risk disease should be screened less often.".
Comorbid illnesses still more likely to kill prostate cancer survivors
Men die with prostate cancer, not of it, even when the disease recurs after treatment, researchers said.
According to this analysis, men with significant comorbidity have a 41% risk of death from other causes six years after treatment, several years before significant survival benefits of aggressive local treatment can be realized. Researchers suggested in a research letter in the August 9/23 Archives of Internal Medicine that men strongly consider conservative treatment for their clinically localized prostate cancer.
Researchers applied a prognostic utility, the Total Illness Burden Index for Prostate Cancer (TIBI-CaP). This is an 84-item questionnaire that measures both presence and severity of comorbid illness. Men with TIBI-CaP scores of 12 or greater were 13 times more likely to die of causes other than prostate cancer within 3.5 years of questionnaire administration, compared with men with the lowest scores.
Researchers sent the TIBI-CaP questionnaire to 4,635 active participants of the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a national, observational prostate cancer registry. Of the 3,389 respondents, 2,900 completed it and were included in the study. The mean time from treatment to TIBI-CaP questionnaire completion was 41.4 months. The primary outcome was death from causes other than prostate cancer.
After a median follow-up of 6.2 years, overall mortality was 14.5% (n=420), while prostate cancer-specific mortality was only 3% (n=86). Among patients with TIBI-CaP scores at least 12, 41% died of other causes, compared with 6% of those with scores of 0 to 2 (P<0.001). Men with the highest TIBI-CaP scores were 10 times more likely to die of causes other than prostate cancer, compared with men with the lowest scores (hazard ratio, 10.3; 95% CI, 5.4 to 19.5)
Medicare expands tobacco cessation coverage
Medicare will now pay for tobacco cessation counseling even if a patient does not have a tobacco-related disease, the Department of Health and Human Services (HHS) announced last week.
Under the new coverage, any smoker covered by Medicare will be able to receive tobacco cessation counseling from a qualified physician or other Medicare-recognized practitioner. Previously, tobacco counseling was covered only for individuals diagnosed with a recognized tobacco-related disease or who showed signs or symptoms of such a disease.
The new benefit will cover two individual tobacco cessation counseling attempts per year, each of which may include up to four sessions. The policy will apply to services under Parts A and B of Medicare. Beneficiaries will continue to have access to smoking-cessation prescription medication through Part D. Under the Affordable Care Act, effective Jan. 1, 2011, Medicare will cover preventive care services, including this tobacco cessation counseling, at no cost to beneficiaries. Later this year, Medicaid benefits will also be expanded to cover tobacco counseling for pregnant beneficiaries, according to HHS.
An estimated 4.5 million of the 46 million Americans who smoke are Medicare beneficiaries 65 or older and fewer than 1 million are younger than 65 and are covered by Medicare due to a disability, a press release reported.
Veterans Affairs solicits applications for centers of excellence
The Department of Veterans Affairs (VA) Office of Academic Affiliations is soliciting applications for VA Centers of Excellence in Primary Care Education. Centers are expected to foster the transformation of clinical education by preparing graduates of health professional schools and programs to work in and lead patient-centered interprofessional teams providing coordinated longitudinal care.
Centers will use ambulatory primary care settings to develop and test innovative approaches for introducing, augmenting, and sustaining curricula related to the core competencies of patient-centered clinical practice. They will evaluate these improvement efforts for effects on desired educational and clinical outcomes, including patient, family, trainee, clinician and institutional experiences. Centers will study the impact of new educational approaches and models on the larger context of health professions education, including collaboration between different professional schools and programs, cultural shifts in educational priorities, and educational and workforce outcomes within and beyond the VA.
Interested facilities should submit letters of intent via e-mail by Sept. 22 to receive consideration. Full proposals will be due on Nov. 17. More information is available online. Questions about this program announcement should be directed to Michelle D. Johnson at 202-461-9492 or Michelle.Johnson5@va.gov or Joanne Pelekakis at 202-461-9593 or Joanne.Pelekakis@va.gov.
