Pregnancy snapshot: a retrospective, observational case-control study to evaluate the potential effects of maternal diabetes treatment during pregnancy on macrosomia.

Objective: Pregnancy in women with diabetes is associated with increased incidence of macrosomia (high birth weight) versus women without diabetes. Macrosomia increases the risk of complications during delivery and neonatally. The potential effect on macrosomia incidence certain diabetes treatments may have is not fully established.

Early treatment revisions by addition or switch for type 2 diabetes: impact on glycemic control, diabetic complications, and healthcare costs.

Background: The study examined the prevalence of early treatment revisions after glycosylated hemoglobin (HbA1c) ≥9.0% (75 mmol/mol) and estimated the impact of early treatment revisions on glycemic control, diabetic complications, and costs.

Research Design And Methods: A retrospective cohort study of administrative claims data of plan members with type 2 diabetes and HbA1c ≥9.

The dynamic relationship between current and previous severe hypoglycemic events: a lagged dependent variable analysis among patients with type 2 diabetes who have initiated basal insulin.

Background And Objective: Past studies have found episodes of severe hypoglycemia (SH) to be serially dependent. Those studies, however, only considered the impact of a single (index) event on future risk; few have analyzed SH risk as it evolves over time in the presence (or absence) of continuing events. The objective of this study was to determine the dynamic risks of SH events conditional on preceding SH events among patients with type 2 diabetes (T2D) who have initiated basal insulin.

Trends in the incidence of diabetes, its clinical sequelae, and associated costs in pregnancy.

Background: Increasing diabetes prevalence affects a substantial number of pregnant women in the United States. Our aims were to evaluate health outcomes, medical costs, risks and types of complications associated with diabetes in pregnancy for mothers and newborns.

Methods: In this retrospective claims analysis, patients were identified from the Truven Health MarketScan(®) database (2004-2011 inclusive).

Value of lifestyle intervention to prevent diabetes and sequelae.

Background: The Community Preventive Services Task Force recommends combined diet and physical activity promotion programs for people at increased risk of type 2 diabetes, as evidence continues to show that intensive lifestyle interventions are effective for overweight individuals with prediabetes.

Purpose: To illustrate the potential clinical and economic benefits of treating prediabetes with lifestyle intervention to prevent or delay onset of type 2 diabetes and sequelae.

Methods: This 2014 analysis used a Markov model to simulate disease onset, medical expenditures, economic outcomes, mortality, and quality of life for a nationally representative sample with prediabetes from the 2003-2010 National Health and Nutrition Examination Survey.

The economic burden of elevated blood glucose levels in 2012: diagnosed and undiagnosed diabetes, gestational diabetes mellitus, and prediabetes.

Objective: To update estimates of the economic burden of undiagnosed diabetes, prediabetes, and gestational diabetes mellitus in 2012 in the U.S. and to present state-level estimates.

Savings in Medical Expenditures Associated with Reductions in Body Mass Index Among US Adults with Obesity, by Diabetes Status.

Background: The prevalence of obesity has more than doubled in the USA in the past 30 years. Obesity is a significant risk factor for diabetes, cardiovascular disease, and other clinically significant co-morbidities. This paper estimates the medical care cost savings that can be achieved from a given amount of weight loss by people with different starting values of body mass index (BMI), for those with and without diabetes.

The association between nonadherence and glycated hemoglobin among type 2 diabetes patients using basal insulin analogs.

Background: The main objective of this study was to investigate the relationship between adherence and both clinical (ie, glycated hemoglobin [HbA1c]) and nonclinical (ie, health status, work impairment, and health care-resource use) health outcomes among type 2 diabetes (T2D) patients using basal insulin.

Materials And Methods: The 2012 US National Health and Wellness Survey dataset was used for this study (n=71,141). A total of 1,198 respondents who reported a diagnosis of T2D, were currently using basal insulin, and reported both their HbA1c and level of nonadherence were included in the analyses.

Severe hypoglycemia rates and associated costs among type 2 diabetics starting basal insulin therapy in the United States.

Objectives: To derive current real-world data on the rates and costs of severe hypoglycemia (SH) for people with type 2 diabetes mellitus (T2D) who have initiated basal insulin therapy and to examine differences in SH rates and costs stratified by history of prior SH events.

