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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
April 30, 2016

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Another Look at Metformin and Vitamin B12 Deficiency
Meta-Analysis: Metformin should still be First-Line Diabetes Therapy, even with
   Newer Drugs Available
Vitamin D Supplementation doesn't Lengthen Walk Distance in Patients with
   Chronic Heart Failure
Guidelines Updated on Botulinum Toxin for Brain Disorders
Stem Cell Treatments for Damaged Corneas and Congenital Cataracts
Does Ovary-Sparing Hysterectomy affect Subsequent Ovarian Function?
FDA: Yeast Infection Drug might increase Miscarriage Risk
Medical Costs for Children's Food Allergies Differ by Family Income
New Look at Old Data finds Diets Rich in Omega-6s of no Mortality Benefit
Teen Birth Rates down in the U.S., Biggest Drops among Hispanic and Black Teens
One Quarter of NICU Patients Receive Acid-Suppressive Medications
Results of Rapid Evaluation and Management of TIA
Aspirin Resistance and Stroke Severity
Ondansetron for Pregnancy-Associated Nausea and Vomiting
Experimental Monoclonal Antibody improves Lung Function in Adults with Asthma
Smoking Cessation: “Cold Turkey” vs. Quitting Gradually
As Smoking Declined, so too did Prostate Cancer Mortality
New Guidance for Gynecologists Counseling Adolescents on Breast and Labial Surgeries
Larger Peptic Ulcer Size Is Associated with Worse Bleeding Outcomes

J Clin Endocrinol Metab 2016 Apr; 101:1754
Another Look at Metformin and Vitamin B12 Deficiency
A study with as long as 13 years of follow-up supports this link.
Several studies have linked metformin to development of vitamin B12 deficiency (NEJM JW Gen Med Jul 1 2010 and BMJ 2010; 340:c2181). Now, researchers provide additional data on this potential complication.
In the randomized Diabetes Prevention Program, 3200 adults at high risk for diabetes received metformin, placebo, or intensive lifestyle modification for 3 years (NEJM JW Gen Med Mar 15 2002 and N Engl J Med 2002; 346:393). After the trial was completed in 2002, participants were invited to a follow-up study in which the metformin group was offered open-label metformin. Among 1700 participants with 5-year follow-up, prevalence of vitamin B12 deficiency (≤203 pg/mL) at year 5 was significantly higher in the metformin group than in the placebo group (4% vs. 2%); at a higher cutoff of 298 pg/mL, prevalences were 19% and 9%, respectively. Although differences between groups diminished after 13 years, years of metformin exposure still correlated with development of B12 deficiency at year 13. Patients with metformin-related low B12 levels had elevated homocysteine levels (an expected finding in B12-deficient patients).
COMMENT: This study strengthens the case for metformin-induced reductions in vitamin B12 levels. However, the clinical importance of this relation remains somewhat unclear: The researchers had no data on changes in red-cell mean corpuscular volume (MCV), and participants' responses on a standardized neuropathy screening instrument did not correlate with vitamin B12 levels. Checking a serum B12 level if the MCV rises or if neuropathic symptoms develop in a metformin-treated patient certainly is appropriate. However, whether we should monitor B12 status routinely in all metformin-treated patients remains unclear.
CITATION(S): Aroda VR et al. Long-term metformin use and vitamin B12 deficiency in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab 2016 Apr; 101:1754. (http://dx.doi.org/10.1210/jc.2015-3754)

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Meta-Analysis: Metformin should still Be First-Line Diabetes Therapy, even with Newer Drugs Available
By Amy Orciari Herman
Evidence from a new meta-analysis "supports current guidelines with metformin as the recommended first-line agent to treat adults with type 2 diabetes, given its beneficial effects on hemoglobin A1c, weight, and cardiovascular mortality ... and relative safety profile," researchers conclude in the Annals of Internal Medicine.
The analysis included over 200 randomized controlled or observational studies (mostly short-term) published through 2015. Participants generally were overweight or obese adults with poorly controlled hemoglobin A1c levels at baseline. Among the findings:

