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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
September 17, 2011

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FDA Issues Warning on Arrhythmia Risk with Ondansetron (Zofran®)
An Omega-3 for ADHD Shows Promise
More research supports omega-3, heart health connection
FDA seeks comments on gluten-free food labeling; from niche to mainstream
Antibiotic Resistance Is Nothing New
Breast Cancer Screening Does Not Seem to Reduce Mastectomy Rates
Mammograms: More New Screening Guidelines
FDA Approval of Gabapentin Enacarbil for RLSn
Glucose Variability Affects Hemoglobin A1c
Alzheimer's Patients May Be Helped by Nasal Insulin
Vitamin B May Help Stave off Alzheimer's Disease
Allergan Testing Eyelash Lengthener for Baldness
Risk in COPD Patients
Air Cleaners Reduce Indoor Particulate Matter and Asthma Symptoms
Cardiovascular Risk: What Good Is Identifying the Lowest of the Low?
How Much CPR Before Defibrillation Shock?
Counseling Can Encourage Intake of Cholesterol-Lowering Foods
Breast Cancer in Women Younger Than 25
Fluconazole and Risk for Birth Defects

MM: A very effective alternative for nausea or anxiety is the compounded transdermal ABDR aka GRALA Cream. This compound typically contains a combination of Lorazepam(Ativan®), Diphenhydramine(Benadryl®), Dexamethasone(Decadron®), Metoclopramide(Reglan®) and /or haloperidol (Haldol®). It is typically applied 2-4 times daily to the wrist or throat
FDA Issues Warning on Arrhythmia Risk with Ondansetron (Zofran®)
     The antinausea drug ondansetron (marketed as Zofran and in generic forms) should not be used in patients with congenital long QT syndrome, as they are at particular risk for developing torsade de pointes while taking the drug, the FDA warned on Thursday.
     Also at increased risk are patients with congestive heart failure or bradyarrhythmias, those predisposed to low potassium and magnesium levels, and those taking other drugs that can lead to QT prolongation. Accordingly, ECG monitoring is now recommended for such patients using ondansetron.
     The drug's label is being revised to include this new information. (The label had previously noted the potential for QT prolongation.) The FDA asks clinicians to report incidents to its Adverse Event Reporting Program.

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J Amer Acad Child Adolesc Psychiatry 2011 Aug 16
An Omega-3 for ADHD Shows Promise
A meta-analysis shows significant, but slight, improvement for one omega-3 fatty acid.
     Increasing evidence for the efficacy of omega-3 polyunsaturated fatty acids for neuropsychiatric illnesses (e.g., JW Psychiatry Mar 8 2010 and JW Pediatr Adolesc Med Aug 16 2006), and some parents' preference for nonpharmacological treatments for attention-deficit/hyperactivity disorder (ADHD) in their children, led these investigators to conduct a meta-analysis of studies of omega-3s for ADHD symptoms.
     Potential studies were screened for rigorous study criteria, including use of ADHD severity scales, randomization, and blinded raters and excluding the initiation of another alternative or drug treatment during the study. The researchers identified 10 reports that included 699 children (range of mean ages, 9–12 years; 60%–87% male; study duration, 7 weeks to 4 months). Eight studies involved monotherapy, and two involved augmentation of stable ADHD therapy. Omega-3s were eicosapentaenoic acid (EPA; ≥750 mg) or docosahexaenoic acid (DHA; ≥480 mg). For placebo, nine studies used palm, olive, canola, or sunflower oil. One study compared the omega-3 precursor alpha-linolenic acid (120 mg) with vitamin C.
Only EPA was significantly more efficacious than placebo, both overall and for hyperactivity and attention symptoms separately, but had a small effect size (0.31). Higher EPA dose was significantly associated with greater response. Study type (monotherapy or augmentation), placebo type, study quality on a standardized scale, and duration did not affect outcomes.
