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Intensive Insulin Therapy Cuts Morbidity in ICU

No significant decline in mortality except for those in intensive care unit for more than three days

Normalizing blood glucose levels with intensive insulin therapy can reduce morbidity but not mortality among medical intensive care unit (ICU) patients, according to a study published in the Feb. 2 issue of the New England Journal of Medicine.

Greet Van den Berghe, M.D., Ph.D., of Catholic University of Leuven in Belgium, and colleagues studied 1,200 adults treated at least three days in their hospital's medical ICU. The patients were assigned to strict normalization of blood glucose levels via insulin infusion (80-110 mg/dL), or conventional therapy in which insulin therapy was initiated if blood glucose was 215 mg/dL or higher.

The researchers found that intensive insulin therapy lowered blood glucose levels and significantly reduced morbidity, including new injuries to the kidneys, but not in-hospital mortality. "Although the risk of subsequent death and disease was reduced in patients treated for three or more days, these patients could not be identified before therapy," the authors write.

In an accompanying editorial, Atul Malhotra, M.D., of Brigham and Women's Hospital in Boston, writes that "as clinicians struggle to understand the best way to manage blood glucose levels in the ICU, one thing is clear: the days of ignoring blood sugar levels or tolerating marked hyperglycemia in the ICU (which was commonplace even five years ago) are over."

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Saw Palmetto Ineffective For Enlarged Prostate

Year-long study concludes that the herb provides no benefits compared to placebo for benign prostatic hyperplasia

The herb saw palmetto is no more effective than placebo in treating symptoms of benign prostatic hyperplasia (BPH), according to the results of a study published in the Feb. 9 issue of the New England Journal of Medicine.

Stephen Bent, M.D., of the Osher Center for Integrative Medicine at the University of California, San Francisco, and colleagues randomly assigned 225 men older than 49 with moderate-to-severe symptoms of BPH to one year of treatment with saw palmetto extract (160 mg twice a day), or a placebo.

The researchers found no significant difference between the saw palmetto and placebo groups in changes in scores on the American Urological Association Symptom Index (AUASI), maximal urinary flow rate, prostate size, residual urinary volume after voiding, quality of life, or serum prostate-specific antigen levels.

"Bent and colleagues took special care to avoid the methodologic pitfalls of previous studies of saw palmetto in men with benign prostatic hyperplasia by treating the participants for a year, optimizing the consistency of the herbal product and measuring the adequacy of blinding," states the author of an accompanying editorial. "Until there is adequate research on an herbal or other botanical product, it is the responsibility of physicians to inform their patients and protect them from the inherent risks of unproven therapies."

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SSRI Use in Late Pregnancy May Place Infants at Risk

SSRIs associated with increased risk of persistent pulmonary hypertension of the newborn

Women who take selective serotonin-reuptake inhibitors (SSRIs) late in pregnancy may have an increased risk of giving birth to an infant with persistent pulmonary hypertension of the newborn (PPHN), according to a study in the Feb. 9 issue of the New England Journal of Medicine.

Christina D. Chambers, Ph.D., of the University of California, San Diego, and colleagues studied 377 women whose infants had PPHN and 836 matched control women and their infants between 1998 and 2003.

The researchers found that 14 infants with PPHN had been exposed to an SSRI after the 20th week of gestation, compared with six control infants (adjusted odds ratio, 6.1). The investigators found no association between an increased risk of PPHN and the use of SSRIs before the 20th week of gestation, nor non-SSRI antidepressant drugs at any time during pregnancy.

"There is a pressing need for experts to compare SSRIs with other forms of treatment to determine which are the safest, the most effective and the best tolerated by pregnant women," states the author of an accompanying editorial. "Clinicians and patients will need to consider the current findings of Chambers et al., along with other available evidence, and decide on an individual basis whether the risks associated with exposure to SSRIs outweigh the benefits."

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Stem-Cell Transplant May Help Lupus Patients

Risk of life-threatening infection with therapy must be weighed against potential benefits

High-dose cyclophosphamide followed by autologous hematopoietic stem cell transplantation (HSCT) can significantly improve symptoms of treatment-refractory systemic lupus erythematosus (SLE), although the treatment carries a high risk of infection, according to a study published in the Feb. 1 issue of the Journal of the American Medical Association.