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J Am Coll Cardiol 2016 Apr 4
Vitamin D Supplementation doesn't Lengthen Walk Distance in Patients with Chronic Heart Failure
But supplementation was associated with improvements in cardiac function and remodeling.
Vitamin D deficiency has been linked to developing chronic heart failure (HF), and patients with chronic HF often are vitamin D–deficient. However, studies of vitamin D supplementation in such patients have yielded inconsistent results. In this study, investigators randomized 223 patients (80% men) with chronic HF and vitamin D deficiency (serum 25-hydroxyvitamin D [25(OH)D] level <20 ng/mL) to vitamin D3 (4000 IU daily) or placebo for 1 year. Enrollment was restricted to those with New York Heart Association class II–III symptoms and left ventricular ejection fractions (LVEFs) ≤45%. The primary outcome was change in 6-minute walk distance at 12 months (compared with the baseline mean of about 290 m).
At 1 year, median 25(OH)D levels were 46 ng/mL in the supplementation group and 9.8 ng/mL in the placebo group. Mean change in 6-minute walk distance was a slight increase in the placebo group (+10 m) and a slight decrease in the vitamin D group (−13 m) — a nonsignificant difference. Patients who took vitamin D showed significantly greater improvements in LVEF (mean increases, 7.6% vs. 1.4%), LV end diastolic dimension, and LV end diastolic volume. No vitamin D–related adverse events occurred.
COMMENT: In this study, vitamin D therapy was associated with favorable changes in secondary endpoints that suggest beneficial effects on cardiac function and structure. However, absolutely no improvement occurred in the clinically relevant primary outcome (6-minute walk distance); although the authors believe their study was underpowered to detect a difference in this endpoint. To prove that vitamin D improves symptoms and quality of life in heart failure patients, additional clinical trials will be necessary.
At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was an accepted manuscript and that subsequent changes might be made.
CITATION(S):Witte KK et al. Effects of vitamin D on cardiac function in patients with chronic HF: The VINDICATE study. J Am Coll Cardiol 2016 Apr 4; [e-pub].
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Guidelines Updated on Botulinum Toxin for Brain Disorders
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
The American Academy of Neurology has updated its 2008 guidelines on using botulinum toxin for brain disorders.
One of the main changes: Botulinum toxin A is now recommended for the management of chronic migraine, defined as attacks lasting 4 or more hours on at least 15 days each month for 3 months. Previously, there wasn't enough evidence for this recommendation, but new placebo-controlled studies show a small, 15% reduction in the number of headache days with treatment. Botulinum toxin A is not recommended for less frequent, "episodic" migraine.
In addition, the guidance states that botulinum toxin is generally safe and effective for treating spasticity in adults, cervical dystonia, and blepharospasm.
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Nature 2016 Mar 17; 531:376
Stem Cell Treatments for Damaged Corneas and Congenital Cataracts
In vitro and in vivo corneal growth from stem cells is possible.
Stem cell biology is starting to become stem cell medicine. Two teams have published advances in ophthalmologic medicine that take advantage of stem cell technology.
Human induced pluripotent stem cells (iPSCs; NEJM JW Gen Med Sep 15 2008 and Science 2008; 321:1218) can be chemically coaxed to become a primitive eye. Japanese researchers took cornea-like cells from such primitive eyes and grew them into sheets that resembled corneas. These “corneas” restored the vision of rabbits that had a blinding corneal stem cell deficiency.
A second group discovered that the lens capsule contains lens stem cells, which can be chemically coaxed to form a lens. They developed a minimally invasive surgical technique that removes a cataractous lens without damaging the lens stem cells that remain in the capsule. They demonstrated that this surgical technique allows monkeys and rabbits to grow new lenses. Then, the researchers employed this technique in 12 human children with congenital cataracts, and the children grew their own cataract-free lenses in the 3 months following surgery, without complications.
COMMENT: The century-old technique of corneal transplantation usually works, although it can be complicated by inflammation and rejection. Although using corneal sheets grown from a person's own iPSCs likely will not enter clinical practice soon, such research opens the door for eventual implementation. In contrast, implanting synthetic lenses for congenital cataracts in children is much less successful than using synthetic lenses in adults — in large part, because a young child's eye keeps growing. The remarkable technique of encouraging a child's eye to regrow its own cataract-free lens might enter clinical practice relatively soon.
CITATION(S):Hayashi R et al. Co-ordinated ocular development from human iPS cells and recovery of corneal function. Nature 2016 Mar 17; 531:376. (http://dx.doi.org/10.1038/nature17000)