     Comment: These promising findings for a nonpharmacological intervention are tempered by the effect size, which is small compared with that for stimulants. But baseline measures of these fatty acids were not included. A larger effect size might be evident if only children with low baseline levels were included. Measuring baseline fatty acids and examining a range of EPA doses would be useful in future studies.
Barbara Geller, MD Published in Journal Watch Psychiatry September 12, 2011
     Citation(s):Bloch MH and Qawasmi A. Omega-3 fatty acid supplementation for the treatment of children with attention-deficit/hyperactivity disorder symptomatology: Systematic review and meta-analysis. J Amer Acad Child Adolesc Psychiatry 2011 Aug 16; [e-pub ahead of print]. (http://dx.doi.org/10.1016/j.jaac.2011.06.008)
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More research supports omega-3, heart health connection
     According to new research, Omega-3 polyunsaturated fats, or PUFAs, found in seafood, may reduce arterial stiffness and against heart failure. PUFA Newsletter editor, Joyce Nettleton states "the consumption of nearly 1 g of omega-3s per day may improve the elasticity of the arteries, especially in individuals at high risk of heart disease. Measurement of arterial stiffness is a powerful predictor of future heart events and the risk of dementia and death." Other studies showed that a high does (4g/day) of omega-3s is linked to improved heart function in people that experience severe chronic heart failure. The findings are more detailed in the Aug. 2011 PUFA Newsletter and Fats of Life newsletters for health professionals and consumers, respectively: Fatsoflife.com
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FDA seeks comments on gluten-free food labeling; from niche to mainstream
     The Food and Drug Administration is looking for comments from consumers, the food industry and others regarding the proposed labeling for gluten-free foods. Gluten is a protein that occurs in wheat, rye and barley. The term 'gluten-free' was originally proposed in 2007 indicating foods that have this label could not contain 20 parts per million or more gluten. The proposal was based on technologies used to detect gluten in food, which can't detect it reliably if the level is less than 20 ppm. The agency is also making available a safety assessment of exposure to gluten for people with celiac disease.
     Affecting around 1% of Americans, Celiac causes intolerance to gluten and can lead to damage of the small intestine and interfere with nutrient absorption. FDA deputy commissioner for foods, Michael Taylor indicated "before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry and others to help assure that the label strikes the right balance." According to research by Packaged Facts, gluten-free products have changed from a niche category to mainstream. Reports indicates that the gluten-free food and beverage market has reached an estimated $2.6 billion in retail sales in 2010 and projects the market to grow to $6 billion by 2015.
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Nature 2011 Aug 31
Antibiotic Resistance Is Nothing New
Genes encoding resistance to several major classes of antibiotics were detected in 30,000-year-old permafrost sediments.
     The rapid emergence of resistance to newly introduced antimicrobial agents suggests that resistance genes likely predated the development and use of such drugs. To explore this hypothesis, investigators studied bacterial DNA obtained from 30,000-year-old permafrost sediments in northwestern Canada.
     Rigorous monitoring was performed to exclude contamination of the samples with modern DNA, and sample age was confirmed by analyses for the presence of DNA from ancient flora and megafauna (such as mammoths) and the absence of DNA from modern flora and fauna (e.g., spruce, elk).
     Analysis of bacterial DNA from these samples identified genes encoding TetM, a ribosomal protection protein that confers tetracycline resistance; VanX, a component of the vancomycin-resistance operon; AAC(3), an aminoglycoside-antibiotic–modifying enzyme; Bla, a penicillin-inactivating β-lactamase; and Erm, a ribosome methyltransferase that confers resistance to macrolide and type B streptogramin antibiotics. More-detailed analysis of the ancient vancomycin-resistance element VanA showed structure and function similar to those of contemporary variants derived from both the clinic and the environment.
     Comment: This elegant work confirms that the basic genetic framework necessary for antibiotic resistance in bacteria long predates modern antibiotics — a finding that is not surprising, given the billions of years of prokaryotic life prior to human existence. The study provides a sobering perspective on the clinically effective life span of our current antibiotics.
