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Content 7

 

The Doctor and the Pharmacist

Radio Show Articles:
June 18, 2011

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Transdermal Estrogen Might Not Raise Risk for Recurrent Thrombosis
Managing Obesity in Primary Care: The Challenge Continues
Olive Oil Use Associated with Lower Stroke Risk
Back-Sleeping in Last Night of Pregnancy Linked to Stillbirth
Another Reason to Promote Breast-Feeding: Fewer Behavior Problems
Antibiotics Are Not Equal to Appendectomy for Appendicitis
Women’s Facial Wrinkles Reflect Their Bone Density
How New-Onset Atrial Fibrillation Affects Survival in Healthy Women
PPIs Might Decrease the Effectiveness of Alendronate to Prevent Fractures
Functional Dyspepsia Linked to Disordered Sleep
Barrett Esophagus Progresses to Cancer Less Often Than Previously Thought
Researchers Question Safety of Mist Inhalers for Delivering Common Drug for
  Chronic Lung Disease

Menopause 2011 May; 18:488
Transdermal Estrogen Might Not Raise Risk for Recurrent Thrombosis
In a small study, oral — but not transdermal — estrogen was associated with excess risk for recurrent venous thromboembolism.
     Oral estrogen therapy raises risk for venous thromboembolism (VTE) in postmenopausal women, so its use generally is contraindicated in women with histories of VTE. Now, French investigators retrospectively assessed the effects of oral and transdermal estrogen on risk for recurrent VTE in 1023 postmenopausal women (age range, 45–70) with prior confirmed first VTE.
     Overall, 130 women used hormone therapy after first VTE; of these, 103 used transdermal estrogen and 10 used oral estrogen. Seventy-seven women experienced recurrent VTE during a mean of 79 months after discontinuing anticoagulant therapy. After adjustment for several potential confounders, no significant association was found between recurrent VTE and use of transdermal estrogen (hazard ratio, 1.0) compared with nonuse. But women who used oral estrogen had significantly increased risk (HR, 6.4).
     Comment: This provocative — but far from definitive — study is limited by inadequate dosing information and small size (recurrent VTE occurred in only 2 and 6 users of oral and transdermal estrogen, respectively). Nonetheless, the results provide additional evidence that VTE risk might differ with route of estrogen administration. The findings also suggest that transdermal estrogen (preferably at low doses) might be considered with caution for women with prior VTE who have intractable menopausal symptoms. As an editorialist notes, use of transdermal estrogen might also be extended to include symptomatic postmenopausal women who have substantial risk factors for thrombosis.
Robert W. Rebar, MD Published in Journal Watch Women's Health June 16, 2011
     Citation(s): Olié V et al. Hormone therapy and recurrence of venous thromboembolism among postmenopausal women. Menopause 2011 May; 18:488.
Lobo RA. Risk of venous thromboembolism by route of administration of estrogen. Menopause 2011 May; 18:469.
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Arch Pediatr Adolesc Med 2011 Apr 4
Managing Obesity in Primary Care: The Challenge Continues
A multicomponent primary care obesity intervention for young children did not have a significant effect on body-mass index.
     Few randomized trials indicate that primary care–based interventions for obesity in children lead to sustained reductions in body-mass index (BMI). The most convincing study involved 12 weeks of cognitive behavioral therapy. Even fewer data are available about management of obesity in preschool children. In a study of 475 children (age range, 2–6 years) with BMI >95th percentile (or >85th percentile if 1 parent was overweight), researchers compared 1-year outcomes between children at five practices randomized to provide a primary care–based intervention and those at five practices randomized to provide usual care. The inte rvention involved restructuring of practices based on a chronic care disease model and training nurses to use motivational interviewing and educational modules for families. Usual care involved well-child visits and follow-up appointments for checking weight.