From the College.
ACP announces new Division of Medical Practice, Professionalism & Quality
ACP is pleased to announce the creation of a new Division of Medical Practice, Professionalism & Quality, led by Michael S. Barr, FACP, MBA, who was promoted to Senior Vice President. Dr. Barr has served as the Vice President of Practice Advocacy and Improvement in ACP's Washington, D.C. office since 2005.
The new division reflects ACP’s commitment to develop and expand innovative practice-oriented programs, products and services that support the clinical, professional and business operations of physicians and other health care professionals in practice. The new division will be home to existing products such as the American EHR Partners Program, the Medical Home Builder, Closing the Gap and ACPNet and the Medical Laboratory Evaluation Program. All of the College’s quality improvement programs, practice support efforts, and the Center for Ethics and Professionalism are now in one division with the expressed intent of promoting evidence-based, effective, ethical, accountable and patient-centered care in collaboration with other health care professionals and providers of health care services (e.g., hospitals, health care facilities, public and private payers and public health agencies).
More information on the programs, products and services included in the Division of Medical Practice, Professionalism & Quality is available online..
ACP Chapter meetings coming up
Attend a fall chapter meeting, earn CME credit, and find out what your local ACP Chapters have to offer. View the Chapter calendar or visit the Chapters and Regions page to find out more about local activities.
For the record.
Clarification to a previous issue
A recent item in ACP InternistWeekly should have noted that new criteria on rheumatoid arthritis were jointly published in the September Arthritis & Rheumatism and the September Annals of the Rheumatic Diseases. The item has been updated.
Cartoon caption contest.
And the winner is …
ACP InternistWeekly has tallied the voting from its latest cartoon contest, where readers are invited to match wits against their peers to provide the most original and amusing caption.
"Did you say you were a little horse? Or a little hoarse?"
This issue's winning cartoon caption was submitted by Patricia J. Peterson, FACP, in practice in Longview, Wash. Readers cast 101 ballots online to choose the winning entry. Thanks to all who voted!
The winning entry captured 62.4% of the votes.
The runners-up were:
"I’ll need to take a look with my oatoscope."
"I think we need to up your dose of Lasix."
MKSAP answer and critique
The correct answer is E) Skin biopsy. This item is available to MKSAP 15 subscribers as item 26 in the Dermatology module.
This patient’s signs and symptoms are consistent with a slowly evolving erythroderma. An underlying cause for erythroderma should always be sought in order to guide therapy and determine prognosis. The diagnosis of idiopathic erythroderma is one of exclusion and should only be made after all other potential causes have been ruled out. Skin biopsy with routine hematoxylin and eosin staining should be performed in every patient with erythroderma; however, histopathologic findings diagnostic of the underlying cause are present in only 50% of patients. If the initial biopsy is nondiagnostic, additional biopsies may be useful and are recommended. This patient’s disease, previously diagnosed as eczema, began in adulthood and has not responded to therapy (topical corticosteroids) that is typically effective in the treatment of atopic dermatitis. In addition, he had no personal or family history of atopy (asthma, atopic dermatitis, allergic rhinitis). Atopic dermatitis rarely presents in adulthood in patients without a personal or family history of atopy and is most commonly confused in this setting with cutaneous T-cell lymphoma. Therefore, the most important next step in the management of this patient is a skin biopsy to rule out cutaneous T-cell lymphoma/Sézary syndrome.
Cyclosporine and phototherapy are potential treatments for erythroderma, either idiopathic or related to a particular cause. However, before treating erythroderma with a systemic agent or phototherapy, the cause of the erythroderma should be sought.
Antinuclear antibody and rapid plasma reagin are tests for autoimmune connective tissue disease and syphilis, respectively. Neither autoimmune connective tissue disease nor syphilis commonly causes erythroderma, making these options incorrect.
- A skin biopsy is always required in the evaluation of a patient with erythroderma.
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