Lin H et al. Lens regeneration using endogenous stem cells with gain of visual function. Nature 2016 Mar 17; 531:323.
(http://dx.doi.org/10.1038/nature17181) - See more at:

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Obstet Gynecol 2016 Apr 4
Does Ovary-Sparing Hysterectomy affect Subsequent Ovarian Function?
Study indicates that ovarian reserve declines faster in women who have undergone hysterectomy than in those with intact reproductive tracts.
Whether to perform bilateral oophorectomy at the time of hysterectomy for benign disease has long been debated. Data support sparing the ovaries because of several negative consequences associated with oophorectomy, including increased risks for cardiac and neurologic disease, cancer mortality, and overall mortality. But does hysterectomy alone affect ovarian function? Investigators conducted a prospective cohort study among racially diverse women and compared those undergoing ovary-sparing hysterectomy for benign disease with women whose reproductive organs were intact. The original analysis showed that women undergoing hysterectomy entered menopause at least 1.9 years sooner than the referent cohort. In this secondary analysis, levels of antimüllerian hormone (AMH; an indicator of ovarian reserve) were assessed at baseline compared with 1 year after hysterectomy in 117 women, and at baseline compared with 1 year later in 129 referent women; baseline AMH levels were also compared between groups.
The median percentage 1-year decrease in AMH levels was greater in the hysterectomy group than in the referent group (–40.7% vs. –20.9%; P<0.001); also, 12.8% of women in the hysterectomy group versus 4.7% in the referent group had undetectable AMH levels 1 year after baseline (P<0.02). These differences were not significant when white women were analyzed independently, but remained significant among black women.
COMMENT: This analysis was complicated by the fact that AMH levels were not normally distributed and more women in the hysterectomy group had irregular menses at baseline. Still, the data confirm that women undergoing ovary-sparing hysterectomy experience menopause at earlier ages and suggest that hysterectomy can damage the ovaries (most likely through diminished ovarian blood flow). Thus, even seemingly benign procedures can have unexpected consequences — and gynecologists and their patients should factor these observations into their decision making about hysterectomy.
CITATION(S): Trabuco EC et al. Association of ovary-sparing hysterectomy with ovarian reserve. Obstet Gynecol 2016 Apr 4; [e-pub]. (http://www.ncbi.nlm.nih.gov/pubmed/?term=Association+of+Ovary-Sparing+Hysterectomy+With+Ovarian+Reserve)
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FDA: Yeast Infection Drug might increase Miscarriage Risk
By Kristin J. Kelley, Edited by Lorenzo Di Francesco, MD, FACP, FHM
Clinicians should exercise caution when prescribing the oral antifungal fluconazole (Diflucan and generics) to pregnant women, the FDA warned on Tuesday, because the drug might pose increased risk for miscarriage.
The warning follows the results of a recent Danish study in which the risk for spontaneous abortion was significantly higher among women who used oral fluconazole than among unexposed women (hazard ratio, 1.48).
In the study, fluconazole was most often taken as one or two 150-mg doses, the FDA notes. The agency warned in 2011 that using high-dose fluconazole in the first trimester could cause birth defects, but the drug's current label says the available data do not suggest an increased risk for pregnancy problems with a single 150-mg dose.
Dr. Allison Bryant of NEJM Journal Watch Women's Health commented: "While differences between patients taking oral fluconazole in pregnancy and others may be partly responsible for the findings, providers should take note and should not consider fluconazole as a first-line treatment for vaginal yeast infections in early pregnancy."