     At baseline, mean BMI was 19.2 kg/m2 and 19.1 in the intervention and usual-care groups. At 1 year, BMI had increased by similar amounts in the two groups (mean increase, 0.31 and 0.49, respectively). In adjusted multivariate analysis, the intervention group had a smaller nonsignificant change in mean BMI compared with the usual-care group, a significantly greater relative reduction in television viewing, (–0.36 hours/day), and a nonsignificant reduction in intake of fast food and sugar-sweetened beverages. Post hoc analyses showed significant effects from the intervention on BMI among girls but not boys and among participants in households with annual incomes of ≤ US$50,000.
Comment: The late child psychiatrist Leon Eisenberg said that "Time with the patient will remain the currency of medical care." Taking adequate time to develop a therapeutic alliance with children and their parents can result in behavioral change, but the effect on childhood obesity is limited. The intervention in this study required a huge commitment for behavioral management, practice restructuring, and clinician training. Even so, BMI measurements at 1 year did not differ between patients who received the intervention and those who received usual care. Data for school-age children and adolescents are somewhat more encouraging but are limited to well-controlled environments with funding for personnel. Until we have interventions with long-term effects, we can do our best to encourage weight reduction through diet and physical activity, recognizing that our efforts may have limited benefits.
Martin T. Stein, MD Published in Journal Watch Pediatrics and Adolescent Medicine May 25, 2011
     Citation(s): Taveras EM et al. Randomized controlled trial to improve primary care to prevent and manage childhood obesity: The High Five for Kids study. Arch Pediatr Adolesc Med 2011 Apr 4; [e-pub ahead of print]. (http://dx.doi.org/10.1001/archpediatrics.2011.44)
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http://www.neurology.org/content/early/2011/06/15/
WNL.0b013e318220abeb.abstract
Olive Oil Use Associated with Lower Stroke Risk
     Regular use of olive oil confers a lower risk for ischemic stroke, according to a French cohort study reported in Neurology.
     Olive oil use was gauged by dietary recall at baseline in some 7600 subjects followed for a median of 5 years. All participants were aged 65 or older; a subgroup of 1200 underwent baseline measurement of plasma fatty acids.
     Compared with nonusers, there was a 41% lower risk for stroke among intensive users of olive oil — i.e., using the oil in dressings as well as for cooking. Similarly, plasma oleic acid levels among the tested subgroup roughly paralleled olive oil intake and an accompanying lower stroke risk.
     Editorialists agree with the authors that oleic acid is only an indirect — and as yet unvalidated — measure of olive oil use.
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http://www.bmj.com/content/342/bmj.d3403.full
Back-Sleeping in Last Night of Pregnancy Linked to Stillbirth
     Women who sleep on their backs during pregnancy might face higher risk for stillbirth than those who sleep on their left sides, according to a case-control study in BMJ.
     Researchers in New Zealand matched, by gestational age, 155 women who experienced stillbirths at 28 weeks' gestation or later with 310 pregnant women who did not have a stillbirth. After multivariable adjustment, women who reported going to sleep in a position other than on their left side on the last night of their pregnancy had twice the risk for stillbirth as those who fell asleep on their left side. Sleeping on one's back accounted for most of the increased risk.
     The authors note that sleeping in the supine position may reduce cardiac output and fetal oxygen saturation.
     Editorialists conclude: "Although the message for mothers to sleep on their left is probably harmless and may be helpful, this study should be seen as one that only generates a hypothesis that needs validation."
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Arch Dis Child 2011 Jul; 96:635
Another Reason to Promote Breast-Feeding: Fewer Behavior Problems
Even after adjustment for confounders, term infants who were breast-fed for ≥4 months were significantly less likely to have parent-reported behavioral problems at age 5 years than infants who were never breast-fed.
     The influence of breast-feeding on behavioral development is uncertain. Investigators in the U.K. used data from a large national cohort to examine the association between duration of breast-feeding and parent-reported behavioral development in 9525 term and 512 preterm singleton white infants born in 2000–2001. Parents (mostly mothers) were surveyed about feeding history when infants were age 9 months and completed the Strengths and Difficulties Questionnaire (SDQ) to assess their child's behavior at age 5 years.
