August 2012 Briefing - Pharmacy

Here are what the editors at HealthDay consider to be the most important developments in Pharmacy for August 2012. 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.

New Drug Approved for Chemo-Related Severe Neutropenia

FRIDAY, Aug. 31 (HealthDay News) -- The U.S. Food and Drug Administration has approved the drug tbo-filgrastim to treat certain cancer patients undergoing chemotherapy who have severe neutropenia, the FDA said in a news release.

Afinitor Disperz Approved for Rare Tumor

THURSDAY, Aug. 30 (HealthDay News) -- The U.S. Food and Drug Administration has approved Afinitor Disperz (everolimus tablets for oral suspension), the first form of the drug Afinitor to be created especially for children.

this approval

New Drug Approved for Irritable Bowel, Chronic Constipation

THURSDAY, Aug. 30 (HealthDay News) -- Linzess (linaclotide) has been approved by the U.S. Food and Drug Administration to treat forms of chronic constipation that don't respond to traditional treatment, and irritable bowel syndrome (IBS) accompanied by constipation, the agency said Thursday in a news release.

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Lower Prostate Cancer-Specific Death With Anticoagulant Use

THURSDAY, Aug. 30 (HealthDay News) -- Anticoagulant (AC) therapy, particularly aspirin, is associated with a reduced risk of prostate cancer-specific mortality (PCSM) among men treated with radical prostatectomy (RP) or radiotherapy (RT), according to a study published online Aug. 27 in the Journal of Clinical Oncology.

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Lung Cancer Risk Unaffected by Metformin Use in Diabetes

THURSDAY, Aug. 30 (HealthDay News) -- Patients with type 2 diabetes who take metformin do not have a reduced risk of lung cancer, in contrast to previous observational studies, according to a study published online Aug. 24 in Diabetes Care.

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Resistance to Second-Line TB Drugs Is Common Globally

THURSDAY, Aug. 30 (HealthDay News) -- Nearly half of patients with tuberculosis in eight countries show resistance to at least one second-line drug, with previous treatment with second-line drugs strongly associated with resistance to these drugs and with extensively drug-resistant (XDR) tuberculosis, according to a study published online Aug. 30 in The Lancet.

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Similar Rate of CV Events With Atenolol, Metoprolol Tartrate

THURSDAY, Aug. 30 (HealthDay News) -- There are no significant differences in the rates of incident myocardial infarction (MI), heart failure, or stroke for patients with hypertension starting treatment with atenolol or metoprolol tartrate, according to a study published online Aug. 27 in the Archives of Internal Medicine.

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Lacunar Stroke Outcomes No Better With Dual Antiplatelets

WEDNESDAY, Aug. 29 (HealthDay News) -- Treating patients with recent lacunar strokes with dual antiplatelet therapy (clopidogrel plus aspirin) is not associated with a reduction in the risk of recurrent stroke, and correlates with significant increases in the risk of major hemorrhage and death, according to research published in the Aug. 30 issue of the New England Journal of Medicine.

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Cetuximab, Paclitaxel Combo Active in Urothelial Cancer

WEDNESDAY, Aug. 29 (HealthDay News) -- The monoclonal antibody against epidermal growth factor receptor (EGFR), cetuximab, augments the antitumor activity of paclitaxel in patients with previously treated urothelial cancer, according to a study published online Aug. 27 in the Journal of Clinical Oncology.

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Long-Term Thrombosis Rates Similar for Drug-Eluting Stents

WEDNESDAY, Aug. 29 (HealthDay News) -- Two types of drug-eluting stents with distinct antiproliferative properties have similar long-term rates of stent thrombosis and outcomes, including death and heart attack, according to a study published online Aug. 27 in The Lancet to coincide with presentation at the annual European Society of Cardiology Congress, held from Aug. 25 to 29 in Munich.

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Once-Daily Pill Approved to Treat HIV

TUESDAY, Aug. 28 (HealthDay News) -- Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) has been approved by the U.S. Food and Drug Administration to treat adults with HIV.

this approval

Pharmacist-Led Intervention Benefits Knee Osteoarthritis

TUESDAY, Aug. 28 (HealthDay News) -- Community-based pharmacists can initiate a coordinated care strategy to better identify knee osteoarthritis (OA) and improve function, pain, and quality of life, according to a study published online Aug. 28 in Arthritis Care & Research.

