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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
September 20, 2014

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Skin Closure After C-Section with Sutures vs. Staples
Is Menopausal Hormone Replacement Therapy Cardioprotective?
Health Outcomes as Drivers of Trends in Hormone Therapy Use
Review Examines Efficacy and Safety of Osteoporosis Dr
Screening All Women Up to Age 75 for Breast Cancer "May Lead to Overdiagnosis"
Antibiotics Prescribed Nearly Twice as Often as Expected in Pediatric Acute
   Respiratory Infections
Older Adults Commonly Overscreened for Cancer
Bisphosphonate-Related Osteonecrosis of the Jaw, Revisited
Could Rapid Breast MRI Supplant Screening Mammography?

MM: I found this particular study interesting. Ease of use with staples had been a big reason that surgeons may be encouraged to use them but I have had a number of patients who have had both methods of wound closure who have said that there was much more post-surgical pain associated with staples tan with sutures. This study indicates that almost twice as many people experience discomfort and complications with staples when compared to sutures & glue.
Obstet Gynecol 2014 Jun; 123:1169
Skin Closure After C-Section with Sutures vs. Staples
A randomized, controlled trial found better wound healing with sutures.
To compare the rates of complications after wound closure with suture and with staples after cesarean delivery, these authors conducted a randomized clinical trial of 746 women who delivered via low-transverse incisions at three centers. Patients were stratified by body-mass index.
Staples were removed at 4 to 10 days, and suture closure employed subcuticular continuous 4.0 poliglecaprone (e.g., Monocryl) or polyglactin (e.g., Vicryl). Of the suture group, 4.9% had complications, compared with 10.6% of those who had staples (odds ratio, 0.43; 95% confidence interval, 0.23–0.78). Wound separation in particular was more common in the staple group (7.4% vs. 1.6%; OR 0.20; 95% CI, 0.07–0.51). Suturing took considerably more time than stapling, an additional 8 to 9 minutes on average.
Comment: Subcuticular sutures were better for dermal and epidermal abdominal repairs than staples in these patients. Aesthetic outcomes were not assessed, but increased scar spread in the staple group would likely be less attractive. Important confounders are the type of suture used and suturing technique. Also, staples were removed fairly early, but the subcutaneous sutures were left in to dissolve and may have continued to provide tension to approximate the wound for much longer.
Citation(s): Mackeen AD et al. Suture compared with staple skin closure after cesarean delivery: A randomized controlled trial. Obstet Gynecol 2014 Jun; 123:1169. (http://dx.doi.org/10.1097/AOG.0000000000000227)

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MM: Here is an example of where quality of life considerations should be taking precedence over a single proposed benefit of a treatment. The studies indicated that although limited cardiovascular (CV) benefits were noted from ERT, there were also no added statistical dangers associated with ERT. Where they missed the boat in these studies was their failure to include bio-identical progesterone with the estrogen therapy. Had that been done, then they could have seen benefits in all areas.
Ann Intern Med 2014 Aug 19; 161:249.
Is Menopausal Hormone Replacement Therapy Cardioprotective?
HRT improved cardiovascular disease markers but did not affect atherosclerosis progression in recently menopausal women.
Whether hormone replacement therapy (HRT) provides cardioprotective benefits in recently menopausal women remains unclear. To examine this issue, investigators conducted a 4-year, randomized, double-blind, placebo-controlled trial involving 727 recently menopausal women (mean age, 52.7; mean time after menopause, 1.4 years; range, 0.5–3.0 years) without prior cardiovascular disease (NCT00154180).Participants were randomized to one of three treatments: oral conjugated estrogen (OCE; 0.45 mg/day), transdermal 17β-estradiol (t-E; 50 mcg/day), or placebo. Annual change in carotid artery intima-media thickness (CIMT), a measure of atherosclerosis progression, was the primary endpoint. Measurement of CIMT for at least one follow-up visit was available for 89% of participants.
Mean durations of treatment for the OCE, t-E, and placebo groups were 37.4, 34.6, and 37.6 months, respectively; 16, 9, and 12 women, respectively, withdrew after adverse events. Changes in CIMT were similar between the OCE and placebo groups and between the t-E and placebo groups. Changes in coronary calcium scores were similar across groups. Levels of low- and high-density lipoprotein cholesterol improved with OCE. At 6 months, hot flashes were more common in the placebo group than in the OCE and t-E groups. Serious adverse events did not differ by treatment.
Comment: Four years of early postmenopausal HRT did not affect progression of atherosclerosis, but it did improve symptoms and markers of cardiovascular risk. The trial was not designed to detect differences in clinical cardiovascular outcomes; however, given that HRT neither improved nor worsened atherosclerosis, its use for symptom relief in recently menopausal women is probably reasonable.
Citation(s): Harman SM et al. Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women: A randomized trial. Ann Intern Med 2014 Aug 19; 161:249. (http://dx.doi.org/10.7326/M14-0353)

