Formulary staff

The long-term use of gingko biloba extract does not lower  the risk of Alzheimer’s disease, according to a 

In a randomized, placebo-controlled clinical trial,  researchers followed 2,854 patients aged 70 years and older who presented to  their primacy care physician (PCP) with memory complaints. Between March 2002  and November 2004, almost half of the patients were randomly assigned to a  twice-daily dose of 120 mg of ginkgo biloba extract and the other half received  placebo. Patients were followed for 5 years by their PCPs or expert memory  centers. The primary end point was the diagnosis of probable Alzheimer’s  disease, according to Bruno Vellas, of Toulouse, France, and colleagues.

Patients were assessed for cognitive, functional, and  depressive status every year using a series of tests, including MMSE, CDR,  FCSRT, trail making test, verbal fluency, visual analogue scales, instrumental  activities of daily living, and the geriatric depression scale. Safety of the  extract was assessed every 3 months by monitoring vital signs, physical and  neurological examinations, and adverse events. The most common reasons for  withdrawal from the study were personal reasons, including withdrawal of  informed consent, relocation, or change of PCP.

Of the patients who received gingko biloba, 61 of the 1,406  patients were diagnosed with probable Alzheimer’s disease compared with 73 of  1,414 in the placebo group (HR=0.84; 95% CI, 0.60-1.18; 

=.306). In the  gingko biloba group, incidence of Alzheimer’s disease was 1.2 per 100 person  years, and in the placebo group, it was 1.4 per 100 person years.

“Long-term administration of standardized ginkgo biloba  extract at 240 mg daily did not affect vital signs, physical function, or  neurological function,” the authors reported.

  The long-term use of standardized gingko biloba extract for  the prevention of Alzheimer’s disease (GuidAge) study was funded by Ipsen,  Boulogne, France, which markets the extract, and the French National  Association of Technical Research.

Articles

The long-term use of gingko biloba extract does not lower the risk of Alzheimerâ€™s disease, according to a report published September 6 online for The Lancet.

Gingko biloba does not stop incidence of Alzheimer's disease, Lancet reports

Tight  glycemic control can be achieved in children following cardiac surgery, but it  does not reduce the infection rate, mortality, or length of hospital stay  compared to standard care, according to a 

The  2-center, prospective, randomized trial, led by Michael S.D. Agus, MD, with  Boston Children’s Hospital, consisted of 980 children who were aged 0 through  36 months. The patients were randomly assigned to receive either tight glycemic  control or standard care in the cardiac intensive care unit (ICU).

Of  the 490 children assigned to tight glycemic control, 444 (91%) received insulin  versus 9 (2%) of 490 children who were assigned to standard care.

The  researchers found that normal glucose levels were achieved earlier with tight  glycemic control than with standard care (6 hours vs 16 hours, 

<.001)  and were maintained for a greater proportion of the critical illness period  (50% vs 33%, 

<.001). However, tight glycemic control was not  associated with a significantly decreased rate of healthcare–associated  infections (8.6 per 1,000 patient-days in the tight glycemic control group  compared with 9.9 per 1,000 patient-days in the standard of care group; 

=.67).  In addition, mortality, length of hospital stay, organ failure, and  hypoglycemia rates did not differ significantly between the groups.

“Our  trial showed that tight glycemic control targeting a glucose level of 80 to 110  mg per deciliter did not change the rate of healthcare–associated infections,  mortality, or length of stay in the cardiac ICU as compared with standard  care,” the researchers wrote.

They  acknowledged that certain limitations of the trial should be considered,  however, and that this group of pediatric patients is unique, so the results  “cannot be extrapolated to other pediatric critical care populations.”