Richard T. Ellison III, MD Published in Journal Watch Infectious Diseases September 14, 2011
     Citation(s): D'Costa VM et al. Antibiotic resistance is ancient. Nature 2011 Aug 31; [e-pub ahead of print]. (http://dx.doi.org/10.1038/nature10388)
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Breast Cancer Screening Does Not Seem to Reduce Mastectomy Rates
     Breast cancer screening does not lead to lower mastectomy rates, according to an observational study from Norway published in BMJ.
Using a national cancer registry, researchers examined breast surgery rates in the following periods: before routine mammography was offered (1993–1995), while mammographic screening was being introduced (1996–2004), and after screening was established (2005–2008).
     The researchers found that while mastectomy rates declined between the prescreening and established screening periods, the decline was seen both among women who were eligible for screening and among younger women who were not. In addition, during the introduction period, annual mastectomy rates actually increased among screen-eligible women (by 9%) and decreased among ineligible women (by roughly 15%).
     The authors conclude: "In contrast with what has been claimed in invitations to screening and on websites supported by numerous governmental screening institutions and cancer charities, screening does not lead to a reduction in mastectomy rates."
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Obstet Gynecol 2011 Aug; 118:372.
Mammograms: More New Screening Guidelines
The American College of Obstetricians and Gynecologists now recommends annual screening beginning at age 40.
     Previous guidelines from the American College of Obstetricians and Gynecologists (ACOG) recommended screening every 1 to 2 years for women in their 40s and annual screens beginning at age 50 (JW Womens Health Apr 21 2011). Now, two critical observations have provided the underpinnings for the ACOG's decision to recommend annual screening for women in their 40s:

     More-frequent screening is associated with more false-positive screens. Because of the high rate of false-positive screens and the large number of screens needed to prevent one breast cancer death among women in their 40s, the 2009 U.S. Preventive Services Task Force guidelines recommended that routine screening mammography be deferred until women reach age 50 and that screening be biennial (JW Womens Health Nov 16 2009). The new ACOG guidance acknowledges these concerns as well as the potential for false-positive mammograms to cause anxiety. Nonetheless, the ACOG also points out that U.S. women generally cope well with such anxiety.
     The ACOG continues to recommend clinical breast exams annually for women who are aged ≥40 and every 1 to 3 years for younger women (age range, 20–39). In addition, the ACOG encourages breast self-awareness for women who are aged ≥20.
     Comment: In discussing screening mammograms with patients, we should be candid about the potential for false-positive findings and their attendant diagnostic imaging and biopsy implications. Advising women in their 40s that false-positive screens are particularly common at their age is appropriate. Ultimately, our patients will be best served if we make recommendations about breast screening in a flexible, non-judgmental manner that is sensitive to their personal values as they attempt to balance the benefits of screening against the risks associated with false-positive results.
Andrew M. Kaunitz, MD Published in Journal Watch Women's Health July 28, 2011
     Citation(s): ACOG Committee on Practice Bulletins–Gynecology. Practice Bulletin No. 122: Breast cancer screening. Obstet Gynecol 2011 Aug; 118:372.
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Food and Drug Administration; Apr 7 , 2011
FDA Approval of Gabapentin Enacarbil for RLS
What does this new option mean for the treatment of restless legs syndrome?
     Gabapentin enacarbil (marketed as Horizant®) has been approved for the treatment of restless legs syndrome (RLS), the FDA announced on April 7, 2011.
     Approval was based on two 12-week clinical trials in which patients who received the once-daily tablets had better overall improvement in their RLS symptoms than those who took a placebo.
     Gabapentin enacarbil is a precursor of the antiepileptic gabapentin; therefore, it will carry the same warning as all epilepsy drugs about an increased risk for suicidality. Additionally, patients will receive a medication guide when filling their prescriptions. Common adverse effects include dizziness and drowsiness.
