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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
October 19, 2013

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More Data Incriminating Gut Bacteria in Obesity, Dyslipidemia, and Insulin Resistance
Metoclopramide in Pregnancy: More Reassuring Safety Data
Invasive Pediatric MRSA on the Rise
Testosterone Gels get Big Ad Push, But Many Clinicians Believe 'Low T' Doesn't Exist
For Cardiovascular Risk, Not All Oral Menopausal Estrogen Formulations Are Alike
Health Outcomes During and After Hormone Therapy: A Comprehensive Look at
   Women's Health Initiative Data
No Strong Evidence of Benefit from Lifestyle Interventions In Established Diabetes
Irregular Bedtimes Associated with Increased Behavioral Problems in Children
Workout Supplement 'Craze' Contains Meth Analog
Unconfirmed Reports of Krokodil Abuse in U.S.
Nasacort Going Over the Counter

MM: Not all probiotics are equal. That is why it is important to use strains that have been demonstrated to be beneficial and why I am quite leery of the probiotics that are being genetically engineered. This study opens the eyes to the potential different effects of different strains of bacterial probiotics and makes us realize that we have to be aware of what we are consuming.
Science 2013 Sep 6; 341:1079
More Data Incriminating Gut Bacteria in Obesity, Dyslipidemia, and Insulin Resistance
New research provides stronger evidence that the composition of gut bacteria influences obesity.
Three new studies involving mice and humans provide new and stronger evidence that the composition of gut bacteria influences obesity.
In a U.S. study, fecal material from four human twin pairs (each set included one obese and one lean twin) was transplanted into genetically identical mice that were raised in a germ-free environment. The mice that received gut microbiota from obese humans became obese and developed obesity-related metabolism traits: dyslipidemia, insulin resistance, and inflammatory markers. In contrast, mice that received microbiota from lean humans stayed lean. Because mice routinely eat each other's feces, researchers tried housing obese mice with lean mice — the obese mice gradually became lean and lost the obesity-related metabolic changes, and their gut flora changed to resemble that of the lean mice.
In a study from France, researchers compared genes from the gut microbiomes of 123 nonobese and 169 obese humans. The nonobese humans typically exhibited a different composition of gut bacteria, although the differences involved just a few species. Certain bacterial species were linked to insulin resistance, fatty liver, and inflammation.
In another French study, investigators found the same “obesity-related” bacteria to be present in their 49 obese participants, particularly those with obesity-related metabolism traits. When participants were placed on energy-restricted diets for 6 weeks, their microbiome changed toward that seen in lean individuals. Returning to their typical diets for 6 weeks moved the participants' microbiomes back toward the initial composition.
Comment: Collectively, these three studies provide strong evidence that the composition of bacteria in our gut affects whether we are obese — and whether we develop obesity-related metabolism traits. They also indicate that what we eat can affect our microbiome. The studies do not prove that the gut microbiome will predict which people will become obese or develop obesity-related metabolism. And they surely don't prove that directly altering the gut microbiome of obese people will improve their health. However, many investigators already are interested in pursuing those possibilities.
Citation(s): Ridaura VK et al. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science 2013 Sep 6; 341:1079.
Le Chatelier E et al. Richness of human gut microbiome correlates with metabolic markers. Nature 2013 Aug 29; 500:541.


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MM: It's nice to know that this long used medication may be used safely and effectively during pregnancy. It is inexpensive and readily available
Metoclopramide in Pregnancy: More Reassuring Safety Data
By Amy Orciari Herman
A new study in JAMA adds to the growing evidence that metoclopramide (Reglan) may be safely used to treat severe nausea in pregnancy.
Examining Danish registries, researchers matched some 40,000 pregnancies in which metoclopramide prescriptions were dispensed to roughly 150,000 unexposed pregnancies. The incidence of overall major congenital malformations did not differ significantly between the groups (roughly 25 per 1000 births), nor did the incidence of 20 specific malformations. In addition, metoclopramide was not associated with increased risk for having a spontaneous abortion, stillbirth, preterm birth, low-birth-weight infant, or small-for-gestational-age infant.
Allison Bryant, an OB/GYN with NEJM Journal Watch, commented: "For women whose health and quality of life are compromised by nausea, this study provides welcome reassurance about the safety of this medication in pregnancy."