Richard K. Burt, M.D., of Northwestern University Feinberg School of Medicine in Chicago, and colleagues studied 50 SLE patients who underwent the procedure between 1997 and 2005.

Two patients died after immune suppression and stem cell mobilization, one from disseminated mucormycosis and another from active lupus after postponing the transplant. In the 48 patients who underwent mobilization and HSCT, the researchers found that five-year survival was 84% and that the probability of disease-free survival at five years was 50%.

"The toxicity of high-dose cyclophosphamide, including the potential for death from infection, always must be balanced against the benefit and risk of these other potential therapies," states the author of an accompanying editorial. The study confirms that the treatment "has benefit in patients with severe refractory lupus. Whether this approach represents a definitive advance over more conventional immunosuppressive therapies will need to be answered in randomized controlled trials."

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Low-Fat Diet Does Not Notably Cut Heart Disease in Study

Fruit- and vegetable-rich diet did not significantly decrease risk in postmenopausal women

A low-fat diet rich in fruits and vegetables does not significantly reduce the risk of coronary heart disease (CHD), stroke or cardiovascular disease (CVD) in postmenopausal women, according to a study published in the Feb. 8 issue of the Journal of the American Medical Association.

Barbara V. Howard, Ph.D., of the MedStar Research Institute in Hyattsville, Md., and colleagues studied data on 48,835 postmenopausal women, ages 50 to 79, who participated in the Women's Health Initiative Dietary Modification Trial. The women were randomly assigned to intervention (40 percent) or a comparison group (60 percent) and were followed-up for 8.1 years.

Of the intervention group, 1,000 (0.63 percent) developed CHD, 434 (0.28 percent) developed stroke and 1,357 (0.86 percent) developed CVD. In the comparison group, 1,549 (0.65 percent) developed CHD, 642 (0.27 percent) developed stroke and 2,088 (0.88 percent) developed CVD.

"Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits and grains did not significantly reduce the risk of CHD, stroke or CVD in postmenopausal women, and achieved only modest effects on CVD risk factors," the authors report.

An accompanying editorial states that despite the study's findings, "dietary changes can have powerful, beneficial effects on CVD risk factors."

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Low-Fat Diet Does Not Cut Women's Breast Cancer Risk

Nor did eight-year diet high in fruits and vegetables reduce colorectal cancer risk in postmenopausal women

A low-fat diet does not reduce the risk of invasive breast cancer or colorectal cancer in postmenopausal women, according to two studies in the Feb. 8 issue of the Journal of the American Medical Association.

Ross L. Prentice, Ph.D., of the Fred Hutchinson Cancer Research Center in Seattle, and colleagues analyzed data on 48,835 postmenopausal women without prior breast cancer from 1993 to 2005.

Women were assigned to a control group, or to a low-fat diet of at least five daily servings of fruits and vegetables and at least six servings of grains. During the 8.1-year follow-up period, 655 of the women in the intervention group (0.42 percent) developed invasive breast cancer, as did 1,072 (0.45 percent) of the controls.

The diet "did not result in a statistically significant reduction of invasive breast cancer risk," the authors write.

In a second study of the same women, Shirley A.A. Beresford, Ph.D., of the University of Washington in Seattle, and colleagues found that the same diet did not reduce colorectal cancer risk, either.

An accompanying editorial states that more research is needed to determine which diets might help prevent breast cancer, the best time to start them and how long to adhere to them.

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Depression Treatment Has Little Impact on Diabetic Care

Study recommends further research into benefits of integrated interventions

Diabetics who receive enhanced depression treatment do not practice better diabetes self-management, according to a study in the January/February issue of the Annals of Family Medicine.

Elizabeth H.B. Lin, M.D., of the Group Health Cooperative in Seattle, and colleagues randomized 329 patients to receive either usual primary care involving routine medical services, or an evidence-based collaborative depression treatment including pharmacotherapy, problem solving treatment, or both.

The researchers found that enhanced depression care was not associated with improved diabetes self-care behaviors such as healthy nutrition, physical activity or smoking cessation. Compared with the usual care group, the intervention group demonstrated differences of limited clinical importance, such as a small decrease in body mass index (mean difference = 0.70 kg/m2) and a higher rate of non-adherence to oral hypoglycemic agents.