     Comment: Current FDA-approved treatment options for RLS are limited to dopaminergic medications. However, gabapentin and other drugs have been used off-label for some time, with varying degrees of evidence behind their usage, as noted by a Movement Disorder Society task force, the European Restless Legs Syndrome Study Group, and others (Mov Disord 2008; 23:2267 and BMC Neurol 2011; 11:28). In addition to having been studied in larger trials than gabapentin, gabapentin enacarbil is purported to have more consistent absorption and may require less frequent dosing. Although this announcement expands the FDA-approved treatment options for RLS, the true therapeutic options for patients with this condition remain largely unchanged. Even though gabapentin enacarbil is FDA-approved and may be easier to dose, given that gabapentin is less costly, one would imagine that many physicians will continue to use generic gabapentin.
— Graham Glass, MD Dr. Glass is Assistant Clinical Professor, Department of Neurology, University of California, San Francisco, and Co-Director, Sleep Center, San Francisco Veterans Affairs Medical Center.
Published in Journal Watch Neurology September 13, 2011
     Citation(s): FDA approves Horizant to treat restless legs syndrome [press release]. Silver Spring, MD: Food and Drug Administration; Apr 7 , 2011.
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Diabetes Care 2011 Aug; 34:1843
Glucose Variability Affects Hemoglobin A1c
At any given average glucose level, high variability results in higher glycosylated hemoglobin level.
     Glycosylated hemoglobin (HbA1c) levels reflect average blood glucose over several months. However, a 3-month average glucose level of 200 mg/dL, for example, could reflect levels mostly clustered tightly around 200 mg/dL, or it could reflect levels varying widely between 100 and 300 mg/dL. The question: At any given average glucose level, does glucose variability affect HbA1c?
     In a study involving 427 diabetic patients (63% had type 1 diabetes), investigators obtained about 2700 blood glucose measurements per patient during a 3-month period. Glucose variability affected HbA1c in type 1 diabetic patients. In patients with poor control (average glucose level, 240 mg/dL), low glucose variability (standard deviation, 30 mg/dL) was associated with HbA1c of 8.7%, whereas high variability (standard deviation, 100 mg/dL) was associated with HbA1c of 9.8%. In patients with better glycemic control (average glucose level, 160 mg/dL), variability had less effect on HbA1c (HbA1c, 7.0% in low-variability patients and 7.4% in high-variability patients).
     Comment: In type 1 diabetic patients — particularly those with poor glycemic control — excessive variability in blood glucose appears to push the HbA1c higher for any given average glucose level. The mechanism is unclear: The authors speculate that the oxidative stress that accompanies highly variable glucose levels might affect the glycation process. The effect was not significant in type 2 diabetic patients, perhaps because the study included too few type 2 patients with substantial variability.
Allan S. Brett, MD Published in Journal Watch General Medicine September 13, 2011
     Citation(s):Kuenen JC et al. Does glucose variability influence the relationship between mean plasma glucose and HbA1c levels in type 1 and type 2 diabetic patients? Diabetes Care 2011 Aug; 34:1843. (http://dx.doi.org/10.2337/dc10-2217)
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Alzheimer's Patients May Be Helped by Nasal Insulin
     (1) Nasally administered insulin seems to improve cognitive function in Alzheimer's patients, according to research appearing in the Journal of Neurology. Nasal delivery results in the drug reaching the brain and central nervous system (CNS) fast. Researchers say insulin plays a role in the CNS and those who suffer from Alzheimer's experience a loss of insulin levels and activity. It's well known that insulin plays an important role in blood-sugar regulation in the body, and this work suggests that it has a number of different and important roles in the brain as well.
     (2) The results are preliminary and must be viewed with caution, "it is a provocative study," said Dr. Jason Karlawish, an Alzheimer's researcher and ethicist at the University of Pennsylvania. He and other experts caution that a bigger and longer study is needed to see if the initial results hold up and whether there are adverse effects that might negate any benefits.
