Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries.

Background: Long-term outcomes following left atrial appendage occlusion outside clinical trials and small registries are largely unknown. Collecting these data was a condition of US market authorization of the WATCHMAN device. The aim of this analysis was to evaluate the rates of stroke, bleeding, and death among Medicare beneficiaries following left atrial appendage occlusion implantation during initial commercial availability of the WATCHMAN left atrial appendage occlusion device overall and in important subgroups.

Complication Prevention and Cost Savings in Total Joint Arthroplasty. The Effect of Orthopedic Procedure Migration within Hospital Referral Regions in the United States.

Background: The shift to value based total joint arthroplasty (TJA) reimbursement strategies has led to an increased focus on quality and the avoidance of poor outcomes. As a result, there has been greater encouragement for patients to undergo joint replacements in high volume centers of excellence. In this study, we examined the potential complications avoided if TJA procedure volume was shifted from poor quality (high incidence) facilities to high quality (low incidence) facilities within Hospital Referral Regions (HRRs).

Use of Add-on Treatment to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A U.S. Database Study.

Background: The American Diabetes Association (ADA) recommends metformin to treat individuals diagnosed with type 2 diabetes and recommends that hemoglobin A1c (HbA1c) be maintained below or around 7%. If the HbA1c target is not achieved or maintained by metformin monotherapy at maximal tolerated dose over 3 to 6 months, treatment modification with addition of a second oral antihyperglycemic agent or by initiating insulin is recommended. Despite the importance of attaining and maintaining HbA1c goals, actual treatment behavior may not follow ADA guidelines to add a second oral agent or to initiate insulin as expected even considering that individual patient's needs are taken into account when treatment decisions are made.

Treatment of obesity: Pharmacotherapy trends in the United States from 1999 to 2010.

Objective: To describe the antiobesity drug-prescribing patterns of US physicians over the past decade.

Methods: Data for adult patients were obtained from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey. Obesity was identified using ICD-9 codes, BMI values, and a chronic-obesity-condition variable.

Safety of long-acting beta agonists and inhaled corticosteroids in children and adolescents with asthma.

The introduction of long-acting beta agonists (LABAs) was considered a major advance in bronchodilator therapy for adult, as well as pediatric, patients with asthma. However, the use of LABAs has raised safety concerns, especially the potential for severe asthma exacerbations (SAEs) resulting in hospitalizations or even death. Meanwhile, the use of inhaled corticosteroids (ICSs), a cornerstone in the treatment of mild-to-severe persistent asthma, has been associated with growth suppression in children.

Firm- and drug-specific patterns of generic drug payments by US medicaid programs: 1991-2008.

Background: The entry of generic drugs into markets previously monopolized by patented, branded drugs often represents large potential savings for healthcare payers in the USA.

Objectives: Our objectives were to describe and explain the trends in drug reimbursement by public Medicaid programmes post-generic entry for as many drug markets and for as long a time period as possible.

Methods: The data were the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services.

Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.

Background: Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive.

Utilization, spending, and price trends for benzodiazepines in the US Medicaid program: 1991-2009.

Background: Although it is well-known that drug costs in the US have risen precipitously over the last 25 years, what is much less appreciated is how this rise in cost has occurred across so many seemingly distinct drug markets.

Objective: To describe trends in the utilization, spending, and average per-prescription cost of benzodiazepines individually, in subgroups, and overall, in the Medicaid program. Medicaid has been the primary public payer for benzodiazepines over the past 2 decades.

Evidence-based prediction of statin use with lipid-panel data from the National Health and Nutrition Examination Survey.

Objectives: This study compared actual use of individual statin drugs to expected use based on their efficacy and safety profiles.

Methods: Five panels covering the years 1999 to 2008 from the National Health and Nutrition Examination Survey provided interview, demographic, and laboratory data for 8769 (365,503,838 weighted) people aged 20 years or older who were not taking a statin medication. An individual's risk for coronary heart disease and low-density lipoprotein (LDL) cholesterol goal were determined, following the Adult Treatment Panel III Cholesterol Guidelines.

Risk of serious asthma exacerbations associated with long-acting beta agonists among patients with asthma: a retrospective cohort study.

Background: After the Serevent Nationwide Surveillance clinical trial, controversy has surrounded the safety of long-acting beta agonists (LABAs).

Objective: Examine the association between LABAs and severe asthma exacerbations (SAEs).

Methods: From a multistate Medicaid database, for the years 2002-2007, a total of 940,449 patients (age <40) with asthma were selected and divided into a cohort with newly-diagnosed asthma and one with pre-existing asthma.

ACE Inhibitor and ARB utilization and expenditures in the Medicaid fee-for-service program from 1991 to 2008.

Background: Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are widely prescribed for the treatment of hypertension and heart failure, as well as for kidney disease prevention in patients with diabetes mellitus and the management of patients after myocardial infarction.

Objective: To (a) describe ACE inhibitor and ARB utilization and spending in the Medicaid fee-for-service program from 1991 through 2008, and (b) estimate the potential cost savings for the collective Medicaid programs from a higher ratio of generic ACE inhibitor utilization.

Methods: A retrospective, descriptive analysis was performed using the National Summary Files from the Medicaid State Drug Utilization Data, which are composed of pharmacy claims that are subject to federally mandated rebates from pharmaceutical manufacturers.

A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group.

Objective: Although regulatory authorities evaluate the risks and benefits of any new drug therapy during the new drug-approval process, quantitative risk-benefit assessment (RBA) is not typically performed, nor is it presented in a consistent and integrated framework when it is used. Our purpose is to identify and describe published quantitative RBA methods for pharmaceuticals.

Methods: Using MEDLINE and other Internet-based search engines, a systematic literature review was performed to identify quantitative methodologies for RBA.

Evaluating safety of long-acting beta agonists (LABAs) in patients with asthma.

The introduction of long-acting beta agonists (LABAs) was considered a major advance in bronchodilator therapy with evidence that their use led to improved lung function and quality of life. However, the use of LABAs has raised safety concerns, such as their potential to provoke severe asthma exacerbations (SAEs) and death. This systematic review of major findings discusses the safety controversy surrounding LABA therapy and provides background for the U.