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MM: The WHI study led to a dramatic decrease in women using HT. There was similar decrease in the use of BHRT as well. Some of the good things that came out of this study was the decreased use of drugs like Premarin that caused cancer and the exposure of the misconception that Premarin helped women by giving them cardiovascular protection. This was simply not so. The harm that this study did was to bring back discomfort and misery to many women who would be helped by bio-identical progesterone and transdermal estrogens who became too scared to use these products and whose physicians failed to understand the differences between these products and those that were studied in the WHI. Bio-identical progesterone is extremely safe and effective for bone density, anxiety and in many cases, vasomotor symptoms. Transdermal or intra-vaginal bio-identical estrogens also confer very little risk and an abundance of befefits ranging from vasomotor symptoms, cognition and vaginal dryness or pain with intercourse. Each patient must be individually assessed and tested to determine what is a risk and what is not. A family medical history may be as important as a personal one to truly determine the level of risk that may be present.
Obstet Gynecol 2014 Oct 15; 124:727
Health Outcomes as Drivers of Trends in Hormone Therapy Use
Long-term U.S. data reflect influence of Women's Health Initiative findings.
The use of combined estrogen–progestin therapy has varied greatly during the past few decades. Researchers evaluated U.S. trends in hormone therapy (HT) use by user age and calendar year between 1970 and 2010. Data from the National Health and Nutrition Examination Survey and the National Prescription Audit were combined in an analysis targeting use of noncontraceptive estrogen–progestin preparations of HT.
Before 1980, prevalence of HT use was <1% regardless of a woman's age but increased almost threefold between 1990 and 1999. For women aged 45 to 64, absolute changes in prevalence of HT were 4.4% (1980 to 1990) and 8.8% (1990 to 2000), peaking at an overall prevalence of 13.5% in 1999. Fewer than 5% of women aged ≤45 or ≥75 reported using HT throughout the study period. Among all women, a steep decline in HT use occurred in the early 2000s, resulting in an 85% decrease between 2001 and 2005. In 2006, prevalence among women aged 45 to 64 was just 1.7%.
Comment: Although the Women's Health Initiative (WHI) study is a landmark, the trial has several inherent flaws (most notably, the predominant enrollment of women with a mean age of 65). As the present long-term, population-based analysis indicates, a direct result of the WHI's publication in 2002 was that many clinicians dramatically curtailed — or discontinued — their prescription of hormone therapy, leaving symptomatic women without therapeutic options. More-recent evidence from 13 years of follow-up among WHI participants (JAMA 2013; 310:1353) supports use of various forms of HT for women who experience vasomotor symptoms, vulvovaginal atrophy, and/or dyspareunia during the menopausal transition; also, we must consider the potential benefits of bone support and prevention of osteoporosis in these women
Citation(s): Jewett PI et al. Trends of postmenopausal estrogen plus progestin prevalence in the United States between 1970 and 2010. Obstet Gynecol 2014 Oct 15; 124:727.
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MM: The various reviews of these universally, potentially dangerous drugs have one thing in common. There is very limited benefit to their use. It take a lot of people a long time of use to justify even a single incident of benefit. Vitamin D3 combined with proper diet, nutrition, mineral supplement through natural foods and added physical weight resistant activity has shown equal to superior response when compared to any of these drugs. The added benefit of these non-drug options is that they are easy, safe and effective with virtually no down side.
Review Examines Efficacy and Safety of Osteoporosis Dr
By Amy Orciari Herman
Bisphosphonates, denosumab, teriparatide, and raloxifene all reduce risk for fracture relative to placebo in women with osteoporosis, according to a federally commissioned systematic review that included nearly 300 studies.
Among the findings published in the Annals of Internal Medicine:

Editorialists caution that the findings "may not apply to patients aged 75 years or older, and especially not to those aged 80 years or older with nonskeletal risk factors for falls," as such patients were insufficiently represented in the review.
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MM: Assessing the risk to benefit of a process or procedure should always be a mitigating factor to consider. If a simple lifestyle change can show distinct benefit with little to no expense or risk then it makes sense to perform that activity. On the other hand, if an activity has a significant downside such as incorrect diagnosis or severe diminished quality of life, then its consideration should be regarded much more cautiously. This should be our mantra, not how many patients can we screen and how much extra revenue can it generate.
Screening All Women Up to Age 75 for Breast Cancer "May Lead to Overdiagnosis"
By Kelly Young, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Increasing the upper limit for breast cancer screening from age 69 to 75 in the Netherlands resulted in a slight decrease in diagnoses of advanced breast cancer, while early-stage cancer incidence increased, according to a BMJ study. (The U.S. Preventive Services Task Force recommends biennial screening for women aged 50 to 74.)
Using Dutch cancer registries, researchers assessed incident breast cancer rates among 25,000 women aged 70 to 75 before and after a mass screening program began to include women up to age 75. The incidence rates of early-stage tumors increased after the screening change, from 248.7 to 369.9 cases per 100,000 women before screening. Meanwhile, incidence rates of advanced stage breast cancers slightly decreased from 58.6 to 51.8 cases per 100,000.
The authors say their results imply that "the effect of the screening program in older women is limited and may lead to overdiagnosis."
Further, they write: "We propose that routine breast cancer screening in women aged more than 70 years should not be performed on a large scale. Instead, the harms and benefits of screening should be weighed on a personalized basis, taking remaining life expectancy, breast cancer risk, functional status, and patients' preferences into account."
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MM: Antibiotics have the potential of being lifesaving but their continued misuse and abuse brings with it the potential to completely nullify their benefits. At this point, antibiotic misuse has been reduced dramatically but we still have a long way to go.
Antibiotics Prescribed Nearly Twice as Often as Expected in Pediatric Acute Respiratory Infections
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Antimicrobial drugs are prescribed almost twice as often as expected to pediatric outpatients presenting with acute respiratory tract infections (ARTI) in the U.S., according to a Pediatrics study.
In a meta-analysis, researchers examined studies assessing the bacterial etiologies of ARTIs in children after the licensure of the pneumococcal conjugate vaccine in 2000. Bacteria were isolated in 65% of acute otitis media visits and 20% of pharyngitis visits. The overall estimated bacteria prevalence — and thus expected antimicrobial prescribing rate — for all ARTIs combined was 27%. However, a retrospective cohort analysis of children in ambulatory clinics found that antimicrobials were prescribed in 57% of ARTI visits.
The authors estimate that there are 11.4 million potentially avoidable prescriptions for antibiotics every year for ARTIs and conclude that this area represents "an important target for ongoing antimicrobial stewardship interventions."
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MM: There is a reason that the American healthcare system spends more and gets less for those expenditures than other countries with similar technology and socio-economic demographics. We try to hang on to life for as long as possible irrespective of the quality of life (QOL) or the prognosis associated with that practice. We must understand that it is not possible to live forever, that death is a part of life and finally, we should perhaps focus on the overall quality of life as compared to the length of it. Bigger or longer is not always better. We are better served with adapting our lives to healthier and more fulfilling approaches that would improve that QOL. These things would be interpersonal relationships with friends and family, optimal levels of physical activity and exercise, reasonable limitations on the volume and types of foods regularly consumed and nutritional supplements such as Vitamin D3, vitamin C and probiotics that will enhance the quality of life by reducing inflammation and supporting the overall immune system.
Older Adults Commonly Overscreened for Cancer
By Kelly Young
Two studies in JAMA Internal Medicine delve into the topic of overscreening older adults for cancer.
In the first, researchers calculated 9-year mortality risk for roughly 27,000 people aged 65 and older who completed the National Health Interview Survey. For participants with a 9-year risk of 75% or higher:

In the second study, researchers simulated "recommended screening" for colorectal cancer (colonoscopies at ages 65 and 75), shorter screening intervals, and screening beyond age 75 among average-risk 65-year-old Medicare beneficiaries. Recommended screening translated to a net benefit of 64.5 quality-adjusted life-years (QALYs) gained per 1000 beneficiaries. When screenings were done after age 75, QALYs declined. When the screening interval was shortened from 10 to 5 years, there was a gain of 0.7 QALYs per 1000 beneficiaries, but the cost per additional QALY gained was $711,000.
A commentator recommends that clinicians change the way they speak with older patients about cancer screening, noting that "assessment of life expectancy should inform individual decision making."
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MM: The use of oral bisphosphonates for osteoporosis is a practice that has been demonized due to the low incidence of jaw related adverse effects. These adverse effects are accompanied by a large number of other problems that are more common but perhaps not as sensational. For these reasons, plus the fact that very poor quality bone is made while using this class of drugs, I would strongly discourage their use in favor of other medication choices and lifestyle adaptations such as weight resistant exercise, limiting high glycemic index carbohydrate intake, encouraging the use of vitamin C, D3, Magnesium and food sources of calcium.
J Clin Endocrinol Metab 2014 Aug; 99:2729
Bisphosphonate-Related Osteonecrosis of the Jaw, Revisited
In a study from Taiwan, this condition developed in 1 of every 200 long-term users of oral alendronate.
Bisphosphonate-related osteonecrosis of the jaw (ONJ) consists of exposed necrotic bone that persists for weeks or months; it can occur spontaneously or after invasive dental procedures. The condition was noted initially after high-dose intravenous bisphosphonate treatment for malignant conditions, but some evidence suggests that it can develop in users of oral bisphosphonate for osteoporosis (NEJM JW Gen Med Apr 8 2008). A report from Taiwan adds to the evidence.
Among 7332 patients who were taking oral alendronate (according to a hospital pharmacy database), 40 (0.55%) were diagnosed with ONJ an average of 4 years after initiating alendronate. Cases were verified by manual review of radiographic, operative, and pathology reports. In contrast, in a control group of 1882 patients who were treated for osteoporosis with raloxifene (a non-bisphosphonate), only 1 patient developed ONJ. After adjustment for potentially confounding factors, the incidence of ONJ was sevenfold higher with alendronate than with raloxifene. Risk factors for developing ONJ among users of alendronate included diabetes, rheumatoid arthritis, older age, and alendronate use for >3 years.
Comment: The possibility that oral bisphosphonate therapy might cause osteonecrosis of the jaw (ONJ) received quite a bit of attention about 5 years ago; more recently, the literature has focused on atypical femur fractures after long-term use of oral bisphosphonates (NEJM JW Gen Med Dec 29 2011). This new study provides additional support for jaw osteonecrosis as a likely — although uncommon — adverse effect of oral bisphosphonate therapy.
Citation(s): Chiu W-Y et al. The risk of osteonecrosis of the jaws in Taiwanese osteoporotic patients treated with oral alendronate or raloxifene. J Clin Endocrinol Metab 2014 Aug; 99:2729.

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MM: Rapid Breast MRI appears to be a better screening tool than mammography with fewer false positives and fewer false negatives. It is unlikely, however, that we will see a rapid or even a slow shift to MRI vs mammography as institutions in North America are heavily invested in this older technology and it is likely that insurance companies will only pay for MRI's for higher risk patients. This is a problem as justification of this equipment requires a significant volume to pay the bills.
J Clin Oncol 2014 Aug 1; 32:2304
Could Rapid Breast MRI Supplant Screening Mammography?
A single-center German study shows that a rapid acquisition MRI protocol is as accurate as conventional breast MRI.
Because of high costs, limited access, and patient stress associated with being in a confined space, breast cancer screening with magnetic resonance imaging (MRI) has largely been limited to high-risk women. In a prospective single-center study in Germany, investigators enrolled women who had been referred for breast MRI because of dense breast tissue and/or personal or family histories of breast cancer but normal or benign findings with digital screening mammography and (in many women) breast ultrasound. Participants underwent full diagnostic protocol (FDP) MRI imaging as well as an abbreviated protocol (AP) consisting of subtracted images acquired before and immediately after intravenous administration of contrast material. Among 443 women (mean age, 54; 37% premenopausal), 163 underwent a second annual screen for a total of 606 evaluable MRI studies.
Invasive cancer and ductal carcinoma in situ were detected in 7 and 4 women, respectively, for an additional cancer yield of 18 per 1000 MRI screens. All cancers were detected with the AP and no more were detected between screenings. All invasive tumors were small (median size, 8 mm) and node negative. Acquisition times for the AP and FDP were 184 and 1024 seconds, respectively. Mean radiologist time to interpret the complete AP was 28 seconds. Negative predictive value for the complete AP was 100%.
Comment: Recent reports have highlighted the limitations of screening mammography (e.g., high false-positive rates, diagnosis of clinically unimportant lesions, overlooking aggressive cancers). Unlike mammography, breast MRI detects tumor neovascularity and peritumoral inflammation, explaining its high sensitivity. This proof-of-concept study demonstrates that, in the hands of highly experienced breast imagers, a rapid (and, presumably, less costly) MRI protocol can effectively screen women at excess risk for breast cancer; thus, these results provide the rationale for a large prospective study of conventional or rapid MRI versus mammography for breast cancer screening.
Citation(s): Kuhl CK et al. Abbreviated breast magnetic resonance imaging (MRI): First postcontrast subtracted images and maximum-intensity projection — A novel approach to breast cancer screening with MRI. J Clin Oncol 2014 Aug 1; 32:2304. (http://dx.doi.org/10.1200/JCO.2013.52.5386)

Rethinking breast cancer screening: Ultra FAST breast magnetic resonance imaging. J Clin Oncol 2014 Aug 1; 32:2281.

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