     Brain cells need insulin and conditions in which the body makes too little insulin or is resistant to its effects—diabetes, prediabetes, even untreated high-blood pressure—are associated with an increased risk of Alzheimer's. The insulin solution was administered using a special device made by Kurve Technology that delivers a spray of insulin deep into the nose. Alzheimer's patients should not rush out and try to take insulin. It is too soon to say if the treatment is even safe, and patients would need the special Kurve device to get it deep into the nose, which is not yet on the market.
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Vitamin B May Help Stave off Alzheimer's Disease
     Vitamins B complex and folic acid may dramatically slow the onset of memory loss in old age and even protect against Alzheimer's disease, researchers have found. They found that it reduced memory decline by 70 per cent in some elderly people. The combination also halved the rate of brain shrinkage in some patients—a physical symptom associated with forgetfulness that can lead to full-blown Alzheimer's disease. A full scale trial is expected to begin within the next year.
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J Clin Oncol 2011 Jan 1; 29:54
Allergan Testing Eyelash Lengthener for Baldness
     Latisse (Allergan) has moved into the second clinical stage of testing as a therapy for baldness and expects to see data by the middle of next year. Latisse was approved in 2008 to aid in eyelash growth, and generated $82 million last year for the Irvine, California-based company. Allergan is currently testing Latisse for men and women. It will grow hair from the existing follicle, and helps to maintain current hair.
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Thorax 2011 Aug; 66:699
Risk in COPD Patients
Results should not deter ICS use in patients with moderate-to-severe chronic obstructive pulmonary disease.
     Patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) often are treated with inhaled corticosteroids (ICS) to decrease the frequency of exacerbations. Systemic absorption clearly occurs at high doses, but whether such absorption results in lower bone density and elevated fracture risk remains unclear.
     A meta-analysis of 16 randomized controlled trials (RCTs) involved 9143 ICS users and 8370 controls; fluticasone or budesonide were used in all but one of the RCTs. Most patients had severe COPD, and older men predominated. All studies included long-term follow-up (mean duration, 90 weeks), but individual studies varied widely. Fracture risk rose significantly with ICS use — 180 fractures occurred in ICS recipients, and 141 occurred in controls (odds ratio, 1.27; P=0.04). None of the RCTs was actually designed to look at bone density or fractures, and the data were largely from unpublished company reports. The authors also analyzed seven controlled observational studies that involved 69,000 patients and found a similar rise in fracture risk with ICS (OR, 1.21; P<0.001).
     Comment: This meta-analysis strongly suggests an elevated risk for fracture with ICS use. The study does not clearly define a dose or duration of use that puts a patient at risk. Providers should not be deterred from adding ICS to long-acting bronchodilators in patients with moderate-to-severe COPD and frequent flares but should use caution in prescribing these medications for patients with milder disease, rare exacerbations, or elevated fracture risk.
Patricia Kritek, MD Published in Journal Watch General Medicine September 13, 2011
     Citation(s):Loke YK et al. Risk of fractures with inhaled corticosteroids in COPD: Systematic review and meta-analysis of randomised controlled trials and observational studies. Thorax 2011 Aug; 66:699. (http://dx.doi.org/10.1136/thx.2011.160028) http://www.ncbi.nlm.nih.gov/pubmed/21602540?dopt=Abstract Inhaled Corticosteroids Raise Fracture
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Arch Pediatr Adolesc Med 2011 Aug; 165:741
Air Cleaners Reduce Indoor Particulate Matter and Asthma Symptoms
But secondhand smoke exposure remains unchanged.
     About half of inner-city children with asthma are exposed to secondhand smoke at home. To evaluate methods for reducing exposure to secondhand smoke, researchers in Baltimore randomized 126 children (97% black; age range, 6–12 years) with persistent asthma to receive two high-efficiency particulate air (HEPA) cleaners, HEPA cleaners plus in-home health coaching designed to achieve a ban on home smoking, or in-home standard asthma education (control). All children lived in homes with smokers, and air cleaners were placed in the living rooms and children's bedrooms.
