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August 2010 Briefing - Pharmacy

Here are what the editors at HealthDay consider to be the most important developments in Pharmacy for August 2010. This roundup includes the latest research news from journal articles, as well as the FDA approvals and regulatory changes that are the most likely to affect clinical practice.

Benefit Seen in RA From Combo of Rituximab, Methotrexate

FRIDAY, Aug. 27 (HealthDay News) -- Rituximab plus methotrexate is associated with improved clinical outcomes in patients with rheumatoid arthritis who have had an inadequate response to methotrexate, according to research published in the September issue of the Annals of the Rheumatic Diseases.

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Opioid Addiction Often Begins With Legal Prescriptions

FRIDAY, Aug. 27 (HealthDay News) -- Many individuals who seek treatment for opioid dependence begin using the drugs legally but later obtain them from illicit sources, according to a study in the June issue of the Journal of Addiction Medicine.

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P2Y12 Inhibitors Reduce Post-PCI Risk of Death

THURSDAY, Aug. 26 (HealthDay News) -- New P2Y12 inhibitors are associated with improved outcomes after percutaneous coronary intervention (PCI) compared with clopidogrel, and appear especially beneficial for ST-segment elevation myocardial infarction (STEMI) patients, according to research published online Aug. 25 in the Journal of the American College of Cardiology.

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Extra-Articular Manifestations of RA Have Declined Since 2000

THURSDAY, Aug. 26 (HealthDay News) -- The prevalence of extra-articular manifestations (EAMs) of rheumatoid arthritis (RA) has declined in recent years, with the timing and pattern of the decline indicating that disease-modifying RA treatments may be changing the natural history of the disease, according to a study in the September issue of Rheumatology.

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Statin Benefits Those With High hsCRP, Intermediate CVD Risk

WEDNESDAY, Aug. 25 (HealthDay News) -- Rosuvastatin may reduce the risk of major adverse cardiovascular events in men and women with normal cholesterol but elevated high-sensitivity C-reactive protein (hsCRP) levels who are at intermediate risk for cardiovascular disease (CVD), according to research published online Aug. 24 in Circulation: Cardiovascular Quality and Outcomes.

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Diabetes Drugs Equal in Risk for Adverse Heart Events

WEDNESDAY, Aug. 25 (HealthDay News) -- The diabetes drugs rosiglitazone and pioglitazone (Avandia and Actos, respectively) appear to be evenly matched when it comes to the risk for acute myocardial infarction (AMI), acute heart failure (AHF), and mortality in patients taking the drugs, according to research published online Aug. 24 in Circulation: Cardiovascular Quality and Outcomes.

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Novel Combo Treatment for Brain Tumors Promising

WEDNESDAY, Aug. 25 (HealthDay News) -- For glioblastoma multiforme, the most common and aggressive type of brain tumor, treatment with the chemotherapy agent temozolomide (TMZ) plus a γ-secretase inhibitor (GSI) to suppress tumor recurrence offers a novel and promising therapeutic approach, according to a study in mice published online Aug. 24 in Cancer Research.

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ACOG Recommends Antibiotics Before Cesarean Delivery

WEDNESDAY, Aug. 25 (HealthDay News) -- All women undergoing cesarean delivery should receive antimicrobial prophylaxis within 60 minutes of the start of the delivery unless they're already receiving appropriate antibiotics for issues such as chorioamnionitis, according to recommendations from the American College of Obstetricians and Gynecologists published in the September issue of Obstetrics & Gynecology.

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Antiherpetic Antiviral Drugs Not Linked to Birth Defects

TUESDAY, Aug. 24 (HealthDay News) -- Exposure to the antiviral drugs acyclovir and valacyclovir during the first trimester of pregnancy is not associated with a higher risk of major birth defects, according to a study in the Aug. 25 issue of the Journal of the American Medical Association.

