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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
February 11, 2017

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Is Treating Pregnant Women with Subclinical Hypothyroidism Beneficial?
Cash Incentives to Low-Income Mothers Improve Breast-Feeding Rates
Stress Ulcer Prophylaxis with Proton-Pump Inhibitors: How Safe?
Tight Glycemic Control Is Not Beneficial — And May Be Harmful —
   In Critically Ill Children
Bariatric Surgery Tied to Long-Term Weight Loss in Obese Adolescents
An Estimated 1 in 28 Americans Will Develop Melanoma in Their Lifetime

BMJ 2017 Jan 25; 356:i6865
Is Treating Pregnant Women with Subclinical Hypothyroidism Beneficial?
Sometimes: Among women with pretreatment thyroid stimulating hormone levels of 4.1 to 10.0 mIU/L, odds of pregnancy loss were reduced compared with those in untreated women.
Subclinical hypothyroidism is defined as elevated thyroid stimulating hormone (TSH) levels along with normal thyroid hormone concentrations; however, exactly what TSH level should be considered as elevated is debatable, particularly during pregnancy, when changes in thyroid physiology result in lower TSH concentrations. The American Thyroid Association has recommended upper TSH thresholds of 2.5 mIU/L during the first trimester of pregnancy and 3.0 mIU/L during the second and third trimesters (Thyroid 2011; 21:1081), but raising the normal cutoff to 4.0 mIU/L has been proposed (Thyroid 2017; [in press]). Some observational studies have suggested adverse pregnancy outcomes in women with subclinical hypothyroidism.
Investigators used a national administrative claims database to conduct a retrospective observational study in a cohort of 5405 pregnant women with subclinical hypothyroidism based on TSH levels between 2.5 and 10.0 mIU/L within 4 weeks before and 3 months after an initial pregnancy visit. Only 16% of these women (mean baseline TSH concentration, 4.8 mIU/L) received thyroid hormone treatment, whereas the remaining 84% (mean baseline TSH, 3.3 mIU/L; P<0.01) did not receive treatment. Compared with untreated women, those who received treatment had statistically significantly lower chances of pregnancy loss (adjusted odds ratio, 0.62) but higher chances of preterm delivery (AOR, 1.60), gestational diabetes (AOR, 1.37), and preeclampsia (AOR, 1.61). Moreover, among treated women, odds of pregnancy loss were significantly lower among those with pretreatment TSH levels between 4.1 and 10.0 mIU/L (AOR, 0.45; 95% confidence interval, 0.30–0.65) but not among those with pretreatment TSH levels between 2.5 and 4.0 mIU/L (AOR, 0.91; 95% CI, 0.65–1.23).
COMMENT: These findings raise questions about the appropriate thresholds of TSH by which to diagnose subclinical hypothyroidism during pregnancy. They also suggest that any benefit of treatment comes with the potential for various adverse pregnancy outcomes (with degrees of risk that have not yet been fully determined). Thus, clinicians should clearly explain these risks and benefits to affected patients as part of an informed decision to initiate thyroid hormone supplementation.
CITATION(S): Maraka S et al. Thyroid hormone treatment among pregnant women with subclinical hypothyroidism: US national assessment. BMJ 2017 Jan 25; 356:i6865. (http://dx.doi.org/10.1136/bmj.i6865)

