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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
June 4, 2016

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Methylphenidate linked to Increased Arrhythmia Risk in Kids with ADHD
Can we Predict Teenage Substance use in Children with ADHD Treated with Stimulants?
New Diabetes Guidelines Recommend Metabolic Surgery in Obese Patients
Risk for 13 Cancers is Lower when Leisure-Time Physical Activity is Higher
Bacteria Resistant to Last-Resort Antibiotic Discovered in U.S.
Cell Phone Radiation tied to Tumor Risk — in Male Rats
Study argues against Low-Sodium Diet for Adults without Hypertension
Half of Men with Early-Stage Prostate Cancer choose Active Surveillance
Does Mode of Breast Milk Feeding affect its Benefit?
Behavioral Interventions for Infant Sleep Training: Effective and not Harmful
Fertility in Obese Women: Benefits of Weight Loss
Antidepressants Commonly Used Off Label
Abortion Around the World
For the Causes of Chronic Pelvic Pain, Search beyond Endometriosis
FDA Simplifies Process for Clinicians Requesting Compassionate use of
   Investigational Therapies

BMJ 2016 May 31; 353:i2550
Methylphenidate linked to Increased Arrhythmia Risk in Kids with ADHD
Though absolute risk is low in otherwise healthy children
Use of methylphenidate in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) is associated with increased risk for arrhythmia — and potentially elevated risk for myocardial infarction — according to a self-controlled case series study in The BMJ.
Using a South Korean health insurance claims database, researchers studied more than 1200 pediatric patients aged ≤17 years who started taking methylphenidate for ADHD and had an adverse cardiovascular event over a 4-year period. By comparing the times that the patient was exposed and unexposed to methylphenidate, each child served as his or her own control.
Overall, methylphenidate use was tied to increased risk for arrhythmia (adjusted incidence rate ratio, 1.6), with the highest risks seen in the 1–3 days after initiation and among children with congenital heart disease. For myocardial infarction, there was an increased risk during the first 2 months of treatment. For hypertension, an increased risk was observed only 4–7 days after treatment initiation.
This study will not likely settle the controversy as to whether use of methylphenidate (and by implication other stimulants) to treat ADHD is associated with an increased risk for cardiovascular events. Even if the findings are correct, the risk of adverse events, as an accompanying editorial points out, are quite small in an otherwise healthy child. Rather, this study reinforces what hopefully already is common practice: Parents (and adolescents) should be informed of the possibility of adverse events before medication is started, and medication should be used only when a comprehensive evaluation demonstrates that the benefits outweigh the risk. All children receiving stimulants need careful monitoring, and certain groups — those with congenital heart disease and those taking medications that also increase the risk for cardiovascular events — require a more careful evaluation at the outset and perhaps consultation with a cardiologist.
CITATION(S): Shin J-Y et al. Cardiovascular safety of methylphenidate among children and young people with attention-deficit/hyperactivity disorder (ADHD): Nationwide self controlled case series study. BMJ 2016 May 31; 353:i2550.

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J Am Acad Child Adolesc Psychiatry 2016 Apr 7
Can we Predict Teenage Substance use in Children with ADHD Treated
with Stimulants?

Starting stimulant therapy early and for a longer duration was associated with lower odds of substance abuse in late adolescence.
Children with attention-deficit/hyperactivity disorder (ADHD) are at elevated risk for developing alcohol and drug addictions as adults. Research has shown that stimulant medications themselves do not increase a child's risk for developing substance abuse problems (JAMA Psychiatry 2013; 70:740).
To study the effects of age of onset, duration, and type of medication therapy for ADHD on substance use during adolescence, researchers analyzed self-administered survey responses from a nationally representative sample of 40,358 U.S. high school seniors. Among the cohort, 3539 individuals (9%) had ever been prescribed stimulant medication therapy for ADHD and 1332 individuals (3%) had been prescribed only nonstimulant medication therapy for ADHD.
Adolescents who started stimulant medication for ADHD at age ≤9 years and were treated for ≥6 years were less likely to report substance use behaviors in adolescence compared with those starting stimulant therapy later and for shorter durations (P<0.05 for most onset/duration group comparisons). Earlier and longer treatment was also associated with lower odds of substance use behaviors compared with patients who reported only nonstimulant medication therapy for ADHD.
