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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
April 8, 2017

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Nutritional Therapy for Postpartum Blues Might Be Effective
Does Direct-to-Consumer Advertising Affect Prescribing Behavior?
CRO's Medicines from India Hit with EMA Suspension as Tests Stated to be "Unreliable"
Is Coffee a Potential Therapy for Nonalcoholic Fatty Liver Disease?
For Obese Patients, a Relatively New Device for Weight Reduction
Radiotherapy for Breast Cancer: Long-Term Consequences
When Is It Reasonable to Stop PSA Monitoring After Radical Prostatectomy?
Acute Fatty Liver Disease of Pregnancy: A Review

Proc Natl Acad Sci U S A d 2017 Mar 28; 114:3509
Nutritional Therapy for Postpartum Blues Might Be Effective
In a small nonrandomized study, a mix of tryptophan, tyrosine, and blueberry juice prevented baby blues.
Postpartum blues occur in about 75% of women, typically peaking on postpartum day 5 and usually disappearing by day 10. Women who experience severe postpartum blues are more likely to develop postpartum depression, which develops in about 13% of all women. Immediately following childbirth, a woman's estrogen and progesterone levels plummet: This leads to marked elevation in brain levels of monoamine oxidase A (MAO-A), which is one mediator of postpartum depression.
Researchers created a dietary supplement (consisting of tryptophan, tyrosine, and blueberry juice) to counter the effects of postpartum elevated MAO-A levels. The open-label supplement was given to 21 women on postpartum days 3, 4, and 5; another 20 matched women served as controls. Enrollment in each group was by open recruitment (not randomized). Two validated depression measures were administered just before delivery and at 5 days postpartum. In the control group, most women's mean depression scores were much worse at 5 days postpartum than prepartum. In the supplement group, mean depression scores generally did not increase after delivery.
COMMENT; Normally, we wouldn't report on a small, nonrandomized, nonblinded study, but these results are very striking. Nevertheless, larger, better-designed studies clearly are required to see if baby blues and postpartum depression really can be prevented by a simple nutraceutical therapy.
CITATION(S): Dowlati Y et al. Selective dietary supplementation in early postpartum is associated with high resilience against depressed mood. Proc Natl Acad Sci U S A 2017 Mar 28; 114:3509.

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JAMA 2017 Mar 21; 317:1159
Does Direct-to-Consumer Advertising Affect Prescribing Behavior?
In the case of testosterone, the answer appears to be yes.
Testosterone prescribing for middle-aged and older men in the U.S. rose nearly fourfold from 2000 through 2011. Given the uncertain risk-benefit ratio of testosterone in late-onset hypogonadism and the substantial prevalence of testosterone prescribing without appropriate testing, researchers assessed the effect of televised direct-to-consumer advertising (DTCA) on testosterone prescribing, testing, and treatment initiation in 75 U.S. major media markets. Measures of advertising exposure from 2009 through 2013 were linked with insurance claims data for more than 17 million men, of whom about 1 million received new testosterone tests and about 283,000 received new testosterone prescriptions.
Monthly testing and prescribing rates rose through 2012 before declining in 2013, possibly in response to growing safety concerns. Exposure to unbranded “low T” testosterone advertising also increased through 2012 and declined in 2013; exposure to brand-specific advertising (Androgel and Axiron) increased in 2012, with no decline in 2013. DTCA exposure was associated with greater testosterone testing and new use; for example, each additional televised DTCA exposure of one advertisement per household monthly for 4 years was associated with monthly increases of 14 new tests, 5 new prescriptions, and 2 new prescriptions without testing per 1 million men exposed. The authors estimate that household exposure to one television ad monthly resulted in an increase in new prescriptions of about 1%.
COMMENT: This study confirms that DTCA results in more patient requests for testosterone products and — at least in some cases — physician acquiescence to those requests. A remarkable proportion of middle-aged men in this study (nearly 2% by my estimate) received testosterone prescriptions during a 4-year period. When patients ask me to prescribe testosterone in response to advertising, I use it as an opportunity to discuss my concerns about DTCA — both specifically for testosterone, and more generally.
CITATION(S): Layton JB et al. Association between direct-to-consumer advertising and testosterone testing and initiation in the United States, 2009-2013. JAMA 2017 Mar 21; 317:1159.
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CRO's Medicines from India Hit with EMA Suspension as Tests Stated
to be "Unreliable"

