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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
February 25, 2017

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Flu Vaccines 48% Effective
A Step Forward in the Quest for a “Liquid Biopsy”
Overuse of Antibiotics and Underuse of Alternative Options for Acne
Do Enough High-Risk Women with Newly Diagnosed Breast Cancer Receive Genetic Testing?
“Chemo Brain” Is Real
An Alternative Radiation Strategy for Early Breast Cancer
Updated Guidelines for Diagnosing, Treating, and Preventing Obesity in Children
Intensive Fecal Microbiota Transplantation for Ulcerative Colitis
Can an Aspirin a Day Lower Risk for Pregnancy Loss?
Are Very Low LDL Cholesterol Levels Safe?
Two Studies Further Weaken Support for Testosterone Therapy in Older Men
Do Children “Outgrow” Tourette Syndrome?

Flu Vaccines 48% Effective
To date this season, flu vaccines have been 48% effective in preventing medical visits, according to a CDC estimate. This year's flu vaccine is working for almost half of recipients. This compares to 59% for last year and 19% for the year before. During the 10 previous flu seasons, vaccine effectiveness has fluctuated each year usually with a percentage in the 40s or 50s. 
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Proc Natl Acad Sci U S A d 2017 Jan 31; 114:1123
A Step Forward in the Quest for a “Liquid Biopsy”
A new technique allows detection of extremely small numbers of circulating cancer cells.
Epithelial cancers shed cells into the bloodstream, often at an early stage. Theoretically, detecting those cells could identify primary tumors even when they are very small. Indeed, many laboratories are trying different approaches for achieving such a “liquid biopsy.” However, this is a classic “needle in a haystack” problem: The “signal” ― the number of circulating tumor cells (CTCs) ― is dwarfed by the “noise” ― the number of blood cells.
Investigators developed a technology for identifying circulating hepatocellular carcinoma (HCC) cells. First, they identified a set of 10 mRNAs for genes expressed in HCC cells (an mRNA “signal”), and a technique (digital polymerase chain reaction) for detecting extremely low levels of that signal. They also developed a technique for depleting leukocytes (reducing the “noise”) without altering the mRNA within CTCs. The technology detected CTCs in 56% of untreated patients with HCC versus 3% of patients with nonmalignant liver disease; it also detected HCC cells in 28% of patients who had been treated for HCC and in 7% who had undergone curative-intent therapies (e.g., liver transplantation). The technology was more accurate than α-fetoprotein testing.
COMMENT: This technology is a step in the right direction. Improvements in its sensitivity and specificity, and testing in larger populations, lie ahead. In principle, the technology also might be useful to detect other epithelial cancers and could play a role in early cancer detection, in determining optimal therapy and response to therapy, and in estimating prognosis. Time will tell.
CITATION(S):Kalinich M et al. An RNA-based signature enables high specificity detection of circulating tumor cells in hepatocellular carcinoma. Proc Natl Acad Sci U S A 2017 Jan 31; 114:1123.

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J Am Acad Dermatol 2016 Dec; 75:1142
Overuse of Antibiotics and Underuse of Alternative Options for Acne
Oral antibiotics often are prescribed for too long; concurrent use of topical retinoids is recommended.
Most current guidelines recommend that a course of oral antibiotic therapy for a patient with acne should be limited to 3 to 6 months. To determine the extent to which physicians follow these guidelines, researchers conducted a retrospective cohort study, using a U.K. primary care database.
The mean duration of oral antibiotic therapy was 175 days, with 29% of courses exceeding 6 months and 12% exceeding 1 year; moreover, 62% of antibiotic courses were not accompanied by concomitant topical retinoid therapy (i.e., tretinoin, adapalene, and tazarotene).
COMMENT: These findings (among general practitioners) are similar to previously published findings among dermatologists. Clinicians should follow acne treatment guidelines and minimize prolonged exposure to oral antibiotics, which can increase costs, lead to antimicrobial resistance, and place patients at higher risk for treatment-related complications. Oral antibiotics are indicated for patients with moderate or severe acne but should be used in conjunction with topical therapies (i.e., benzoyl peroxide, topical antibiotics, or retinoids). Topical retinoids, unlike other agents, target the primary lesion of acne — comedones; in particular, greater use of these agents might help to limit overall oral antibiotic use and antibiotic resistance. Topical retinoids are recommended for monotherapy, in conjunction with topical antimicrobial therapy, or for patients who are receiving oral antibiotics (except pregnant women — topical retinoids range from pregnancy category C to X, and patients should be advised accordingly).
Dr. Rosenbach is an Assistant Professor of Dermatology and Internal Medicine at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.