      From baseline to 6-month follow-up, children in both air-cleaner groups had significantly greater decreases in particulate matter levels in their homes and a significant increase in symptom-free days than children in the control group (1.36 vs. 0.24 symptom-free days in 2 weeks). Health coaching did not provide additive benefits to air cleaners. No significant changes from baseline were noted among groups in air nicotine and urine cotinine levels, symptom-free nights, interference with activity because of asthma, and healthcare utilization. Air cleaner use was about 60% in a subset of homes.
     Comment: Studies suggest that particulate matter from secondhand smoke worsens asthma in exposed children. In this inner-city population, HEPA cleaners decreased particulate matter and asthma symptoms (equivalent to 33 more symptom-free days per year), but contact with secondhand smoke persisted as shown by unchanged nicotine exposure. Even with health coaching, a ban on home smoking is a difficult goal to achieve. HEPA cleaners, when used regularly and maintained, can be beneficial to children with persistent asthma who live with smokers, but should not be a substitute for bans on home smoking.
Cornelius W. Van Niel, MD Published in Journal Watch Pediatrics and Adolescent Medicine September 14, 2011
     Citation(s):Butz AM et al. A randomized trial of air cleaners and a health coach to improve indoor air quality for inner-city children with asthma and secondhand smoke exposure. Arch Pediatr Adolesc Med 2011 Aug; 165:741.
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Lancet 2011 Aug 20; 378:684.
Cardiovascular Risk: What Good Is Identifying the Lowest of the Low?
Coronary artery calcium may be better than hsCRP for stratifying cardiac risk, but the benefits of using either marker to guide statin treatment in low-risk patients remain unproven.
     In the placebo-controlled JUPITER trial, rosuvastatin significantly lowered the incidence of cardiovascular events in healthy men (aged ≥50) and women (aged ≥60) with normal LDL levels (<130 mg/dL) and elevated high-sensitivity C-reactive protein (hsCRP) levels (≥2 mg/L; JW Cardiol Nov 10 2008). To evaluate whether "JUPITER-eligible" patients could be further risk-stratified to avoid potentially unnecessary treatment, investigators analyzed data from >2000 participants in the MESA study who underwent computed tomography for baseline coronary artery calcium (CAC) scores.
     A total of 950 MESA participants met JUPITER-eligibility criteria. During a median follow-up of 5.8 years, the 25% of patients with baseline CAC scores >100 accounted for nearly 75% of all coronary events and about 60% of all cardiovascular events. Almost 50% of JUPITER-eligible patients had CAC scores of 0. This group had an extremely low event rate; applying the hazard ratios from JUPITER, the number needed to treat (NNT) with rosuvastatin to prevent one coronary event was 549. In contrast, NNTs were 94 for CAC scores of 1–100 and 24 for CAC scores >100. Similarly, NNTs for any cardiovascular event were 124, 54, and 19 for CAC scores of 0, 1–100, and >100, respectively. In the entire cohort (including patients who were not JUPITER-eligible), any detectable CAC was associated with significantly increased risks for coronary and cardiovascular events; no such association was found with hsCRP levels.
     Comment: These findings suggest that a coronary artery calcium score of 0 identifies a subset of individuals meeting JUPITER criteria who are unlikely to derive any benefit from statin therapy. However, MESA was not a randomized trial of statin therapy based on CAC scores; no such trial has yet been conducted, nor do we have substantial evidence that statin therapy lowers CAC levels. Practice change must await clinical outcomes trials and cost-effectiveness analyses. Both high-sensitivity C-reactive protein and CAC may be useful for stratifying cardiovascular risk, but unlike hsCRP measurement, CAC testing exposes individuals to low levels of ionizing radiation and often produces incidental findings that lead to unnecessary follow-up procedures.