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Sustained Response to Repeat Rituximab Seen in RA

MONDAY, Aug. 23 (HealthDay News) -- Three rituximab (RTX) dosing regimens have similar efficacy for rheumatoid arthritis that is no longer responding to methotrexate, and retreatment after 24 weeks results in a more sustained response through to 48 weeks, according to a study in the September issue of Rheumatology.

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Adalimumab Found Effective, Safe in Psoriasis Subgroups

MONDAY, Aug. 23 (HealthDay News) -- Adalimumab is consistently efficacious in the treatment of moderate to severe psoriasis across patient subgroups, and there are no significant differences in the risk of serious adverse events between adalimumab- and placebo-treated patients across weight categories, according to a post hoc analysis of REVEAL trial data in the September issue of the Journal of the American Academy of Dermatology.

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Memantine Appears Beneficial in Dementia With Lewy Bodies

MONDAY, Aug. 23 (HealthDay News) -- Treatment with memantine may lessen deterioration and improve behavioral symptoms in patients with dementia with Lewy bodies (DLB) but not those with Parkinson's disease dementia (PDD), according to a study published online Aug. 23 in The Lancet Neurology.

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Antihypertensive Drugs Tied to Pressor Responses

MONDAY, Aug. 23 (HealthDay News) -- Commonly used antihypertensive drugs cause pressor responses fairly frequently, particularly in patients with low renin levels who receive β-blockers or angiotensin-converting enzyme (ACE) inhibitors, according to a study published online Aug. 19 in the American Journal of Hypertension.

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Long-Term Entecavir Therapy Improves Histology in HBV

THURSDAY, Aug. 19 (HealthDay News) -- Long-term treatment (at least three years) with entecavir appears to result in histologic improvements and regression of fibrosis or cirrhosis in people with chronic hepatitis B virus, according to research published in the September issue of Hepatology.

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Ipilimumab Linked to Survival Benefit in Melanoma

WEDNESDAY, Aug. 18 (HealthDay News) -- Ipilimumab may improve survival in patients with previously treated metastatic melanoma, but with risk of severe adverse events, according to research published in the Aug. 19 issue of the New England Journal of Medicine.

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Steroid Doses in Tonsillectomy Compared for Bleeding Risk

WEDNESDAY, Aug. 18 (HealthDay News) -- Giving the steroid dexamethasone to children undergoing tonsillectomy is not associated with a dose-dependent increased risk of postoperative hemorrhage, according to a review in the August issue of the Archives of Otolaryngology -- Head & Neck Surgery.

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Steroids in Cadaveric Donor Don't Benefit Kidney Recipient

WEDNESDAY, Aug. 18 (HealthDay News) -- Treating deceased kidney donors with corticosteroids in advance of kidney harvesting does not reduce the incidence or duration of acute renal failure (ARF) after transplantation in organ recipients, according to a study in the Aug. 17 issue of the Annals of Internal Medicine.

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Review Focuses on New Drug Class in the Treatment of Gout

TUESDAY, Aug. 17 (HealthDay News) -- Febuxostat, part of a new drug class to treat gout, may be useful for patients intolerant to long-established gout medication, but clinicians should be sure they are properly using existing therapies first, according to a review published online Aug. 17 in The Lancet.

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FDA Proposes Withdrawal of Approval for Midodrine

TUESDAY, Aug. 17 (HealthDay News) -- In the absence of post-approval trials demonstrating the clinical benefits of midodrine hydrochloride (ProAmatine), the U.S. Food and Drug Administration has issued a proposal to withdraw approval of the drug.

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Sertraline May Not Be Effective for Depression in Heart Failure

TUESDAY, Aug. 17 (HealthDay News) -- Sertraline does not appear any better than placebo at improving depressive symptoms or cardiovascular status among patients with both heart failure and depression, according to research published in the Aug. 24 issue of the Journal of the American College of Cardiology.