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MM: Could this increase in Pediatric MRSA be due to overuse of antibiotics in this population? If this is the case then we need to be even more diligent about being proactive in building/strengthening our children's immune systems with things like Probiotics, Vitamin D3, Vitamin C, Year Round Full Spectrum Sunlight and healthy diets.
Pediatrics 2013 Sep 23
Invasive Pediatric MRSA on the Rise
Unlike the incidence in adults, incidence in children is on the rise, driven predominately by community-onset cases.
Both healthcare-associated methicillin-resistant Staphylococcus aureus (HA-MRSA) infections and community-associated MRSA (CA-MRSA) infections are associated with high morbidity and mortality. Recent surveys demonstrate decreasing rates of both types of infections in adult populations, which may result from increased awareness of hospital-acquired infections and institution of measures to reduce central-line infections. Is the same true for MRSA in children?
Researchers report surveillance data for MRSA infections in children (aged <18 years) from nine U.S. metropolitan areas in 2005–2010. Cases of invasive MRSA infection were defined by isolation from sterile sites (blood, cerebrospinal fluid, pleural fluid).Among 876 identified cases (mean age, 2.1 years; 59% male), 42% were considered CA-MRSA, 35% HA-MRSA, and 23% healthcare-associated community-onset (HACO) MRSA (cultures obtained in the outpatient setting in a patient with healthcare risk factors). Most children (91%) were hospitalized, and 6% (53 patients) died. Blood stream infections accounted for 79% of infections; other sources included bone and joint (20%), skin and soft tissue (17%), empyema (15%), and meningitis (4%). The strain predominantly responsible for CA-MRSA (USA300) was implicated in 54% of HA-MRSA and 63% of HACO-MRSA cases. The incidence of CA-MRSA infections increased 10% per year across all age groups, in seven of the nine surveillance sites, and overall rates were highest in black children and those aged 3–89 days. The incidence of HA-MRSA or HACO-MRSA did not change significantly, except for a decrease in late-onset infections in infants aged 3–89 days.
Comment: Although this study only addresses invasive methicillin-resistant Staphylococcus aureus infection, it provides a snapshot of MRSA trends in children. The decrease in healthcare-associated MRSA in young infants reflects tremendous efforts in hospital infection control, but the rise in invasive community-associated MRSA in all age groups, both in and outside health-care settings, appears unique to the pediatric population and mirrors the rise in noninvasive MRSA infections in pediatric populations. If rates of invasive MRSA infections in children are indeed on the rise, particularly in the youngest patients, dedicated prevention strategies are needed.
Citation(s): Iwamoto M et al. Trends in invasive methicillin-resistant Staphylococcus aureus infections. Pediatrics 2013 Sep 23; [e-pub ahead of print].
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MM: Although there may be some controversy on whether 'Low T' is a real diagnosis, I have seen tremendous benefits from Testosterone supplementation in many of my male patients. The reluctance of some physicians to provide testosterone supplementation is in my opinion borne from fear and ignorance of the facts relating to testosterone and optimal levels in the body. Just as many women have benefitted from bio-identical hormones, many men have benefitted from this same class of treatments.
Testosterone Gels get Big Ad Push, But Many Clinicians Believe 'Low T' Doesn't Exist
By Joe Elia
Pumped up by expansive ad budgets last year, testosterone gels generated over $2 billion in U.S. sales, the New York Times reports. One manufacturer spent $80 million advertising its gel.
Aimed at aging men, the ads offer a solution to something called "low T" — which many clinicians believe is an "invented condition," according to the Times.
One source, an endocrinologist, commented: "There is no such disease." Another, a cardiologist, asks patients presenting with self-described low T why they would even get tested, since "there isn't really a normal."
A drug company spokesman said their product advertising is educational and meant to encourage patients to talk with their physicians "to determine if testing and treatment may be appropriate."
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MM: There is no question in my mind that oral CEE are dangerous. There is also no question in my mind that although oral estradiol may not be a detrimental as CEE, transdermal estradiol (E2) in combination with estriol (E3) is a better choice. It follows a different biological pathway that does not create the same level of dangerous breakdown products called metabolites from the liver. It is these active metabolites that are developed from oral use of estrogens that tend to be the most dangerous.
JAMA Intern Med 2013 Sep 30
For Cardiovascular Risk, Not All Oral Menopausal Estrogen Formulations Are Alike
Oral estradiol was safer than conjugated equine estrogens.