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Pediatrics 2017 Feb 6
Cash Incentives to Low-Income Mothers Improve Breast-Feeding Rates
Providing up to $270 in cash to low-income Puerto Rican mothers over the first 6 months postpartum dramatically increased breast-feeding maintenance.
Despite promotional efforts in the U.S., breast-feeding initiation and duration among low-income, minority women tend to fall short of the American Academy of Pediatrics recommendation that mothers breast-feed their infants for at least 6 months.
In the current study, 36 new, breast-feeding mothers who self-identified as Puerto Rican were recruited from a Northeastern U.S. hospital and randomized to receive either usual breast-feeding services from the Women, Infants and Children (WIC) program or WIC services plus a cash incentive. Both groups were assessed at 1, 3, and 6 months during visits at their WIC office or home. Mothers in the incentive group received increasing cash payments for each of six monthly visits in which they visibly demonstrated breast-feeding or pumping, up to $270 total.
Thirty-five of 36 mothers completed all postpartum visits. Breast-feeding rates among incentive-group mothers were significantly higher than among control-group mothers at 1, 3, and 6 months (89% vs. 44%, 89% vs. 17%, and 72% vs. 0%, respectively). Secondary outcomes, including infant weight, emergency department visits, and exclusive breast-feeding, did not differ significantly at any point. Almost all mothers used supplemental formula by 1 month, and only one mother (in the incentive group) was exclusively breast-feeding at 6 months.
COMMENT: This small, randomized study was not blinded and did not include quantification of breast-feeding in either group (proportion of breast milk vs. formula feeds). Nonetheless, the large difference in breast-feeding maintenance in a population with typically low rates and duration make this an intriguing investment, given the potentially large savings in illness prevention. A larger trial powered to evaluate infants' and mothers' health outcomes, in addition to breast-feeding, should be the next step.
CITATION(S): Washio Y et al. Incentive-based intervention to maintain breastfeeding among low-income Puerto Rican mothers. Pediatrics 2017 Feb 6; [e-pub]. (http://dx.doi.org/10.1542/peds.2016-3119)
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Clin Gastroenterol Hepatol 2017 Jan 18
Stress Ulcer Prophylaxis with Proton-Pump Inhibitors: How Safe?
PPIs do not significantly increase risk for bloodstream infections in intensive care patients.
Proton-pump inhibitors (PPIs) are frequently administered to patients in intensive care to prevent stress gastritis. However, prior studies suggest that PPIs may increase the risk for bloodstream infections (BSIs) in critically ill patients.
To examine this potential association, investigators retrospectively reviewed the records of 24,774 critically ill patients in 14 intensive care units in a three-hospital network between 2008 and 2014. They compared the rate of BSIs in patients taking a PPI to prevent stress gastritis versus those not taking a PPI.
The rate of BSIs was higher in PPI recipients versus nonrecipients (3.7% vs. 2.2%; P<0.01). However, multivariable analysis incorporating potential confounding factors showed that the difference was not significant. Factors independently associated with BSI included increased comorbidities, use of mechanical ventilation, and use of narrow- and broad-spectrum antibiotics. The same model also found no association between H2 receptor antagonist (H2RA) use and BSIs. Multiple sensitivity analyses produced the same results. The authors conclude that the use of PPIs for stress ulcer prophylaxis is not associated with an increased risk for BSIs.
COMMENT:It has long been established that acid reduction with H2RAs or PPIs can reduce the risk for stress gastritis bleeding. Bacterial colonization of the stomach by acid reduction and the potential increase in intestinal permeability by PPIs have been suggested as potential causes of increased BSI rates. However, although PPIs change the intestinal microbiome and may increase intestinal permeability, they do not contribute to the risk for BSIs in critically ill patients as much as other factors, such as comorbid illnesses and antibiotic use. The potential risk for gastrointestinal bleeding from stress gastritis warrants the use of PPIs in appropriately selected patients.
Note to readers: At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S): Cohen ME et al. Prophylaxis for stress ulcers with proton pump inhibitors is not associated with increased risk of bloodstream infections in the intensive care unit. Clin Gastroenterol Hepatol 2017 Jan 18; [e-pub].
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N Engl J Med 2017 Jan 24
Tight Glycemic Control Is Not Beneficial — And May Be Harmful — In Critically Ill Children
A randomized trial found that maintaining blood glucose between 80–100 mg/dL, compared with 150–180 mg/dL, did not result in fewer intensive care unit days or lower mortality.
Whether tight glycemic control benefits critically ill children in the intensive care unit (ICU) is unclear. To address this issue, researchers randomized 713 children (ages 1.4–12.8 years) with hyperglycemia (blood glucose >130 mg/dL) admitted to 32 ICUs to a target blood glucose level of 80 to 100 mg/dL or 150 to 180 mg/dL. Children with diabetes or cardiac surgery were excluded. The study protocol included continuous glucose monitoring and a computerized algorithm for insulin adjustment.
Insulin was administered to 98.6% of patients in the lower-target group and 61.6% in the higher-target group. The median number of ICU-free days to day 28 (the primary outcome measure) did not differ significantly between the two groups in either a per-protocol analysis (698 patients) or intention-to-treat analysis. There were also no significant differences between groups in mortality at 28 days or 90 days, number of ventilator-free days, number of hospital-free days, or severity of illness. Severe hypoglycemia (blood glucose <40 mg/dL) occurred in significantly more patients in the lower-target group (5.2% vs. 2.0%). The incidence of healthcare-related infections was significantly higher in the lower-target group (3.4% vs. 1.1%). The study was terminated early because of risk of harm and low likelihood of benefit.
COMMENT: Maintaining a lower blood glucose level (80–100 mg/dL) is not beneficial and may impose risks in critically ill children admitted to intensive care units.
CITATION(S):Agus MSD et al. Tight glycemic control in critically ill children. N Engl J Med 2017 Jan 24; [e-pub].
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Bariatric Surgery Tied to Long-Term Weight Loss in Obese Adolescents
By Kelly Young, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Bariatric surgery among obese adolescents is associated with long-term improvements in weight and cardiometabolic risk factors, according to a pair of studies in the Lancet Diabetes & Endocrinology.
In the first study, U.S. researchers followed 58 people who'd had Roux-en-Y gastric bypass before age 21 (mean BMI, 58.5 kg/m2). After a mean of 8 years, the average reduction in BMI was 16.9. However, nearly two-thirds still had a BMI of 35 or more.
In the second study, 81 Swedish teenagers with severe obesity (mean BMI, 45.5) underwent Roux-en-Y. At 5 years' follow-up, BMI was reduced by an average of 13.1, equivalent to 28% weight loss. This compares with a BMI increase of 3.3 among 72 control adolescents who underwent conservative treatment for obesity, and a BMI reduction of 12.3 among 71 obese adults who underwent Roux-en-Y.
In both studies, cardiometabolic risk factors like dyslipidemia and hypertension improved while nutritional deficiencies were common.
The Swedish authors write: "The literature base now seems sufficiently mature to consider formal integration of bariatric surgery into treatment pathways for adolescents with severe obesity."
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An Estimated 1 in 28 Americans Will Develop Melanoma in Their Lifetime
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM
The estimated lifetime risk for invasive or in situ melanoma in the U.S. is 1 in 28, according to a research letter in JAMA Dermatology.
Using national cancer statistics, researchers examined trends in melanoma diagnoses between 2009 and 2016. The incidence of invasive melanoma rose over the study period, from 22.2 to 23.6 per 100,000 population. Increases were higher for in situ than invasive disease. Melanoma deaths also increased, from 2.8 per 3.1 per 100,000.
"The overall burden of disease for melanoma is increasing," the authors write, "and rising rates are not simply artifact owing to increased detection of indolent disease."

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