Methods: We used a nation-wide electronic health records database that included encounter and laboratory data, as well as clinical notes, to estimate the rates and costs of SH events among adults with T2D who initiated basal insulin between 2008 and 2011. Unadjusted and regression-adjusted rates and quarterly costs were calculated for all patients as well as stratified by history of a SH event before starting basal insulin and history of a SH event during the basal insulin titration period.

The association of body mass index with the risk of type 2 diabetes: a case-control study nested in an electronic health records system in the United States.

Objectives: Obesity is a known risk factor for type 2 diabetes (T2D). We conducted a case-control study to assess the association between body mass index (BMI) and the risk of being diagnosed with T2D in the United States.

Methods: We selected adults (≥ 18 years old) who were diagnosed with T2D (defined by ICD-9-CM diagnosis codes or use of anti-diabetic medications) between January 2004 and October 2011 ("cases") from an electronic health records database provided by an integrated health system in the Middle Atlantic region.

Economic evaluation of tocilizumab combination in the treatment of moderate-to-severe rheumatoid arthritis in Italy.

Objective: This study was designed to evaluate the cost utility of tocilizumab in rheumatoid arthritis (RA) patients, with inadequate responses to traditional disease-modifying anti-rheumatic drugs (tDMARDs) from a payer's perspective in Italy.

Methods: An individual patient simulation model was used to project lifetime medical costs (payer's perspective) and quality-adjusted life-years (QALYs). Treatment sequences starting with tocilizumab or the most commonly prescribed biologics (etanercept, adalimumab, or infliximab) were compared.

Renal toxicity in patients with multiple myeloma receiving zoledronic acid vs. ibandronate: a retrospective medical records review.

Aims: This retrospective study investigated the rates of renal impairment in patients with multiple myeloma treated with zoledronic acid and ibandronate.

Materials And Methods: We retrospectively reviewed medical records in a German oncology clinic, from May 2001 to December 2005. Creatinine measurements were analyzed from baseline (before zoledronic acid or ibandronate treatment) to last evaluation for each patient.

Indirect comparison of tocilizumab and other biologic agents in patients with rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs.

Objectives: To compare the patterns of American College of Rheumatology (ACR) response between tocilizumab and other biologic agents in patients with rheumatoid arthritis who have inadequate response to disease-modifying antirheumatic drugs (DMARD-IR).

Methods: Systematic literature review identified similarly designed double-blind, randomized, placebo-controlled trials over an 18-year period that investigated the effectiveness of abatacept (2), rituximab (2), and TNF-alpha inhibitors etanercept, infliximab, and adalimumab (11) in DMARD-IR patients; data from 3 placebo-controlled, phase 3 trials for tocilizumab, a newly developed IL-6 inhibitor, were included. The endpoint of interest was ACR20/50/70 response criteria at 24 to 30 weeks.

Risk of renal impairment after treatment with ibandronate versus zoledronic acid: a retrospective medical records review.

Purpose: This retrospective study compared renal impairment rates in breast cancer, multiple myeloma, prostate cancer and non-small cell lung cancer patients treated with ibandronate or zoledronic acid.

Study Design: Medical records in two German oncology clinics from May 2001 to March 2006 were retrospectively reviewed. Creatinine measurements were analyzed from baseline (before bisphosphonate treatment) to last available measurement for each patient.

Comparing the safety, tolerability and quality of life in patients with chronic hepatitis B vs chronic hepatitis C treated with peginterferon alpha-2a.

Background/aims: Hepatitis B and C viruses (HBV and HCV) are two clinically distinct but related diseases. Pooled data from five studies of peginterferon alpha-2a in patients with chronic HCV infection (CHC) were compared with two studies of the drug in patients with chronic HBV infection (CHB).

Method: The HBV studies included both hepatitis B e antigen (HBeAg)-positive (n=271) and HBeAg-negative (n=177) patients; 791 patients took part in the HCV trials.

Cost-effectiveness of enfuvirtide in HIV therapy for treatment-experienced patients in the United States.

Enfuvirtide (ENF) is the first of a new class of antiretrovirals (ARVs) known as the HIV fusion inhibitors. Two phase III studies of ENF, TORO 1 and TORO 2, demonstrated that ENF given in combination with optimized background (OB) therapy significantly improved virological response, increased the time to virological failure, and increased CD4-cell count compared with OB alone among highly treatment-experienced patients. The present study investigated the long-term clinical outcomes, costs, and cost-effectiveness of ENF.