     Overall, 29% of term and 21% of preterm infants were breast-fed for ≥4 months. Nearly 12% of term and 15% of preterm children had abnormal SDQ scores at age 5 years. In logistic regression (adjusted for demographic and socioeconomic factors, mother's mental health, and mother–infant attachment), term infants who were breast-fed for ≥4 months had significantly lower odds of having abnormal SDQ scores than children who were never breast-fed (adjusted odds ratio, 0.67; 95% confidence interval, 0.54–0.83; P<0.001). Results were similar for any or exclusive breast-feeding and across all SDQ subscales, although risk was lowest for conduct and emotional problems and inconsistent for hyperactivity, peer problems, or prosocial behavior. In preterm infants, the association between breast-feeding and lower risk for abnormal SDQ scores was no longer statistically significant in adjusted analysis (including adjustment for admission to the neonatal intensive care unit).
     Comment: A potential benefit of breast-feeding on childhood behavior in term children is another reason to promote breast-feeding. The benefit in preterm infants was less certain. This study cannot determine whether the benefit is a result of the nutrient content of breast milk or mother–infant attachment. The message continues to be breast is best for all infants.
F. Bruder Stapleton, MD Published in Journal Watch Pediatrics and Adolescent Medicine
June 15, 2011
     Citation(s):Heikkilä K et al. Breast feeding and child behaviour in the Millennium Cohort Study. Arch Dis Child 2011 Jul; 96:635. (http://dx.doi.org/10.1136/adc.2010.201970)
http://www.ncbi.nlm.nih.gov/pubmed/21555784?dopt=Abstract
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Lancet 2011 May 7; 377:1573
Antibiotics Are Not Equal to Appendectomy for Appendicitis
The incidence of peritonitis at 30 days was higher in the antibiotic group than in the surgery group; 68% of patients treated with antibiotics did not require appendectomy.
     Four recent randomized trials suggest that antibiotics alone can cure uncomplicated appendicitis or be used as first-line treatment. In this noninferiority trial, 239 adults with computed tomography–confirmed acute uncomplicated appendicitis at six academic hospitals in France were randomized to receive amoxicillin plus clavulanic acid (3 g daily for 8 to 15 days) or emergent appendectomy.
     Incidence of peritonitis at 30 days, the primary endpoint, was significantly higher in the antibiotic group than the surgery group (8% vs. 2%). Overall, 68% of antibiotic-treated patients did not require appendectomy during 1 year of follow-up.
     Comment: Although at first glance the results of this trial support emergency appendectomy over antibiotics, the result might have been different if researchers had chosen a higher noninferiority margin and more-appropriate antibiotics (i.e., better Escherichia coli coverage). Appendectomy remains, for now, the sole treatment modality for uncomplicated appendicitis in the U.S., even though it is associated with a complication rate as high as 23%, including a 3% rate of bowel obstruction, within 10 years.
John A. Marx, MD, FAAEM Published in Journal Watch Emergency Medicine June 3, 2011
Citation(s): Vons C et al. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: An open-label, non-inferiority, randomised controlled trial. Lancet 2011 May 7; 377:1573.
http://www.ncbi.nlm.nih.gov/pubmed/21550483?dopt=Abstract
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http://www.imakenews.com/eletra/mod_print_view.cfm?this_id=2129563&u=
vitalchoiceseafood&show_issue_date=F&issue_id=000524563&lid=bjBtQqj&uid=b1h1R7NC

Women’s Facial Wrinkles Reflect Their Bone Density
Extent of women’s facial wrinkles in early menopause predicted their bone-scan results; novel finding may help reveal women’s osteoporosis/fracture risk
by Craig Weatherby
     Unprecedented clinical tests showed that the severity of a woman's face/neck wrinkles during early menopause reflects her bone density. In postmenopausal women the appearance of the skin may offer a glimpse of the skeletal well-being, a relationship not previously described,” said lead author Lubna Pal, M.D., an associate professor at Yale University School of Medicine.