CITATION(S): Barbieri JS et al. Duration of oral tetracycline-class antibiotic therapy and use of topical retinoids for the treatment of acne among general practitioners (GP): A retrospective cohort study. J Am Acad Dermatol2016 Dec; 75:1142.
Zaenglein AL et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol 2016May; 74:945.
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JAMA 2017 Feb 7; 317:531
Do Enough High-Risk Women with Newly Diagnosed Breast Cancer Receive Genetic Testing?
Population-based study indicates almost half of such women are not tested.
As costs associated with BRCA mutation testing have dropped, it is worthwhile to evaluate whether and how such testing is being performed. Investigators identified women (age range, 20–79) in two U.S. regions with recently diagnosed breast cancer, then surveyed them about their risk factors and whether they wanted — and received — genetic testing and counseling.
Among 2529 respondents (response rate, 71%; mean age, 62; 57% white, 18% black, 71% with some college education), 66% reported wanting testing and 29% reported being tested. Among the 773 respondents at high mutation risk, 81% wanted testing, 71% discussed testing with a health professional, 40% received genetic counseling, and 53% were tested (among these tested women, 62% received counseling). Among high-risk women who were not tested, the most common reasons were “not recommended by physician” (56%), “too costly” (14%), and “testing not desired” (11%). Parameters associated with nonreceipt of testing included older age and Asian ethnicity.
COMMENT: As the authors note, the finding that only 40% of all high-risk women and 62% of tested high-risk women received genetic counseling emphasizes the limited number of genetic counselors. That almost half of high-risk women were not tested underscores the missed opportunities to prevent deaths from ovarian and other cancers in mutation carriers and their relatives. When clinicians identify high-risk women, they should be prepared either to offer testing and counseling directly or to provide referrals genetic counselors.
CITATION(S):Kurian AW et al. Genetic testing and counseling among patients with newly diagnosed breast cancer.JAMA 2017 Feb 7; 317:531.
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J Clin Oncol 2016 Dec 28
“Chemo Brain” Is Real
Breast cancer patients had significantly more cognitive difficulties up to 6 months after chemotherapy than did noncancer controls assessed at similar times.
A common question new breast cancer patients pose when discussing a recommendation for adjuvant chemotherapy is whether they are likely to experience “chemo brain.” The physician refrain is that it can happen in some, it is poorly understood, it will usually be self-limited, and there is nothing that can be done to prevent it.
Now, investigators have conducted a multicenter, prospective, longitudinal study to compare cognitive function between 581 patients with stage I–IIIc breast cancer (mean age, 53 years; 48% received an anthracycline-based regimen) and 364 age-matched noncancer controls. Patients and controls were evaluated before and after scheduled chemotherapy and 6 months later using a validated tool to evaluate total cancer-related cognitive impairment as well as impairment in four specific domains: perceived cognitive impairment, perceived cognitive abilities, the impact of cognitive impairment on quality of life, and cognitive impairment perceived by others.
Patients reported significantly more impairment overall and in the four domains postchemotherapy and in the 6-month follow-up period than before chemotherapy, compared with controls assessed at similar times (P<0.001 for all). Individuals with higher baseline anxiety, depression, and decreased cognitive reserve were most likely to have low total impairment scores. The type of systemic treatment (chemotherapy regimen or endocrine therapy) or radiation therapy did not influence total impairment scores between postchemotherapy and 6-month follow-up.
COMMENT: These data affirm what so many patients describe both during and after the completion of adjuvant chemotherapy. Cognitive impairment is common and manifests itself in many ways that are evident to patients and their loved ones. Although no specific therapy is available, identifying patients at greatest risk according to baseline characteristics would allow for interventions that may attenuate the severity of cognitive dysfunction.
CITATION(S): Janelsins MC et al. Cognitive complaints in survivors of breast cancer after chemotherapy compared with age-matched controls: An analysis from a nationwide, multicenter, prospective longitudinal study. J Clin Oncol 2016 Dec 28; [e-pub].
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Lancet Oncol 2017 Feb; 18:259
An Alternative Radiation Strategy for Early Breast Cancer
Partial breast irradiation was noninferior to whole breast irradiation in terms of efficacy, toxicity, and cosmetic outcomes.
Efforts to reduce the duration of adjuvant radiation therapy for patients with early-stage breast cancer have been tempered by the need to ensure that brevity does not diminish efficacy. Standard treatment has been whole-breast irradiation (WBI), generally delivered in 25–28 weekday fractions of 1.8–2.0 Gy over 5 weeks for a total dose of 50.0 to 50.4 Gy. Accelerated partial breast irradiation (APBI) is an alternative strategy that could shorten the duration of radiation to 1 week or less, while also limiting unnecessary radiation exposure to normal tissue (i.e., heart, lungs, and skin).
