In the News for the Week of 10-16-07
- Conference coverage: AIDS, Lyme disease studies unveiled at infectious disease meeting
- Paclitaxel doesn't benefit women with most common breast cancer, study finds
- Study finds no benefit from common treatments for knee osteoarthritis
- Complications more likely with anastomotic leaks after bariatric surgery, study finds
- Positive effects of statins continue over time
- High blood pressure increases women’s diabetes risk, study finds
- Annals of Internal Medicine:
- Two heart interventions--CABG and PCI--compared for effectiveness
- E-Quality: Electronic health record test finds quality improved with a price
- Knee buckling can be downfall for adults
- Medication shows potential for treatment of alcohol problems
- Generic oxcarbazepine wins FDA approval
- Olanzapine gets stronger warning for hyperglycemia, hyperlipidemia
- ACP to cosponsor conference on access to care
For the record
- Correction to last week's story on flu shots for seniors
SAN DIEGO-New research on HIV/AIDS, Lyme disease and Rocky Mountain spotted fever was presented at the 45th annual Infectious Diseases Society of America conference held here Oct. 4-7. Study highlights include:
Rocky Mountain spotted fever cases nearly tripled between 2001 and 2005 in the U.S., from 695 to 1,936 cases. While the illness was most common in men age 50-59 and in the South Atlantic states, there was a substantial increase in occurrence among adults over age 50, women and suburban dwellers.
The first study to evaluate molecular evidence of recurrent Lyme disease found that people who experience a second episode of erythema migrans were probably bitten by another tick rather than experiencing a relapse of the first infection. Doctors should continue to urge prevention of tick bites.
While excessive weight loss was once a key characteristic of HIV/AIDS, a new study found that 63% of HIV-positive patients are overweight or obese, roughly the same percentage as in the general population. Use of highly active retroviral therapy (HAART) wasn’t related to weight gain. While doctors have typically focused efforts on keeping infections at bay, they now should focus on weight gain, blood pressure control and cancer prevention with HIV/AIDS patients, researchers said. Earlier studies have shown younger HIV/AIDS patients on HAART may have a higher risk of heart attack, but a new study found HIV-positive people over age 50 on HAART were no more likely to have heart disease, diabetes, osteoporosis or cognitive deficits than the general population. They were more likely to have high blood pressure (51%) compared with a control group (31%), however.
--By Jessica Berthold, senior writer, ACP ObserverWeekly
The Infectious Diseases Society of America is online.
Paclitaxel is not effective in treating the most common form of breast cancer, according to a new study that used genetic testing to reanalyze data from earlier research on the drug.
In the retrospective analysis, researchers looked at 1,322 tissue blocks from a 1994 trial that tested the benefit of adding taxane paclitaxel following four cycles of doxorubicin plus cyclophosphamide to treat women with lymph node-positive breast cancer. The use of adjuvant paclitaxel went up dramatically after researchers reported in 1998 that the addition of paclitaxel led to better outcomes.
In the new study, researchers applied modern genetic tools to determine whether paclitaxel was equally beneficial to all subgroups of women in the earlier study. They found that adding paclitaxel benefited women with HER2-positive breast cancer (regardless of estrogen-receptor status) but that women with HER2-negative, estrogen-receptor positive breast cancer did not benefit. The findings appear in the Oct. 11 New England Journal of Medicine.
The results suggest that women with HER-2 negative breast cancer might be able to escape the toxic side effects of paclitaxel (such as persistent numbness in the hands and feet) without increasing their risk of recurrence, said the authors. However, they cautioned physicians not to change clinical practice based on their analysis, and that more research is needed.
New treatment developments over the past decade have given physicians alternatives to adding paclitaxel to chemotherapy, said an accompanying editorial. For example, adding an aromatase inhibitor to adjuvant therapy for postmenopausal women with HER2-negative, estrogen-receptor positive breast cancer has been shown to prolong disease-free survival more than does tamoxifen.
The findings highlight the importance of more individualized treatment regimens for breast cancer, continued the editorial. Future research should focus on analyzing results of trials using paclitaxel with respect to HER2 and estrogen-receptor status.
A new analysis of common ways of treating osteoarthritis of the knee, including popular dietary supplement ingredients, injected preparations and arthroscopy, found scant evidence that these treatments are effective.
Researchers reviewed meta-analyses, individual trials and articles about vicosupplementation, glucosamine/chondroitin and arthroscopy. The review was conducted for the Agency for Healthcare Research and Quality at the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center in Chicago.
Glucosamine/chondroitin and arthroscopic surgery were no more effective than placebo, judging by the best available evidence, said the September 2007 AHRQ report. Injections with hyaluronan preparations improved scores on patient questionnaires used to measure pain and function, but the evidence was uncertain because of variation in study quality.
According to authors, better-quality randomized clinical trials are needed. This study relied heavily on meta-analyses, they noted, which have limitations including often failing to "convey the real uncertainty and potential bias accompanying pooled estimates."
