HHAL MEDICAL NEWS OCTOBER 2010

Coronary Artery Calcium Score to Identify Patients with Chest Pain Who Can Be Discharged

Only 0.3% of chest pain patients with coronary artery calcium scores of 0 experienced acute coronary syndromes during follow-up.

To evaluate whether the coronary artery calcium score (CACS) can help identify patients with chest pain who can be safely discharged without further testing, researchers prospectively identified 1031 adult patients at an urban emergency department (ED) who were admitted for further evaluation of low-risk chest pain (chest pain suggestive of ischemia, negative initial troponin, no new ST elevation or depression on electrocardiogram (ECG), hemodynamic stability, and no history of coronary artery disease). Patients underwent stress myocardial perfusion single-photon emission computed tomography (SPECT) imaging and assessment of coronary artery calcification by noncontrast CT, which is fast, requires no patient preparation, and is completed in a single breathhold helical CT sequence.

The frequency of abnormal SPECT results increased significantly with increasing CACS, and ranged from 0.8% in 625 patients with CACS of 0 to 16.9% in 83 patients with CACS >400. Among five patients with CACS of 0 and abnormal SPECT results, four underwent angiography and had normal coronary arteries. Two of 625 patients (0.3%) with CACS of 0 experienced cardiac events during initial hospitalization or after discharge (mean follow-up, 7.4 months); both patients had elevated initial troponin levels but normal serial ECG and SPECT results. The event rate was 7.4% in patients with CACS >0.

http://emergency-medicine.jwatch.org/cgi/content/full/2010/1015/1?q=etoc_jwgenmed

Severe Hypoglycemia and Risks of Vascular Events and Death

N Engl J Med 2010; 363:1410-1418October 7, 2010

Background

Severe hypoglycemia may increase the risk of a poor outcome in patients with type 2 diabetes assigned to an intensive glucose-lowering intervention. We analyzed data from a large study of intensive glucose lowering to explore the relationship between severe hypoglycemia and adverse clinical outcomes.

Methods

We examined the associations between severe hypoglycemia and the risks of macrovascular or microvascular events and death among 11,140 patients with type 2 diabetes, using Cox proportional-hazards models with adjustment for covariates measured at baseline and after randomization.

Results

During a median follow-up period of 5 years, 231 patients (2.1%) had at least one severe hypoglycemic episode; 150 had been assigned to intensive glucose control (2.7% of the 5571 patients in that group), and 81 had been assigned to standard glucose control (1.5% of the 5569 patients in that group). The median times from the onset of severe hypoglycemia to the first major macrovascular event, the first major microvascular event, and death were 1.56 years (interquartile range, 0.84 to 2.41), 0.99 years (interquartile range, 0.40 to 2.17), and 1.05 years (interquartile range, 0.34 to 2.41), respectively. During follow-up, severe hypoglycemia was associated with a significant increase in the adjusted risks of major macrovascular events (hazard ratio, 2.88; 95% confidence interval [CI], 2.01 to 4.12), major microvascular events (hazard ratio, 1.81; 95% CI, 1.19 to 2.74), death from a cardiovascular cause (hazard ratio, 2.68; 95% CI, 1.72 to 4.19), and death from any cause (hazard ratio, 2.69; 95% CI, 1.97 to 3.67) (P<0.001 for all comparisons). Similar associations were apparent for a range of nonvascular outcomes, including respiratory, digestive, and skin conditions (P<0.01 for all comparisons). No relationship was found between repeated episodes of severe hypoglycemia and vascular outcomes or death.

Conclusions

Severe hypoglycemia was strongly associated with increased risks of a range of adverse clinical outcomes. It is possible that severe hypoglycemia contributes to adverse outcomes, but these analyses indicate that hypoglycemia is just as likely to be a marker of vulnerability to such events. (Funded by Servier and the National Health and Medical Research Council of Australia; ClinicalTrials.gov number, NCT00145925.)

http://www.nejm.org/doi/full/10.1056/NEJMoa1003795?query=TOC

You Snooze, You Win

A large, longitudinal cohort study demonstrated a convincing association between short sleep duration and hypercholesterolemia in young women.