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Lactobacillus Reuteri Is Safe, Effective for Colicky Infants

MONDAY, Aug. 16 (HealthDay News) -- Lactobacillus reuteri (L. reuteri) appears to be a safe and effective treatment for infantile colic in breast-fed infants, and gut microbiota changes induced by this probiotic may play a role in symptom improvements, according to research published online Aug. 16 in Pediatrics.

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Ella Emergency Contraceptive Approved

MONDAY, Aug. 16 (HealthDay News) -- The ella (ulipristal acetate) emergency contraceptive has been approved by the U.S. Food and Drug Administration. It's been available in Europe for more than a year under the brand name ellaOne.

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Prednisone Chronotherapy Safe in RA Patients

MONDAY, Aug. 16 (HealthDay News) -- Long-term, chronotherapy with a modified-release (MR) prednisone does not appear to increase the risk of hypothalamus-pituitary-adrenal (HPA) axis insufficiency in patients on daily prednisone for rheumatoid arthritis (RA), according to research published in the August issue of the Journal of Rheumatology. This formulation of prednisone is taken at bedtime but results in peak blood levels at about 2 a.m., mimicking the timing of the endogenous cortisol cycle.

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Rimonabant Trial Stopped Early Due to Suicide Risk

FRIDAY, Aug. 13 (HealthDay News) -- A study evaluating the cardiovascular outcomes related to rimonabant, a weight loss drug, was discontinued due to concerns regarding the risk of suicide associated with the drug, according to a report in the Aug. 14 issue of The Lancet.

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FDA: Aseptic Meningitis Risk Related to Lamictal Use

FRIDAY, Aug. 13 (HealthDay News) -- The U.S. Food and Drug Administration has issued a drug safety communication to warn that the seizure and bipolar disorder medication Lamictal (lamotrigine) can cause aseptic meningitis. The FDA is revising the Warnings and Precautions section of the drug label as well as the patient Medication Guide to include this information.

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Younger Patients Benefit Less From Medicare

THURSDAY, Aug. 12 (HealthDay News) -- Medicare does not appear as effective in meeting the health care needs of beneficiaries younger than 65 with disabilities as it is for beneficiaries age 65 and older, according to research published online Aug. 12 in Health Affairs.

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Lithium Carbonate Not Found to Be Beneficial for ALS

WEDNESDAY, Aug. 11 (HealthDay News) -- Lithium carbonate is ineffective as a treatment for amyotrophic lateral sclerosis (ALS) and has a high frequency of adverse effects, according to research published online Aug. 11 in Neurology.

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Antibiotic Use Rose With Better Drug Coverage After Part D

WEDNESDAY, Aug. 11 (HealthDay News) -- The use of antibiotics in older adults increased after their drug coverage improved with the implementation of the Medicare Part D drug benefit, and Part D has been linked to a drop in beneficiaries' out-of-pocket expenses on drugs, especially if they previously lacked drug coverage, according to research published in the Aug. 9/23 issue of the Archives of Internal Medicine.

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Travel Linked to Spread of Antibiotic Resistance Gene

WEDNESDAY, Aug. 11 (HealthDay News) -- A gene that creates antibiotic resistance has been found to be widespread in Enterobacteriaceae of patients in India and Pakistan and in patients from the United Kingdom who have visited India or Pakistan for elective surgery; this could indicate an emerging public health threat, according to research published online Aug. 11 in The Lancet Infectious Diseases.

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Consumer Drug Information Shows Areas of Concern

WEDNESDAY, Aug. 11 (HealthDay News) -- Consumer medication information (CMI) accompanying prescription drugs dispensed at retail pharmacies is often subject to concerns about format, comprehensibility, and excessive length, according to research published in the Aug. 9/23 issue of the Archives of Internal Medicine.

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Bisphosphonate Exposure Not Linked With Esophageal Cancer

TUESDAY, Aug. 10 (HealthDay News) -- There appears to be no association between oral bisphosphonate use and risk of esophageal or gastric cancer, according to research published in the Aug. 11 issue of the Journal of the American Medical Association.