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Medical Costs for Children's Food Allergies differ by Family Income
By John D. Cowden, MD
Dr. Cowden is an associate editor with NEJM Journal Watch Pediatrics and Adolescent Medicine, from which this story was adapted. Full coverage is available to subscribers at the link below.
For children with food allergies, lower household income is associated with higher emergency department and hospitalization costs, but with lower specialist costs and out-of-pocket medication spending, according to a Pediatrics study.
Using survey responses from over 1600 families, researchers estimated direct healthcare utilization costs and out-of-pocket spending (medications, special foods, travel) related to the child's food allergy. They compared these costs by annual household income group.
Overall direct medical costs did not differ by income. However, compared with families in the highest income group (>$100,000), those in the lowest (<$50,000) incurred 2.5 times higher mean emergency department and hospitalization costs, slightly higher primary care costs, and slightly lower specialist costs. Higher income was associated with higher out-of-pocket spending on medications.
Comment: These results suggest that lower-income families have less access to the support needed to prevent and treat food allergy complications (e.g., specialist care, epinephrine injectors), resulting in more ED visits and hospitalizations. These families often need help obtaining allergen-free foods, and they benefit from referral to allergy specialists with experience supporting low-income families.
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New Look at Old Data finds Diets rich in Omega-6s of No Mortality Benefit
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Swapping out saturated fats with omega-6 fatty acid doesn't seem to improve clinical outcomes and may even be tied to worse survival among seniors, according to a reanalysis of 45-year-old data. The new findings appear in The BMJ.
In the 1968–73 Minnesota Coronary Experiment, a cohort of adults in mental institutions or a nursing home were randomized to one of two diets: one that replaced saturated fats with vegetable oil rich in omega-6 linoleic acid or a control diet high in saturated fat. Researchers have now reanalyzed the data, including unpublished material, of 2400 participants who followed the diets for at least 1 year.
The intervention group had a greater reduction in serum cholesterol than the control group. However, this didn't translate to a lower mortality rate. Among seniors, mortality risk seemed higher with the intervention diet, but there were not enough data to confirm this finding.
An editorialist concludes: "The benefits of choosing polyunsaturated fat over saturated fat seem a little less certain than we thought. While we wait for further clarification, we should continue to eat (and to advise others to eat) more fish, fruits, vegetables, and whole grains."
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Teen Birth rates down in the U.S., Biggest drops among Hispanic and
Black Teens

By Kelly Young, Edited by André Sofair, MD, MPH
Teen birth rates fell a dramatic 41% nationwide from 2006 to 2014, and the racial disparity in birth rates appears to be shrinking, according to a report in MMWR.
The CDC used data from the National Vital Statistics System to look at trends in births for teenagers aged 15 to 19 from 2006 to 2014.
Hispanics saw the largest decrease, at 51%, followed by non-Hispanic blacks, at 44%. The birth rate ratio for Hispanic relative to white teens fell from 2.9 to 2.2. The rate ratio for black relative to white teens fell from 2.3 to 2.0.
Every state reported a decline in overall teen births, but not necessarily a reduction in racial disparity.
Counties with the highest teen birth rates had higher unemployment rates, lower average household incomes, and lower percentages of people with at least an associate's degree
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J Pediatr 2016 Apr 27
One Quarter of NICU Patients receive Acid-Suppressive Medications
Despite no evidence of efficacy or safety in neonates, H2RAs and PPIs are frequently prescribed.
Although current guidelines caution against it, routine use of histamine-2 receptor antagonists (H2RAs) and proton-pump inhibitors (PPIs) in neonates has been documented in U.S. neonatal care intensive units (NICUs).
Researchers evaluated the frequency and determinants of H2RA or PPI use in a retrospective cohort study of 122,000 infants admitted to NICUs at 43 U.S. children's hospitals from 2006 to 2013. Admissions occurred on postnatal day 0 or 1 and lasted ≥7 days. Results included:

COMMENT: F. Bruder Stapleton, MD
Histamine-2 receptor antagonists and PPIs are used with alarming frequency in infants, particularly extremely premature neonates, despite the lack of evidence for efficacy or proof of safety. Although this study does not examine either efficacy or safety, it offers a bit of optimism as the use of these agents in infants appears to be declining in recent years.
CITATION(S):Slaughter JL et al. Neonatal histamine-2 receptor antagonist and proton pump inhibitor treatment at United States children's hospitals. J Pediatr 2016 Apr 27; [e-pub]. (http://dx.doi.org/10.1016/j.jpeds.2016.03.059)
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N Engl J Med 2016 Apr 21; 374:1533
Results of Rapid Evaluation and Management of TIA
In a prospective European registry, rates of stroke after transient ischemic attack or minor ischemic stroke were two-thirds lower than the rates reported 2 decades ago.
A seminal study published in 2000 reported a 10% risk for stroke during the 90 days after a transient ischemic attack (TIA; JAMA 2000; 284:2901). This and other studies led many centers to create systems for rapid TIA evaluation and management. To assess the effects of this more-aggressive approach, investigators conducted an industry-sponsored study of stroke risk after TIA and minor stroke. They prospectively enrolled patients with recent (<7 days) TIA or minor ischemic stroke (modified Rankin Scale score, 0–1) at 61 sites in 21 European countries. All sites had a dedicated system in which stroke specialists cared for ≥100 TIA patients per year. After the baseline visit, stroke specialists evaluated patients at 1, 3, and 12 months. Any stroke occurring after the index visit (a secondary study outcome) was included in this analysis.
Of 4789 patients enrolled from 2009 through 2011, approximately 80% were evaluated by stroke specialists within 24 hours after symptom onset. Cumulative rates of stroke were 2.1% at 7 days, 3.7% at 90 days, and 5.1% at 1 year. Higher ABCD2 scores were associated with higher stroke risk, but 22% of strokes occurred in those with an ABCD2 score of 0 to 3.
COMMENT: These findings point to remarkable progress over the past few decades: Compare the 90-day stroke risk of 3.7% in this study to the 10.5% risk reported in 2000. This decrease is almost certainly due to more-aggressive care by stroke specialists rather than changes in patient characteristics, because this was a high-risk group, most of whom were not receiving therapy for vascular risk-factor modification before presentation. The approach described in this study should stand as the standard of care for patients with TIA and minor stroke. Healthcare organizations must ensure that they have appropriate systems to rapidly provide or refer patients for this type of care.
CITATION(S):Amarenco P et al. One-year risk of stroke after transient ischemic attack or minor stroke. N Engl J Med 2016 Apr 21; 374:1533.