Gangwisch JE et al. Sleep 2010 Jul 1; 33:956

Adequate Sleep Seems Necessary for Effective Dieting, Small Study Finds

Getting sufficient sleep may play an important role in losing weight, according to a small crossover study in the Annals of Internal Medicine.

Researchers studied 10 overweight sedentary volunteers in a sleep laboratory for two 2-week periods: one period was restricted to 5.5 bedtime hours per night and the other to 8.5 hours per night. (The two study periods were separated by at least 3 months.)

Subjects lost significantly more lean-mass weight and less body fat when sleeping 5.5 hours a night than when sleeping 8.5 hours. In addition, less sleep led to higher circulating levels of ghrelin, which increases the sense of hunger.

Both the researchers and editorialists point to the study's small sample size and its artificial conditions, and they caution against generalizing without further research. Editorialists speculate that "perhaps sleep should be included as part of the lifestyle package that traditionally has focused on diet and exercise."

http://www.annals.org/content/153/7/435.abstract

Measures of Physical Capability Predict Early Mortality

Grip strength, walking speed, and chair rising were markers in elders.

A growing body of evidence indicates that physical capability — the ability to perform physical daily tasks — predicts future health and mortality. In this systematic review and meta-analysis, investigators determined the associations between objective measures of physical capabilities (e.g., grip strength, walking speed, chair rising) and early mortality.

Most studies involved people older than 60. Follow-up ranged from about 5 to 20 years. Meta-analysis of 14 studies that involved 53,000 people showed that those in the lowest grip-strength quartile were 67% more likely to die during follow-up than people in the highest quartile. Meta-analysis of five studies that involved 15,000 people showed that those in the slowest walking-speed quartile were three times more likely to die during follow-up than people in the fastest quartile. Meta-analysis of five studies that involved 28,000 people showed that those in the slowest chair-rise–time quartile were twice as likely to die during follow-up as were those in the fastest quartile. All analyses were adjusted for age, sex, and body size.

http://us.mg201.mail.yahoo.com/dc/launch?.partner=sbc&.gx=1&.rand=1cqgir8fkgcqq

Does Walking Prevent Cognitive Decline?

Older adults who walk frequently have lower risk for cognitive decline years later, according to an observational study in Neurology.

Some 300 adults aged 65 or older reported how much they walked per week, and then had MRI scans 9 years later. Those who walked at least 72 blocks (6–9 miles) a week had greater gray matter volume on later MRI, compared with those who walked less. In turn, those with more gray matter volume were less likely to have cognitive impairment 4 years after the MRI, relative to those with less gray matter volume.

The authors say their findings "are in line with data that aerobic activity induces a host of cellular cascades that could conceivably increase [gray matter] volume." Still, they caution that their study does not prove a causal link between walking and better cognition.

http://www.neurology.org/cgi/content/abstract/WNL.0b013e3181f88359v1

Children Conceived by In Vitro Fertilization Perform Well on Standardized Achievement Tests

Couples who are considering IVF should be reassured of normal cognitive development in IVF children, as evidenced by their performance on standardized tests of academic achievement

http://womens-health.jwatch.org/cgi/content/full/2010/1028/1?q=pfw-featured

Light Drinking in Pregnancy Does Not Seem to Affect Offspring's Behavior, Cognition

Patients may ask about a study suggesting that children of mothers who drink lightly during pregnancy are not at increased risk for behavioral or cognitive difficulties. The study appears online in the Journal of Epidemiology and Community Health.

U.K. researchers asked roughly 11,500 women about their drinking habits during pregnancy and then assessed their offspring's development at age 5. They found that children of mothers who drank 1–2 units per week while pregnant were at no greater risk for behavioral problems (e.g., hyperactivity) or cognitive deficits (e.g., trouble with vocabulary) than those whose mothers abstained during pregnancy (but drank at other times).