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Finasteride Use Up in VHA System but Not for Prevention

TUESDAY, Aug. 10 (HealthDay News) -- Finasteride prescriptions in the Veterans Health Administration (VHA) increased between 2000 and 2005, but the increase probably was not due to doctors prescribing it for prostate cancer chemoprevention, according to research published online Aug. 10 in Cancer Epidemiology, Biomarkers & Prevention.

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Study Sheds More Light on Hormones, Breast Cancer Risk

TUESDAY, Aug. 10 (HealthDay News) -- Longer use of estrogen or estrogen-progestin therapy (EPT) is associated with a higher risk of breast cancer, with risks varying by body mass index (BMI) and tumor subtype, according to research published online Aug. 10 in Cancer Epidemiology, Biomarkers & Prevention.

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Warning System May Reduce Orders for Inappropriate Meds

TUESDAY, Aug. 10 (HealthDay News) -- The implementation of a computerized provider order entry (CPOE) drug warning system can reduce orders for potentially inappropriate medications (PIMs) in hospitalized older patients, according to a study published in the Aug. 9/23 issue of the Archives of Internal Medicine.

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Medication Compliance Three Months After Stroke Is Poor

TUESDAY, Aug. 10 (HealthDay News) -- Nearly one quarter of stroke patients discontinue at least one of their prescribed secondary prevention medications within three months after hospital discharge, leaving this group at higher risk of another stroke, according to research published online Aug. 9 in the Archives of Neurology.

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Oncologists From Canada, U.S. Share Attitudes on Drug Costs

TUESDAY, Aug. 10 (HealthDay News) -- Canadian oncologists and those from the United States have similar attitudes and concerns about the costs and cost-effectiveness of cancer drugs as well as related health policies, according to research published online Aug. 9 in the Journal of Clinical Oncology.

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Boceprevir Can Improve Response Rate in Hepatitis C

MONDAY, Aug. 9 (HealthDay News) -- The addition of boceprevir, an NS3 protease inhibitor, to the standard regimen of peginterferon alfa-2b and ribavirin for patients with treatment-naive genotype 1 chronic hepatitis C infection can nearly double the sustained virological response (SVR) rate, according to a study published online Aug. 9 in The Lancet.

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Researchers Test Three Agents for Hereditary Angioedema

WEDNESDAY, Aug. 4 (HealthDay News) -- Researchers have found C1 inhibitor concentrate, ecallantide (a recombinant plasma kallikrein inhibitor), and icatibant (a selective bradykinin B2 receptor antagonist) effective in the management and relief of symptoms of hereditary angioedema, according to three studies published in the Aug. 5 issue of the New England Journal of Medicine.

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Antiepileptics Don't Raise Risk of Suicide in Epilepsy Patients

WEDNESDAY, Aug. 4 (HealthDay News) -- Use of antiepileptic drugs isn't linked to a higher risk of suicide-related events in patients with epilepsy, but it is linked to higher risk in patients with depression and those without epilepsy, depression, or bipolar disorder, according to research published in the Aug. 5 issue of the New England Journal of Medicine.

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Neurogenetic Risk Mechanism ID'ed for Bipolar Disorder

WEDNESDAY, Aug. 4 (HealthDay News) -- A genetic variant linked to bipolar disorder manifests itself as altered hippocampal brain function even in those without overt disease, according to research published in the August issue of the Archives of General Psychiatry. In a related study in the same issue, an N-methyl-D-aspartate (NMDA) receptor antagonist was found to result in rapid antidepressant effects in individuals with treatment-resistant bipolar depression.

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TNFα Blockers May Raise Risk of Malignancies in Children

WEDNESDAY, Aug. 4 (HealthDay News) -- Children taking tumor necrosis factor α (TNFα) blockers may be at increased risk for developing malignancies, but confounding factors make it difficult to establish a causal relationship, according to research published in the August issue of Arthritis & Rheumatism.

