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0

The Strange Allure of State “Right-to-Try” Laws

from ArchInte - 01 Dec 14

State “right-to-try” laws that purport to allow patients to be treated with unapproved drugs or devices seem likely to be futile.



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The Withdrawal of Drugs for Commercial Reasons The Incomplete Story of Tositumomab

from ArchInte - 01 Dec 14

This Viewpoint describe the case of the commercial withdrawal of tositumomab as a cautionary tale of the weaknesses in our current drug-approval system.



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Statin-Related Cognitive Impairment in the Real World You’ll Live Longer, but You Might Not Like It

from ArchInte - 01 Dec 14

They say that the most dangerous kind of ignorance is not knowing what you don’t know. It took me a long time to realize I had statin-related cognitive impairment because I had no idea what it was.






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ß-Lactam Monotherapy vs ß-Lactam–Macrolide Combination Treatment in Moderately Severe Community-Acquired Pneumonia A Randomized Noninferiority Trial

from ArchInte - 01 Dec 14

ImportanceThe clinical benefit of adding a macrolide to a ß-lactam for empirical treatment of moderately severe community-acquired pneumonia remains controversial.ObjectiveTo test noninferiority of a ß-lactam alone compared with a ß-lactam and macrolide combination in moderately severe community-acquired pneumonia.Design, Setting, and ParticipantsOpen-label, multicenter, noninferiority, randomized trial conducted from January 13, 2009, through January 31, 2013, in 580 immunocompetent adult patie



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Attitudes of Hospital Leaders Toward Publicly Reported Measures of Health Care Quality

from ArchInte - 01 Dec 14

ImportancePublic reporting of quality is considered a key strategy for stimulating improvement efforts at US hospitals; however, little is known about the attitudes of hospital leaders toward existing quality measures.ObjectivesTo describe US hospital leaders’ attitudes toward hospital quality measures found on the Centers for Medicare & Medicaid Services’ Hospital Compare website, assess use of these measures for quality improvement, and examine the association between leaders’ attitudes and ho



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Use and Prescription of Antibiotics in Primary Health Care Settings in China

from ArchInte - 01 Dec 14

ImportanceAppropriate antibiotic use is a key strategy to control antibacterial resistance. The first step in achieving this is to identify the major problems in antibiotic prescription in health care facilities, especially in primary health care settings, which is where most patients receive medical care.ObjectiveTo identify current patterns of antibiotic use and explore the reasons for inappropriate prescription in primary health care settings in China.Design, Setting, and ParticipantsA total



0

Estimation of Cigarette Smoking–Attributable Morbidity in the United States

from ArchInte - 01 Dec 14

ImportanceCigarette smoking has been found to harm nearly every bodily organ and is a leading cause of preventable disease, but current estimates of smoking-attributable morbidity by condition for the United States are generally unavailable.ObjectiveTo estimate the burden of major medical conditions attributable to cigarette smoking in the United States.Design, Setting, and ParticipantsThe disease burden of smoking was estimated using population-attributable risk calculations, taking into accoun



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Reports of Pathological Gambling, Hypersexuality, and Compulsive Shopping Associated With Dopamine Receptor Agonist Drugs

from ArchInte - 01 Dec 14

ImportanceSevere impulse control disorders involving pathological gambling, hypersexuality, and compulsive shopping have been reported in association with the use of dopamine receptor agonist drugs in case series and retrospective patient surveys. These agents are used to treat Parkinson disease, restless leg syndrome, and hyperprolactinemia.ObjectivesTo analyze serious adverse drug event reports about these impulse control disorders received by the US Food and Drug Administration (FDA) and to a



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Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in US Food and Drug Administration Drug Labels

from ArchInte - 01 Dec 14

ImportanceGenetic biomarkers that predict a drug’s efficacy or likelihood of toxicity are assuming increasingly important roles in the personalization of pharmacotherapy, but concern exists that evidence that links use of some biomarkers to clinical benefit is insufficient. Nevertheless, information about the use of biomarkers appears in the labels of many prescription drugs, which may add confusion to the clinical decision-making process.ObjectiveTo evaluate the evidence that supports pharmacog



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Primary Care–Based Buprenorphine Taper vs Maintenance Therapy for Prescription Opioid Dependence A Randomized Clinical Trial

from ArchInte - 01 Dec 14

ImportancePrescription opioid dependence is increasing and creates a significant public health burden, but primary care physicians lack evidence-based guidelines to decide between tapering doses followed by discontinuation of buprenorphine hydrochloride and naloxone hydrochloride therapy (hereinafter referred to as buprenorphine therapy) or ongoing maintenance therapy.ObjectiveTo determine the efficacy of buprenorphine taper vs ongoing maintenance therapy in primary care–based treatment for pres



0

Initial Choice of Oral Glucose-Lowering Medication for Diabetes Mellitus A Patient-Centered Comparative Effectiveness Study

from ArchInte - 01 Dec 14

ImportanceAlthough many classes of oral glucose-lowering medications have been approved for use, little comparative effectiveness evidence exists to guide initial selection of therapy for diabetes mellitus.ObjectiveTo determine the effect of initial oral glucose-lowering agent class on subsequent need for treatment intensification and 4 short-term adverse clinical events.Design, Setting, and ParticipantsThis study was a retrospective cohort study of patients who were fully insured members of Aet