Although many studies have compared cardiovascular risks in menopausal hormone therapy users versus nonusers, few data address the comparative safety of different oral estrogen formulations. Investigators conducted a case-control study of menopausal women taking oral estradiol (E2) or conjugated equine estrogens (CEE) from 2003 through 2009. Cases had incident venous thromboembolism (VTE), myocardial infarction (MI), or ischemic stroke; controls had no history of these cardiovascular events. Endogenous thrombin potential-based normalized activated protein C sensitivity ratio (nAPCsr), a measure that predicts VTE risk in the setting of estrogen use, was assessed in a subset of controls.]
A total of 68, 67, and 49 cases of incident VTE, MI, and stroke (as well as 201 controls) were identified during the study period. More than 90% of participants were white; mean age varied from 63 to 68. In analyses adjusted for confounders such as body-mass index and smoking status, CEE use was associated with higher risk for VTE (odds ratio, 2.1; P=0.045) and MI (OR, 1.9; not statistically significant) but not ischemic stroke. Among controls, nAPCsr was higher in CEE users (P<0.001), suggesting a greater tendency to clot.
Comment: Although oral estrogen may carry higher risk for venous thromboembolism than does transdermal estrogen (NEJM JW Womens Health May 2 2013), many users of menopausal hormone therapy prefer oral formulations for their convenience (and because of concerns about patch adherence). Estradiol and conjugated equine estrogens may seem comparable with respect to efficacy for menopausal symptoms, but a 1-month supply of 1-mg E2 tablets costs US$4.00 at some chain pharmacies whereas 0.625-mg CEE tablets cost $84.92 (http://www.goodrx.com/). Accordingly, for menopausal women who opt to use oral estrogen formulations, E2 is a wise choice from the perspective of both cost and cardiovascular safety.
Citation(s): Smith NL et al. Lower risk of cardiovascular events in postmenopausal women taking oral estradiol compared with oral conjugated equine estrogens. JAMA Intern Med 2013 Sep 30; [e-pub ahead of print].
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MM: Once again we must clarify and differentiate between Bio-Identical Progesterone and Synthetic Progestin. They are NOT THE SAME! Simply put, Bio-Identical: GOOD, Synthetic: BAD. The adverse effects of the Synthetic Progestins are not shared by Bio-Identical Progesterone. Although this article appropriately states the dangers of medroxyprogesterone (MPA), it fails to provide this other extremely important data that not all progestins are the same.
JAMA 2013 Oct 2; 310:1353
Health Outcomes During and After Hormone Therapy: A Comprehensive Look at Women's Health Initiative Data
Long-term analyses clarify the differing effects of menopausal HT formulation and user age at initiation.
Earlier findings from the Women's Health Initiative hormone therapy trials, which enrolled women aged 50 to 79, are well known. Now, investigators have published an outcomes analysis of both trials based on extended cumulative follow-up (median, 13 years) with stratification by age.
Among women randomized to oral conjugated equine estrogens (CEE) + medroxyprogesterone acetate (MPA) compared with placebo, small but statistically significant elevations in risk for invasive breast cancer (hazard ratio, 1.24), stroke (HR, 1.37), and pulmonary embolism (HR, 1.98), as well as reductions in risk for colorectal cancer (HR, 0.62), hip fracture (HR, 0.67), and diabetes (HR, 0.81) occurred during the intervention phase. The changes in risk for all of these outcomes except breast cancer diminished during the post-intervention phase. Among women randomized to CEE compared with placebo, small but statistically significant elevations in risk for stroke (HR, 1.35) as well as statistically significant reductions in hip fracture (HR, 0.67) and diabetes (HR, 0.86) were observed during the intervention phase, with the changes in risk for these outcomes again diminishing during the post-intervention phase. Cumulatively, randomization to CEE was associated with reduced risk for invasive breast cancer (HR, 0.79). Neither CEE + MPA nor CEE alone significantly affected all-cause mortality during or after the intervention phase. Among the subset of women aged 50 to 59, the CEE-alone group had fewer myocardial infarctions and significantly lower all-cause mortality. Comment Menopausal hormone therapy remains the most effective treatment for vasomotor symptoms, which are experienced by more than half of menopausal women and are most likely to be bothersome during late perimenopause and early menopause with mean duration >10 years (NEJM JW Womens Health May 12 2011). This long-term analysis confirms that the risk–benefit ratio of HT is most favorable when initiated in younger menopausal women, and for estrogen-only versus estrogen-progestin therapy. While HT should not be used to prevent cardiovascular disease, use of low-dose HT specifically to prevent osteoporosis is appropriate in selected women at elevated risk for this condition.
