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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
March 22, 2014

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Another Trial Suggests the Safety of Short-Term Estrogen-Only Therapy
Joint Replacement Numbers may Surprise You!
Which Parenteral Treatment Is Best for Acute Migraine?
Potential Benefits of Nutritional Support in ALS
Caregivers Often Absorbed in Mobile Devices During Meals Out With Kids
Azithromycin, Levofloxacin Linked to Increased Risks for Arrhythmia and Mortality
   Compared to Amoxicillin
Trends in Management of Testosterone in the U.K. and the U.S.
Can We Reverse Age-Related Loss of Muscle Mass?

MM: Unfortunately this study fails to recognize the benefits of bio-identical progesterone. It only considers synthetic progestin that has the only benefit of cervical and uterine protection when used in conjunction with estrogen. In any case, the detrimental effects of estrogen continue to be questioned. The first rule of medicine is to do no harm. In regards to estrogen, avoid oral estrogens of any strength whenever possible. Avoid synthetic progestins and consider using bio-identical progesterone whenever estrogens are administered, regardless of the route.
BJOG 2014 Feb 18
Another Trial Suggests the Safety of Short-Term Estrogen-Only Therapy
Postmenopausal women with an intact uterus surviving a first myocardial infarction were not at excess risk for cancer or death during extended follow-up.
Investigations of the cardiovascular safety of estrogen-only menopausal therapy typically have excluded women with an intact uterus because of concerns about endometrial cancer. To determine if unopposed estrogen lowered long-term risk for reinfarction or death in myocardial infarction (MI) survivors, investigators conducted extended follow-up in a U.K. trial involving 1017 postmenopausal women (age range, 50–69) with an intact uterus who were recruited at the time of their first MI.
Participants were randomized to receive 2-mg estradiol valerate or placebo daily for 2 years, and were closely monitored for episodes of vaginal bleeding. All women who experienced such bleeding during the intervention received active management.
During a mean follow-up of 14 years, 214 deaths occurred in the estrogen arm and 204 in the placebo arm. The hazard ratio for all-cause mortality by treatment was 1.07 (95% confidence interval, 0.88–1.29). Heart disease was the underlying cause in 177 of deaths among all participants; estimates of HRs for death by specific cause showed that 2 years of estrogen-only therapy was neither detrimental nor protective. Seven cases of breast cancer occurred in the treatment arm and 15 in the placebo arm (HR, 0.47). In three cases of endometrial cancer (one in the treatment arm and two in the placebo arm), no deaths occurred.
Comment: Although this trial confirms that estrogen-only menopausal hormone therapy (at a higher dose than typically used in the U.S.) does not protect against a second myocardial infarction, the results suggest that short-term use of unopposed estrogen in women with an intact uterus — even at these relatively high doses — is safe: In the presence of appropriate surveillance, this treatment did not raise risk for endometrial cancer. For women with an intact uterus who are concerned about excess risk for breast cancer with use of estrogen–progestin therapy, unopposed estrogen may be offered if they are willing to undergo vaginal ultrasound and endometrial biopsy for any genital-tract bleeding. A short commentary accompanying the paper by Cherry et al. was written by Dr. Andrew Kaunitz, Editor-in-Chief of NEJM Journal Watch Women's Health; however, Dr. Kaunitz had no role in the preparation of this summary.
Citation(s): Cherry N et al. Long-term safety of unopposed estrogen used by women surviving myocardial infarction: 14-year follow-up of the ESPRIT randomised controlled trial. BJOG 2014 Feb 18; [e-pub ahead of print].
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MM: We have truly become a bionic people! There is no need to wait for science fiction.
We are living it!

Joint Replacement Numbers may Surprise You!
By Joe Elia
More than 2% of everyone in the U.S. has had a hip or knee replacement, the Associated Press reports from the American Academy of Orthopaedic Surgeons' annual meeting.
Among those older than 50, about 5% have had a knee replaced.
