In the News for the Week of 8-21-07
- Government report: Insurance should reimburse for cancer prevention
- Diabetes drug labels get black box for heart failure
- Undiagnosed diabetes on the decline in U.S. men
- FDA issues updated prescribing information for warfarin
- Spirometry underused in confirming COPD, study says
- Annals of Internal Medicine
- Implantable defibrillators safe for patients with LVSD
- Cranial irradiation helps lung cancer patients
- Diabetes increases death risk for acute coronary syndrome patients
Insurance policies should pay health professionals for advising patients on eating, exercise and non-smoking habits that could help prevent cancer, a new government report said.
“The links between cancer, diet and obesity have not been accepted sufficiently by the health insurance industry to motivate widespread coverage for health-promoting/cancer prevention services such as nutrition counseling or obesity-related treatment,” the 2006-2007 Annual Report of the President’s Cancer Panel said.
The health care community should work to simplify and harmonize cancer risk reduction messages for patients, as well as advocate for funding and policy changes that support research into lifestyle and cancer rates, the report advised.
The report also urged the federal government to institute several policies that encourage healthy behavior, such as using farm subsidies to encourage more production of fruits and vegetables, regulating more closely the tobacco industry and food advertising, eliminating unhealthy foods in school meal programs and increasing school physical education programs.
In addition, the report stressed a need for more research into how to change behaviors that can lead to cancer. While most federally sponsored research on cancer prevention focuses on genetic or molecular biologic indicators, behavioral and environmental factors offer the most immediate pathway to reduce cancer rates, the report said.
The President’s Cancer Panel report is online.
Diabetes drugs rosiglitazone and pioglitazone will carry black-box warnings about the risk of heart failure, the FDA announced last week. In addition to Avandia and Actos, the warning will apply to combination drugs Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin) and Duetact (pioglitazone and glimepiride).
An FDA review of adverse events associated with the drugs found cases of significant weight gain and edema as well as reports of continued therapy resulting in death, which led the agency to ask manufacturers GlaxoSmithKline and Takeda to add the stronger warnings.
The new warning advises health care professionals to observe patients carefully for signs of heart failure--including shortness of breath, edema and excessive and rapid weight gain--after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management and reconsider use of the drug, the FDA said. The black box also warns that the drugs should not be used by people with serious or severe heart failure.
The new warning is separate from the FDA’s ongoing review of evidence that rosiglitazone increases heart attack risk. Last month, an FDA advisory panel recommended that the drug stay on the market but have information added to the label about ischemic risks.
The FDA release is online.
Although diabetes rates have climbed over the past three decades, vastly fewer cases are going undetected among American men, a new report says. The trend particularly affects black and Hispanic men, who are significantly more likely to know about their diabetes now than they were in the 1970s.
The study, published last week, tracked diabetes in U.S. men from 1976-1980, 1988-1994 and 1999-2002. In the first study period, 48% of men with diabetes were undiagnosed. By 1999-2002, the rate had fallen to 22%. The percentage of Hispanic men who did not know about their diabetes dropped even more dramatically, from 65% in the 1970s to 21% in 1999-2002. The rate of undiagnosed diabetes among black men has also dropped to the level of the general population, the study found. The research was conducted by the RAND Corporation and was published in the Aug. 14 Proceedings of the National Academy of Sciences.
One troubling finding of the study, the author noted, was the continuing presence of educational disparities in diabetes rates. In 1999-2002, 6% of men who graduated from high school had diabetes, compared with 10% of non-graduates. Less educated patients also had more difficulty managing the disease. Overall, the study found that diabetes prevalence among U.S. men rose from 6% to 9%, less of an increase than is often claimed, the study author said in a RAND press release.
The author concluded that health providers and officials have done well to eliminate disproportionate rates of undiagnosed diabetes among racial minorities, but that targeted efforts need to be made to reduce other equally important sources of health disparity.
The Proceedings of the National Academy of Science is online.
The RAND press release is online.
The FDA has approved updated prescribing information for warfarin that explains the potential benefits of genetic testing in determining the correct dose of the drug.
In a press release, the FDA said studies show that variants of the genes CYP2C9 and VKORC1 can indicate how patients will respond to warfarin, and testing for these variants can help determine whether to prescribe higher or lower initial doses. The new labeling instructions do not require genetic testing but recommend that physicians consider adjusting initial warfarin doses in patients with certain genetic makeups.
Some experts have expressed concern about the new prescribing information, according to the Aug. 16 Wall Street Journal, saying that the research is preliminary and the tests are expensive. Medicare covers the costs of the test, which range from $300 to $500, but many large insurers do not, the newspaper reported.
The FDA, however, told the Wall Street Journal that the evidence supporting testing is substantial and that the tests offer a large potential benefit. It is funding efforts to help doctors determine accurate warfarin doses based on test results, its press release said.
The FDA press release is online.
The Wall Street Journal is online (subscription required).
Many patients diagnosed with chronic obstructive pulmonary disease (COPD) do not have that diagnosis confirmed by spirometry, according to a new study.