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Gabapentin Efficacious for Refractory Chronic Cough

TUESDAY, Aug. 28 (HealthDay News) -- For patients with refractory chronic cough, treatment with gabapentin is associated with improved cough-specific quality of life and is well-tolerated, according to a study published online Aug. 28 in The Lancet.

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LABA Withdrawal Increases Asthma-Related Impairment

TUESDAY, Aug. 28 (HealthDay News) -- For patients with asthma controlled with a combination of an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA), withdrawal of the LABA once asthma is controlled correlates with increased asthma-associated impairment, according to a study published online Aug. 27 in the Archives of Internal Medicine.

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New Class of Drugs Shows Promise for Heart Failure

TUESDAY, Aug. 28 (HealthDay News) -- After 12 weeks of treatment, the first-in-class angiotensin receptor neprilysin inhibitor, LCZ696, lowers N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in patients with New York Heart Association (NYHA) class II to III heart failure and preserves left ventricular ejection fraction (LVEF) significantly more than valsartan, according to a study published online Aug. 26 in The Lancet to coincide with presentation at the annual European Society of Cardiology Congress, held from Aug. 25 to 29 in Munich.

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For Patients With Prior MI, Vorapaxar Cuts Cardiac Events

MONDAY, Aug. 27 (HealthDay News) -- When added to standard antiplatelet treatment, including aspirin, the protease-activated receptor 1 inhibitor vorapaxar reduces the risk of a primary end point of cardiovascular (CV) death, myocardial infarction (MI), or stroke, for patients with a history of MI, according to a study published online Aug. 26 in The Lancet to coincide with presentation at the annual European Society of Cardiology Congress, held from Aug. 25 to 29 in Munich.

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Prasugrel, Clopidogrel Similar for Acute Coronary Syndromes

MONDAY, Aug. 27 (HealthDay News) -- For patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization, intensified platelet inhibition with prasugrel does not reduce the frequency of the primary end point (death from cardiovascular causes, myocardial infarction, or stroke) and has similar risks of bleeding as clopidogrel, according to a study published online Aug. 26 in the New England Journal of Medicine to coincide with presentation at the annual European Society of Cardiology Congress, held from Aug. 25 to 29 in Munich.

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Multidisciplinary Approach Cuts Symptoms of Fibromyalgia

FRIDAY, Aug. 24 (HealthDay News) -- Multidisciplinary treatment adapted for women with low educational levels is superior to conventional pharmacotherapy in reducing key symptoms of fibromyalgia (FM), including sleep disturbances, catastrophizing, and psychological distress, according to research published online Aug. 16 in Arthritis Care & Research.

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Muscle-Related Statin Effects Seem to Correlate With Potency

FRIDAY, Aug. 24 (HealthDay News) -- The rates of muscle-related adverse effects (AEs) differ greatly for various statins, with the highest reported rates seen for rosuvastatin, according to research published online Aug. 22 in PLoS One.

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Experimental Combo Treatment Worsens Type 1 Diabetes

THURSDAY, Aug. 23 (HealthDay News) -- A treatment regimen that is effective in preventing diabetes in a mouse model of the disease leads to worsening disease in patients with type 1 diabetes, according to a study published online June 20 in Diabetes.

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Metastatic Melanoma Responds to First-Line Interleukin-21

THURSDAY, Aug. 23 (HealthDay News) -- In the first-line treatment of metastatic melanoma, interleukin-21 (IL-21) shows an overall response rate (ORR) of 22.5 percent and warrants further study, according to research published online Aug. 20 in the Journal of Clinical Oncology.

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Dual Action Antibody Reverses Menopausal Bone Loss

THURSDAY, Aug. 23 (HealthDay News) -- An antibody can reverse bone loss in menopausal mice by both blocking bone breakdown and stimulating bone formation, according to an experimental study published online Aug. 20 in the Proceedings of the National Academy of Sciences.

