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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
December 12, 2015

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False-Positive Screening Mammograms linked to Higher Risk for Breast Cancer
Racial Differences and Preoperative Therapy for Breast Cancer
Guidelines Issued on Caring for Breast Cancer Survivors study suggests
FDA approves Cooling Cap that may help Cancer Patients keep their Hair
Melatonin for Children with Eczema
Another Study of the Statin–Diabetes Relation
CDC: Infant Mortality down, Alzheimer's Deaths up
Weight Gain in Infancy and Type 1 Diabetes might be Related
We've been Over-testing for HbA1c, Researchers Assert
AHA Statement Highlights Cardiovascular Burden in Diabetic Women vs. Men
Safety Warnings added to Newer Diabetes Drugs
Providing Quality Care for Patients with Multiple Sclerosis
Use of Aromatase Inhibitors Raises Risk for Carpal Tunnel Syndrome

False-Positive Screening Mammograms Linked to Higher Risk for Breast Cancer
By Kelly Young
Women with false-positive results on screening mammography are more likely to be subsequently diagnosed with breast cancer than women with true-negative results, suggests a study from Cancer Epidemiology, Biomarkers & Prevention.
Using data from U.S. breast cancer registries, researchers identified over 2.2 million screening mammograms that were false-positives or true-negatives among women without a history of breast cancer.
After an average follow-up of 5.4 years, women with a false-positive result in which biopsy was recommended had the highest risk for subsequent breast cancer diagnosis (7.01 per 1000 person-years), followed by those with a false-positive result in which additional imaging was requested (5.51 per 1000) and those with true-negative mammograms (3.91 per 1000). The elevated risk persisted at 10 years after the false-positive results.
NEJM Journal Watch Women's Health Editor-in-Chief Dr. Andrew Kaunitz comments: "I agree with the authors that their findings may facilitate better breast cancer prediction tools which in turn may inform future individualized screening and chemoprevention strategies."
Why We Chose This as Our Top Story:
Andre Sofair, MD, MPH: This article gives us further information in terms of risk-stratifying women who are undergoing mammography or biopsy. Those with false-positives should be followed more carefully than those with true-negatives.
William E. Chavey, MD, MS: This article highlights the importance of closely following all women with positive mammography and shows once again the challenges of using mammography as our primary screening tool for breast cancer.
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J Clin Oncol 2015 Nov 23
Racial Differences and Preoperative Therapy for Breast Cancer
Hispanic, black, and Asian women are more likely than white women to receive neoadjuvant chemotherapy.
Interest in neoadjuvant chemotherapy for operable, HER2-positive, or triple-negative breast cancer (TNBC) has increased with the availability of new HER2-directed therapies and the potential for chemotherapies to translate an increased pathologic complete response (pCR) rate into improved overall survival (OS). However, whether the likelihood of attaining a pCR differs among racial groups receiving preoperative therapy is unclear.
To further examine this issue, investigators interrogated the National Cancer Database (NCDB) to analyze women with stage 1 to 3 breast cancer diagnosed in 2010 and 2011. A total of 27,300 patients (22.5% of the total database) were determined to have received neoadjuvant chemotherapy. The outcome evaluated was pCR, defined as the absence of invasive cancer in the breast and axillary lymph nodes.
Women with HER2-positive, TNBC, larger tumors, lymph node-positive disease, and young age at diagnosis were more likely to receive neoadjuvant chemotherapy. Women lacking insurance and in the lowest income and education brackets were most likely to receive neoadjuvant chemotherapy. Hispanic women were the most likely of all groups to receive neoadjuvant chemotherapy. Compared with white women, black, but not Hispanic or Asian women had a lower pCR for HER2-positive breast cancer (43% vs. 54%) or TNBC (37% vs. 43%).
COMMENT: There are many limitations to the analysis. The finding that blacks are least likely to attain a pCR contrasts with most other reports, which have failed to find a difference in pCR based on race. Whether the larger numbers of subjects in this analysis have identified a true difference or whether factors including dose intensity or completion of planned therapy could be different among groups is unknown. Also, the notion that biologic factors in black patients influence outcome remains an open question.
CITATION(S): Killelea BK et al. Racial differences in the use and outcome of neoadjuvant chemotherapy for breast cancer: Results from the National Cancer Database. J Clin Oncol 2015 Nov 23; [e-pub].
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Guidelines Issued on Caring for Breast Cancer Survivors
By Kristin J. Kelley, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
The American Cancer Society and the American Society of Clinical Oncology have released guidelines for primary care clinicians and other providers on how to best care for adult women after breast cancer treatment.
The guidelines, published in the Journal of Clinical Oncology, provide recommendations for five key areas of survivorship, and include the following:

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FDA Approves Cooling Cap that may help Cancer Patients keep their Hair
By Kelly Young, Edited by Susan Sadoughi, MD
The FDA has cleared the DigniCap scalp cooling system for marketing, according to an announcement from the manufacturer. The cap aims to reduce chemotherapy-induced hair loss among women with breast cancer.
In a trial of over 100 women receiving chemotherapy (mostly taxanes) for stage 1 or 2 breast cancer, just 34% of patients who underwent scalp cooling lost over half of their hair, compared with 100% in the control group. There were no serious adverse events, although three patients discontinued use because of the cold sensation, which does not dip below 32 degrees F (0 degrees C).
During treatment, patients wear a tight-fitting silicone cap through which coolant circulates. When the scalp temperature is lowered, blood vessels constrict, which leads to less chemotherapy being delivered to the area. In addition, the intra-follicular metabolic rate is reduced, leading to less uptake of the chemotherapy drugs, according to the manufacturer.
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JAMA Pediatr 2015 Nov 16
Melatonin for Children with Eczema
Melatonin improves skin inflammation as well as sleep-onset latency.
For children with eczema, sleep disturbance is common and can adversely affect quality of life. Melatonin, a known sedative, has demonstrated anti-inflammatory effects. To assess its efficacy in reducing eczema severity (and, secondarily, sleep disturbance), investigators in Taiwan randomized 48 children (age range, 1–18 years) with eczema involving at least 5% of their body surface area and documented sleep difficulties to receive 3 mg of melatonin or placebo at bedtime for 4 weeks, followed by a 2-week wash-out period and then 4 weeks of the other treatment. Each child continued their usual topical regimen.
In a modified intention-to-treat analysis adjusted for age and sex, the Scoring Atopic Dermatitis (SCORAD) index for severity of eczema decreased by 9 points more for patients treated with melatonin than with placebo — a statistically and clinically significant difference. A significant 9-point difference favoring melatonin was also seen in the objective SCORAD index, which excludes assessments of pruritus and sleep disturbance. Time duration to falling asleep decreased significantly by 21 minutes more in those treated with melatonin than with placebo. Sleep and skin improvements were not significantly correlated, suggesting the independence of these two outcomes. No between-group differences were noted for other sleep outcomes or total or allergen-specific immunoglobulin E levels. There was no carryover effect between the two 4-week treatment periods, and no adverse effects were reported.
COMMENT: Melatonin seems to offer children with eczema a double bonus of improved sleep and decreased skin involvement. A larger randomized controlled trial in a U.S. population would add more weight to this finding, but for now I will offer my patients with eczema melatonin instead of diphenhydramine or hydroxyzine at bedtime and see how they do.
CITATION(S):Chang Y-S et al. Melatonin supplementation for children with atopic dermatitis and sleep disturbance: A randomized clinical trial. JAMA Pediatr 2015 Nov 16; [e-pub]. (http://dx.doi.org/10.1001/jamapediatrics.2015.3092)
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J Gen Intern Med 2015 Nov; 30:1599
Another Study of the Statin–Diabetes Relation
In a cohort study of relatively healthy people, diabetes developed in 31% of statin users and in 19% of nonusers.
Much of the data on the association between statin therapy and new-onset diabetes has been generated from high-risk populations. In this retrospective cohort study, researchers examined this association in a relatively healthy population of patients enrolled in the Tricare healthcare program for U.S. military families.
The researchers compared 3351 nondiabetic statin users and 3351 nonusers with no history of cardiovascular, pulmonary, renal, rheumatologic, or psychiatric disorders. Patients in these two groups were matched closely on numerous demographic and clinical variables through propensity-scoring. During a 7-year follow-up, the proportion of patients who developed diabetes was significantly higher among statin users than nonusers (30.9% vs. 19.4%). Users of high-intensity statins were more likely to develop diabetes than were users of moderate- or low-intensity statins.
COMMENT: The magnitude of reported excess risk for diabetes among statin users has varied considerably, depending on study methodology (randomized trial vs. cohort study), duration of statin use, and characteristics of the studied populations. However, this finding seems to be consistent and should be considered in decision-making about statin use, especially in primary-prevention populations. But an important issue that hasn't been discussed widely and, to my knowledge, hasn't been investigated adequately is whether statin-related diabetes is reversible when the statin is stopped.
CITATION(S): Mansi I et al. Statins and new-onset diabetes mellitus and diabetic complications: A retrospective cohort study of US healthy adults. J Gen Intern Med 2015 Nov; 30:1599.

