In the News
for the Week of 8-19-08
- Flu vaccine did not lower risk of pneumonia in elderly, study finds
- Updated guidelines for treating allergic rhinitis now online
- PCI slightly more effective than meds alone for angina, but only for limited time
- Naltrexone can cause adverse injection site reactions
- Caution urged when mixing simvastatin, amiodarone
- Tenofovir disoproxil fumarate approved for chronic Hepatitis B
- Class I recall for carotid artery stenosis device
Annals of Internal Medicine
- Good long-term prognosis after West Nile Virus infection
- Vitamin D deficiency puts older women at risk for hip fracture
- Documentary evidence reveals motives of pharmaceutical “seeding” trials
Tools and resources
- New patient education video: HIV guide for Latinos
- MKSAP quiz: acute dyspnea
From ACP Internist
- On the blog: Genetic studies could personalize warfarin administration
- Cartoon caption contest: vote for your favorite entry
Flu vaccine did not lower risk of pneumonia in elderly, study finds
Contrary to results of other similar studies, getting an influenza vaccine before the flu season did not lower older patients' risk of contracting community-acquired pneumonia (CAP) during the flu season compared with older patients who were not vaccinated, a recent study concluded.
The population-based, nested case-control study included elderly people aged 65-94 years (1,173 cases and 2,346 controls) enrolled in a health maintenance organization during the 2000, 2001 and 2002 flu seasons. Researchers randomly selected two age-matched, sex matched controls for each case, or individual who had either outpatient or inpatient CAP and, after adjusting for comorbidities, found that flu vaccination was not associated with a reduced risk of CAP (odds ratio 0.92, 95% CI 0.77-1.10) during the flu season. The study appears in the Aug. 2, 2008 Lancet.
Before adjusting for confounders, vaccinated patients had a 40% lower risk for CAP than unvaccinated patients in the pre-influenza period, but there was no difference between the groups after researchers adjusted for chronic diseases and functional impairment. There was no difference in CAP risk between the two groups during the flu season, whether or not adjustments were made.
Researchers at the Group Health Center for Health Studies, which conducted the study, noted that their study had several strengths over other studies that may have overestimated the benefits of the flu vaccine, most notably that it controlled for frailty and chronic diseases, which make seniors more susceptible to pneumonia. Group Health researchers also used medical records to determine health status and included pneumonia cases treated inside and outside hospitals..
Updated guidelines on treating allergic rhinitis now online
"The diagnosis and management of rhinitis: An updated practice parameter," developed jointly by a coalition of allergy medical societies, offers discussion and guidance on the latest developments in treatment.
The guideline introduces for the first time a classification of episodic allergic rhinitis, cases that are neither seasonal nor perennial but rather triggered by sporadic exposure to an allergen and therefore require a modified treatment plan. It also uses charts to aid physicians in assessing symptom severity and determining treatment.
Other highlights of the guidelines include:
- recognizing co-morbidities, such as asthma, sinusitis and sleep apnea, and testing pulmonary function in these patients,
- use of non-sedating antihistamines during pregnancy,
- advantages and disadvantages of single and combination treatments,
- medications released in the past 10 years,
- using a rhinitis action plan, and
- when to refer to an allergist/immunologist.
The guideline was developed by the Joint Task Force on Practice Parameters for Allergy & Immunology, a coalition of the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma and Immunology; and the Joint Council of Allergy, Asthma and Immunology. It will run in the August edition of the Journal of Allergy and Clinical Immunology.
Menopause Society offers guidance on HRT
The North American Menopause Society recently released a revised position statement to help physicians and patients resolve questions and confusion about estrogen and progestogen use in postmenopausal women.
The guidelines conclude that recent data support the initiation of hormone therapy around the time of menopause to treat symptoms and/or to reduce the risk of disorders such as osteoporosis. The benefit-risk ratio for menopausal hormone therapy is favorable close to menopause but decreases with aging and with time since menopause in previously untreated women, the statement authors said. Undue fear and confusion had developed around these subjects in recent years and required a clearer explanation, according to a press release explaining the guidelines.
The guidelines also address the risks and benefits of different doses, routes of administration, bioidentical hormones, and timing of therapy. The most recent evidence on hormone therapy’s effects on sexual function, urinary health, osteoporosis, cardiovascular disease, diabetes, breast and endometrial cancer, mood and cognition are also assessed. An addendum offers advice on how to understand and explain risk. In addition to the official guidelines, a slide set of key points is available.
The guidelines were developed by a panel of 14 clinicians and researchers and were endorsed by the American Medical Women’s Association, The Endocrine Society, the National Association of Nurse Practitioners in Women’s Health and the National Women’s Health Resource Center..
Synthetic HRT reduces fractures but ups stroke risk
Tibolone, a synthetic hormone replacement drug, reduces fractures, breast cancer and possibly colon cancer, but it significantly increases the risk of stroke, according to a new study.