Asked to comment, Dr. Timothy Naimi, an alcohol expert with Boston University School of Medicine, said: "These findings are highly implausible, given that ethanol is the world's leading fetal neurotoxin. This and related studies are hopelessly confounded by socioeconomic factors since those with higher socioeconomic status are far less likely to have children with behavioral or cognitive problems and are the most likely to drink small amounts in pregnancy." He added: "Obviously, drinking any alcohol in pregnancy is discouraged, and there is no safe level of ethanol when it comes to the developing fetal brain."

[Editor's note: Although the journal has released this article from embargo, it has not posted the article on its website. We have provided a link to the journal's online-first page, where it should appear shortly.]

http://click.jwatch.org/cts/click?q=227%3B67451973%3BtXdU0iqXEHy3%2FQWsRFyBRmRd7ZAEBhMzse%2FdIWhS4cw%3D

Low Glomerular Filtration Rate Is Associated with Future Stroke

October 28, 2010 | Paul S. Mueller, MD, MPH, FACP

Risk for stroke was 43% higher among people with renal insufficiency.

Lee M et al. BMJ 2010 Sep 30; 341:c4249

AHA issues new cardiac arrest guidelines
New guidelines released by the American Heart Association underscore that "activation of the EMS [emergency medical services] system, provision of CPR and operation of a defibrillator" should be done immediately after a cardiac arrest to improve the chances of survival. The group also revised its recommendations for rescue workers to stress that compressions should be performed first, followed by airway and breathing, to keep blood and oxygen flowing to the heart and brain. Bloomberg Businessweek/HealthDay News (10/18

Chest Compression-Only CPR by Lay Rescuers Increases Survival

A statewide public education and training program in Arizona yielded impressive results.

Bobrow BJ et al. JAMA 2010 Oct 6; 304:1447

http://emergency-medicine.jwatch.org/cgi/content/full/2010/1022/1?q=etoc_jwgenmed

http://www.heart.org/idc/groups/heart-public/@wcm/@ecc/documents/downloadable/ucm_317267.pdf

Study supports use of hands-only CPR on cardiac arrest patients
A study in the Journal of the American Medical Association looked at 4,415 adult cardiac arrests outside of hospitals in Arizona over a four-year period. The researchers found that 13% of cardiac arrest patients who were given hands-only cardiopulmonary resuscitation survived, compared with only 8% of those who received conventional CPR. The lead author said this method is simpler and more accessible, adding, "We want to take away all the reasons bystanders do nothing when they witness another person collapse." Yahoo!/The Associated Press (10/5

Time use survey finds 5% of adults exercise vigorously
The American Time Use Survey of some 80,000 U.S. adults showed about 5% of people said they did vigorous physical activity on any given day, including 2.2% who used cardiovascular exercise equipment and 1.1% who ran. The most frequent moderate activities were food and drink preparation and lawn, garden and plant care, researchers said. USA TODAY (10/3)

Children should not become fatter during puberty
Though a child's body mass index will increase during puberty, increases in percent body fat and in waist circumference adjusted for height are abnormal and may suggest an increased risk for adiposity-associated morbidity.

http://www.jahonline.org/article/PIIS1054139X10001758/abstract

http://www.jahonline.org/article/PIIS1054139X10001758/fulltext

Study: Obesity costs make up 17% of medical spending
Health care costs attributed to obesity total $168 billion, or about 17% of all medical spending, far higher than previously estimated, U.S. researchers said in a report from the National Bureau of Economic Research. The study also found that obesity adds more than $2,800 to a person's annual medical bills, which is twice as much as a previous estimate. The Washington Post/The Associated Press (10/15