     The study demonstrates only an association between bone density and skin wrinkling, stressed Dr. Pal. But as described in our sidebar – see “Skin, bones, and omega-3s”, below – these two kinds of connective tissue share key characteristics that support the plausibility of wrinkle-bone links. And as Dr. Pal said, “This information may allow for the possibility of identifying postmenopausal women at fracture risk at a glance, without dependence on costly tests.” Dr. Pal's findings apply only to wrinkle severity during early menopause, and the power of wrinkles to predict bone density would be weakened by skin-aging factors like smoking and sun exposure. Also, since facial wrinkles increase naturally over time, the usefulness of using them to predict bone density at a glance probably lessens as menopause recedes further into a woman's past. Let's take a closer look at these remarkable, promising results, presented earlier this month at The Endocrine Society’s 93rd Annual Meeting in Boston.
Study ties bone strength to skin smoothness
The study was part of an ongoing trial called the Kronos Early Estrogen Prevention Study, or KEEPS.
     It included 114 women in their late 40s and early 50s who’d had their last menstrual period within the past three years and who were not taking hormone therapy. (Women were excluded from participating if they had undergone any cosmetic skin procedures.) The women’s wrinkles were measured at 11 sites on their face and neck, and each participant received a score based on the number of sites with wrinkles and the depth of the wrinkles. The skin firmness or rigidity was measured at the forehead and the cheek with a device called a durometer. Study participants also underwent measurement of bone density by dual X-ray absorptiometry (DEXA) and by a portable heel ultrasound device. The investigators found a significant inverse correlation between the wrinkle score and the bone density, meaning the higher the score (and the worse the wrinkles), the lower the bone density. This relationship was evident in all skeletal areas – hip, lumbar spine and heel – and was independent of age, body composition, or other factors known to influence bone density. As one might expect from the link between severe wrinkling and low bone density, having firmer skin of the face and forehead was associated with greater bone density. As the authors concluded, “In a population of early postmenopausal women, study of the skin is observed to provide a glimpse into the status of the skeleton, a relationship not previously described.”
Wrinkle-bone connection could be collagen-related
     Although the connection between bones and skin may seem unclear, Pal explained that they share common building blocks … the group of connective-tissue proteins known as collagens. As we age, changes in collagen occur that account for age-related skin changes including worsening skin wrinkles and sagging skin … and also contribute to declines in bone quality and quantity.
     The authors say that long-term studies are needed to substantiate a relationship between wrinkles and the risk of bone fracture. “Ultimately, we want to know if intensity of skin wrinkles can allow identification of women who are more likely to fracture a bone, especially the femoral neck or the hip, an often fatal injury in older people,” said Dr. Pal. And as she said, her team’s findings hold serious implications for revealing women’s bone health while curbing the rise in health care costs tied to pricey bone-scan technology:If this is the case, then including the study of skin wrinkles to other clinical risk factors may allow identification of fracture risk in populations that do not have access to more costly technology.” (ES 2011)
     Sources: Pal L et al. [P3-126] Skin Wrinkling and Rigidity Are Predictive of Bone Mineral Density in Early Postmenopausal Women. Monday, June 6, 2011, 1:30 pm. ENDO 2011 - Endocrine Society 93rd Annual Meeting in Boston. Accessed at http://www.abstracts2view.com/endo/view.php?nu=ENDO11L_P3-126. The Endocrine Society. Severity of facial wrinkles may predict bone density in early menopause. June 4, 2011. Accessed at http://www.eurekalert.org/pub_releases/2011-06/tes-sof060311.php
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JAMA 2011 May 25; 305:2080
How New-Onset Atrial Fibrillation Affects Survival in Healthy Women
Risk for premature death was elevated for both cardiovascular and noncardiovascular causes.