To compare the two strategies, European investigators conducted a multinational randomized, controlled phase III trial involving 1184 patients (age, ≥40 years) with stage 0–IIA breast cancer who underwent breast-conserving surgery with clear margins. Patients were randomized to WBI as outlined above or APBI using interstitial multicatheter brachytherapy delivered at either high-dose rate (32.0 Gy in 8 fractions or 30.1 Gy in 7 fractions, delivered twice daily) or pulse-dose rate (total 50 Gy at 0.6–0.8 Gy/hour, 24 hours/day).
Prior efficacy results with 5-year follow-up showed that local control, disease-free survival, and overall survival were similar between APBI and WBI (Lancet 2016; 387:229). Now, with a median follow-up of 6.6 years, the 5-year toxicity profiles and patient-reported cosmetic outcomes also were similar between the two arms, although grade 2 or 3 late skin adverse effects were less common in patients receiving interstitial brachytherapy versus WBI.
COMMENT: These data suggest that APBI with interstitial multicatheter brachytherapy produces similar efficacy, toxicity, and cosmetic outcomes in patients with early-stage breast cancer. In contrast to prior studies describing late toxicity and/or inferior cosmetic outcomes with APBI versus WBI, the current findings support consideration of APBI for this group of patients.
CITATION(S): Polgár C et al. Late side-effects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial. Lancet Oncol 2017 Feb; 18:259.
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J Clin Endocrinol Metab 2017 Jan 31
Updated Guidelines for Diagnosing, Treating, and Preventing Obesity in Children
These Endocrine Society guidelines include updated information about extreme obesity, laboratory testing, genomic syndromes, and bariatric surgery.
Sponsoring Organization: The Endocrine Society
Target Audience: Pediatricians and other clinicians who treat children
Background and Objective
Based on evidence from two systematic reviews, an expert task force updated the original 2008 guidelines.
Key Points
1. Diagnosis

2. Treatment

COMMENT: These comprehensive, evidence-based guidelines include detailed tables and algorithms to help clinicians implement the recommendations and are an excellent resource.
CITATION(S): Styne DM et al. Pediatric obesity — assessment, treatment, and prevention: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2017 Jan 31; [e-pub].
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Lancet 2017 Feb 14
Intensive Fecal Microbiota Transplantation for Ulcerative Colitis
Multidonor FMT via enema 5 to 7 days per week was superior to placebo for clinical remission and endoscopic response at 8 weeks.
Fecal microbiota transplantation (FMT) has been proposed for the treatment of ulcerative colitis. Of the two randomized, controlled trials of single-donor FMT (at a maximum once-weekly frequency) that have been performed in patients with ulcerative colitis, one study showed a possible improved outcome.
In the current double-blind study, researchers utilized a protocol of intensive FMT from multiple donors, randomizing 85 patients to FMT or placebo delivered via an initial colonoscopy and then by enema on at least 5 out of 7 days per week for 8 consecutive weeks. At least 3 to 7 individual donors contributed to each batch of FMT material. Participants were allowed to be on medications other than enema therapy prior to the trial if their doses were stable.
The primary outcome of steroid-free clinical remission and endoscopic remission or response at week 8, as defined by Mayo scores, was significantly higher with FMT versus placebo (27% vs. 8%). Steroid-free clinical remission was significantly higher (44% vs. 20%), as were steroid-free clinical response (54% vs. 23%) and steroid-free endoscopic response (32% vs. 10%) but not full endoscopic remission (12% and 8%; P=0.48).
COMMENT: The overall response rates for FMT in ulcerative colitis seem low in this study, but the number needed to treat for steroid-free clinical remission is only 4, which is similar to the number needed to treat for steroid-free endoscopic response. This could become a landmark study if it paves the way for multidonor FMT to become a mainstay of therapy for ulcerative colitis.
CITATION(S): Paramsothy S et al. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: A randomised placebo-controlled trial. Lancet 2017 Feb 14; [e-pub]. (http://dx.doi.org/10.1016/S0140-6736(17)30182-4)
Siegmund B.Is intensity the solution for FMT in ulcerative colitis? Lancet 2017 Feb 14; [e-pub]. (http://dx.doi.org/10.1016/S0140-6736(17)30313-6)
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J Clin Endocrinol Metab 2017 Feb 3
Can an Aspirin a Day Lower Risk for Pregnancy Loss?
Low-dose aspirin increased live-birth rates in some women with prior pregnancy loss and high levels of high-specificity C-reactive protein.