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Lower MI Risk With TNF Inhibitor Therapy for Psoriasis

WEDNESDAY, Aug. 22 (HealthDay News) -- Patients with psoriasis who are treated with tumor necrosis factor (TNF) inhibitors have a significantly lower risk and incidence of myocardial infarction (MI) compared with those who are treated with topical agents, according to a study published online Aug. 20 in the Archives of Dermatology.

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Prolonged Dexamethasone Cuts Delayed Nausea After Chemo

WEDNESDAY, Aug. 22 (HealthDay News) -- Adding dexamethasone to prochlorperazine on days two and three, following palonosetron and dexamethasone on day one, reduces delayed nausea (DN) in patients receiving chemotherapy containing a platinum-based drug or an anthracycline, according to research published online Aug. 20 in the Journal of Clinical Oncology.

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Infant Exposure to Antibiotics Linked to Later Obesity

WEDNESDAY, Aug. 22 (HealthDay News) -- Infants exposed to antibiotics at younger than 6 months of age are at higher risk of being overweight in childhood, according to a study published online Aug. 21 in the International Journal of Obesity.

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Meta-Analysis Links Statins to Reduced Pancreatitis Risk

TUESDAY, Aug. 21 (HealthDay News) -- For patients with normal or mildly elevated triglyceride levels, statin therapy correlates with a reduction in the risk of pancreatitis, according to a meta-analysis published in the Aug. 22/29 issue of the Journal of the American Medical Association.

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Prior Substance Abuse Linked to Opioid Abuse in Young Men

TUESDAY, Aug. 21 (HealthDay News) -- Any prior substance abuse is associated with current abuse of prescription opioids among 18- to 25-year-old men, but only previous marijuana use correlates with subsequent prescription opioid abuse in young women, according to a study published online Aug. 21 in the Journal of Adolescent Health.

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No Benefit Seen for Adjuvant Oxaliplatin in Stage II Colon CA

TUESDAY, Aug. 21 (HealthDay News) -- For elderly patients with colon cancer or those with stage II disease, the addition of oxaliplatin to fluorouracil with leucovorin (FL) does not seem to offer any survival benefit, according to a study published online Aug. 20 in the Journal of Clinical Oncology.

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Azathioprine May Benefit Pediatric Atopic Dermatitis

TUESDAY, Aug. 21 (HealthDay News) -- For pediatric patients with refractory atopic dermatitis (AD), oral azathioprine is associated with clinical improvement, and measurement of thiopurine methyltransferase (TPMT) activity seems useful for monitoring treatment, according to a study published online Aug. 13 in the Journal of the American Academy of Dermatology.

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Study Shows 'SuperAgers' Have Thicker Cortex, No Atrophy

MONDAY, Aug. 20 (HealthDay News) -- 'SuperAgers,' individuals over the age of 80 with episodic memory performance as good as normative values for 50- to 65-year-olds, do exist, and they have a thicker cerebral cortex, with no atrophy, according to a study published online Aug. 16 in the Journal of the International Neuropsychological Society.

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Ecallantide Efficacious for Hereditary Angioedema Attacks

FRIDAY, Aug. 17 (HealthDay News) -- Patients with unpredictable and recurring attacks of acute hereditary angioedema (HAE) may be effectively treated with ecallantide, with relapse occurring in a small proportion of patients and little evidence of rebound, according to a study published in the September issue of Allergy.

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Study Affirms Marijuana, 'Spice' Harmful in Pregnancy

FRIDAY, Aug. 17 (HealthDay News) -- Exocannabinoids, such as the major psychoactive component of marijuana, Δ9-tetrahydrocannabinol (Δ9-THC), interfere with the function of the endocannabinoid system, present in the developing central nervous system from conception onward, according to a study published online Aug. 13 in Drug Testing and Analysis.

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Mepolizumab Effective in Treating Eosinophilic Asthma

FRIDAY, Aug. 17 (HealthDay News) -- For patients with severe eosinophilic asthma, treatment with mepolizumab, a monoclonal antibody against interleukin 5, is effective at reducing clinically significant exacerbations, according to a study published in the Aug. 18 issue of The Lancet, a theme issue on respiratory medicine.