     Whereas some studies — particularly the Framingham Heart Study — have shown excess long-term mortality in people with new-onset atrial fibrillation (AF), others have not. Because the Framingham study showed greater excess mortality for women than for men with incident AF, investigators conducted a prospective cohort follow-up of the Women's Health Study to assess mortality in nearly 35,000 women without prior adverse cardiovascular events. The median age at study enrollment was 53 for women without subsequent incident AF. Women who developed incident AF were substantially older (59 at baseline) and had a higher prevalence of hypertension and hypercholesterolemia.
     During median follow-up of 15.4 years, 1011 women developed AF, and 63 of them died (28 of 656 with paroxysmal AF). In adjusted analyses, the hazard ratio for all-cause mortality in women with incident AF was 2.1 (cardiovascular, 4.2; noncardiovascular, 1.7). When risk was adjusted additionally for the occurrence of nonfatal adverse cardiovascular events, mortality was attenuated but still elevated (all-cause, 1.7; cardiovascular, 2.6; noncardiovascular, 1.4). However, in the fully adjusted model, mortality was not elevated in patients with only paroxysmal AF (as opposed to persistent or chronic AF). In 74 women with "lone" AF, no deaths occurred during 7 years of follow-up.
     Comment: Editorialists question whether these women can be considered "healthy," given that a high prevalence of hypertension and hypercholesterolemia (about 40% for each) suggests the presence of subclinical cardiovascular disease. Aggressive treatment to manage cardiovascular risk factors and to prevent stroke are recommended for women with incident AF.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine June 16, 2011
     Citation(s): Conen D et al. Risk of death and cardiovascular events in initially healthy women with new-onset atrial fibrillation. JAMA 2011 May 25; 305:2080. (http://dx.doi.org/10.1001/jama.2011.659)
http://www.ncbi.nlm.nih.gov/pubmed/21610240?dopt=Abstract
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Arch Intern Med 2011 Jun 13; 171:998
PPIs Might Decrease the Effectiveness of Alendronate to Prevent Fractures
Concurrent use of proton-pump inhibitors blunted the efficacy of the bisphosphonate in reducing risk for hip fractures in patients aged 70 and older.
     Alendronate, a bisphosphonate, is frequently used to prevent osteoporotic fractures in elders. Proton-pump inhibitors (PPIs) are also commonly prescribed in this population, sometimes to treat gastrointestinal symptoms from the bisphosphonate. Some studies suggest that PPIs decrease absorption of bisphosphonates, calcium, and vitamin B12; others imply a direct association between PPIs and risk for hip fracture, but findings have been mixed (JW Gastroenterol May 21 2010).
     To address the potential impact of PPI use on the efficacy of alendronate, investigators used national databases from Denmark to identify 38,088 new users of alendronate during a 10-year period. Researchers followed these patients for a mean of 3.5 years, monitoring their alendronate and PPI use and occurrences of hip fractures.
     Alendronate use alone was associated with a reduced risk for hip fractures (hazard ratio, 0.61; 95% confidence interval, 0.52–0.71), but concurrent use of PPIs was not (HR, 0.81; 95% CI, 0.64–1.01). The latter result was limited to patients aged 70 and older. PPI use was not associated with nonhip osteoporotic fractures, with or without concurrent use of histamine-2 receptor antagonists.
     Comment: The authors conclude that concurrent PPI use attenuates the beneficial effect of alendronate to prevent hip fractures and suggest that PPI use should be avoided in patients taking oral bisphosphonates. Although this population-based study is large and well executed, the conclusions might be somewhat overstated; data on other bisphosphonates are not included, and the result for concurrent use of PPIs was borderline statistically significant and limited to patients aged 70 and older. Nonetheless, these results warrant some caution with regard to PPI use among older patients taking alendronate; they also warrant additional studies to establish causality and the mechanism of this observed effect.