Researchers reviewed the records of patients from five health plans who had received a diagnosis of COPD from July 1, 2002, through June 30, 2003. The goal of the study was to determine how often spirometry, considered the "gold standard," was used to diagnose COPD. The results appear in the August issue of Chest.
Of the nearly 1.6 million patients in the five studied health plans, 5,039 had been diagnosed with COPD during the study period. Of these, only 32% had had their diagnosis confirmed with spirometry. Spirometry use was least common among patients age 75 and older. In contrast to previous studies, spirometry was slightly more common in women than in men.
The authors concluded that spirometry is underused for COPD diagnosis in the U.S. and speculated that this may lead to under- or overdiagnosis of the disease. They recommended that efforts should be made to improve practice by optimizing spirometry use.
Chest is online.
The following article will appear in the Aug. 21, 2007 issue of Annals of Internal Medicine. The full text is available to College members and subscribers online.
- Review: Defibrillators are safe and effective for patients with LVSD. A systematic review found that implantable cardioverter defibrillators (ICDs) are safe and significantly reduce death for adults with left ventricular systolic dysfunction. In this review of eight randomized controlled trials that reported on mortality and 76 observational studies that examined safety or effectiveness, ICDs reduced death from all causes in patients with left ventricular systolic dysfunction by 20%. This reduction came mostly from a 54% relative reduction in sudden cardiac deaths, which are usually caused by dangerous heart rhythms. ICDs are small machines placed under the skin below the collarbone. They monitor the heart’s rhythm and give the heart an electrical shock if a dangerous rhythm occurs. Left ventricular systolic dysfunction--heart muscle weakened from coronary artery disease or heart attack--carries a high risk for sudden cardiac death.
Prophylactic cranial irradiation can prolong the survival of patients with extensive small-cell lung cancer, a new study found.
In the randomized, controlled trial, 286 patients with extensive small-cell lung cancer were assigned to undergo either prophylactic cranial irradiation or no therapy. Patients in the irradiation group showed a lower rate of symptomatic brain metastases and increased median disease-free survival and overall survival compared to the control group. The one-year survival rate was 27.1% in the irradiation group and 13.3% in the control group. The researchers noted that the side effects of the irradiation did not have a clinically significant effect on global health status. The study was published in the Aug. 16 New England Journal of Medicine.
According to background information in the study, 13% of all newly diagnosed lung cancer patients have small-cell lung cancer and 18% of those patients have brain metastases at diagnosis. The researchers undertook the study in the hopes of finding a better means to treat and prevent the brain metastases, which they noted are unresponsive to chemotherapy and difficult to detect through computed tomography (CT).
Based on the study results, the authors concluded that prophylactic cranial irradiation should be offered to all responding small-cell lung cancer patients with extensive disease. However, under current recommendations cranial irradiation is used only for lung cancer patients who have had a complete response to chemotherapy, the Aug. 15 Washington Post reported. That recommendation is based on concerns that cranial irradiation could cause brain damage, the Washington Post said, although the study authors found that side effects--such as headache and nausea--were minimal and did not affect quality of life.
The New England Journal of Medicine is online.
The Washington Post is online.
Acute coronary syndrome patients with diabetes were more likely to die at 30 days or a year than those without diabetes, a new study found.
Researchers pooled data from 11 independent, randomized trials on 62,036 patients with acute coronary syndrome (ACS), 10,613 (17.1%) of whom had diabetes. They measured mortality at 30 days and one year after ACS. The article was published in the August 15 Journal of the American Medical Association.
Diabetic patients with unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) were significantly more likely than non-diabetic patients with UA/NSTEMI to die at 30 days (2.1% vs. 1.1%). The same held true for STEMI patients, with 8.5% of diabetic patients dying at 30 days compared to 5.5% of non-diabetic patients. It didn’t make a difference if the diabetic patients had taken insulin before ACS or not. ACS patients with diabetes were also more likely to die one year after UA/NSTEMI (7.2% vs. 3.1%) or STEMI (13.2% vs. 8.1%).
Though efforts to control blood pressure, cholesterol and tobacco use have led to a drop in U.S. coronary deaths in the last 20 years, the gains have been offset by the rise in diabetes and the heart risk it presents, the authors noted. “There must be ongoing reevaluation of traditional guidelines for diabetes management to further mitigate this critical, independent risk factor,” the authors said.
As well, major new research needs to be done into how to manage heart disease among diabetes patients, because past research suggests modern therapies don’t work as well at reducing cardiovascular mortality among diabetic patients as they do among non-diabetics, the authors said.
The Journal of the American Medical Association is online.
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A 24-year-old woman undergoes routine evaluation. She is pregnant at 12 weeks' gestation. Medical history is notable for homozygous sickle cell anemia (Hb SS). She has had multiple uncomplicated painful crises treated at home with hydration, nonopioid analgesia, and incentive spirometry. Following a physical exam and lab studies, what is the most appropriate management?
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