 Citation(s): Manson JE et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA 2013 Oct 2; 310:1353.
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MM: In spite of the findings in this study I will continue to recommend diet, exercise, smoking cessation and other lifestyle modifications to my patients with type 2 diabetes. To do otherwise, in my opinion, is tantamount to malpractice.
No Strong Evidence of Benefit from Lifestyle Interventions In Established Diabetes
By Joe Elia
People at high risk for developing type 2 diabetes benefit from lifestyle interventions, but those with established disease might not, according to an Annals of Internal Medicine meta-analysis.
Investigators reviewed two groups of randomized controlled trials: one group of trials examined the effects of lifestyle interventions (diet, exercise, plus at least one additional component, such as smoking cessation or counseling) in people at high risk for diabetes. The other group looked at the interventions' effects among people with established diabetes. All interventions lasted at least 6 months.
The interventions were more successful than usual care in preventing progression to diabetes for up to 10 years post-intervention. However, among patients with established diabetes, lifestyle interventions did not significantly reduce mortality, and there was "insufficient evidence to suggest benefit on cardiovascular and microvascular outcomes," the authors write.
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Irregular Bedtimes Associated with Increased Behavioral Problems in Children
By Joe Elia
Children with irregular weekday bedtimes have more parent- and teacher-rated behavioral problems than those with regular bedtimes, a Pediatrics study finds.
Some 10,000 U.K. children had their bedtimes reported by their mothers at ages 3, 5, and 7. At age 7, mothers and teachers assessed the children's behavior.
Children with irregular bedtimes had higher rates of behavioral problems than those with regular bedtimes. There was a dose-response pattern, with irregular bedtimes at all three age assessments having the greatest effect on behavioral scores.
Shifting to regular bedtimes was associated with improved behavior. Accordingly, the researchers point to "potential opportunities for interventions," noting that "screening for disruptions to bedtime schedules could be built into routine primary health care consultations."
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Workout Supplement 'Craze' Contains Meth Analog
By Joe Elia
The workout supplement marketed as "Craze" contains a potentially dangerous designer drug — a methamphetamine analog — according to an article in Drug Testing and Analysis.
The analog, N,alpha-diethyl-phenylethylamine (N,alpha-DEPEA), was found in three different samples of the product obtained from separate sources and analyzed by two labs. The product's label claims it contains phenylethylamines derived from dendrobium, but the authors say the component identified as N,alpha-DEPEA has never been identified in dendrobium. They say the amounts of N,alpha-DEPEA found "strongly suggest" that it's not a minor contaminant, adding that if their findings are confirmed, the FDA should "remove all N,alpha-DEPEA-containing supplements from the marketplace."
The Boston Globe reports that another supplement, "Detonate," also contained N,alpha-DEPEA upon analysis
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Unconfirmed Reports of Krokodil Abuse in U.S.
By Kelly Young
Physicians in the Chicago area suspect that the street drug krokodil, pronounced and occasionally spelled "crocodile," has reached their region after a handful of people were identified with symptoms consistent with its abuse, the Chicago Tribune reports.
Suspected cases have also been reported in Arizona and Oklahoma, according to CNN. Federal officials, however, say there have been no confirmed cases in the U.S.
The injectible drug is a homemade version of desomorphine that's made using corrosive substances, such as lighter fluid or cleaning products, to dissolve codeine tables. The drug necrotizes tissue, sometimes leading to green, scaly-looking lesions, not unlike a crocodile.
Krokodil abuse is widespread in Russia and the Ukraine, where it's a cheap alternative to heroin.
Rich Saitz, an addiction medicine specialist with Physician's First Watch, said: "When the latest abused drug gets attention, it can distract us from the more mundane but harmful effects of alcohol and other commonly abused substances. Nonetheless, it is helpful to be aware of new drugs of abuse ... to help us identify and ... treat substance use disorders."
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Nasacort Going Over the Counter
Sanofi announced that the FDA approved an over-the-counter (OTC) version of the company's allergy nasal spray Nasacort. This is the second time that Sanofi has moved one of its allergy medications from Rx to OTC status; the first being the antihistamine Allegra. It will be marketed by Chattem Inc., Sanofi's consumer health division in the U.S. The company said it should be available by the spring of 2014.

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