Over a million knee and hip joints are replaced in the U.S. annually, and up to 12% of these "may face future revision," according to an announcement at the conference from the American Joint Replacement Registry.
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MM: With migraine, an ounce of prevention is worth a pound of cure. There are many possible triggers for a migraine and identification of those triggers may be the first step in treatment or better yet, prevention. Some of these triggers may be dietary, hormonal or environmental. I have had patients who were so poisoned by environmental toxins that had been trapped in their fatty tissue and were slowly leaching into their bloodstream that they thought that they were doomed to have migraines forever. This was not the case. We have had more than a dozen patients with histories of migraine who experienced the virtual or complete elimination of these attacks secondary to their use of the HCG Metabolic Syndrome and Weight Loss protocol. Please contact your Mark Drugs pharmacist for more information on this topic.
Neurology 2014 Feb 12
Which Parenteral Treatment Is Best for Acute Migraine?
A randomized, double-blind, comparative-efficacy trial suggests that intravenous valproate is inferior to both metoclopramide and ketorolac for treatment of acute migraine.
Treatment for acute migraine is a common reason for emergency department (ED) visits, where adequate therapy can prevent admission for symptom control. In this study, researchers randomized 330 patients presenting to a single ED with acute migraine to receive one of three parenteral therapies: valproate (1 g), metoclopramide (10 mg), or ketorolac (30 mg). Baseline pain severity on a verbal 0-to-10 scale was ≥7 in all enrolled patients. The primary outcome was improvement in pain severity 1 hour after treatment, with a between-group difference of 1.3 points representing a minimum clinically significant change. The authors performed an intention-to-treat analysis for each of the three pairwise comparisons.
Valproate recipients improved by 2.8 points, compared with 4.7 points for metoclopramide and 3.9 points for ketorolac. More valproate recipients required additional rescue medications (69%) compared with metoclopramide (33%) and ketorolac recipients (52%). Despite a 6% incidence of feeling “very restless” in the metoclopramide group (vs. 1% each in the valproate and ketorolac groups), a greater proportion of metoclopramide recipients would want to receive the same medication at a future ED visit for migraine compared with the other two groups (61%,vs. 26% valproate and 40% ketorolac).
Comment: Several small, open-label series have shown intravenous valproate to be an effective acute migraine therapy. In most of the small, randomized trials, valproate was similarly or more efficacious compared with other commonly used acute migraine treatments, including two trials with metoclopramide as part of the comparator group. This trial is by far the largest and showed valproate to be inferior to metoclopramide. Metoclopramide also trended toward being superior to ketorolac on most outcomes. Almost all patients enrolled in this study were not taking a migraine preventive, and the generalizability of these results to a more severe or refractory population is not known. Even with the use of additional rescue medications, few patients in all groups experienced sustained headache freedom for 24 hours (valproate 4%; metoclopramide 11%; ketorolac 16%), highlighting an unmet need in the acute treatment of severe migraine.
Citation(s): Friedman BW et al. Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine. Neurology 2014 Feb 12; [e-pub ahead of print].
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MM: This study had a miniscule number of participants that makes the results highly questionable. The HC/HC patients started with a more favorable profile than the other groups and this may have contributed to the outcome. Unfortunately, allopathic medicine offers nothing of any real value to this patient group so there was nothing to lose by trying these methods. Who knows., maybe future studies will exhibit these same or similar results. When that happens I will be more optimistic with this approach.
Lancet 2014 Feb 28
Potential Benefits of Nutritional Support in ALS
A small, phase II, randomized trial raises the possibility that caloric supplementation with high-carbohydrate feeds may benefit patients with amyotrophic lateral sclerosis.
