Use of Contrave, Naltrexone with Bupropion, Bupropion, or Naltrexone and Major Adverse Cardiovascular Events: A Systematic Literature Review.

Naltrexone/Bupropion extended release (ER; Contrave) is an extended-release, fixed-dose combination medication of naltrexone (8 mg) and bupropion (90 mg) for patients with obesity or overweight with at least one weight-related comorbidity. Obese and overweight patients with or without comorbidities are at increased cardiovascular (CV) risk. Due to the increased CV risk profile in this patient population, this systematic literature review was conducted to assess human studies reporting major adverse CV events (MACE) and other CV events.

Risk of interstitial lung disease in patients treated for atrial fibrillation with dronedarone versus other antiarrhythmics.

Purpose: To compare risks of interstitial lung disease (ILD) between patients treated with dronedarone versus other antiarrhythmics.

Methods: Parallel retrospective cohort studies were conducted in the United States Department of Defense Military Health System database (DoD) and the HealthCore Integrated Research Database (HIRD). Study patients were treated for atrial fibrillation (AF) with dronedarone, amiodarone, sotalol, or flecainide.

Variations in erythropoiesis-stimulating agent administration in transfusion-dependent myelodysplastic syndromes impact response.

Introduction: Erythropoiesis-stimulating agents (ESAs) reduce red blood cell (RBC) transfusions in approximately 40% of patients with myelodysplastic syndrome (MDS) in clinical trials. We studied the association of timing of ESA initiation, agent (epoetin alfa, darbepoetin) and number of weeks of ESA use with response in MDS patients in routine practice.

Methods: Patients diagnosed with MDS from 2001 to 2005 were identified in the Surveillance Epidemiology and End Results-Medicare linked database.

Adverse event reporting patterns of newly approved drugs in the USA in 2006: an analysis of FDA Adverse Event Reporting System data.

Background: The Weber effect states that adverse event (AE) reporting tends to increase in the first 2 years after a new drug is placed onto the market, peaks at the end of the second year, and then declines. However, since the Weber effect was originally described, there has been improvement in the communication of safety information and new policies regarding the reporting of AEs by healthcare professionals and consumers, prompting reassessment of the existence of the Weber effect in the current AE reporting scenario.

Objectives: To determine the AE reporting patterns for new molecular entity (NME) drugs and biologics approved in 2006 and to examine these patterns for the existence of the Weber effect.

Patterns of erythropoiesis-stimulating agent use among Medicare beneficiaries with myelodysplastic syndromes and consistency with clinical guidelines.

Erythropoiesis-stimulating agents (ESA) are used commonly to reduce symptomatic anemia in patients with myelodysplastic syndromes (MDS). We assessed population-based patterns of ESA use relative to treatment guidelines using data from the Surveillance, Epidemiology, and End Results (SEER) registries, with linked Medicare claims providing detailed treatment data from 2001 through 2005. The study found widespread use (62%) of ESA in Medicare beneficiaries with MDS.

Looking beyond urban/rural differences: emergency department utilization by asthmatic children.

Asthma causes pediatric morbidity throughout the US with substantial regional variability. Emergency department (ED) utilization data were studied to determine if geographic variability of pediatric asthma cases exists within a state. Records for non-neonatal Maryland children less than 18 years of age seen and discharged from Maryland EDs from April 1997 through March 2001 were analyzed.

Risk areas for pediatric acute care: asthma differs from upper and lower respiratory illness.

Objective: To determine if emergency department utilization for pediatric respiratory illness varies across small geographic jurisdictions within a large urban city.

Design: A retrospective analysis of Maryland Health Services Cost Review Commission Emergency Department discharge data.

Setting/patients: All non-neonatal, Baltimore City residents <18 years old with valid diagnoses admitted and discharged from emergency departments (ED) in the state of Maryland from April 1, 1997 to December 31, 2000 (n=245,339).

National patterns of medication use during pregnancy.