COMMENT: In this large population-based study, early onset and longer duration of stimulant treatment for ADHD was associated with a risk for substance use during adolescence that is similar to youth without ADHD. Important limitations of the study include the reliance on self-reporting, the absence of information on social/family environment, and the lack of differentiation of outcomes between amphetamine and methylphenidate treatment. These results are useful in therapeutic decision-making and counseling parents of children with ADHD.
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): McCabe SE et al. Age of onset, duration, and type of medication therapy for attention-deficit/hyperactivity disorder (ADHD) and substance use during adolescence: A multi-cohort national study. J Am Acad Child Adolesc Psychiatry 2016 Apr 7; [e-pub].
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New Diabetes Guidelines Recommend Metabolic Surgery in Obese Patients
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Metabolic surgery, such as gastric bypass, is recommended to treat type 2 diabetes in obese patients, according to new international guidelines that came out of the 2nd Diabetes Surgery Summit (DSS-II) and were endorsed by 45 professional medical and surgical societies.
Among the recommendations, published in Diabetes Care:

Editorialists write: "Compared with previous guidelines for bariatric surgery, which used only BMI thresholds to select surgical candidates, the DSS-II recommendations introduce the use of diabetes-related parameters to help identify clinical scenarios where surgical treatment of [diabetes] should be prioritized."
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JAMA Intern Med 2016 May 16
Risk for 13 Cancers is Lower when Leisure-Time Physical Activity is Higher
However, malignant melanoma and prostate cancer were more common in those who exercised more.
Risks for colon, breast, and endometrial cancers are reduced with increased physical activity. In this analysis, researchers pooled the results of 12 prospective cohort studies that involved 1.44 million participants (median age, 59) to assess associations between self-reported leisure-time physical activity and 26 cancers.
During a median 11 years of follow-up, about 187,000 incident cancers were identified. In analyses adjusted for a wide range of clinical and demographic factors including smoking and alcohol consumption, participants in the 90th percentile for moderate and vigorous physical activity, compared with those in the 10th percentile, had a significant relative reduction in risk for 13 cancers (e.g., 42% lower risk for esophageal adenocarcinoma, 23% lower for renal carcinoma, 20% lower for myeloid leukemia). However, the 90th-percentile population had significantly increased relative risk for malignant melanoma (27%) and prostate cancer (5%). Overall risk for cancer was 7% lower in the 90th-percentile population than in the 10th-percentile population.
COMMENT: These associations between exercise and cancers give patients another reason to increase their leisure-time physical activity. However, the findings don't prove cause and effect, and some confounding is likely. Biologically plausible explanations for these findings include hormonal regulation and enhanced immune surveillance for the beneficial effects and more sun exposure for the excess malignant melanoma finding.
CITATION(S):Moore SC et al. Association of leisure-time physical activity with risk of 26 types of cancer in 1.44 million adults. JAMA Intern Med 2016 May 16; [e-pub]. (http://dx.doi.org/10.1001/jamainternmed.2016.1548)
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Bacteria Resistant to Last-Resort Antibiotic Discovered in U.S.
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH
Escherichia coli resistant to colistin — the last-resort antibiotic used to treat carbapenem-resistant bacteria — has been identified in the U.S. for the first time, researchers report in Antimicrobial Agents and Chemotherapy. If colistin resistance eventually extends to carbapenem-resistant bacteria, those microbes will become "unstoppable," the New York Times notes.
The resistant E. coli was found in a woman who presented to a Pennsylvania military clinic in late April with a urinary tract infection. Her urine sample was sent to a research institute that, in May, began testing certain E. coli isolates for colistin resistance. The woman's E. coli strain carried 15 antibiotic resistance genes, including the colistin resistance gene, mcr-1. It was not resistant to carbapenems, however.
This E. coli strain has previously been identified in Europe and Asia, although the patient — who has recovered — reported no recent travel.
Infectious disease expert Dr. Paul Sax commented: "Although only a single case, this report underscores that highly resistant bacteria are now found both in and out of the hospital — and raises the importance of policies and programs that limit antibiotic use."
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Cell Phone Radiation tied to Tumor Risk — in Male Rats
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH
Patients may ask about a widely reported study suggesting an association between exposure to cell phone radiation and cancer risk.
The study, from the National Toxicology Program, found that male rats exposed to levels of radiofrequency radiation (RFR) emitted by cell phones for roughly 2 years had "low incidences" of two types of tumors — malignant gliomas of the brain and schwannomas of the heart. The researchers write: "Given the extremely large number of people who use wireless communication devices, even a very small incidence of disease resulting from exposure to the RFR generated by those devices could have broad implications for public health."