Chronic inflammation has been implicated as a cause of pregnancy loss. High-specificity C-reactive protein (hsCRP), a marker of chronic inflammation, is commonly moderately elevated in individuals at excess risk for cardiovascular mortality. Daily low-dose aspirin (LDA; 81 mg) can safely lower this risk; moreover, LDA is recommended to prevent preeclampsia (Ann Intern Med 2014; 161:819). Investigators conducted a randomized trial in which LDA or placebo was administered to 1228 women (age range, 18–40) who were attempting to conceive after 1 or 2 prior pregnancy losses. Participants received study pills for six menstrual cycles or until gestational week 36. To determine whether any benefit of LDA on pregnancy and live-birth rates was affected by degree of preconception inflammation, analysis was stratified by baseline hsCRP levels.
Overall rates of pregnancy and live birth were 67% and 55%, respectively. For women in the lowest and middle hsCRP tertiles, pregnancy and live-birth rates did not differ between treatment groups. Among those in the highest tertile (hsCRP ≥1.95 mg/L), compared with placebo, LDA was associated with a 31% increase in clinically confirmed pregnancies (54% vs. 71%) and a 35% increase in live births (44% vs. 59%; P≤0.01 for both comparisons).
COMMENT: These data persuade me to discuss the possibility of trying daily low-dose aspirin for certain women with previous pregnancy losses. The risks associated with LDA are relatively low and the potential benefits high. However, LDA probably should be offered only to women with moderately elevated hsCRP — and not to all who have experienced pregnancy loss.
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): Sjaarda LA et al. Preconception low-dose aspirin restores diminished pregnancy and live birth rates in women with low grade inflammation: A secondary analysis of a randomized trial. J Clin Endocrinol Metab2017 Feb 3; [e-pub]. (https://academic.oup.com/jcem/article/2967890/Preconception-low-dose-aspirin-restores-diminished
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J Am Coll Cardiol d 2017 Feb 7; 69:471
Are Very Low LDL Cholesterol Levels Safe?
Cataracts and adverse neurocognitive events might be more common with very low LDL cholesterol levels.
The proprotein convertase subtilisin-kexin type 9 (PCSK-9) inhibitors (evolocumab [Repatha] and alirocumab [Praluent]) are potent lipid-lowering agents that can result in very low levels of LDL cholesterol. But can LDL cholesterol be driven so low that adverse events ensue? In two meta-analyses, researchers explore this possibility.
In an industry-sponsored analysis, data from 14 trials in which alirocumab was added to background lipid-lowering therapy were pooled. Treatment duration ranged from 8 to 104 weeks. Among 3340 alirocumab patients, 25% had two consecutive LDL cholesterol measurements <25 mg/dL, and 9% achieved levels of <15 mg/dL. Rates of any reported adverse event were similar in patients with LDL cholesterol levels <15 mg/dL, <25 mg/dL, and ≥25 mg/dL. In propensity-adjusted analyses, rates of specific adverse events, such as diabetes and its complications or neurological and neurocognitive effects, were not significantly different in those with very low LDL cholesterol levels and those with higher levels, but propensity analysis for incident diabetes in those without diabetes at baseline was not presented. Rates of incident cataracts were significantly higher in those with LDL cholesterol levels <25 mg/dL than in those with higher levels (2.6% vs. 0.8%), but overall cataract incidence was similar in the alirocumab and control groups.
A second meta-analysis, which was limited to studies with at least 6 months of follow-up, also showed no significant difference in serious adverse events; however, subgroup analysis of the larger outcome studies suggested excess incidence of neurocognitive adverse events in the very low cholesterol group (odds ratio, 2.85), although the overall incidence was low (<1%).
COMMENT: In the first analysis, very low LDL cholesterol levels weren't associated with excess adverse events, except for a higher incidence of cataracts. (This finding has biological plausibility — an editorialist reminds us that the lens of the eye synthesizes cholesterol for structure and clarity.) The second analysis suggests excess neurocognitive adverse events in subgroup analysis only, but a low incidence overall, and authors note that the type and severity of these adverse events are unknown. Although these results are generally reassuring, longer-term monitoring and structured assessment of neurocognitive adverse events will be needed before the safety of very low LDL cholesterol levels with PCSK-9 inhibitors can be assessed fully.
CITATION(S): Robinson JG et al. Safety of very low low-density lipoprotein cholesterol levels with alirocumab: Pooled data from randomized trials. J Am Coll Cardiol 2017 Feb 7; 69:471. (http://dx.doi.org/10.1016/j.jacc.2016.11.037)

Khan AR et al. Increased risk of adverse neurocognitive outcomes with proprotein convertase subtilisin-kexin type 9 inhibitors. Circ Cardiovasc Qual Outcomes 2017 Jan; 10:e003153.