Plasma fatty acid-binding proteins 4 and 5: Mediators and biomarkers?
This study provides evidence for an additive relation of fatty acid-binding proteins (FABP) 4 and 5 with the metabolic syndrome, inflammatory cardiovascular disease risk factors, and coronary atherosclerosis in Type 2 diabetes mellitus. The findings suggest that FABP4 and FABP5 may represent mediators of and biomarkers for metabolic and cardiovascular disease in Type 2 diabetes mellitus. The American Journal of Cardiology (10/15/2010)

http://www.ajconline.org/article/S0002-9149(10)01215-4/fulltext

Alcohol, infection are linked to short-term stroke risk
A review in the journal Stroke of 26 stroke studies suggests that people who consumed 40 to 60 grams of alcohol -- about three to four drinks -- had an almost threefold increase in the risk of stroke within the next 24 hours. Researchers also found that those who had a cold, flu or other infections were two to three times more likely than others to suffer a stroke over the next seven to 30 days. Reuters (10/26)

Modest lifestyle changes could prevent 23% of colorectal cancers

A Danish study in BMJ of people ages 50 to 64 suggests that adherence to five lifestyle recommendations, including 30 minutes of daily exercise, a healthy diet and moderate drinking, could help prevent 23% of colorectal cancer cases. "Even a modest difference in your lifestyle habits may have a substantial impact on your colorectal cancer risk," the lead researcher said. HealthDay News (10/26)

Almost a Quarter of Bowel Cancers Could Be Avoided Through Lifestyle Choices

Making simple lifestyle changes can decrease colorectal cancer risk, according to a BMJ study.

To test a simple lifestyle index for counseling patients, a prospective cohort study followed some 55,000 middle-aged Danes free of cancer at entry for a median of 10 years. In the analysis, almost one quarter of colorectal cancers might have been prevented with adherence to all five lifestyle recommendations (not smoking; daily physical activity for at least 30 minutes; avoiding heavy drinking; eating a healthy diet; and waist-circumference control — i.e., <40 inches for men and <35 inches for women).

http://www.bmj.com/content/341/bmj.c5504.full

Constipation, risk factors and abdominal radiography
Constipation and stool retention is highly prevalent in the elderly, but patient perceptions and reporting of constipation vary widely. This study used abdominal radiographies to assess the severity of stool retention and achieved a 95% confidence interval. Clinical constipation was associated with the use of statins and antimuscarinics.

http://www.jamda.com/article/S1525-8610(09)00418-6/abstract

Higher serum uric acid levels? Type 2 diabetes in the future
These prospective data from two generations of the Framingham Heart Study provide evidence that individuals with higher serum uric acid, including younger adults, are at a higher future risk of Type 2 diabetes independent of other known risk factors. These data expand on cross-sectional associations between hyperuricemia and the metabolic syndrome, and extend the link to the future risk of Type 2 diabetes. The American Journal of Medicine (10/2010)

Aspirin, C-reactive protein and post-acute coronary syndrome: There is an association
This study found a strong association between aspirin adherence and C-reactive protein levels after post-acute coronary syndrome. The American Journal of Cardiology (10/15)

http://www.ajconline.org/article/S0002-9149(10)01201-4/fulltext

What's your risk? Look at lifestyle before genes
Family history, lifestyle and other risk factors are better than genetic information in predicting a person's risk for diseases because "the liability and increased risk of any one of these genes is often trivially small," according to the lead author of a study in PLoS Medicine. The warning is in response to the prevalence of genetic tests that are offered directly to consumers. Reuters (10/12)

New tools for identifying CVD risk
Traditionally, clinicians have relied on biological risk factors to identify subjects at risk of cardiovascular disease. The discovery that certain biomarkers of endothelial dysfunction and low-grade inflammation are strongly associated with risk of CVD in adolescents gives clinicians a new diagnostic tool. (Full-text access is time-limited.) Journal of Adolescent Health (10/2010)

Another independent predictor for heart disease risk
This study concluded that higher red cell distribution width appears to be a powerful independent predictor of future coronary heart disease risk. The American Journal of Cardiology (10/1)

http://www.ajconline.org/article/S0002-9149(10)01132-X/fulltext

NIH says 2.6% of Americans have a food allergy
An NIH study indicates that about 2.6% of Americans -- or about 7.6 million people -- have allergic reactions to food, with children ages 1 to 5 having the highest rates and adults older than 60 having the lowest rates for food allergies. The study also showed that asthmatics with a food allergy were nearly seven times more likely to experience a severe asthma attack compared with those without a food allergy. The Hill/Healthwatch blog (10/4)

Lycopene from Tomatoes and Photoprotection

After 12 weeks of eating tomato paste, women had slightly diminished erythemal reactions to ultraviolet radiation.