Given the aging of the population and increasing prevalence of obesity, investigators said, "research on new approaches to prevention and treatment of osteoarthritis of the knee should be a high priority."
Patients who develop anastomotic leaks after Roux-en-Y gastric bypass (RYGB) have longer hospital stays and worse outcomes than those who don't, according to a new study.
Researchers at University of South Florida Health Sciences Center in Tampa examined data on 840 consecutive patients who had RYGB between 1998 and 2005. They wanted to determine whether those who developed anastomotic leaks after the surgery were also more likely to develop major complications. The results appear in the October Archives of Surgery.
Anastomotic leaks occurred in 36 patients (4.3%) after RYGB. In this group, 61% developed complications compared with 20% of patients who did not have leaks. Mortality rate (14% vs. 4%) and length of hospital stay (24.5 days vs. 4.5 days) were also statistically significantly higher in those who developed leaks. Sepsis, renal failure, small bowel obstruction, incisional hernia, thromboembolism and internal hernia were all more common in patients with leaks than in those without.
The authors cautioned that their study does not imply causality and that their results may not be clinically significant. However, they wrote, their data indicate that patients undergoing RYGB should be monitored closely for complications, in the ICU if possible, and treated aggressively as needed.
The Archives of Surgery is online.
Statins may reduce men’s risk of myocardial infarction (MI) or death from coronary artery disease (CAD) for up to a decade after they stop taking the drugs, according to a new study.
Researchers used follow-up data from the West of Scotland Coronary Prevention Study, a randomized trial that compared pravastatin to placebo in more than 6,000 middle-aged men with very high cholesterol (mean of 192 mg/dL). The men were given either the statin or placebo for five years, and then followed up within five and 10 years after the trial ended. In this new analysis, researchers found that 10 years later, the risk of MI or death from CAD was 10.3% in the placebo group and 8.6% in the statin group. The statin group also had lower rates of death from cardiovascular causes and death from any cause.
An accompanying editorial said that one weakness of the study was the finding that five years after the trial, more men from the statin group than the placebo group were taking statins (38.7% vs. 35.2%). Researchers countered that this difference was not significant enough to explain their findings and suggested that their results may actually underestimate the effect of the five years of statin treatment, because men who later exhibited symptoms of CAD would have been more likely to start taking the drugs after the trial.
The study authors hypothesized that their results could be attributed to statins stabilizing existing plaque and slowing of the progression of CAD. The study showed that in men with hypercholesterolemia and no history of MI, statin treatment for about five years provided a reduction in the risk of coronary artery events for up to an additional 10 years, they concluded. The study was partially funded by statin manufacturers and was published in the Oct. 11 New England Journal of Medicine.
Women with high blood pressure have a significantly higher risk of developing type 2 diabetes compared with those with optimal blood pressure, a new study found.
The Oct. 9 European Heart Journal prospective cohort study examined 38,172 U.S. female health professionals who were free of diabetes at baseline. Subjects were divided into four categories of self-reported blood pressure: less than 120/75 mm Hg, or optimal; 120-129/75-84 mm Hg, or normal; 130-139/85-89 mm Hg, or high-normal; and established hypertension. The latter meant the subject had a self-reported history of hypertension or of taking antihypertensive treatment, or a blood pressure of at least 140/90 mm Hg.
At 10.2 years of follow-up, 1,672 women had developed diabetes. Of all the women in the highest blood pressure group, 9.4% developed diabetes, compared with 5.7% in the high-normal group, 2.9% in the normal group and 1.4% in the optimal group. The study adjusted for age, body mass index, exercise level, family history, alcohol use and smoking.
Women whose blood pressure rose during the course of the study also had a greater risk of developing diabetes. If a woman’s blood pressure rose but stayed in the “normal” range, her risk increased 26% compared with a woman whose blood pressure was stable or decreased. A woman whose blood pressure rose to become hypertensive had a 64% higher risk of developing diabetes.
While self-report of blood pressure is a possible limitation of the study, the validity of the approach was examined in the Nurses’ Health Study, where 99% of self-reports were confirmed accurate, the authors said. The study thus provides strong evidence that baseline blood pressure and blood pressure progression are associated with a higher risk of type 2 diabetes, and clinicians should bear this in mind for patient management, they said.
The European Heart Journal abstract is online.
The Washington Post is online.
The following articles will appear in the Oct. 16, 2007 issue of Annals of Internal Medicine. The full text is available to College members and subscribers online.
Two heart interventions--CABG and PCI--compared for effectiveness. A new systematic review of trials of the comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) in patients in whom both procedures are feasible found that survival to 10 years was similar. CABG was more effective in relieving angina and led to fewer repeated revascularizations but had a higher risk for procedural stroke. PCI led to more repeated revascularization procedures. Researchers reviewed 23 randomized trials but did not look at literature that involved drug-eluting stents or patients with extensive coronary disease. This article was released early online. It will appear in the Nov. 20 print edition of the journal.