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Vancomycin Overprescribed in Bloodstream MSSA Infections

FRIDAY, Aug. 17 (HealthDay News) -- In U.S. dialysis centers treating end-stage renal (ESRD) patients with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia, vancomycin is overprescribed, despite evidence of lower rates of hospitalization and death in cefazolin-treated patients, according to a study published online Aug. 16 in the Journal of the American Society of Nephrology.

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Exenatide Has Hemodynamic Effects in Healthy Men

THURSDAY, Aug. 16 (HealthDay News) -- The glucagon-like peptide-1 agonist, exenatide, used in the treatment of type 2 diabetes mellitus, has significant acute hemodynamic effects on healthy volunteers, according to a study published in the September issue of the British Journal of Clinical Pharmacology.

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Chemo for Breast Cancer Acceptable During Pregnancy

THURSDAY, Aug. 16 (HealthDay News) -- For women diagnosed with early breast cancer during pregnancy, chemotherapy seems acceptable for both mother and infant, with most adverse effects relating to premature birth, according to a study published online Aug. 16 in The Lancet Oncology.

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Enzalutamide Prolongs Survival in Resistant Prostate Cancer

THURSDAY, Aug. 16 (HealthDay News) -- Men with metastatic castration-resistant prostate cancer after chemotherapy have improved survival and secondary end points after treatment with enzalutamide versus placebo, according to a study published online Aug. 15 in the New England Journal of Medicine.

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Pegylated Interferon Affects Growth, BMI in Children

THURSDAY, Aug. 16 (HealthDay News) -- Pegylated interferon alpha-2a (Peg-IFN-α2a) treatment is linked to significant changes in body weight, linear growth, body mass index (BMI), and body composition in children treated for hepatitis C, according to a study published in the August issue of Hepatology.

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FDA: Codeine May Be Fatal in Subset of Children

WEDNESDAY, Aug. 15 (HealthDay News) -- Some children may be at risk for serious adverse events, including death, after taking codeine for relief of pain following tonsillectomy and/or adenoidectomy for obstructive sleep apnea, according to a safety communication issued Aug. 15 by the U.S. Food & Drug Administration.

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Tofacitinib Benefits Patients With Active Ulcerative Colitis

WEDNESDAY, Aug. 15 (HealthDay News) -- Tofacitinib, an oral inhibitor of Janus kinas 1, 2, and 3, can reduce disease severity and induce remission better than a placebo in patients with moderately to severely active ulcerative colitis, according to a study published in the Aug. 16 issue of the New England Journal of Medicine.

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Tissue Platinum Concentrations Linked to Response in NSCLC

TUESDAY, Aug. 14 (HealthDay News) -- For patients with non-small-cell lung cancer (NSCLC) who undergo neoadjuvant platinum-based chemotherapy, tissue platinum concentrations correlate positively with improved outcome, according to a study published online Aug. 13 in the Journal of Clinical Oncology.

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Benefits Unclear for 1st Versus 2nd Generation Antipsychotics

TUESDAY, Aug. 14 (HealthDay News) -- There is insufficient evidence to draw conclusions regarding the benefits of first-generation antipsychotics (FGAs) versus second-generation antipsychotics (SGAs) for adults with schizophrenia, according to a study published online Aug. 14 in the Annals of Internal Medicine.

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Vandetanib Slows Progression of Advanced Thyroid Cancer

TUESDAY, Aug. 14 (HealthDay News) -- The tyrosine kinase inhibitor vandetanib is associated with longer progression-free survival (PFS) compared with placebo for patients with locally advanced or metastatic differentiated thyroid carcinoma, according to a study published online Aug. 14 in The Lancet Oncology.

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Risk of Liver Injury Up With Certain Fluoroquinolones

MONDAY, Aug. 13 (HealthDay News) -- Moxifloxacin and levofloxacin use correlates with an increased risk of acute liver injury in older patients without a history of liver disease, according to a study published online Aug. 13 in CMAJ, the journal of the Canadian Medical Association.