The trial was halted early when a more than double risk of stroke was found to be associated with the drug, which has not been formally approved in the U.S. The randomized study included 4,538 women between age 60 and 85 who had osteoporosis. The women received either once-daily tibolone (at a dose of 1.25 mg) or placebo. They were followed for a median of 34 months and received annual spine radiographs. The study was published in the Aug. 14 New England Journal of Medicine.
Women in the tibolone group had 70 cases of vertebral fracture per 1,000 person-years, compared with 126 per 1,000 in the placebo group. Those who took medication also had a 68% lower risk of invasive breast cancer and 69% less colon cancer (although researchers noted that the total number of colon cancer cases was small). Researchers noted that the decreased risk for breast cancer contradicted prior research, and an accompanying editorial suggested that the drug be avoided in women who either have or are at high risk for breast cancer.
Both the editorial writer and study authors recommended that tibolone be avoided in older women and women with risk factors for stroke such as hypertension, smoking, diabetes or atrial fibrillation. The study did find that the stroke risk rose exponentially with age, and researchers noted that the drug has been used by women between age 50 and 60 for menopausal symptoms and osteoporosis prevention.
PCI slightly more effective than meds alone for angina, but only for limited time
Patients with stable coronary disease who receive percutaneous coronary intervention (PCI) plus medication do slightly better after surgery than those who take medication only, but the advantage disappears after three years, according to a new analysis from the COURAGE trial.
Researchers randomly assigned 2,287 patients with stable coronary disease to PCI plus optimal drug therapy or drug therapy alone. They assessed angina-specific health status using the 19-item Seattle Angina Questionnaire (SAQ), which quantifies physical limitations due to angina, recent change in angina severity, angina frequency, satisfaction with treatment and quality of life. They also used the RAND-36 health survey to assess physical and mental function. The study was published in the Aug. 14 New England Journal of Medicine.
As previously reported, there was no difference between the two groups in terms of death or myocardial infarction after 4.6 years. After three months, 53% of patients in the PCI group were angina-free vs. 42% in the drug-only group; the PCI group's SAQ scores were also significantly higher at this time (for eg, 85 vs. 80 for decreased angina frequency and 73 vs. 68 for quality of life.) In general, PCI patients had small, but significant, incremental benefits for six to 24 months, but these benefits disappeared by 36 months. Patients with more severe and frequent angina saw the greatest benefit from PCI.
Given that drug therapy alone works well, that PCI is expensive and its advantage evaporates over time, it seems reasonable for physicians to try optimal medical therapy first then turn to PCI if drugs are ineffective for these patients, an editorial writer said. A major challenge for doctors will be to choose optical medical therapy in a health care system that provides strong financial incentives for PCI, yet few rewards for carefully managing medication, he said.
Naltrexone can cause adverse injection site reactions
Physicians should tell patients receiving naltrexone (Vivitrol) injections to monitor the injection site for adverse reactions, the FDA said in an alert last week.
About 200 people have reported reactions like hematoma, abscess, cellulitis, induration and necrosis after receiving the drug. Naltrexone, which is used for alcohol dependence, is an intramuscular gluteal injection and shouldn't be given intravenously, subcutaneously or inadvertently into fatty tissue.
Patients who develop pain, swelling, tenderness, bruising, pruritus, or redness at the injection site that doesn't improve within two weeks should call their doctors, and doctors should refer these patients to surgeons, the FDA said..
Caution urged when mixing simvastatin, amiodarone
Physicians should avoid prescribing more than 20 mg per day of simvastatin (Zocor, Vytorin, Simcor) if a patient is taking amiodarone (Cordarone, Pacerone), because the combination increases the risk of rhabdomyolysis, the FDA said in an alert.
The risk of rhabdomyolysis with the combination is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. This risk was described in 2002 in revised simvastatin labeling, but FDA still receives reports of the combination being used, and of adverse results, it said..
Tenofovir disoproxil fumarate approved for chronic Hepatitis B
The FDA last week approved tenofovir disoproxil fumarate (Viread) for chronic hepatitis B in adults.
The recommended daily dose is 300 mg. Patients who discontinue the drug should have their hepatic function monitored closely for several months, as acute exacerbations of hepatitis have occurred in those who stopped treatment, the drug's manufacturer said.
The manufacturer also recommends assessing creatinine clearance (CrCl) before starting treatment with the drug, and monitoring CrCl and serum phosphorus in patients at risk. Tenofovir disoproxil fumarate, which has been available in the U.S. since 2001 to treat HIV infection, shouldn't be administered with concurrent or recent use of nephrotoxic drugs, and all patients should be offered HIV antibody testing before starting the drug, the manufacturer said.
The most common side effects to the drug are nausea, abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain and skin rash..
Class I recall for carotid artery stenosis device
The FDA last week issued a Class I recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008, due to a product defect.
Used to treat carotid artery stenosis, the product is being recalled because the tip of the stent delivery system may detach during a stenting procedure, which could cause vessel wall injury, stroke and/or emergency surgery to remove the tip. The recall doesn’t affect stents that have already been implanted.