Lycopene, a carotenoid in tomatoes and other red fruits, is a potent antioxidant that has gained a reputation as a possible chemopreventive agent against prostate cancer. With dietary supplementation, increased amounts of lycopene are found in the skin, raising the possibility that lycopene might have potential as a cutaneous photoprotectant.

To examine this issue, investigators performed a randomized, controlled trial in nine healthy adult women with Fitzpatrick skin types I or II who were instructed to add 55 grams of tomato paste (approximately 16 mg of lycopene), mixed with olive oil on bread, to their daily diet. Before and at the end of 12 weeks of supplementation, the investigators measured the ultraviolet (UV) light–induced erythemal sensitivity of these women and eight others who ate only olive oil and bread. A modest but statistically significant increase in the mean erythemal dose was seen with supplemental tomato paste, but not with olive oil alone. Moreover, in biopsied skin, mitochondrial DNA mutations, a sensitive method of detecting UV-induced DNA damage, were markedly reduced after tomato paste supplementation but not after the control diet. Addition of tomato paste also produced a slight improvement in two parameters associated with photoaging: procollagen-1 (increased) and matrix metalloproteinase-1 (reduced).

http://dermatology.jwatch.org/cgi/content/full/2010/1008/1?q=topic_nutrition

Obesity and Adenovirus

Data support an association between adenovirus and obesity in children but do not prove causality.

Gabbert C et al. Pediatrics 2010 Oct 126:721

Low-Carbohydrate Diets — Plant- vs. Animal-Based — and Mortality

Plant-based low-carb diets were associated with lower all-cause and cardiovascular mortality.

Recent studies have shown equivalence of low-carbohydrate and low-fat diets for weight loss (JW Gen Med Aug 19 2010). In this large prospective study, researchers assessed whether type of low-carb diet — plant-based or animal-based — affects length of life. They used self-reported diet histories gathered during 20-plus years of follow-up in the observational Nurses' Health Study (>85,000 women) and the Health Professionals Follow-up Study (>44,000 men) to determine whether participants reported a low-carb diet pattern.

The researchers calculated a vegetable low-carbohydrate score for each participant: Compared with those in the lowest decile of vegetable protein and fat intake, those in the highest decile had lower all-cause mortality (hazard ratio, 0.80) and cardiovascular mortality (HR, 0.77) — but not lower cancer mortality (HR, 0.96). Similarly, animal low-carbohydrate scores were calculated: Compared with those in the lowest decile of animal protein and fat intake, those in the highest decile had greater overall mortality (HR, 1.23), cardiovascular mortality (HR, 1.14), and cancer mortality (HR, 1.28). Analyses were adjusted for multiple confounders.

Yancy WS Jr et al. Animal, vegetable, or . . . clinical trial? Ann Intern Med 2010 Sep 7; 153:337. (http://www.annals.org/content/153/5/337.extract)

http://www.ncbi.nlm.nih.gov/pubmed/20820038?dopt=Abstract

Heavy Smoking in Midlife Linked to Increased Dementia Risk Decades Later

Heavy smoking in midlife is associated with more than a doubling of risk for dementia in older age, according to an Archives of Internal Medicine study.

An ethnically diverse group of some 21,000 adults aged 50 to 60 were interviewed about their smoking habits between 1978 and 1985. Researchers then assessed the participants' medical records from 1994 to 2008 and found that a quarter had developed dementia, Alzheimer disease, or vascular dementia.