E-Quality: Electronic health record test finds quality improved with a price. Eighteen months after implementing a full-featured electronic health record (EHR) in their practice, four internists in this small-practice study used the system to measure and improve their mammography rate. They ultimately achieved a 10% absolute improvement in rates at a modest, but unreimbursed, cost. The author describes challenges such as acquiring structured data in an environment shaped by paper-chart thinking. The experience highlighted critical elements for EHR adopters who use the systems for quality improvement projects, including the need for standardized reports from other health care providers and redesign of practice work flows.
Knee buckling can be downfall for adults. A study of 2,351 men and women 36 to 94 years old who did not have arthritis or knee replacement found that 12% had experienced knee buckling at least once in the past 3 months. Of those whose knees gave way, 13% fell as a result. The frequency of buckling was similar both among men and women and among middle-aged and older persons. Most people were walking or climbing stairs when their knees buckled.
Topiramate, a drug used in the treatment of migraines and epilepsy, reduced alcohol dependence in a short-term trial, a new study reported last week.
In the double-blind, randomized trial, researchers provided up to 300 mg/d of topiramate (brand name Topamax) or placebo to 371 men and women diagnosed with alcohol dependence. The patients also received weekly compliance enhancement intervention during the 14 weeks of the study. On average, the topiramate group had 8% fewer heavy drinking days (defined as 5 or more drinks for men and 4 or more for women) and a 16% decrease in all drinking outcomes (including days abstinent, drinks per day and a laboratory measure of alcohol consumption).
The patients who took topiramate did report higher rates of adverse events, including paresthesia, taste perversion, anorexia and difficulty with concentration. Authors of the study, which was funded by the drug manufacturer, concluded that topiramate is a safe and consistently efficacious treatment for alcohol dependence and that it should be studied in community practice settings. The study was published in the Oct. 10 Journal of the American Medical Association.
An accompanying editorial bemoaned the fact that physicians receive minimal education in the identification and treatment of alcohol dependence. The editorial noted that the participants recruited for trials such as this one are similar to patients seen in primary care settings, indicating that primary care may be the ideal place to implement medication therapy for alcohol dependence along with brief behavioral support.
The FDA last week approved the first generic versions of the anticonvulsant drug oxcarbazepine (Trileptal).
The drug, made in 150-mg, 300-mg and 600-mg doses, can be used either alone or with other medications in the treatment of partial seizures in adults and children age four and older. Side effects may include serious skin reactions, which patients should immediately report to their health care providers, as well as dizziness and drowsiness.
The FDA release is online.
Eli Lilly, manufacturer of olanzapine (Zyprexa) and olanzapine plus fluoxetine (Symbyax) is updating the drugs’ labels with stronger warnings for hyperlipidemia, hyperglycemia and weight gain.
Olanzapine is a treatment for schizophrenia and bipolar disorder, while olanzapine with fluoxetine treats bipolar depression. The updates reflect recently pooled analyses of Lilly’s clinical trial data, as well as other studies of atypical antipsychotics. Olanzapine is associated with higher glucose levels than other atypical antipsychotics, and doctors should consider the risks when prescribing it (alone or in combination) to patients with diabetes, as well as monitor all patients for glucose control, Eli Lilly said in a release. Doctors should also monitor lipid levels since the drug can significantly increase triglycerides, it said.
The revised olanzapine label will also say that patients may continue to gain weight for two years after starting therapy, with one in six patients gaining more than 33 pounds after two years, the Sept. 6 New York Times reported.
Eli Lilly’s press release is online.
The New York Times is online.
ACP is a cosponsor of the National Congress on the Un and Under Insured to be held in Washington, D.C., Dec. 9-12. The theme of the Congress is “From Practical Local and Regional Solutions to State and National Health Reform.” Over 150 national experts will provide a roadmap through the complexities of local, state and national health reform and will suggest responsive strategies from health care providers, health plans, government and policy makers.
The conference seeks to analyze the current regulatory environment for serving the uninsured; to identify initiatives happening across the country to deal with the problem at a local level; to analyze the role of Medicare, Medicaid and SCHIP; to assess federal and state health reform proposals; and to describe and compare various international approaches to the issue.
Registration for the conference is $995 before Nov. 2 or $1,095 after that date. The conference will be held at the Hyatt Regency Washington on Capitol Hill, and special room rates are available for conference attendees who make reservations before Nov. 12.
For the record
An article on the effectiveness of influenza vaccines for the elderly in last week's ObserverWeekly inadvertently stated that seniors who received flu or pneumonia shots reduced their risk of hospitalization. The article should have stated that influenza vaccination was associated with significant reductions in the risk of hospitalization for pneumonia or influenza. We apologize for the error.
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Copyright 2007 by the American College of Physicians.
A 52-year-old man is evaluated for low back pain of 3 months' duration that is nonradiating, progressive, and worse with ambulation. He reports no preceding injury. Medical history is notable for smoldering multiple myeloma diagnosed 1 year ago; he has been stable since that time. His only medication is as-needed acetaminophen. Following a physical exam and lab results, what is the most appropriate management?
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