The New York Times emphasizes that while the reported association should not be dismissed, numerous caveats apply. For example, the findings are preliminary, the RFR-tumor link was not observed in female rats, and "it was unusual that the control group had zero tumors."
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Study argues against Low-Sodium Diet for Adults without Hypertension
By Kelly Young
High sodium excretion is associated with elevated risk for cardiovascular events, but only in people with preexisting hypertension, a Lancet study finds. Meanwhile, low sodium excretion is also associated with increased risk.
The study, which received industry funding, combined patients from four international studies. Over 130,000 participants provided morning fasting urine samples and baseline blood pressure measurements. Nearly half had hypertension at baseline.
After a median follow-up of 4 years, 11% of participants with hypertension and 4% without experienced the primary outcome, a composite of death, myocardial infarction, stroke, and heart failure.
In hypertensive patients, a sodium excretion rate of at least 7 g/day was associated with increased CV risk (adjusted hazard ratio 1.23), relative to 4–4.99 g/day. A low excretion rate (less than 3 g/day) was also associated with increased risk (HR, 1.34). But in non-hypertensive patients, only low sodium excretion was tied to higher risk (HR, 1.26).
Dr. Harlan Krumholz, editor-in-chief of NEJM Journal Watch Cardiology, comments: "This extraordinary study reveals the complexity of sodium consumption and the risk of hypertension and cardiovascular events. In a precision medicine era, we will want to know which level of sodium consumption is optimal for each individual. In the meantime, our patients should be informed that low and high sodium intake appears to have risks and that moderating sodium intake is likely best overall for those with hypertension and high sodium diets. And don't expect this study to settle the debate."
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Half of Men with Early-Stage Prostate Cancer choose Active Surveillance
By the Journal Watch Editors
Half of U.S. men diagnosed with early-stage prostate cancer are opting for active surveillance instead of treatment, a huge change from 5 years ago when radiation and surgery were the norms, the New York Timesreports.
The Times used data from one state and two national registries. Early results for 2016 indicate that the active surveillance figure is increasing and may be even higher than 50%.
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J Pediatr 2016 May 9
Does Mode of Breast Milk Feeding affect its Benefit?
Feeding at the breast provides greater protection against otitis media compared with feeding expressed breast milk.
While it is well known that breast-feeding provides important health benefits to infants, little is known about whether the mode of receiving breast milk — at the breast or expressed — affects these benefits. To examine this question, researchers surveyed mothers 12 months postpartum about infant feeding practices, otitis media, and diarrhea.
Of 491 respondents, 22% of infants received no formula in the first 6 months and 10% were exclusively bottle fed. Among all infants, longer duration of feeding at the breast was associated with reduced odds of otitis media. In adjusted analyses, the risk for otitis media was reduced by 16% in infants fed at the breast for 6 months. Among infants who did not receive formula, longer duration of expressed breast milk feeding was associated with increased risk for otitis media. Among all infants, longer duration of breast milk feeding, at the breast or expressed, was associated with reduced risk for diarrhea compared with formula feeding. Risk for diarrhea was reduced by 25% in children fed breast milk for 6 months.
COMMENT: This study suggests that feeding at the breast has advantages over feeding expressed breast milk in reducing the risk for otitis media. Nonetheless, we should encourage mothers to feed breast milk regardless of technique. Breast milk, whether fed at the breast or expressed, reduces the risk for diarrhea compared with formula.
CITATION(S): Boone KM et al. Feeding at the breast and expressed milk feeding: Associations with otitis media and diarrhea in infants. J Pediatr 2016 May 9; [e-pub]. (http://dx.doi.org/10.1016/j.jpeds.2016.04.006)
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Pediatrics 2016 May 24
Behavioral Interventions for Infant Sleep Training: Effective and not Harmful
Gradually delaying infant's bedtime or parents' response to infant's crying improved sleep and was not associated with increased stress or emotional problems.
For infants with frequent nighttime wakening, graduated extinction and other behavioral interventions have been shown to improve sleep, but concerns have been raised that these methods increase infant and parent stress.