Sacco RL and Rundek T.The value of urgent specialized care for TIA and minor stroke. N Engl J Med 2016 Apr 21; 374:1577.
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Neurology 2016 Apr 8
Aspirin Resistance and Stroke Severity
High residual platelet activity correlated with more-severe strokes and larger infarcts, but measurement remains a challenge.
In patients being treated for long-term stroke prevention with aspirin, patients who have a new ischemic event while taking aspirin are frequently considered to have aspirin failure. One potential mechanism for aspirin failure is aspirin resistance, operationally defined as high amounts of residual platelet aggregation despite aspirin administration.
To examine the potential effect of aspirin resistance on stroke severity, researchers evaluated 310 patients admitted within 48 hours after stroke onset who were taking aspirin for at least the 7 previous days. High residual platelet reactivity (HRPR) on aspirin treatment was assessed using the VerifyNow assay. The researchers assessed correlations of assay values with stroke severity, as measured by the NIH stroke scale, and with infarct volume using diffusion-weighted imaging (DWI) sequences on magnetic resonance imaging.
HRPR was observed in 86 patients (27.7%). The median NIH stroke scale score was significantly higher in patients with high HRPR compared with the non-HRPR group (6 vs. 3). DWI stroke volumes were also significantly higher in the HRPR group compared with the non-HRPR group (5.4 cm3 vs. 1.7 cm3). Stroke subtypes did not differ in the two groups; 26% of both groups had cardioembolic stroke and about one third had large-artery atherosclerosis. One baseline factor that differed in the two groups was median onset-to-arrival time (5.8 hours in the HRPR group vs. 12.8 hours in the non-HRPR group).
COMMENT : Aspirin resistance has been studied more commonly with regard to preventive treatment strategies, such as intensification of antiplatelet therapy in the setting of aspirin resistance. This study suggests that strokes are more severe with aspirin resistance, possibly due to larger thrombus size. However, concerns regarding the reproducibility and validity of the assay used to define aspirin resistance persist, leading to a common perception that testing for aspirin resistance is “not ready for prime time.”
CITATION(S): Oh MS et al. Aspirin resistance is associated with increased stroke severity and infarct volume. Neurology 2016 Apr 8; [e-pub]. (http://dx.doi.org/10.1212/WNL.0000000000002657)
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Obstet Gynecol 2016 May; 127:878
Ondansetron for Pregnancy-Associated Nausea and Vomiting
Anna Wald, MD, MPH reviewing Carstairs SD. Obstet Gynecol 2016 May. Siminerio LL et al. Obstet Gynecol 2016 May.
First-trimester use seems safe, although data are still limited.
As many as 8 in 10 women experience debilitating pregnancy-associated nausea and vomiting. Ondansetron, which has emerged as the most common therapy for chemotherapy-associated nausea and vomiting, also appears to be the most effective drug during pregnancy — but is it safe? In a systematic review and a separate in-depth commentary based on a literature search, two groups address this question.
In the systematic review of potential malformations following first-trimester exposure to ondansetron, researchers identified some 4000 exposed infants in eight studies. Overall, no excess risk for major malformations was seen, although risk for septal heart defects was slightly increased in two studies; in addition, risk for cleft palate was increased in one study but decreased in another. The authors concluded that, although risk for ondansetron-associated birth defects appears to be low, this medication should be used only in women whose symptoms are not relieved by other approaches.
The authors of the commentary noted that the strongest evidence regarding safety of ondansetron was from a Danish national study (NEJM JW Womens Health Mar 2013 and N Engl J Med 2013; 368:814), which showed similarly low rates of major birth defects (2.9%) in exposed and unexposed infants. These authors concluded that “current data do not support a reluctance to treat women with ondansetron in clinical practice.”
COMMENT: How do we advise patients about ondansetron, even as various researchers — studying the same data — reach differing conclusions? Safety studies that utilize large prospective databases in Scandinavian countries are more reassuring than case-control studies. Factors likely to influence the decision whether or not to use ondansetron include risk aversion as well as severity of nausea and vomiting and its impact on quality of life. Alternatives such as smaller, more-frequent meals or other medications (e.g., pyridoxine plus doxylamine, which costs US$5.00 per pill) seem less effective. After reviewing the data, I have few concerns about offering ondansetron to women whose symptoms are not controlled by these tactics (despite its cost of $3.00 per pill at discount). However, we need better risk estimates in larger cohorts to fully understand the potential harm from this medication.
CITATION(S):Carstairs SD.Ondansetron use in pregnancy and birth defects: A systematic review. Obstet Gynecol 2016 May; 127:878. (http://dx.doi.org/10.1097/AOG.0000000000001388)

Siminerio LL et al. Ondansetron use in pregnancy. Obstet Gynecol 2016 May; 127:873. (http://dx.doi.org/10.1097/AOG.)

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Experimental Monoclonal Antibody improves Lung Function in
Adults with Asthma