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that has proven stubbornly resistant to therapy development efforts. The absence of effective drug therapies has focused attention on the importance of comprehensive multidisciplinary care and the potential utility of nonpharmacological measures such as respiratory and nutritional support. Investigators undertook this small, randomized, double-blind, placebo-controlled trial of a hypercaloric diet in ALS patients already receiving percutaneous enteral nutrition. Twenty-four participants were randomized 1:1:1 to receive 4 months of treatment with a high-carbohydrate hypercaloric (HC/HC) diet, a high-fat hypercaloric diet (HF/HC) — each with the goal of mild weight gain — or an isocaloric diet with the goal of weight stability (control).
Four participants withdrew consent before starting the study diet. At baseline, the HC/HC group was slightly younger and had a shorter disease duration and less frequent need for noninvasive ventilation than the other groups and had a higher frequency of riluzole use than the control group. For the primary outcome of tolerability, 7 of 8 HC/HC participants (88%) and 5 of 6 HF/HC participants (83%) completed the trial on the assigned diet, meeting predefined tolerability criteria. For the secondary outcomes, both controls and HC/HC subjects gained weight (mostly fat mass), whereas the HF/HC group lost weight (mostly lean body mass). Rates of decline of the revised ALS functional rating scale and vital capacity were comparable across the treatment groups, but there were no deaths in the HC/HC group, compared with 3 of 7 in the control group (43%) and 1 of 8 (13%) in the HF/HC group.
Comment: The results of this trial, as with so many small phase II trials, are difficult to interpret. The possible survival advantage observed in the high-carbohydrate hypercaloric diet group is potentially confounded by their more favorable clinical profile. So, should these results change practice? A hypercaloric diet is relatively easy to implement in patients with feeding tubes. However, the benefits of this approach are far from proven. As the authors note, only the results of a large randomized trial will definitively address this important question.
Citation(s): Wills A-M et al. Hypercaloric enteral nutrition in patients with amyotrophic lateral sclerosis: A randomised, double-blind, placebo-controlled phase 2 trial. Lancet 2014 Feb 28; [e-pub ahead of print].
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MM: There is nothing as effective in adjusting a child's behavior as direct involvement. It is too easy to be distracted from our kids by the outside world. Whether it is angry Birds, text messages or simply talking on the phone, we need to pay attention to and engage our kids. I realize that we all need an occasional break but when we are in public or they are not interacting with other children, then we need to be intellectually, emotionally and physically present.
Caregivers Often Absorbed in Mobile Devices During Meals Out With Kids
By Kelly Young
Caregivers frequently use their mobile devices when eating out with children and often become absorbed in the devices, researchers observed in a study in Pediatrics.
Acting like anthropologists, the researchers sat in fast food restaurants and observed 55 anonymous caregivers with children (who appeared to be aged 0 to 10 years). During the course of the meal, 40 caregivers used a mobile device, 16 of whom used it almost continuously.
While the adults were absorbed in their devices, children often engaged in limit-testing behavior. Adults who were paying attention to their devices often responded by first ignoring the behavior and then scolding the child, giving robotic instructions without looking at the child, not addressing the child's needs, or responding physically.
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MM: Azithromycin and Levofloxacin are considered somewhat broad spectrum drugs. They have a detrimental effect on skeletal muscles and other connective tissue. Now we see that they also have a negative effect on the heart. In general, antibiotics are not the answer and should not be our go to treatment of choice. In many cases, a wait and see attitude is of benefit. Unfortunately, clinicians all too often feel that they must treat a condition as if it is a catastrophic and lie-threatening condition. When it is, then it is appropriate to use these very powerful antibiotics. However, they should be reserved for those cases irrespective of whether the patient is a small child or an elderly patient.
Azithromycin, Levofloxacin Linked to Increased Risks for Arrhythmia and Mortality Compared to Amoxicillin
By Amy Orciari Herman
Azithromycin and levofloxacin carry higher arrhythmia and mortality risks than amoxicillin, according to an observational study in the Annals of Family Medicine. The FDA issued a cardiac warning on azithromycin in March 2013.