The European Medicines Agency (EMA) wants to suspend around 300 marketed generic medicines and applications coming out of Indian CRO Micro Therapeutic Research Labs. This is related to concerns over "misrepresentation of study data and deficiencies in documentation and data handling."
Austrian and Dutch authorities inspected the sites a year ago and were concerned that the company was not accurately describing study data and was causing problems with its paper work and handling of trial data. The EMA conducted its own review and said that data from studies, which were made at the sites between mid-2012 and to the summer of 2016, "are unreliable and cannot be accepted as a basis for marketing authorization in the EU." 
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Clin Gastroenterol Hepatol 2017 Mar 11
Is Coffee a Potential Therapy for Nonalcoholic Fatty Liver Disease?
A protective, dose-response effect and a dearth of treatment options justify an intervention trial.
Coffee consumption is suggested to decrease risk for liver disease and improve liver-related outcomes in patients with chronic hepatitis C virus (HCV) infection, likely via reduction in oxidative stress. Limited data point to similar findings in nonalcoholic fatty liver disease (NAFLD).
To evaluate the association between coffee consumption and chronic liver disease with and without cirrhosis by liver disease etiology, investigators conducted a nested case-control study involving 95,197 Medicare fee-for-service participants who completed a standardized questionnaire on coffee consumption as part of a larger cohort study. Liver disease status was identified using Medicare claims data. Case and control patients were matched by age, sex, ethnicity, and program enrollment duration.
Risks for chronic liver disease due to alcoholic liver disease, NAFLD, and HCV infection decreased with increasing daily coffee consumption (minimum daily intake ≥2 cups/day; P for all trends <0.05). For alcoholic liver disease and HCV infection etiologies, risk was reduced only among patients with cirrhosis, whereas for NAFLD, risk reduction was evident with and without cirrhosis. Coffee was not protective against chronic liver disease from other etiologies, and the association did not vary by race/ethnicity.
COMMENT: These findings demonstrate a protective, dose-response effect of coffee consumption on risk for chronic liver disease — not only in patients with HCV infection but also in those with fatty liver disease. The mechanism is still unclear but could be related to more than the antioxidative effect of coffee; a unique effect on the steatotic process in fatty liver disease is possible. Because we currently do not have a specific medical treatment for NAFLD, an intervention trial involving coffee or its ingredients might lead to a novel therapeutic option.
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): Setiawan VW et al. Coffee drinking and alcoholic and nonalcoholic fatty liver diseases and viral hepatitis in the multiethnic cohort. Clin Gastroenterol Hepatol 2017 Mar 11; [e-pub].
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Am J Gastroenterol d 2017 Mar; 112:447
For Obese Patients, a Relatively New Device for Weight Reduction
With the AspireAssist system, partially digested food is removed through a gastrostomy tube.
In 2016, the FDA approved the AspireAssist System, a weight-loss device that involves endoscopic placement of a specially designed gastrostomy tube. About 20 minutes after a meal, an external drainage tube is attached to the gastrostomy tube port and partially digested food (typically about 30% of ingested calories) is flushed out and discarded. The study that led to FDA approval involved 171 adults (body-mass index [BMI], 35–55 kg/m2; mean BMI, 42 kg/m2); now, results of the study have been published.
Patients were randomized in a 2:1 ratio to receive AspireAssist plus lifestyle counseling or lifestyle counseling only. During 1 year of follow-up, device patients lost a significantly larger proportion of excess body weight than did controls (32% vs. 10%); mean weight reductions were 14 kg and 4 kg, respectively. Quality-of-life scores were higher in device patients than in controls. Among 111 device patients, 4 had adverse events rated as serious (i.e., severe abdominal pain, peritonitis, pyloric ulcer, and tube malfunction); many others had nonsevere side effects (e.g., peristomal granulation tissue, nonspecific abdominal pain, dyspepsia). No patient developed an eating disorder (patients with previous bulimia or binge-eating disorder were excluded from the study).
COMMENT: The AspireAssist device is associated with less average weight loss than standard bariatric surgical procedures, but it is reversible and less invasive; longer-term follow-up will be important. Many observers find the idea of expelling partially digested food to be distasteful, but I also discovered supportive testimonials from patients who have these devices. I was unable to find data on how many devices have been placed so far, or a listing of centers that provide it.
CITATION(S): Thompson CC et al. Percutaneous gastrostomy device for the treatment of class II and class III obesity: Results of a randomized controlled trial. Am J Gastroenterol 2017 Mar; 112:447.
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J Clin Oncol 2017 Mar 20
Radiotherapy for Breast Cancer: Long-Term Consequences