JoAnne M. Foody, MD Published in Journal Watch Cardiology September 14, 2011
     Citation(s):Blaha MJ et al. Associations between C-reactive protein, coronary artery calcium, and cardiovascular events: Implications for the JUPITER population from MESA, a population-based cohort study. Lancet 2011 Aug 20; 378:684.
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N Engl J Med 2011 Sep 1; 365:787.
How Much CPR Before Defibrillation Shock?
Administering more cardiopulmonary resuscitation before defibrillation and rhythm analysis does not improve outcomes.
     To examine the theory that a more perfused heart will respond better to defibrillation shock, researchers conducted a cluster-randomized study in 9933 patients with nontraumatic out-of-hospital cardiac arrest at 10 Resuscitation Outcomes Consortium sites in the U.S. and Canada. Patients were divided into two groups and received cardiopulmonary resuscitation (CPR) by emergency medical services (EMS) providers for either 30 to 60 seconds (until pads were applied) or 180 seconds before defibrillation and initial electrocardiograph rhythm analysis. EMS providers received study-specific training every 6 months that emphasized uninterrupted compressions and ventilations in a 30:2 ratio.
     The primary outcome — survival to hospital discharge with satisfactory neurological function as measured by the modified Rankin score — was 5.9% in both groups. The authors concluded that delaying analysis of cardiac rhythm during EMS-administered CPR provided no advantage. Of note, despite aggressive training of already "high-functioning" EMS providers, the duration of CPR before the first rhythm analysis did not fall within the assigned target for 36% of patients.
     Comment: Even the best CPR delivers only a small fraction of normal cardiac output, which, as this study shows, is insufficient to "prime" the heart for defibrillation shock. Achieving a normal effective rhythm as soon as possible remains the single most important goal of resuscitation. The 64% adherence to the assigned duration of CPR by EMS providers shows how messy things are in real-life delivery of care for out-of-hospital cardiac arrest. This study does not alter the mantra for bystander-delivered CPR: "Always push early and often."
J. Stephen Bohan, MD, MS, FACP, FACEP Published in Journal Watch Emergency Medicine September 9, 2011
     Citation(s): Stiell IG et al. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. N Engl J Med 2011 Sep 1; 365:787.
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JAMA 2011 Aug 24/31; 306:831
Counseling Can Encourage Intake of Cholesterol-Lowering Foods
Mean LDL-C levels fell significantly with only two counseling sessions.
     Certain foods have specific cholesterol-lowering properties (e.g., plant sterol-enriched margarine, viscous fiber, soy protein), but whether routine counseling protocols can be used to motivate people with hyperlipidemia to eat these foods has not been investigated. In a Canadian study, 351 adults (mean age, 56; mean weight, 76 kg; mean LDL-C, 171 mg/dL) were randomized to three dietary interventions for 6 months: active promotion of specific types and amounts of cholesterol-lowering foods (e.g., 9.8 g of viscous fiber from oats, barley, or psyllium per 1000 kcal intake) with two dietitian counseling sessions; the same intervention with seven counseling sessions; or control dietary advice that focused on the intake of whole grain cereals, fruits, and vegetables. Control participants were asked to avoid the cholesterol-lowering foods.
     The attrition rate was similar in the three groups (about 20%). Mean LDL-C levels fell by 13.8% (26 mg/dL) and 13.1% (24 mg/dL) in the seven-session and two-session groups, respectively, (a nonsignificant difference) and by 3.0% (8 mg/dL) in the control group (a significant difference compared with either intervention group).
     Comment: These results show that a diet high in cholesterol-lowering foods can lower LDL-C levels, even in patients who were already consuming a diet low in saturated fat. The two-session counseling intervention was as effective as the seven-session intervention, suggesting that a fairly modest intervention can be useful. However, adherence in a higher-risk and more overweight (and more typical) patient population may be lower.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine September 15, 2011
     Citation(s): Jenkins DJA et al. Effect of a dietary portfolio of cholesterol-lowering foods given at 2 levels of intensity of dietary advice on serum lipids in hyperlipidemia: A randomized controlled trial. JAMA 2011 Aug 24/31; 306:831.