David J. Bjorkman, MD, MSPH (HSA), SM (Epid.) Published in Journal Watch Gastroenterology June 17, 2011
Citation(s): Abrahamsen B et al. Proton pump inhibitor use and the antifracture efficacy of alendronate. Arch Intern Med 2011 Jun 13; 171:998. http://www.ncbi.nlm.nih.gov/pubmed/21321287?dopt=Abstract
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Clin Gastroenterol Hepatol 2011 May; 9:410.
Functional Dyspepsia Linked to Disordered Sleep
But, the nature of the association remains unclear.
     Although gastroesophageal reflux disease (GERD) and irritable bowel syndrome have been associated with sleep disorders, a link between functional dyspepsia (FD) and sleep disorders has not been established.
     Now, investigators have examined the magnitude and extent of sleep disorders in 121 adults who met Rome III criteria for FD and 50 healthy controls without dyspepsia or potentially confounding comorbid conditions. Participants completed validated questionnaires about general health, depression, and sleep disorders.
     Mean scores for anxiety and depression were significantly higher for FD patients than controls. FD patients with moderate or severe symptoms had poorer sleep quality and insomnia index scores than did FD patients with mild symptoms or controls. Multivariate analysis showed that FD (odds ratio, 3.25; 95% confidence interval, 1.47–7.20) and female sex (OR, 2.36; 95% CI, 0.99–5.7) were independently associated with sleep disorders.
      Comment: The authors concluded that FD is associated with disordered sleep, particularly in patients with more-severe symptoms and higher levels of anxiety. However, it is difficult to determine whether a cause-and-effect relationship exists between FD and disordered sleep — or whether both are part of a broader symptom complex.
David J. Bjorkman, MD, MSPH (HSA), SM (Epid.) Published in Journal Watch Gastroenterology June 17, 2011
     Citation(s): Lacy BE et al. Functional dyspepsia is associated with sleep disorders. Clin Gastroenterol Hepatol 2011 May; 9:410.
http://www.ncbi.nlm.nih.gov/pubmed/21334461?dopt=Abstract
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Barrett Esophagus Progresses to Cancer Less Often Than Previously Thought
     A recalculation of the rate at which Barrett esophagus progresses to cancer calls into question the frequency of surveillance endoscopy for follow-up of this condition, according to a Journal of the National Cancer Institute study.
     The recalculation is based on outcomes in some 8500 patients with Barrett esophagus included in Northern Ireland registries. After a mean 7 years' follow-up, progression to cancer of the esophagus or gastric cardia or the development of high-grade dysplasia was 0.22% per year for the entire cohort. (The authors cite studies estimating progression rates twice as high.)
     Progression was highest among those with low-grade dysplasia at initial biopsy (1.40% vs. 0.17% in those without dysplasia). Rates were also elevated among patients with specialized intestinal metaplasia on biopsy (0.38% vs. 0.07%).
An editorialist concludes that surveillance in patients with intestinal metaplasia may be cost-effective, "if surveillance or treatment is effective (an unproved tenet to date)."
http://jnci.oxfordjournals.org/content/early/2011/06/16/jnci.djr203.abstract
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Researchers Question Safety of Mist Inhalers for Delivering
Common Drug for Chronic Lung Disease

     The British Medical Journal reports that patients who use a mist inhaler to deliver a drug widely prescribed in more than 55 countries to treat chronic obstructive pulmonary disease (COPD) may be 52 percent more likely to die, new Johns Hopkins-led research suggests. The mist inhaler delivers the soluble form of tiotropium (Spiriva®). The mist inhaler has not yet gained regulatory approval in the U.S., but the drug in its powdered form is commonly used to treat COPD here.
     Thoughts are that the problem is that the mist inhaler is delivering a higher concentration of tiotropium than it should be and that may be increasing the risk of death. The increased deaths linked to the inhaler are primarily from cardiovascular disease.
http://pharmalive.com/news/index.cfm?articleID=788197&categoryid=9&newsletter=1

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