The benefits far outweigh the risks for most patients, thanks largely to efforts to reduce smoking and to expose less normal tissue to RT.
Patient with early-stage breast cancer often ask about the long-term effects of the therapies we recommend to reduce the risk for disease recurrence. The long-term effects of systemic therapies are well characterized, and in the modern era the long-term effects of breast radiotherapy (RT) are thought to be minimal. However, one focus of concern regarding RT is the effect on the lungs and heart. For more than 2 decades, the Early Breast Cancer Trialists' Group (EBCTG), with its unique ability to analyze data from all randomized clinical trials, has provided insights into the benefits of breast cancer therapy.
Now, based on an analysis of 647 regimens published between 2010 and 2015, the EBCTG determined that the average radiation dose to the heart and whole lung was 5.7 Gy and 4.4 Gy, respectively. The analysis also included 40,781 patients in trials of breast cancer RT versus no RT and a calculation of excess second primary cancers and cause-specific mortality. Excess rates of cardiac mortality and lung cancer/Gy were calculated. The excess rates of cardiac mortality or lung cancer using doses of RT utilized between 2010 and 2015 were applied to current smoker and nonsmoker lung cancer, and cardiac mortality rates were derived for nonsmokers in the American Cancer Society Prevention Study, smokers in the UK Million Women Study, and ischemic heart disease from the World Health Organization.
The analysis yielded the following absolute risks from modern breast cancer RT: lung cancer, approximately 4% for long-term continuing smokers and 0.3% for nonsmokers; cardiac mortality, approximately 1% for smokers and 0.3% for nonsmokers.
COMMENTL: In the discussion and accompanying editorial, the authors note that modern RT for early-stage breast cancer is generally very effective with benefits outweighing risks for most patients. The favorable risk-benefit ratio is largely attributable to efforts to reduce smoking, and to expose less normal tissue to RT by using careful planning and minimizing the radiated target volume. The risk factor that patients can modify in their favor — smoking cessation — remains challenging.
CITATION(S): Taylor C et al. Estimating the risks of breast cancer radiotherapy: Evidence from modern radiation doses to the lungs and heart and from previous randomized trials. J Clin Oncol 2017 Mar 20; [e-pub].
Shaitelman SF et al. Effects of smoking on late toxicity from breast radiation. J Clin Oncol 2017 Mar 20; [e-pub].
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J Urol 2017 Mar; 197:655
When Is It Reasonable to Stop PSA Monitoring After Radical Prostatectomy?
If prostate-specific antigen was undetectable 5 years after prostatectomy, biochemical recurrence didn't ensue during additional long-term follow-up.
In patients who have undergone radical prostatectomy for localized prostate cancer, periodic monitoring of prostate-specific antigen (PSA) levels is recommended to screen for “biochemical recurrence” — a rise in PSA that might predict clinically evident recurrence. In this Japanese study, researchers sought to determine when postprostatectomy PSA monitoring can be stopped.
Nearly 600 patients who underwent radical prostatectomy were followed an average of 10 years; patients had PSA testing (using an ultrasensitive assay) every 3 to 6 months during the first 3 postprostatectomy years and annually thereafter. Among 187 patients with undetectable PSA (<0.01 ng/mL) at 3 years, only 2 patients had later biochemical recurrence (defined as PSA elevation to >0.2 ng/mL). Among 162 patients with undetectable PSA at 5 years, none had later biochemical recurrence.
COMMENT: This study suggests that if the PSA level, measured by an ultrasensitive assay, remains undetectable 3 to 5 years after radical prostatectomy, probability of biochemical recurrence is extremely low, and PSA monitoring could reasonably be stopped. The authors also remind us that biochemical recurrence is a surrogate marker: It doesn't necessarily predict clinically evident progression of prostate cancer during the patient's lifetime.
CITATION(S): Matsumoto K et al. Determining when to stop prostate specific antigen monitoring after radical prostatectomy: The role of ultrasensitive prostate specific antigen. J Urol 2017 Mar; 197:655.
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Am J Gastroenterol 2017 Mar 14
Acute Fatty Liver Disease of Pregnancy: A Review
The state of the science and clinical practice for early recognition and management of this potentially fatal condition
Acute fatty liver disease of pregnancy (AFLP) is an uncommon but serious obstetrical emergency, usually occurring during the third trimester. The current review covering etiology, diagnosis, clinical outcomes, and management of AFLP includes these key take-home points:

COMMENT: As highlighted here, AFLP is typically marked by signs of liver dysfunction, which should tip off the clinician to its diagnosis and lead to prompt delivery of the fetus. Future research is needed to better understand AFLP pathogenesis in order to develop specific treatments beyond supportive care.
CITATION(S): Liu J et al. Acute fatty liver disease of pregnancy: Updates in pathogenesis, diagnosis, and management.Am J Gastroenterol 2017 Mar 14; [e-pub].

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