Researchers studied nearly 1.8 million U.S. veterans (mean age, 57) who received outpatient prescriptions for one of the three antibiotics from 1999 to 2012. On weighted analysis, the numbers of deaths by day 5 of treatment per million antibiotics dispensed were 154 for amoxicillin, 228 for azithromycin, and 384 for levofloxacin. Patients receiving azithromycin had roughly a 50% increased risk for death and an 80% increased risk for serious arrhythmia, compared with those on amoxicillin. Risk increases were even greater for levofloxacin.
The researchers conclude: "There are usually multiple antibiotic choices available for older patients, especially those with cardiac comorbidities; physicians may consider prescribing medications other than azithromycin and levofloxacin."
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MM: Testosterone dosing is being mis-used and abused. Many men have been convinced by TV, radio and magazine Ads that they have "Low T", and that by correcting this condition they will obtain the equivalence of the fountain of youth. Many men may indeed have this condition and require treatment but unfortunately there are quite a few clinicians who are failing to do the appropriate initial and follow-up testing to determine whether this is a legitimate concern or not. rather, there are likely many more men who are suffering from adrenal fatigue which is a much more challenging condition to remedy. It can't be changed by a simple cream or a shot. It requires a lifestyle change, a dietary change and an attention to one's self that many people are unwilling to do.
J Clin Endocrinol Metab 2014 Mar; 99:835
Trends in Management of Testosterone in the U.K. and the U.S.
During the past decade, testing and treatment have risen substantially — especially in the U.S.
In a new study, researchers evaluated a U.S. insurance claims database and a U.K. general practice database to document trends in testosterone testing and prescribing in these two countries during the past decade. Findings include the following:

Comment: Not unexpectedly, testosterone testing and prescribing have increased more dramatically in the U.S. than in the U.K. Heavy drug-company marketing of transdermal testosterone products — including direct-to-consumer advertising in the U.S. — surely accounts for some of these findings. High rates of treatment without testing, treating men with normal blood testosterone levels, and prescribing for ill-defined symptoms such as “fatigue” frankly are appalling, especially in view of recent concern about adverse cardiovascular effects of testosterone therapy (NEJM JW Gen Med Feb 4 2014 and NEJM JW Gen Med Nov 19 2013).
Citation(s): Layton JB et al. Testosterone lab testing and initiation in the United Kingdom and the United States, 2000 to 2011. J Clin Endocrinol Metab 2014 Mar; 99:835.
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MM: Here is my geek of the week article. This is the research that Stan Lee alludes to when de created the Amazing Hulk!
Nature 2014 Feb 20; 506:316
Can We Reverse Age-Related Loss of Muscle Mass?
In a mouse model, researchers have discovered a molecular target for preventing sarcopenia of aging.
We've all seen it, in our patients and in ourselves: As we grow older, we lose muscle mass and restoring that mass with exercise gets more difficult. In mammals, muscle contains tissue-specific adult stem cells (called satellite cells) that are recruited to produce new myocytes in response to muscle damage or stress. For some reason, these satellite cells become less vigorous with age.
A team from Spain studied this phenomenon in mice. The investigators confirmed that, in older mice, satellite cells are less able to accomplish the two things muscle stem cells need to do: reproduce and differentiate into muscle tissue. Instead, the satellite cells entered senescence. The investigators compared the gene expression profiles of satellite cells in younger versus older mice and identified a particular molecule that appeared to be critical in driving older satellite cells into senescence. When production of that molecule was “silenced” by RNA interference technology (NEJM JW Gen Med Dec 31 2003), satellite cells no longer entered senescence and retained full stem cell function.
Comment: This report of skeletal muscle rejuvenation in mice mirrors reports of similar rejuvenation of cardiac muscle (NEJM JW Gen Med Jan 17 2013 and NEJM JW Gen Med May 23 2013). These researchers might have identified a potential molecular target for preventing or even reversing the sarcopenia of aging.
Citation(s): Sousa-Victor P et al. Geriatric muscle stem cells switch reversible quiescence into senescence. Nature 2014 Feb 20; 506:316.

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