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Further Insight Into the Cardiovascular Risk Calculator The Roles of Statins, Revascularizations, and Underascertainment in the Women’s Health Study

from ArchInte - 01 Dec 14

ImportanceWhile the pooled cohort equations from the recent American College of Cardiology/American Heart Association (ACC/AHA) Guideline on the Assessment of Cardiovascular Risk have overestimated cardiovascular risk in multiple external cohorts, the reasons for the discrepancy are unclear.ObjectiveTo determine whether increased use of statins over time, incident coronary revascularization procedures, or underascertainment of vascular events explain overestimation of risk in a more contemporary



0

Association of Opioid Agonist Therapy With Lower Incidence of Hepatitis C Virus Infection in Young Adult Injection Drug Users

from ArchInte - 01 Dec 14

ImportanceInjection drug use is the primary mode of transmission for hepatitis C virus (HCV) infection. Prior studies suggest opioid agonist therapy may reduce the incidence of HCV infection among injection drug users; however, little is known about the effects of this therapy in younger users.ObjectiveTo evaluate whether opioid agonist therapy was associated with a lower incidence of HCV infection in a cohort of young adult injection drug users.Design, Setting, and ParticipantsObservational coh



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Outcomes Associated With Invasive and Noninvasive Ventilation Among Patients Hospitalized With Exacerbations of Chronic Obstructive Pulmonary Disease

from ArchInte - 01 Dec 14

ImportanceSmall clinical trials have shown that noninvasive ventilation (NIV) is efficacious in reducing the need for intubation and improving short-term survival among patients with severe exacerbations of chronic obstructive pulmonary disease (COPD). Little is known, however, about the effectiveness of NIV in routine clinical practice.ObjectiveTo compare the outcomes of patients with COPD treated with NIV to those treated with invasive mechanical ventilation (IMV).Design, Setting, and Particip



0

The Debate on Antibiotic Therapy for Patients Hospitalized for Pneumonia Where Should We Go From Here?

from ArchInte - 01 Dec 14

Although our understanding of pneumonia dates back thousands of years to when symptoms were recognized by Hippocrates, the first typical bacterial pathogen responsible for causing community-acquired pneumonia (CAP), Streptococcus pneumoniae, was not isolated until the late 19th century. Another half a century passed before 3 atypical bacteria were discovered as pneumonia pathogens (ie, Mycoplasma pneumoniae in 1944, Legionella species in 1976, and Chlamydia pneumoniae in 1981). Meanwhile, treatm



0

Virtual Quality The Failure of Public Reporting and Pay-for-Performance Programs

from ArchInte - 01 Dec 14

Is there too much focus on measuring and reporting quality rather than on the conditions needed for improving it? The Centers for Medicare & Medicaid Services (CMS) and other organizations require physicians and hospitals to publicly report performance on quality measures, and the CMS and private payers are tying reimbursement partly to data from such measures in pay-for-performance programs. However, as the director of an intensive care unit performance improvement program, I know that it is di



0

Antibiotic Misuse A Global Crisis

from ArchInte - 01 Dec 14

Antibiotics are an essential medical resource. The ability to treat infections not only saves lives but provides a safety net for medical advances that now seem routine: trauma surgery, cancer chemotherapy, and stem cell and organ transplantation—each inherently reliant on effective antibiotics in order to deliver their life-saving potential. Antibiotic resistance has developed and spread predictably since the advent of the first antibiotics and with each new drug brought to market. To make matt



0

Even More Illness Caused by Smoking Than Previously Estimated

from ArchInte - 01 Dec 14

The most striking statistic on the harms of smoking is the number of estimated deaths from tobacco exposure. There are an estimated 480?000 annual deaths caused by tobacco use in the United States, and approximately 5.7 million deaths each year globally, making smoking the most common cause of preventable death in the United States and worldwide.



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Finding Meaningful Patterns in Adverse Drug Event Reports

from ArchInte - 01 Dec 14

Apophenia is the perception of meaningful patterns and causal connections among random data. Are case reports of severe impulsive behaviors associated with the use of dopamine receptor agonist drugs examples of apophenia or of a causal connection between the drugs and impulse control disorders?



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Dopamine Receptor Agonist Drugs and Impulse Control Disorders

from ArchInte - 01 Dec 14

The discovery of striatal dopamine deficiency and the introduction of levodopa in the 1960s as treatment for the motor symptoms of Parkinson disease revolutionized neurology and neurotherapeutics. For the first time, patients with an apparently hopeless chronic degenerative brain disorder were able to regain function and return to the mainstream of life. Levodopa was subsequently combined with carbidopa, as the latter prevented the adverse effects associated with peripheral dopamine synthesis wi



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A Call for Accurate Pharmacogenetic Labeling Telling It Like It Is

from ArchInte - 01 Dec 14

Individual differences in response to medications are an important challenge in clinical practice. Drugs that work well for some patients are ineffective for others, and individuals vary markedly in their experience of adverse drug reactions. Some of this variation is associated with individual differences in the genes involved in drug uptake, distribution, metabolism, target engagement, and action. For example, individuals with the HLA-B*5701 variant have an almost 50% risk of a hypersensitivit


 

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