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CDC: Infant Mortality Down, Alzheimer's Deaths Up
The U.S. infant mortality rate declined 2.3% from 2013 to 2014, reaching a record low of 582.1 per 100,000 live births, according to data released on Wednesday by the CDC's National Center for Health Statistics.
At the same time, deaths from Alzheimer disease rose 8.1%, to 25.4 per 100,000 population. As in 2013, Alzheimer's was the sixth leading cause of death in 2014.
Since 2012, life expectancy at birth has held steady at 78.8 years -- the highest it's ever been.
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Weight Gain in Infancy and Type 1 Diabetes might be Related
By Jenni Whalen, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Higher weight gain during the first year of a child's life is correlated with a higher risk for type 1 diabetes, an observational study in JAMA Pediatrics finds.
Researchers analyzed data from two population-based cohort studies in Norway and Denmark, following nearly 100,000 children born between 1998 and 2009. Changes in weight and body length from birth to 12 months were recorded for each child.
Increasing weight gain from birth to 12 months was positively associated with increased risk for developing type 1 diabetes during childhood (adjusted hazard ratio, 1.24 per standard deviation increase).
The authors speculate that early rapid growth could increase demand on beta cells to release insulin, which could then make them more vulnerable to cytokine damage. They conclude that their work "supports the early environmental origins of type 1 diabetes."
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We've Been Over-testing for HbA1c, Researchers Assert
By Joe Elia, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Most patients with well-controlled type 2 diabetes have been subject to overtesting, according to a study in The BMJ.
Using U.S. claims data on some 32,000 patients with serial hemoglobin A1c levels indicating stable glycemic control, researchers ascertained how often levels were remeasured during a 24-month follow-up.
Guidelines recommended up to two tests per year, but 55% of the cohort received frequent testing (three or four per year) and 6% received excessive testing (five or more tests). Patients at highest risk for excessive testing were from the Northeast, while those in the Midwest were at lowest risk. The frequency of overtesting dropped after 2009.
An editorialist writes that "we are prone to treating numbers and not individuals." He advises that more attention be paid to absolute risk reductions accruing from testing, and "much less" to single measures (such as HbA1c).
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AHA Statement Highlights Cardiovascular Burden in Diabetic Women vs. Men
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Women with type 2 diabetes are twice as likely as diabetic men to have coronary heart disease, according to a new scientific statement from the American Heart Association.
Published in Circulation, the statement highlights numerous sex differences regarding diabetes and cardiovascular health. These include:

In an AHA press release, the chair of the writing group said, "We don't fully understand how the inherent hormonal differences between men and women affect risk... This statement is a call for action to do the compelling research that is so important for all people with diabetes."
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Safety Warnings Added to Newer Diabetes Drugs
By Kristin J. Kelley, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
The labels of sodium-glucose co-transporter 2 (SGLT2) inhibitors — drugs used to treat type 2 diabetes — will be updated to warn of the risks for ketoacidosis and serious urinary tract infections, the FDA announced on Friday.
Updating a May 2015 safety communication, the FDA says 73 cases of diabetic ketoacidosis and 19 cases of urosepsis and pyelonephritis (that began as UTIs) have been reported in patients taking the drugs. All patients needed to be hospitalized or treated in the emergency department.
Clinicians should evaluate patients taking SGLT2 inhibitors for ketoacidosis if they present with associated symptoms (e.g., abdominal pain, vomiting), the FDA advises, noting that ketoacidosis can occur even if blood glucose levels aren't particularly high. If ketoacidosis is suspected, the SGLT2 inhibitor should be stopped and the complication treated immediately. Similarly, UTIs should be treated promptly.
Manufacturers of SGLT2 inhibitors, which include canagliflozin, dapagliflozin, and empagliflozin, are now required to perform postmarketing safety studies for 5 years.

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Neurology 2015 Nov 24; 85:1904
Providing Quality Care for Patients with Multiple Sclerosis
The American Academy of Neurology provides a first list of measures to establish best practices and outcomes in MS.
To establish a basis for improving the care of patients with multiple sclerosis (MS), a working committee within the American Academy of Neurology proposed 11 measures for inclusion in the AAN 2015 MS Quality Measurement Set. These patient-centered measures include the proportion of a clinician's or practice's patients diagnosed with MS who:

COMMENT: The proposed domains are reasonable in that they are derived from evidence and involve validated measures. If reimbursement were established to provide fair compensation to perform such measures, we might better assess our own practices. Ultimately, guidelines can someday permit us to compare outcomes across centers, further refining our measures and best practices. Additional outcomes worth considering for quality assessment include determining the proportion of patients with signs of disease activity (relapses or new MRI lesions), and counseling on smoking cessation. However, many concerns remain among some practitioners on items such as unfunded mandates, the potential to deny claims, and marginalizing the community general neurologist treating MS patients.

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J Clin Oncol 2015 Nov 23
Use of Aromatase Inhibitors Raises Risk for Carpal Tunnel Syndrome
Excess risk probably reflects low estrogen levels.
Carpal tunnel syndrome (CTS) results from compression of the median nerve in the wrist as it courses from the arm to the hand. In a large double-blind study, 3864 postmenopausal women (median age, 59.5) at elevated risk for breast cancer were randomized to the aromatase inhibitor (AI) anastrozole or placebo for 5 years.
At a median follow-up of 6.4 years, CTS was reported in 96 participants (3.4% and 1.6% in the anastrozole and placebo groups, respectively; P<0.001). Median time on study drug to diagnosis of CTS was 1.99 years. Most CTS in the AI group was considered mild to moderate in severity. Although the incidence of severe CTS was four times higher among women receiving the AI, this difference did not achieve statistical significance. Less than 1 percent of women randomized to the AI discontinued this medication because of CTS. Surgery for CTS was performed in 0.9% and 0.3% of participants receiving AI and placebo, respectively (P=0.018).
COMMENT: The AIs anastrozole, exemestane, and letrozole are more effective than tamoxifen in preventing breast cancer recurrence; thus, this group of medications is widely used in the adjuvant setting following initial treatment of receptor-positive breast cancer in postmenopausal women. Their efficacy is thought to result from the ability of AIs to profoundly reduce endogenous systemic estrogen levels. Hypoestrogenemia is also a risk factor for CTS. Accordingly, CTS as well as the well-known arthralgias constitute important adverse outcomes of AI use. Because long-term adjuvant therapy with AIs is often recommended — and musculoskeletal side effects can lead to early discontinuation of these important medications — identifying ways to lessen or prevent these adverse effects in ongoing users remains an important challenge.
CITATION(S): Spagnolo F et al. Anastrozole-induced carpal tunnel syndrome: Results from the International Breast Cancer Intervention Study II prevention trial. J Clin Oncol 2015 Nov 23; [e-pub].

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