Everett BM.Low-density lipoprotein cholesterol and the on-target effects of therapy: How low is too low?J Am Coll Cardiol 2017 Feb 7; 69:483.

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JAMA d 2017 Feb 21; 317:717
Two Studies Further Weaken Support for Testosterone Therapy in Older Men
No evidence of improved cognitive function, and concern about excess coronary artery plaque formation, suggest testosterone use should be discouraged.
The Testosterone Trials are a set of interrelated U.S. multicenter randomized controlled trials of testosterone therapy in older men. The overall study involved 788 men (mean age, 72) with serum testosterone levels <275 ng/dL and at least one qualifying symptom: low libido or sexual function, difficulty walking, or fatigue. Participants were randomized to testosterone gel therapy (adjusted to maintain testosterone levels of 350 to 800 ng/dL) or placebo for 12 months. The overall results have been reported previously (NEJM JW Gen Med Mar 15 2016 and N Engl J Med 2016; 374:611) and showed statistically significant, but clinically modest, improvement in sexual function. Results of two individual studies that addressed the effect of testosterone therapy on cognitive function and coronary artery plaque volume now are available.
One study involved a subgroup of 493 participants with age-associated memory impairment. Verbal memory recall was assessed at 6 and 12 months and improved slightly and similarly in both treatment and placebo groups (attributed to practice effects), with no statistical difference. Assessments of visual memory, spatial ability, executive function, subjective memory complaints, and global cognitive function all showed similar, nonsignificant changes.
In another study, 170 participants were assessed at baseline and 12 months by coronary computed tomographic angiography for coronary artery plaque volume. Half of the men had baseline coronary artery calcification (CAC) scores >300 Agatston units, indicating above-average coronary risk. Median noncalcified plaque volume increased significantly more in the testosterone group than in the placebo group (P=0.003). Changes in CAC score did not differ between groups.
COMMENT: The lack of cognitive benefit with testosterone is consistent with other trials. The significantly greater increase in coronary artery plaque volume with testosterone compared with placebo is ominous, although actual clinical outcomes are lacking and changes in CAC scores were not significantly different. An editorialist believes that these results are further reasons to discourage use of testosterone in older men who hope to reverse the effects of aging.
CITATION(S): Resnick SM et al. Testosterone treatment and cognitive function in older men with low testosterone and age-associated memory impairment. JAMA 2017 Feb 21; 317:717.
Budoff MJ et al. Testosterone treatment and coronary artery plaque volume in older men with low testosterone. JAMA 2017 Feb 21; 317:708.
Handelsman DJ.Testosterone and male aging faltering hope for rejuvenation. 
JAMA 2017 Feb 21; 317:699.
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J Am Acad Child Adolesc Psychiatry 2017 Feb 1
Do Children “Outgrow” Tourette Syndrome?
Regrettably, no. At 6-year follow-up, most patients still had tics plus comorbid attention-deficit/hyperactivity disorder or obsessive-compulsive disorder.
To better characterize the course of Tourette syndrome, investigators in Denmark annually examined changes in symptoms during a 6-year follow-up. Participants were 314 patients with Tourette syndrome who were recruited from a tertiary care clinic (mean age, 12 years; range, 5–20 years; 18% female).
The 6-year follow-up involved 227 patients (72%; mean age, 19). Tics decreased significantly during each year of follow-up. By the end of follow-up, 18% of patients age >16 had no tics, 60% had mild or moderate tics, and 23% had severe tics. Of participants with persistent tics, 56% had comorbidities, most typically attention-deficit/hyperactivity disorder (ADHD) or obsessive-compulsive disorder (OCD). ADHD occurred in 41% at baseline and in 33% at follow-up; OCD occurred in 39% at baseline and in 26% at follow-up. Outcomes did not differ by sex.
COMMENT: Among the study limitations, analyses did not control for medications and interrater reliability was not ascertained on assessment instruments. Nevertheless, these data attest to the need for continued clinical attention to tics and comorbid ADHD and OCD as children age. The results may not generalize to other Tourette patients because study participants came from tertiary care. That ADHD persisted in a third of cases is important — for many Tourette patients, especially those with mild or moderate tics, ADHD symptoms may be more bothersome than the tics.
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):Groth C et al. Course of Tourette syndrome and comorbidities in a large prospective clinical study. J Am Acad Child Adolesc Psychiatry 2017 Feb 1; [e-pub]. (http://dx.doi.org/10.1016/j.jaac.2017.01.010)

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