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Obstet Gynecol 2011 Sep; 118:529
Breast Cancer in Women Younger Than 25
Although cancer is uncommon in this age group, all breast masses should be evaluated.
     Little published research addresses breast cancer in very young women. In a retrospective case series, investigators assessed diagnostic approaches, incidence, and outcomes in girls and women younger than 25 who received primary breast cancer diagnoses at Mayo Clinic between 1935 and 2005.
     Breast cancer was diagnosed in 12 women (age range, 18–24). Of 11 women with available clinical presentations and histories, 8 had self-detected breast masses, 1 noted bloody nipple discharge associated with constitutional symptoms, 1 had symptoms associated with disseminated malignancy, and 1 had an asymptomatic breast mass detected by a physician. Mean time between presentation and biopsy was 1.1 months (range, 0–16 months). Two women had strong family histories of breast cancer, six had weak family histories, and none were tested for BRCA mutations. Regional and local recurrences occurred in three women, and contralateral breast cancer occurred in two women (ovarian cancer was subsequently diagnosed in one). At the time of last follow-up (median, 25.5 months), four women had died from their breast malignancies, two were alive with disease, and five were alive with no evidence of disease.
     Comment: Because primary breast cancer in adolescents and young women is unusual (and benign breast conditions are relatively common), low suspicion of malignancy can delay diagnosis. In addition, breast malignancies in young women typically are more aggressive than those in older women. Thus, breast cancer survival is relatively poor in young women. The infrequency of malignancies in very young women should not prevent clinicians from evaluating breast masses in this age group. At minimum, assessment should include palpation and ultrasound imaging. Some clinicians believe that standard evaluation of breast masses in young women should include biopsy; however, the authors propose that tissue diagnosis should be reserved for women with clinical features that meet certain criteria. Lastly, the prevalence of suspected hereditary breast cancer in this case series (taken together with other reports that 10% of women with breast cancer who are younger than 40 harbor BRCA1 or BRCA2 mutations) underscores the appropriateness of offering genetic testing to young women with breast cancer.
Andrew M. Kaunitz, MD Published in Journal Watch Women's Health September 15, 2011
     Citation(s): Simmons PS et al. Breast carcinoma in young women. Obstet Gynecol 2011 Sep; 118:529.
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Fluconazole and Risk for Birth Defects
High-dose fluconazole is now in FDA category D; single-dose therapy for vaginal candidiasis remains category C.
     Fluconazole (Diflucan) is used to treat fungal infections (including some that are life-threatening) and vaginal candidiasis. Chronic high-dose fluconazole (400–800 mg daily) during the first trimester of pregnancy has been associated with an uncommon set of skeletal abnormalities and congenital heart defects in offspring. Accordingly, the FDA has changed fluconazole's pregnancy risk category from C to D (positive evidence of human fetal risk) for indications other than vaginal candidiasis. This warning does not affect the 150-mg single dose for vaginal candidiasis, which remains category C (available data in humans do not suggest excess risk for congenital anomalies).
     Comment: Women who require high-dose antifungal therapy should be provided with counseling and effective contraception to avoid unintended pregnancy. Single low-dose fluconazole for vaginal candidiasis has not been associated with teratogenicity, although definitive evidence of safety is lacking (and over-the-counter as well as prescription topical antifungal alternatives are available). Nonetheless, clinicians can reassure women who have received single-dose fluconazole for vaginal yeast infections and have subsequently learned that they are pregnant.
Anna Wald, MD, MPH Published in Journal Watch Women's Health September 15, 2011
     Citation(s):Food and Drug Administration (FDA). FDA Drug Safety Communication: Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants. Aug 3, 2011. (http://www.fda.gov/Drugs/DrugSafety/ucm266030.htm

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