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Diabetes Drug Spurs Weight Loss, Better Cardiac Profile

WEDNESDAY, Aug. 4 (HealthDay News) -- In type 2 diabetes patients, treatment with a glucagon-like peptide (GLP-1) receptor agonist is associated with weight loss and an improved cardiovascular risk profile, according to research published in the August issue of Diabetes Care.

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B Vitamins Do Not Prevent Vascular Events After Stroke

WEDNESDAY, Aug. 4 (HealthDay News) -- Supplementation with folic acid, vitamin B6, and vitamin B12 is safe but does not appear to reduce the incidence of major vascular events in patients who have experienced a recent stroke or transient ischemic attack, according to a study published online Aug. 4 in The Lancet Neurology.

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FDA: NeoProfen Recalled Due to Visible Particulate Matter

TUESDAY, Aug. 3 (HealthDay News) -- The U.S. Food and Drug Administration has alerted health care professionals of a voluntary recall of two lots of Lundbeck Inc.'s ibuprofen lysine (NeoProfen) injection, as the product did not meet a visible particulate quality requirement.

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FDA: Nimodipine Should Never Be Administered Intravenously

TUESDAY, Aug. 3 (HealthDay News) -- The U.S. Food and Drug Administration is reminding health care professionals that nimodipine should never be administered intravenously but only given by mouth or through a feeding or nasogastric tube, as intravenous administration may lead to cardiac arrest, severe decreases in blood pressure, other cardiac adverse events, or death.

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Hormone Combination Effective in Metastatic Breast Cancer

TUESDAY, Aug. 3 (HealthDay News) -- The combined use of the aromatase inhibitor anastrozole and the luteinizing hormone-releasing hormone agonist goserelin appears to have substantial antitumor activity in the treatment of premenopausal women who have hormone receptor-positive metastatic breast cancer, according to a study published online Aug. 2 in the Journal of Clinical Oncology.

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In-Lab Clopidogrel as Effective as Pre-Loading Before PCI

TUESDAY, Aug. 3 (HealthDay News) -- Giving clopidogrel after coronary angiography but before percutaneous coronary intervention (PCI) appears to be as effective as pre-loading the drug four to eight hours before PCI, according to research published in the Aug. 10 issue of the Journal of the American College of Cardiology.

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Industry-Funded Clinical Trials Yield More Positive Outcomes

TUESDAY, Aug. 3 (HealthDay News) -- Drug clinical trials supported by industry are more likely to produce favorable results than trials supported by government or nonprofit/nonfederal organizations, and they are less likely to be published within two years of the study being completed, according to research published in the Aug. 3 issue of the Annals of Internal Medicine.

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Use of Some Common Drugs May Lower PSA Levels

TUESDAY, Aug. 3 (HealthDay News) -- The use of nonsteroidal anti-inflammatory drugs (NSAIDs), statins, or thiazide diuretics can significantly lower tested levels of prostate-specific antigen (PSA), according to research published online Aug. 2 in the Journal of Clinical Oncology.

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FDA Issues Label Change for Afluria Influenza Vaccine

MONDAY, Aug. 2 (HealthDay News) -- The U.S. Food and Drug Administration has updated the Warnings and Precautions sections of the Prescribing Information for the influenza virus vaccine Afluria, as the vaccine has been associated with an increased incidence of fever and febrile seizure in children younger than 5 years of age in Australia.

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Oral Antidiabetic Agents Usually Drop A1C 1.5 Percent or Less

MONDAY, Aug. 2 (HealthDay News) -- Oral antidiabetic (OAD) agents generally result in a maximum 1.5 percent drop in A1C levels, with sulfonylureas and thiazolidinediones having a slightly more beneficial effect than other classes of oral agents, according to research published in the August issue of Diabetes Care.

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