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Aspirin Use Again Linked to Slightly Lower Cancer Mortality

MONDAY, Aug. 13 (HealthDay News) -- Daily aspirin use is associated with lower overall cancer mortality, but the association may be smaller than previously reported, according to a study published online Aug. 10 in the Journal of the National Cancer Institute.

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Adalimumab Effective for Pediatric Crohn's Disease

MONDAY, Aug. 13 (HealthDay News) -- For pediatric patients with moderate-to-severe Crohn's disease, for whom conventional treatment has been unsuccessful, adalimumab induction and maintenance therapy is effective, and appears to be safe, according to a study published in the August issue of Gastroenterology.

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PSA Change After 5α Reductase Therapy Aids Cancer Diagnosis

FRIDAY, Aug. 10 (HealthDay News) -- The magnitude of change in serum prostate specific antigen (PSA) after 5α-reductase inhibitor therapy may help diagnose prostate cancer in men with persistently increased serum PSA and previously negative biopsies, according to a study published in the September issue of The Journal of Urology.

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Statin Benefits Outweigh Risk of Developing Diabetes

FRIDAY, Aug. 10 (HealthDay News) -- Statins increase the risk of developing diabetes, but only in individuals already at risk of the disease, and the benefits of statins in the prevention of cardiovascular disease and death outweigh the risks, according to a study published in the Aug. 11 issue of The Lancet.

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Reasons for Discontinuation Vary by Psoriasis Treatment

FRIDAY, Aug. 10 (HealthDay News) -- The reasons for discontinuation of commonly used treatments for psoriasis vary by treatment, according to a study published online July 30 in the Journal of the American Academy of Dermatology.

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Marqibo Approved for Ph- Acute Lymphoblastic Leukemia

THURSDAY, Aug. 9 (HealthDay News) -- Marqibo (vincristine sulfate liposome injection) has been approved by the U.S. Food and Drug Administration to treat adults with Philadelphia chromosome negative acute lymphoblastic leukemia (ALL).

this approval

Vaccine Transiently Modifies Autoimmunity in Diabetes

THURSDAY, Aug. 9 (HealthDay News) -- A tuberculosis vaccine can reduce autoimmunity and increase insulin production in patients with long-term type 1 diabetes, according to a study published online Aug. 8 in PLoS One.

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Subcutaneous, IV Trastuzumab Comparable for Breast Cancer

THURSDAY, Aug. 9 (HealthDay News) -- For human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, a subcutaneous formulation of trastuzumab is non-inferior to the standard intravenous formulation, according to a study published online Aug. 9 in The Lancet Oncology.

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Similar Mortality With Different TNF-α Inhibitor Therapies in RA

THURSDAY, Aug. 9 (HealthDay News) -- For patients with rheumatoid arthritis there are no significant differences in the overall mortality risk with different tumor necrosis factor-α inhibitor (TNFi) therapies (adalimumab, etanercept, and infliximab), according to a study published online Aug. 8 in Arthritis & Rheumatism.

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Nonoperative Approach Feasible in Advanced Colon Cancer

WEDNESDAY, Aug. 8 (HealthDay News) -- Treating patients with surgically unresectable metastatic colon cancer and an asymptomatic intact primary tumor with bevacizumab and infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) chemotherapy is a viable and safe option, according to research published online Aug. 6 in the Journal of Clinical Oncology.

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Tofacitinib Superior to Placebo for Rheumatoid Arthritis

WEDNESDAY, Aug. 8 (HealthDay News) -- For patients with rheumatoid arthritis, a novel oral Janus kinase inhibitor, tofacitinib, is associated with reduced symptoms when used as monotherapy or in addition to background methotrexate, according to two phase 3 studies published in the Aug. 9 issue of the New England Journal of Medicine.

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R-CHOP Benefits Older Mantle-Cell Lymphoma Patients

WEDNESDAY, Aug. 8 (HealthDay News) -- In older patients with mantle-cell lymphoma, a rituximab-based chemotherapy regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) followed by maintenance therapy with rituximab improves survival, according to a study published in the Aug. 9 issue of the New England Journal of Medicine.