Purpose: To describe patterns of medication use during pregnancy in ambulatory care settings according to the U.S. Food and Drug Administration (FDA) pregnancy risk classification.

Antidiabetic therapy and the risk of heart failure in type 2 diabetic patients: an independent effect or confounding by indication.

Purpose: This study assesses the effect of the type of antidiabetic treatment on the risk of developing congestive heart failure (CHF) in type 2 diabetes.

Methods: The study was derived from the U.K.

Impact of regulatory labeling for troglitazone and rosiglitazone on hepatic enzyme monitoring compliance: findings from the state of Ohio medicaid program.

Purpose: Troglitazone, the first drug of the thiazolidinediones class for type II diabetes, was first marketed in March 1997 and was removed from the U.S. market 36 months later after 90 cases of liver failure were reported despite multiple warnings containing liver enzyme monitoring recommendations.

Impact of an educational intervention for secondary prevention of myocardial infarction on Medicaid drug use and cost.

Objectives: The objectives of this drug utilization review program were (1) to increase beta-blocker prescribing to fee-for-service post-acute myocardial infarction (AMI) Medicaid patients; (2) to improve compliance among patients who were prescribed beta-blockers post-AMI; and (3) to evaluate the economic implications of increased beta-blocker prescribing.

Study Design: Pre-post nonequivalent group design.

Patients And Methods: The intervention targeted physicians of Pennsylvania Medicaid recipients who had an AMI between November 1, 1998, and November 1, 1999.

Temporal dynamics of emergency department and hospital admissions of pediatric asthmatics.

Asthma is a chronic disease that can result in exacerbations leading to urgent care in emergency departments (EDs) and hospitals. We examined seasonal and temporal trends in pediatric asthma ED (1997-1999) and hospital (1986-1999) admission data so as to identify periods of increased risk of urgent care by age group, gender, and race. All pediatric ED and hospital admission data for Maryland residents occurring within the state of Maryland were evaluated.

Environmental allergens and asthma in urban elementary schools.

Background: Asthma in school children is rising, and indoor allergens are very common triggers of asthma attacks; however, the risk of the school environment on asthma has not been well studied.

Objective: To determine the presence and the levels of common aeroallergens in schools, where asthma prevalence rates are high.

Methods: Settled dust samples were collected from 12 Baltimore City public elementary schools, and they were analyzed for the following allergens: cockroaches (Bla g 1/2), dust mites (Der f 1/p 1), dog (Can f 1), cat (Fel d 1), and mouse (Mus m 1).

Using seasonal variations in asthma hospitalizations in children to predict hospitalization frequency.

Asthma hospitalization rates have increased in the United States since 1980. The exposure risk of many environmental factors, which contribute to respiratory disease, vary throughout the year. The objective of this study was to investigate the seasonal variation of pediatric asthma hospitalizations and predict hospitalization frequency.

Patterns of pharmacotherapy and counseling for osteoporosis management in visits to US ambulatory care physicians by women.

Background: Women experience rapid bone loss following menopause. Currently available guidelines recommend lifestyle counseling and pharmacotherapy for osteoporosis prevention and treatment in postmenopausal women.

Methods: We analyzed 2 years of National Ambulatory Medical Care Survey data (1997-1998), a national representative survey evaluating recent national patterns of antiosteoporosis medication (AOM) use and lifestyle counseling among office visits made by nonpregnant women 40 years and older.

Reported adverse drug events in infants and children under 2 years of age.

Objective: To characterize risks to infants and young children from drugs and biological products that were identified in spontaneous adverse event reports submitted to the US Food and Drug Administration.

Methods: Of >500 000 MedWatch adverse event reports received by the Food and Drug Administration from November 1997 through December 2000, we identified 7111 reports about infants and children younger than age 2. The reports were analyzed for health outcome (eg, death, hospitalization, congenital anomaly), principal suspect drug, and whether the route of drug exposure was direct administration or through the mother in the perinatal period.