Researchers in Australia randomized 43 infants (aged 6–16 months) with sleep problems to one of three groups: graduated extinction (gradually delaying parents' response to infant's cry), bedtime fading (gradually delaying infant's bedtime), or control (basic infant sleep education). The primary outcome was infant sleep during the first 3 months (measured by parent-completed sleep diaries and infant actigraphy); secondary outcomes included infant and parent stress (assessed serially by infant salivary cortisol levels and parent survey) and child behavior/emotions/parent attachment at 12 months (assessed with the Child Behavior Checklist and strange situation procedure).
Both interventions were associated with improved sleep. For example, at 3 months there were large decreases in sleep latency (at least 10 minutes) in both groups and in the number of awakenings and duration of wake after sleep onset in the graduated extinction group. Infant salivary cortisol levels and parental stress also declined in the intervention groups. At 12 months, there were no differences among the three groups in emotional/behavioral problems or child-parent attachment.
COMMENT: Graduated extinction is sometimes mistaken for “letting a baby cry it out,” a phrase that reflects concerns that it is a neglectful or even harmful way to train infants to sleep. This small study reinforces the method's effectiveness and adds new evidence suggesting it does not harm parents or children. No matter the method of sleep training pediatricians recommend, pairing reassurance of its safety with counseling on the risks of prolonged parental sleep deprivation can help convince hesitant parents to try new ways of getting everyone more sleep.
CITATION(S): Gradisar M et al. Behavioral interventions for infant sleep problems: A randomized controlled trial. Pediatrics 2016 May 24; [e-pub]. (http://dx.doi.org/10.1542/peds.2015-1486)
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N Engl J Med 2016 May 19; 374:1942
Fertility in Obese Women: Benefits of Weight Loss
In a randomized trial, reduced calorie intake and increased physical activity raised the odds of natural conception in obese infertile women.
High body-mass index (BMI) and sedentary lifestyles decrease fertility potential. To test the efficacy of weight loss and increased activity on augmenting fertility, Dutch investigators randomized 574 infertile women (BMI ≥29 kg/m2; median, 36 kg/m2) to a 6-month lifestyle intervention followed by infertility treatment or to immediate treatment (control). The intervention consisted of reduced caloric intake (to lower BMI by ≥5%) and increased activity (10,000 steps daily plus 30 minutes of moderate exercise 2–3 times weekly).
Women in the intervention and control groups lost a mean of 4.4 kg (9.7 lb) and 1.1 kg (2.4 lb), respectively (P<0.001). Natural conception was achieved by 26% of women in the intervention group and 16% of those in the control group (rate ratio, 1.6). However, 22% of women in the intervention group discontinued participation within 3 months — and, overall, only 38% of those in the intervention group achieved weight loss of ≥5%. Within the 2 years after randomization, ongoing pregnancy was achieved with fertility treatments in 28% and 43% of women in the intervention and control groups, respectively. Treatments included ovulation induction, intrauterine insemination, and in vitro fertilization. Ovulation induction resulted in the greatest number of pregnancies in either group.
COMMENT:The chances of natural conception can be augmented by achieving an optimal BMI; thus, for young infertile women with high BMI, modest weight loss and increased exercise should be considered and encouraged before initiating resource-intensive fertility treatments. This study shows that such lifestyle intervention makes natural conception more likely, thereby helping to obviate the need for fertility interventions. However, achieving the target goal of ≥5% weight reduction was difficult for most participants (despite guidance and coaching). In the real world, more-effective intervention strategies are clearly needed.)
CITATION(S): Mutsaerts MAQ et al. Randomized trial of a lifestyle program in obese infertile women. N Engl J Med 2016 May 19; 374:1942.
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Antidepressants Commonly Used Off Label
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Over a quarter of all antidepressant prescriptions in Canada were for unapproved conditions, according to a research letter in JAMA.
Using electronic medical records in Quebec, researchers assessed over 100,000 prescriptions for antidepressants written in primary care for 20,000 patients between 2006 and 2015. Roughly 29% of all antidepressant prescriptions were for off-label uses, including insomnia, pain, migraine, menopause symptoms, attention-deficit/hyperactivity disorder, digestive system disorders, and others.
Dr. Thomas Schwenk of NEJM Journal Watch General Medicinecommented: "Primary care physicians are exploring a wide range of off-label uses for all classes of antidepressants. Clinical studies to provide better evidence for guiding these uses would be helpful."
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Lancet 2016 May 11
Abortion Around the World
Legal restrictions do little to reduce abortion rates.