In fully adjusted analyses, the risk for dementia rose as the amount of smoking increased. In particular, participants who smoked more than two packs a day in midlife had more than twice the risk for dementia, AD, or vascular dementia two decades later, compared with those who'd never smoked.

Commenting on the potential reason behind the association, the authors write: "It is well recognized that smoking augments oxidative stress and inflammation, which are also believed to be important pathophysiologic mechanisms in AD."

http://archinte.ama-assn.org/cgi/content/short/archinternmed.2010.393

Serum and Dietary Potassium and Risk of Incident Type 2 Diabetes Mellitus

The Atherosclerosis Risk in Communities (ARIC) Study

Ranee Chatterjee, MD, MPH; Hsin-Chieh Yeh, PhD; Tariq Shafi, MD, MHS; Elizabeth Selvin, PhD, MPH; Cheryl Anderson, PhD, MPH; James S. Pankow, PhD, MPH; Edgar Miller, MD, PhD; Frederick Brancati, MD, MHS

Arch Intern Med. 2010;170(19):1745-1751. doi:10.1001/archinternmed.2010.362

Background Serum potassium levels affect insulin secretionby pancreatic β-cells, and hypokalemia associated withdiuretic use has been associated with dysglycemia. We hypothesizedthat adults with lower serum potassium levels and lower dietarypotassium intake are at higher risk for incident diabetes mellitus(DM), independent of diuretic use.

Methods We analyzed data from 12 209 participantsfrom the Atherosclerosis Risk in Communities (ARIC) Study, anongoing prospective cohort study, beginning in 1986, with 9years of in-person follow-up and 17 years of telephone follow-up.Using multivariate Cox proportional hazard models, we estimatedthe hazard ratio (HR) of incident DM associated with baselineserum potassium levels.

Results During 9 years of in-person follow-up, 1475 participantsdeveloped incident DM. In multivariate analyses, we found aninverse association between serum potassium and risk of incidentDM. Compared with those with a high-normal serum potassium level(5.0-5.5 mEq/L), adults with serum potassium levels lower than4.0 mEq/L, 4.0 to lower than 4.5 mEq/L, and 4.5 to lower than5.0 mEq/L had an adjusted HR (95% confidence interval [CI])of incident DM of 1.64 (95% CI, 1.29-2.08), 1.64 (95% CI, 1.34-2.01),and 1.39 (95% CI, 1.14-1.71), respectively. An increased riskpersisted during an additional 8 years of telephone follow-upbased on self-report with HRs of 1.2 to 1.3 for those with aserum potassium level lower than 5.0 mEq/L. Dietary potassiumintake was significantly associated with risk of incident DMin unadjusted models but not in multivariate models.

Conclusions Serum potassium level is an independent predictorof incident DM in this cohort. Further study is needed to determineif modification of serum potassium could reduce the subsequentrisk of DM.

http://archinte.ama-assn.org/cgi/content/abstract/170/19/1745?ct

Omega-3 Supplements Don't Seem to Lower Risk for Postpartum Depression or Improve Cognition in Offspring

Maternal supplementation with docosahexaenoic acid (DHA) does not lower risk for postpartum depression or improve offspring's cognitive or language development, according to a JAMA study.

Researchers randomized some 2400 Australian women to take three omega-3 fatty acid capsules (containing a total of 800 mg DHA) or three vegetable oil capsules daily for the second half of pregnancy. Overall, rates of high depression scores at 6 weeks and 6 months postpartum did not differ between the groups. Similarly, cognitive and language development, assessed in roughly 700 children at 18 months, did not differ.

Editorialists conclude that pregnant women should get 200 mg of DHA daily, as recommended by some groups, but that "the benefit of higher intakes remains unclear."