Annals of Internal Medicine.
Good long-term prognosis after West Nile Virus infection
The long-term prognosis of patients infected with West Nile virus is good, according to a new study appearing in the Aug. 19 issue of Annals of Internal Medicine. This is the largest study of the long-term outcomes of West Nile virus infection.
Many people infected by West Nile virus never get sick, so the disease can be difficult to diagnose. However, about 20% have symptoms that range from mild flu-like illness to neurological problems such as meningoencephalitis, encephalitis and acute flaccid paralysis. Recent studies report that troublesome symptoms such as fatigue, cognitive dysfunction and motor abnormalities can persist for months. However, little is known about long-term recovery.
This is the first study to comprehensively look at a large population of infected persons to study the long-term effects of West Nile virus, and concluded both physical and mental functions, as well as mood and fatigue, seemed to return to normal in about one year.
Researchers followed 156 patients between 2003 and 2007 to record patterns of physical and mental effects of West Nile virus infection. Researchers anticipated greater severity and a longer course of depression and fatigue in participants with neurological problems. However, they found symptoms and recovery times to be similar to those in participants without neurological consequences.
Pre-existing health conditions were an important factor in long-term prognosis. Patients who were healthy at the time of infection returned to normal health more quickly on average than those who had pre-existing conditions.
Researchers say the data might help patients infected with West Nile virus and their health care providers know the expected rate of recovery of physical and mental functioning, fatigue and depression.
A streaming video report is online..
Vitamin D deficiency puts older women at risk for hip fracture
Previous studies of the effect of low blood vitamin D levels on the risk for hip fractures in older women have given inconsistent results. In this study, researchers took blood to measure vitamin D levels and gathered information about fracture risk from 800 women between the ages of 50 and 79. After following the women for up to nine years, the researchers re-examined them to see who developed hip fractures. The women with hip fractures had lower vitamin D levels, the very lowest of which seemed to increase the risk for hip fractures independently of other factors known to increase hip fracture risk..
Documentary evidence reveals motives of pharmaceutical “seeding” trials
A new study finds strong evidence that pharmaceutical company trials done as marketing but posed as scientific research are harmful.
Clinical studies designed by pharmaceutical companies to promote use of their drugs are called “seeding” trials. While much has been written about the marketing tactics of the pharmaceutical industry, seeding trials have not been characterized in depth.
Researchers reviewed internal documents that became public during litigation against the drug manufacturer. The company’s marketing division designed the trial, and handled all collection, analysis and dissemination of data. The company hid their motive for the trial from participants, investigators and institutional review board members. Researchers concluded that seeding trials are harmful for three reasons:
- Because the company disguises its motives, informed consent is impossible;
- Good quality research is at risk when marketers rather than scientists design a study; and
- The scientific question posed by a seeding trial often has little merit.
An accompanying editorial warns institutional research review boards to avoid approving seeding trials and physicians to avoid enrolling their patients in them.
Tools and resources.
New patient education video: HIV guide for Latinos
Approximately 18% of newly diagnosed cases of HIV come from Latino communities despite the fact that Latinos comprise only 15% of the population. To assist physician members in their treatment of these patients, ACP has released Our Community, Learning about HIV: A Guide for Latinos, a new patient education video and guidebook. The purpose of the 30-minute video and guidebook is to present facts about HIV to patients in an easy-to-understand format to improve their understanding of how to prevent HIV infection in Latino communities and how to better manage the disease. The guidebook is in both English and Spanish and the DVD can be viewed in English or Spanish.
All patient education DVDs are free (a small shipping fee applies). Order online or by phone by calling ACP’s Customer Service at 800-523-1546, extension 2600 or 215-351-2600 (M-F, 9 a.m.-5 p.m. ET).
MKSAP quiz: acute dyspnea
A 25-year-old male respiratory therapist is evaluated in the office for recurrent episodes of acute dyspnea associated with rapid breathing, chest and throat tightness, voice changes, and inspiratory difficulty. On most occasions the symptoms start and resolve abruptly. Treatment with albuterol provides minimal relief. Which of the following would be the most appropriate next diagnostic step?
A. Chest radiography
B. Neck computed tomography
C. Flow volume loops
D. Thyroid function test
Click here or scroll to the bottom of the page for the correct answer.
From ACP Internist.
On the blog
Genetic studies could personalize warfarin administration, making this tricky medication easier to use. The NIH has reviewed the evidence on Vitamin D—what does it mean for your practice? Find these stories and a new edition of Medical News of the Obvious at ACP Internist's blog..
Cartoon caption contest: 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.
Go online to view the cartoon and pick the winner, who receives a copy of "Medicine in Quotations," ACP's comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history..
C. Flow volume loops
The complete MKSAP critique on this topic is available to subscribers in the Pulmonary and Critical Care Medicine section, item 100.
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
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- 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 Internist Weekly.
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Copyright 2008 by the American College of Physicians.
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