In the U.S., induced abortion poses minimal risks to women's health; however, in countries where abortion is illegal, complications are common. In 2012, 6.9 million women worldwide received treatment for complications of unsafe abortion. To examine changes in global rates of abortion over the last 20 years, as well as the effects of legal restrictions on abortion, investigators compiled data from multiple international sources for 1069 country-years.
Among women of reproductive age (range, 15–44), an estimated 35 abortions per 1000 women worldwide occurred annually in 2010–2014, compared with 40 per 1000 women in 1990–1994. However, because of population growth, the absolute annual number of abortions rose from 50 million to 56 million. From 2010 to 2014, the abortion rate was lowest in North America (17 per 1000 women), while in developing countries the rate was 37 per 1000 women and in the Caribbean the rate was 65 per 1000 women. In the 58 countries that prohibit abortion or allow the procedure only to save a woman's life, the abortion rate was 37 per 1000 women; for the 63 countries in which abortion is legal on request, the rate was 34 abortions per 1000 women.
COMMENT: These data provide a stark reminder that legal restrictions on abortion do little to reduce abortion rates, but dramatically raise risk for abortion complications. Although increasing access to highly effective contraception has been clearly shown to reduce rates of abortion, few of the 24 U.S. states with targeted restrictions on abortion provision have made access to contraception a priority.
CITATION(S):Sedgh G et al. Abortion incidence between 1990 and 2014: Global, regional, and subregional levels and trends. Lancet 2016 May 11; [e-pub].
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Obstet Gynecol 2016 Jun; 127:1045
For the Causes of Chronic Pelvic Pain, Search beyond Endometriosis
Fewer than 25% of women undergoing hysterectomy for chronic pelvic pain had endometriosis.
Although hysterectomy is common for management of chronic pelvic pain (CPP) — a condition that may be associated with endometriosis — the prevalence of surgically confirmed endometriosis in women with CPP is not definitively known. Investigators conducted a retrospective cohort study of 9622 women undergoing laparoscopic or abdominal hysterectomy for benign indications as part of the Michigan Surgical Quality Collaborative. Endometriosis was documented by review of surgical pathology reports and operative notes; adenomyosis was not reported.
Among hysterectomies, 39% had a preoperative indication of CPP, 13% of endometriosis, 9% of both CPP and endometriosis, and 57% of another benign condition. In all, 15% of women undergoing hysterectomy were found at surgery to have endometriosis. Specifically, 21% of women with a preoperative indication of CPP, 57% of those with an indication of endometriosis, and 58% of those with indications of both CPP and endometriosis had confirmed endometriosis at surgery. Women with CPP and confirmed endometriosis were more likely to have at least moderate adhesions and twice as likely to undergo concurrent oophorectomy, but only 22% of women undergoing oophorectomy had a pathologically confirmed endometrioma.
COMMENT: This study shows that, although chronic pelvic pain is a frequent indication for hysterectomy, surgically confirmed endometriosis is relatively uncommon among women undergoing hysterectomy for CPP. I was surprised at the relatively low likelihood that a preoperative diagnosis of endometriosis was proven at surgery. The study is hampered by the failure to document presence or absence of adenomyosis, which has been estimated to occur in as many as 30% of hysterectomy specimens. As the authors note, studies are needed to determine if women undergoing hysterectomy for CPP are actually pain-free following surgery. Otherwise, it's difficult to justify the surgery in the first place. In addition, the data indicate that oophorectomy was performed in many women who did not have endometriosis. Given the benefits of ovarian preservation on general health, the question (also raised by the authors) remains: Why was oophorectomy performed so commonly in surgery for benign disease?
CITATION(S): Mowers EL et al. Prevalence of endometriosis during abdominal or laparoscopic hysterectomy for chronic pelvic pain. Obstet Gynecol 2016 Jun; 127:1045. (http://dx.doi.org/10.1097/AOG.0000000000001422)
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FDA Simplifies Process for Clinicians Requesting Compassionate use of Investigational Therapies
By the Editors of Journal Watch
The FDA on Thursday released a new form for clinicians to request expanded access to investigational treatments for individual patients with serious or immediately life-threatening conditions that require treatment beyond currently approved therapies.
The new form is shorter than the previous version and should take about 45 minutes to complete.
The FDA also released a question-and-answer document that clarifies what expanded access is and how it should be requested. In addition, the agency published guidance for industry on charging patients for investigational treatments.


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