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Bortezomib Beneficial in Graft-Versus-Host Disease Prophylaxis

WEDNESDAY, Aug. 8 (HealthDay News) -- Patients with hematologic malignancies undergoing an HLA-mismatched unrelated donor (MMUD) reduced-intensity conditioning (RIC) hematopoietic stem cell transplantation (HSCT) may benefit from a prophylactic, short-course, bortezomib-based regimen to reduce the incidence of graft-versus-host disease (GVHD), according to research published online Aug. 6 in the Journal of Clinical Oncology.

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Oral Corticosteroids Deemed Ineffective for Rhinosinusitis

TUESDAY, Aug. 7 (HealthDay News) -- Systemic corticosteroids are not effective for symptom control in patients with acute rhinosinusitis, according to a study published online Aug. 7 in CMAJ, the journal of the Canadian Medical Association.

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Topical Treatment Shows Potential for Infantile Eczema

TUESDAY, Aug. 7 (HealthDay News) -- Ten days of treatment with a cream containing 15(R/S)-methyl-lipoxin A4 (LXA4) is well tolerated and reduces the severity of infantile eczema, according to a study published online July 26 in the British Journal of Dermatology.

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Photosensitizing Antihypertensive Meds Up Risk of Lip Cancer

TUESDAY, Aug. 7 (HealthDay News) -- For non-Hispanic whites, long-term treatment with photosensitizing antihypertensive agents correlates with an increased likelihood of lip cancer, according to a study published online Aug. 6 in the Archives of Internal Medicine.

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Drug Helps Control Glucose in Congenital Hyperinsulinism

TUESDAY, Aug. 7 (HealthDay News) -- An experimental drug may be able to control blood glucose levels in patients with a form of congenital hyperinsulinism, according to a study published online Aug. 1 in Diabetes.

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Sleep Duration Affects Hepatitis B Vaccine Response

MONDAY, Aug. 6 (HealthDay News) -- Sleeping less than six hours per night lowers the secondary antibody response to hepatitis B vaccination and significantly reduces the likelihood of individuals being clinically protected from hepatitis B, according to research published in the Aug. 1 issue of SLEEP.

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Zaltrap Approved for Advanced Colorectal Cancer

FRIDAY, Aug. 3 (HealthDay News) -- Zaltrap (ziv-aflibercept) has been approved by the U.S. Food and Drug Administration in combination with a FOLFIRI regimen for adults with advanced metastatic colorectal cancer, the agency said Friday.

National Cancer Institute

Clinicians Can Unintentionally Prompt Nocebo Effect

THURSDAY, Aug. 2 (HealthDay News) -- The nocebo effect, or induction of a symptom perceived as negative by sham treatment and/or the suggestion of negative expectation, may arise from suggestions by doctors and nurses, according to a study published in Deutsches Ärzteblatt International.

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Exercise, Drugs Compared for Depression Tx in CHD Patients

THURSDAY, Aug. 2 (HealthDay News) -- In patients with coronary heart disease, aerobic exercise and the antidepressant sertraline are both associated with reduced depressive symptoms when compared to placebo, and they both tend to improve heart rate variability, according to a study published online Aug. 1 in the Journal of the American College of Cardiology.

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Drug Combo Ups Survival in Metastatic Breast Cancer

WEDNESDAY, Aug. 1 (HealthDay News) -- The combination of anastrozole and fulvestrant improves survival in patients with hormone receptor-positive metastatic breast cancer, according to a study published in the Aug. 2 issue of the New England Journal of Medicine.

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Taxane-Induced Neuropathy Not Tied to Breast Cancer Outcome

THURSDAY, Aug. 2 (HealthDay News) -- For patients with operable breast cancer, peripheral neuropathy due to adjuvant taxane therapy does not correlate with improved outcomes, according to research published online July 30 in the Journal of Clinical Oncology.

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Caffeine Has Positive Effect on Motor Symptoms in Parkinson's

WEDNESDAY, Aug. 1 (HealthDay News) -- Caffeine has a limited effect on excessive daytime somnolence in patients with Parkinson's disease (PD), but is associated with an improvement in objective motor measures, according to a study published online Aug. 1 in Neurology.

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