Treatment of chronic hepatitis C patients with persistently normal alanine aminotransferase levels with the combination of peginterferon alpha-2a (40 kDa) plus ribavirin: impact on health-related quality of life.

Background: Peginterferon alpha-2a (40 kDa) plus ribavirin is equally effective in chronic hepatitis C patients with normal or elevated alanine aminotransferase (ALT) values. This analysis, in patients with normal ALT levels, compared health-related quality of life (HRQoL) measurements between untreated control patients and treated patients grouped by virological response. HRQoL in the present population was also compared with HRQoL in patients with elevated ALT levels, observed in a previous study.

Cost-effectiveness of enfuvirtide for treatment-experienced patients with HIV in Italy.

Background: Enfuvirtide (ENF) plus an optimized background (OB) antiretroviral regimen delays virological failure (VF), reduces HIV-1 viral load, and increases CD4 count compared with OB only in pretreated patients.

Purpose: To forecast long-term outcomes, costs, and cost-effectiveness of ENF+OB vs. OB in the Italian health care system.

Health-related quality of life with enfuvirtide (ENF; T-20) in combination with an optimized background regimen.

This study assessed the impact of enfuvirtide on health-related quality of life (HRQoL). Patients enrolled in 2 phase 3 trials T-20 versus Optimized Regimen Only (TORO 1 and 2) completed the Medical Outcomes Study (MOS)-HIV questionnaire at baseline and at 4, 8, 16, and 24 weeks. A total of 995 treatment-experienced HIV-1-infected individuals received either self-administered enfuvirtide (90 mg twice daily) + optimized background (OB) or OB alone and had at least 1 follow-up visit.

The impact of peginterferon alfa-2a plus ribavirin combination therapy on health-related quality of life in chronic hepatitis C.

Background/aims: Peginterferon alfa-2a plus ribavirin improves sustained virological responses compared with interferon alfa-2b and ribavirin, or peginterferon alfa-2a alone in chronic hepatitis C. We examined the impact of these treatments on health related quality of life (HRQOL).

Methods: Patients (n=1121) were randomized to peginterferon alfa-2a weekly plus ribavirin or placebo, or interferon alfa-2b thrice weekly plus ribavirin.

Cost effectiveness of peginterferon alpha-2a plus ribavirin versus interferon alpha-2b plus ribavirin as initial therapy for treatment-naive chronic hepatitis C.

Introduction: In adults with previously untreated chronic hepatitis C (CHC), the combination of peginterferon alpha-2a plus ribavirin produces a higher rate of sustained virological response (SVR) than interferon alpha-2b plus ribavirin, but it is still unproven whether this increase is cost effective. The objective of this study was to determine if the gain in SVR with peginterferon alpha-2a plus ribavirin is worth the incremental cost.

Methods: We constructed a Markov model of disease progression in which cohorts of patients received peginterferon alpha-2a plus ribavirin or interferon alpha-2b plus ribavirin for 48 weeks (hepatitis C virus [HCV] genotype 1 and non-1 patients with fibrosis) or 24 weeks (genotype non-1 patients without fibrosis), and were followed for their expected lifetimes.

Patient acceptance of self-injected enfuvirtide at 8 and 24 weeks.

Purpose: Enfuvirtide is the first of a new class of antiretrovirals called the fusion inhibitors. It is administered twice daily by self-injection. This study assessed patient acceptance of enfuvirtide self-injection.

Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C.

Background: Use of unmodified interferon alpha-2a in chronic hepatitis C is associated with impaired health-related quality of life during therapy. Treatment with peginterferon alpha-2a (40kD) provides an improved sustained response over unmodified interferon alpha-2a.

Objectives: To compare health-related quality of life during treatment for patients receiving peginterferon alpha-2a (40kD) [Pegasys] versus unmodified interferon alpha-2a [Roferon].

Subcutaneous injection survey: psychometric evaluation of a treatment satisfaction instrument associated with a novel HIV medication.

Purpose: The 20-item Subcutaneous Injection Survey (SIS) was developed to assess patients' experience with subcutaneous self-injection of an innovative anti-HIV fusion inhibitor (T-20). It measures ease of use and impact of treatment on daily life. This study presents the results of a psychometric evaluation of the SIS.