Tight glycemic control can be achieved in children following cardiac surgery, but it does not reduce the infection rate, mortality, or length of hospital stay compared to standard care, according to a study published in the September 7 issue of The New England Journal of Medicine

Tight glycemic control after pediatric heart surgery shows no benefit

An  Endocrine Society task force has established new clinical-practice guidelines  that recommend screening adults for high triglyceride levels once every 5 years  because of the potential risk of cardiovascular disease and pancreatitis  associated with hypertriglyceridemia.

 are published in the September 2012 issue of the 

Journal of Clinical  Endocrinology & Metabolism

Lars Berglund, MD, PhD, with the University of California, Davis,  and colleagues, received approval to recommend the following:

Diagnosis  of hypertriglyceridemia should be based on fasting levels

Mild  and moderate hypertriglyceridemia (triglycerides of 150–999 mg/dL) should be  diagnosed to aid in the evaluation of cardiovascular risk

Severe  and very severe hypertriglyceridemia (triglycerides of > 1,000 mg/dL) should  be considered as a risk for pancreatitis

Patients  with hypertriglyceridemia should be evaluated for secondary causes of  hyperlipidemia

Patients  with primary hypertriglyceridemia should be evaluated for a family history of  dyslipidemia and cardiovascular disease

The  task force also recommends that the treatment goal in patients with moderate  hypertriglyceridemia be a non-HDL cholesterol level in agreement with National  Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) 

.  Lifestyle therapy should be the initial treatment, followed by a combination of  diet changes and drug therapy. And, in patients with severe or very severe hypertriglyceridemia,  a fibrate should be used as a first-line agent.

  "Severe  and very severe hypertriglyceridemia increase the risk for pancreatitis, while  mild or moderate hypertriglyceridemia may be a risk factor for cardiovascular  disease," the authors wrote. "Therefore, similar to the NCEP ATP III  guidelines committee's recommendations, we recommend screening adults for  hypertriglyceridemia as part of a fasting lipid panel at least every five  years."

The task force  consisted of Berglund, who was selected by the Endocrine Society Clinical  Guidelines Subcommittee (CGS), five additional field experts, and a  methodologist. The guidelines were reviewed and approved sequentially by the  CGS, Clinical Affairs Core Committee, members responding to a web posting, and  The Endocrine Society Council.

An Endocrine Society task force has established new clinical-practice guidelines that recommend screening adults for high triglyceride levels once every 5 years because of the potential risk of cardiovascular disease and pancreatitis associated with hypertriglyceridemia.

New guidelines: Screen adults for hypertriglyceridemia every 5 years

Biologic response modifiers developed for the treatment of  rheumatoid arthritis do not appear to be associated with an increased risk of  cancer, according to a 

Journal of  the American Medical Association.

Maria A. Lopez-Olivo, MD, PhD, of the University of Texas M.D.  Anderson Cancer Center in Houston and colleagues conducted a large systematic  review and meta-analysis to examine the risk of developing cancer. They  reviewed data for nearly 3,000 rheumatoid arthritis patients being treated with  biologic response modifiers (BRMs), such as tumor necrosis factor (TNF)  inhibitors, who were enrolled in 63 randomized controlled trials. 

Because these biologic agents interfere with the immune  system, concerns have been expressed about their safety, specifically with  respect to infections and malignancies. However, data linking these treatments  with potential cancer risks is not definitive. 

The authors found no statistically significant risk for  malignancies among patients taking BRMs when compared with patients using other  treatments. Of the 29,423 patients, 211 developed a malignancy during the  trial. The incidence rate for any malignancy during the first year of therapy  was very low in the BRM plus methotrexate group (0.77%; 95% CI, 0.65%–0.92%),  the BRM monotherapy group (0.64%; 95% CI, 0.42%–0.95%), and the controls  (0.66%; 95% CI, 0.52%–0.84%). Anakinra plus methotrexate showed lower odds  compared with methotrexate alone (Peto odds ratio, 0.11; 95% CI, 0.03–0.45),  according to the abstract.

“Patients are understandably concerned when treatments are linked  to cancer risk. With this knowledge, clinicians can effectively demonstrate  that the benefits of BRMs far outweigh the risk,” said Maria E. Suarez-Almazor,  MD, professor in the department of general internal medicine, in an Anderson  news release.

The authors concluded that further studies need to look at  long-term risk and risk of recurrence in patients with RA with history of  cancer or cancer risk factors, which remain unknown.

Biologic response modifiers developed for the treatment of rheumatoid arthritis do not appear to be associated with an increased risk of cancer, according to a study published September 5 in the Journal of the American Medical Association.