By Amy Orciari Herman, Edited by Susan Sadoughi, MD
The experimental human monoclonal antibody dupilumab improves lung function when used as add-on therapy in adults with poorly controlled asthma, according to an international, industry-funded, phase 2b trial in the Lancet. Dupilumab inhibits two key drivers of inflammation, interleukins 4 and 13.
Nearly 800 adults with uncontrolled asthma despite treatment with inhaled corticosteroids and long-acting beta-agonists were randomized to receive add-on therapy with subcutaneous dupilumab (200 or 300 mg every 2 or 4 weeks) or placebo for 24 weeks.
The primary outcome — change in forced expiratory volume at week 12 among patients with baseline eosinophil counts of 300 per µL or higher — significantly favored dupilumab, with the greatest benefit seen with treatment every 2 weeks. Findings were similar in the overall study population. Treatment-emergent adverse events did not differ between dupilumab and placebo.
A commentator says the study "establishes dupilumab as a first-in-class potential new treatment for asthma, particularly for severe asthma where there is an urgent unmet need for new efficacious treatments."
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Ann Intern Med 2016 Mar 15
Smoking Cessation: “Cold Turkey” vs. Quitting Gradually
In a randomized trial, quitting abruptly was more likely to result in abstinence.
Most smoking cessation guidelines advise patients to set a quit date and stop smoking abruptly, rather than gradually; however, data to support the superiority of abrupt quitting have been inconsistent. In this U.K. study, 697 adult smokers (mean cigarettes daily, 20) were randomized to set a quit date and stop smoking abruptly on that date, or to set a quit date and cut back gradually for 2 weeks before quitting. All participants received nicotine replacement therapy and behavioral support. Abstinence was confirmed by exhaled carbon monoxide measurement.
At 4 weeks, 49% of patients in the abrupt-cessation group were abstinent, compared with 39% of those in the gradual-cessation group; at 6 months, abstinence rates remained significantly higher in the abrupt-cessation group (22% vs. 16%). At baseline, 51% of all participants said they would have preferred gradual cessation, and 32% preferred abrupt cessation; at 4 weeks, those whose baseline preference was to quit gradually were significantly less likely to be abstinent, regardless of allocation, than those who preferred to quit abruptly (38% vs. 52%).
COMMENT: These findings support current smoking cessation guidelines, which advise quitting abruptly. However, for patients who are unwilling to do so, cutting back gradually still might be worthwhile. Results also suggest that willingness to quit abruptly, rather than gradually, might indicate a higher level of motivation.
CITATION(S): Lindson-Hawley N et al. Gradual versus abrupt smoking cessation: A randomized, controlled noninferiority trial. Ann Intern Med 2016 Mar 15; [e-pub]. (http://dx.doi.org/10.7326/M14-2805)
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As Smoking Declined, so too did Prostate Cancer Mortality
By Kelly Young, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Declines in prostate cancer mortality occurred concurrently with drops in smoking prevalence over a decade, according to an ecological analysis published in Preventing Chronic Disease.
Researchers assessed smoking prevalence and prostate cancer mortality among men aged 35 and older in four states from 1999 to 2010.

Meanwhile, the control condition — mortality from external causes — did not change significantly during this time (except in Kentucky, where it increased).
The authors write that increased prostate-specific antigen testing and better treatment options during this period do not fully explain the observed reduction in prostate cancer mortality. They say this reduction "may be due, in part, to decreases in smoking."
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New Guidance for Gynecologists Counseling Adolescents on Breast and
Labial Surgeries

By Kelly Young, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
The American College of Obstetricians and Gynecologists has published guidance for clinicians counseling adolescent patients seeking breast augmentation or reduction surgeries or labiaplasties.
The group recommends the following:

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Aliment Pharmacol Ther 2016 Mar 22
Larger Peptic Ulcer Size Is Associated with Worse Bleeding Outcomes
Consider ulcer size in risk stratification of patients with PUB.
Multiple clinical predictors of short-term outcomes for severe peptic ulcer bleeding (PUB) have been identified. Factors that affect longer-term (30-day) outcomes are less well studied.
In a prospective cohort study, investigators assessed 30-day rebleeding, mortality, and surgery in 1264 patients with endoscopically proven PUB, of whom 688 (55%) had stigmata of recent hemorrhage (SRH) at initial endoscopy and received endoscopic therapy.
Results were as follows:

COMMENT: Most of the clinical factors identified here (SRH, inpatient bleeding and transfusions) have been previously associated with poor clinical outcomes, but ulcer size has not been well evaluated. As the authors conclude, these findings suggest that the size of the ulcer, as well as its endoscopic characteristics, can be used to stratify patients for aggressive care.
CITATION(S): Camus M et al. Independent risk factors of 30-day outcomes in 1264 patients with peptic ulcer bleeding in the USA: Large ulcers do worse. Aliment Pharmacol Ther 2016 Mar 22; [e-pub].
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