Effects of Lowering Homocysteine Levels With B Vitamins on Cardiovascular Disease, Cancer, and Cause-Specific Mortality

Meta-analysis of 8 Randomized Trials Involving 37 485 Individuals

Arch Intern Med. 2010;170(18):1622-1631. doi:10.1001/archinternmed.2010.348

Elevated plasma homocysteine levels have been associated withhigher risks of cardiovascular disease, but the effects on diseaserates of supplementation with folic acid to lower plasma homocysteinelevels are uncertain. Individual participant data were obtainedfor a meta-analysis of 8 large, randomized, placebo-controlledtrials of folic acid supplementation involving 37 485 individualsat increased risk of cardiovascular disease. The analyses involvedintention-to-treat comparisons of first events during the scheduledtreatment period. There were 9326 major vascular events (3990major coronary events, 1528 strokes, and 5068 revascularizations),3010 cancers, and 5125 deaths. Folic acid allocation yieldedan average 25% reduction in homocysteine levels. During a medianfollow-up of 5 years, folic acid allocation had no significanteffects on vascular outcomes, with rate ratios (95% confidenceintervals) of 1.01 (0.97-1.05) for major vascular events, 1.03(0.97-1.10) for major coronary events, and 0.96 (0.87-1.06)for stroke. Likewise, there were no significant effects on vascularoutcomes in any of the subgroups studied or on overall vascularmortality. There was no significant effect on the rate ratios(95% confidence intervals) for overall cancer incidence (1.05[0.98-1.13]), cancer mortality (1.00 [0.85-1.18]) or all-causemortality (1.02 [0.97-1.08]) during the whole scheduled treatmentperiod or during the later years of it. Dietary supplementationwith folic acid to lower homocysteine levels had no significanteffects within 5 years on cardiovascular events or on overallcancer or mortality in the populations studied.

^{http://archinte.ama-assn.org/cgi/content/abstract/170/18/1622?ct}

Glucosamine and Chondroitin, for Hip or Knee Osteoarthritis

Alone or in combination, the supplements do not reduce joint pain or limit joint-space narrowing.

Wandel S et al. BMJ 2010 Sep 16; 341:c4675

Warfarin Therapy During Fecal Occult Blood Testing

Warfarin was not associated with excess false-positive FOBTs.

Iles-Shih L et al. Am J Gastroenterol 2010 Sep 105:2030

FDA Says Bisphosphonates Might Increase Femoral Fracture Risk, Orders Label Change

In contrast with earlier reassurance that there was no "clear connection" between use of bisphosphonates and atypical femoral fractures, the FDA now says labeling changes are needed.

Changes to the warnings section of all bisphosphonates given for osteoporosis will highlight the potential risk for subtrochanteric and diaphyseal femoral fractures. In addition, manufacturers will need to include a medication guide for use by patients.

The FDA says that the fractures being reported "may be related to use of bisphosphonates for longer than five years." Consequently, physicians are being asked to reevaluate the need for the drugs if their patients have been using them longer than that.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229171.htm

Does Vitamin D Status Affect Mortality?

No association between vitamin D status and mortality at 7 years was found.

These days, many clinicians are checking vitamin D levels routinely. Patients with the lowest levels clearly are at risk for metabolic bone disease, which can be prevented with vitamin D supplementation. Another premise is that screening and supplementation will prevent a variety of disorders involving other organ systems. However, randomized trials in which researchers are examining the effect of vitamin D supplementation on mortality have not yet been completed, and not every observational study has demonstrated an association between vitamin D status and mortality.

In this U.S. study, 1500 relatively healthy community-dwelling men (age, 65) were randomly selected from participants in the prospective Osteoporotic Fractures in Men study (Contemp Clin Trials 2005; 26:569). At baseline, 25-hydroxyvitamin D levels were <20 ng/mL in 25% of men, and between 20 and 30 ng/mL in 50% of men. During an average follow-up of 7 years, 22% of participants died. In both unadjusted analyses and in analyses adjusted for potentially confounding variables, no significant associations were observed between vitamin D levels (across quartiles) and all-cause, cancer-related, or cardiovascular mortality.

Cawthon PM et al. J Clin Endocrinol Metab 2010 Oct 95:4625