Biologics for RA treatment do not increase cancer risk

Children with asthma who use glucocorticoid  inhalers may grow shorter on average than those who do not use inhaled  corticosteroids (ICS), according to a 

Previous studies have shown that the use of these drugs decreases  growth rate, but it was believed that growth returned to normal after the first  few years of therapy, according to lead author H. William Kelly, PharmD, of the University of New Mexico, Albuquerque, and  colleagues. However, in this follow-up to the earlier Childhood Asthma  Management Program (CAMP) clinical trial, the authors found that children who  were given the glucocorticoid inhalers grew up to  be on average one-half inch shorter than those who used placebo.

Beginning at aged 5 to 13 years, the researchers randomly  assigned patients to receive 400 μg of budesonide,  16 mg of nedocromil, or placebo daily for 4 to 6 years.

At the mean age of 25 years, 943 of the original 1,041 patients  were measured for adult height and weight. The authors found that patients who  had taken budesonide during the trial had a mean height 1.2 cm shorter than  those assigned to a placebo inhaler (171.1 cm vs 172.3 cm, 95% CI, -0.5 to -1.9  cm, 

=.001). In addition, a larger  daily dose was associated with a lower adult height (−0.1 cm for each microgram  per kilogram, 

=.007), and the  deficit in adult height was greater for women (−1.8 cm, 

=.10)  and for participants who were younger at trial entry than for those who were  older.

The mean adult height in the  nedocromil group (172.1 cm) was similar to that of the placebo group (

"The potential effect on adult  height must be balanced against the large and well-established benefit of these  drugs in controlling persistent asthma,” the authors cautioned. “It seems  prudent to select inhaled glucocorticoids and devices with higher therapeutic  indexes and to use them in the lowest effective doses in children with  persistent asthma."

Children with asthma who use glucocorticoid inhalers may grow shorter on average than those who do not use inhaled corticosteroids (ICS), according to a study published September 6 in the New England Journal of Medicine.

Glucocorticoid inhalers may impact adult height

The risks of end stage renal disease (ESRD), chronic kidney  disease, and sustained doubling of serum creatinine concentration are  significantly higher in people with at least 1 symptomatic kidney stone  episode, according to the results of a 

According to R. Todd Alexander,  assistant professor at the University of Alberta in Alberta, Canada, and  colleagues, kidney stones are common and potentially preventable, and  therefore an accurate assessment of their potential long-term consequences  would be important to inform health interventions. 

The researchers sought to assess whether  the presence of kidney stones would increase the risk of ESRD or other adverse  renal outcomes, including the development of stage 3b–5 chronic kidney  disease (estimated glomerular filtration rate <45 mL/min/1.73m2), and  sustained doubling of serum creatinine concentration from baseline.

Using the Alberta Kidney Disease  Network database, the authors identified a cohort of 3,089,194 adults aged ≥18  years who resided in Alberta, Canada, between April 1997 and March 2009  and who did not have ESRD at baseline; 1,954,836 had outpatient serum  creatinine measurements and were included in analyses of chronic kidney disease  and doubling of serum creatinine level.

During the median follow-up period of  11 years, 23,706 (0.8%) patients developed at least one kidney stone; 5,333 (0.2%) developed ESRD. In the subset of patients  with serum creatinine data, the median follow-up period was four years, during  which 68,525 (4%) patients developed stage 3b–5 chronic kidney disease and  6,581 (0.3%) experienced sustained doubling of serum creatinine from baseline.

The authors noted that those at higher risk for all 3 adverse  outcomes included women and those younger than aged 50 years who had at least 1  episode of stones. Those who had more than 1 episode of stones were at an even  higher risk than those with a single episode. 

“These findings suggest that kidney stones are an important  potential contributor to the risk of ESRD and that patients with prior kidney  stones should be considered at increased risk for adverse renal  outcomes-especially younger women or those with multiple symptomatic episodes,”  the authors noted. They concluded that further research should focus on  explaining this association and assessing a way to prevent kidney stones.

The risks of end stage renal disease, chronic kidney disease, and sustained doubling of serum creatinine concentration are significantly higher in people with at least 1 symptomatic kidney stone episode, according to the results of a study published August 30 in the British Medical Journal.