"Patients with depression and co-occurring medical illnesses require interventions that advance beyond single-disease case management," the authors conclude. "Focusing patients on disease management of one chronic illness can have unintended adverse effects on management of other important disorders. Further research is needed to determine whether integrated diabetes and depression care management, including specific support for diabetes medication adherence and self-care activities, as well as systematic depression care, can help patients achieve better psychological and diabetes outcomes."

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SSRI Use in Late Pregnancy May Place Infants at Risk

SSRIs associated with increased risk of persistent pulmonary hypertension of the newborn

Women who take selective serotonin-reuptake inhibitors (SSRIs) late in pregnancy may have an increased risk of giving birth to an infant with persistent pulmonary hypertension of the newborn (PPHN), according to a study in the Feb. 9 issue of the New England Journal of Medicine.

Christina D. Chambers, Ph.D., of the University of California, San Diego, and colleagues studied 377 women whose infants had PPHN and 836 matched control women and their infants between 1998 and 2003.

The researchers found that 14 infants with PPHN had been exposed to an SSRI after the 20th week of gestation, compared with six control infants (adjusted odds ratio, 6.1). The investigators found no association between an increased risk of PPHN and the use of SSRIs before the 20th week of gestation, nor non-SSRI antidepressant drugs at any time during pregnancy.

"There is a pressing need for experts to compare SSRIs with other forms of treatment to determine which are the safest, the most effective and the best tolerated by pregnant women," states the author of an accompanying editorial. "Clinicians and patients will need to consider the current findings of Chambers et al., along with other available evidence, and decide on an individual basis whether the risks associated with exposure to SSRIs outweigh the benefits."

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ECG Abnormalities Predict Heart Disease in Women

Wide QRS/T angle and ECG-MI predict coronary heart disease events and mortality

Electrocardiographic ventricular repolarization abnormalities are important predictors of events and mortality due to coronary heart disease in postmenopausal women, researchers report in the Jan. 31 issue of Circulation: Journal of the American Heart Association.

Pentti M. Rautaharju, M.D. Ph.D., from Wake Forest University in Winston-Salem, N.C., and colleagues examined ECG variables in 38,283 postmenopausal women and assessed their value in predicting coronary heart disease and mortality during up to 9.2 years of follow-up.

The strongest predictors of coronary heart disease events were wide QRS/T angle (hazard ratio 1.90) and ECG-demonstrated myocardial infarction, or ECG-MI, (1.62), while six other repolarization variables were also strong predictors. Wide QRS/T angle, ECG-MI, and prolonged QT were dominant predictors when evaluated with other ECG variables.

The strongest predictors of coronary heart disease mortality were wide QRS/T angle (2.70), ECG-MI (2.41), and high QRS nondipolar voltage (2.18). Wide QRS/T angle, ECG-MI, high QRS nondipolar voltage, reduced heart rate variability, and QT prolongation were also dominant predictors of mortality risk.

"Ventricular repolarization abnormalities in postmenopausal women are as important predictors of coronary heart disease events and coronary heart disease mortality as ECG-MI and other QRS abnormalities," Rautaharju and colleagues conclude. "Repolarization variables and QRS nondipolar voltage warrant attention in future investigations."

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Renal Function Predicts Heart Failure Outcome

Patients with impaired kidney function had highest risk for cardiovascular hospitalization, death

Impaired kidney function is an independent risk factor for cardiovascular death and hospitalization in patients who have heart failure, an international team reports in the Feb. 7 issue of Circulation: Journal of the American Heart Association.

The Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) study involved 2,680 patients with baseline creatinine levels below 3.0 mg/dL. Patients with severe renal impairment were excluded from the study. Hans L. Hillege, M.D., of the University of Groningen in the Netherlands, and colleagues analyzed the effect of estimated glomerular filtration rate (eGFR) and left ventricular ejection fraction (LVEF) on risk of cardiovascular death, risk of hospitalization for heart failure and risk of death from all causes.

Reduced eGFR and low LVEF were significant and independent risk factors for poor outcome. "After an average follow-up of nearly three years, very few (patients) progressed to dialysis, but many had heart complications," the authors state in a press release. "The patients with the worst kidney function had the highest risk for heart complications, with the risk being almost twice as high as in patients with normal kidney function."

Hillege added that "the effect of the study treatment, candesartan, in reducing the risk of cardiovascular death or heart failure hospitalization was evident regardless of kidney function."

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