Antidiabetic drug use trends in patients with type 2 diabetes mellitus and chronic kidney disease: A cross-sectional analysis of the National Health and Nutrition Examination Survey.

BACKGROUND: There is little information on medication use, trends across time, and the impact of guidelines on appropriate use of antidiabetic drugs in participants with type 2 diabetes mellitus (T2DM) with chronic kidney disease (CKD). METHODS: A cross-sectional analysis of the National Health and Nutrition Examination Survey (NHANES) from 2005-2016 was carried out for participants with T2DM with and without CKD. Multivariate survey-weighted regression models were used to evaluate trends in antidiabetic drug use across the time periods and CKD severity. Guideline-discordant use of metformin and glyburide were assessed among those with glomerular filtration rate and serum creatinine-based contraindications. RESULTS: Out of 3237 study participants with T2DM, 35.9% had CKD. Comparing 2013-2016 with 2005-2008, use of metformin (non-CKD: 69% vs 83.8%, CKD: 58.6% vs 68.2%) increased, whereas the use of sulfonylureas (non-CKD: 46.3% vs 27.2%, CKD: 54.7% vs 36.6%) and thiazolidinediones (non-CKD: 29.3% vs 3.9%, CKD: 24.6% vs 5.5%) decreased. In combined NHANES cycles and across stages of CKD severity, metformin use decreased (non-CKD, stage 1/2, stage 3, stage 4/5: 78.4%, 69.5%, 54.6%, 4.9%, respectively; P < .01), and insulin use increased (18.5%, 26.8%, 25%, 52.8%, respectively; P < .01) from non-CKD to progressed CKD. Guideline-discordant use of metformin and glyburide was observed in 8.3% and 2.8% of the participants, respectively, in 2013-2016. CONCLUSIONS: Use of particular antidiabetic medications in patients with CKD changed noticeably over the years, most in accordance with guidelines and regulatory decisions. Gaps in quality of care still exist, which warrants increasing awareness and implementing programs to mitigate inappropriate use.

Risk of Serious Bacterial Infection Associated With Tumor Necrosis Factor-Alpha Inhibitors in Children and Young Adults With Inflammatory Bowel Disease.

Background: Prior studies evaluating the relationship between tumor necrosis factor-alpha inhibitors (TNFI) and infection were conducted in adults and had conflicting findings. We sought to examine the risk of serious infection associated with TNFIs compared with nonbiologic immunomodulators in children and young adults with inflammatory bowel disease (IBD) and to compare the risk among individual TNFIs. Methods: We conducted a cohort study using the Truven MarketScan Commercial Claims and Encounters database of patients age <30 years with a diagnosis of IBD who initiated treatment with a TNFI or immunomodulator (thiopurines or methotrexate) between 2009 and 2013. The outcome of interest was serious infection, defined as a nongastrointestinal bacterial infection requiring hospitalization. Cox proportional hazard models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for serious infection associated with TNFIs compared with immunomodulators. Results: We identified 10,838 children and young adults with IBD; 236 and 192 cases of serious infection were observed in 4502 TNFI initiators (5.25/100 person-years) and 6336 immunomodulator initiators (3.59/100 person-years), respectively. Compared with immunomodulators, TNFIs were associated with a higher risk of serious infection (HR, 1.36; 95% CI, 1.08-1.72). Among TNFI users, certolizumab showed a 3.38-fold (95% CI, 2.25-5.09) increased risk vs infliximab, and subcutaneously administered TNFIs also exhibited a higher risk (HR, 1.34; 95% CI, 1.18-1.53) than intravenous TNFIs. Conclusions: TNFIs pose a higher risk of serious infection compared with immunomodulators in children and young adults with IBD, and this risk differs among individual TNFIs and routes of administration.

High number of newly initiated direct oral anticoagulant users switch to alternate anticoagulant therapy.

Real-world evidence focusing on medication switching patterns amongst direct oral anticoagulant (DOACs) has not been well studied. The objective of this study is to evaluate patterns of prescription switching in non-valvular atrial fibrillation (NVAF) patients initiated on a DOAC and previously naïve to anticoagulation (AC) therapy. Data was obtained from Truven Health MarketScan® Commercial and Medicare Supplemental database (2009-2013). AC naïve (those without prior anticoagulant use) NVAF patients initiated on a DOAC, with 6 months of continuous health plan enrollment before and after treatment initiation and maintained on continuous therapy for a minimum of 6 months were included. Of 34,022 AC naïve NVAF patients initiating a DOAC, 6613 (19.4%) patients switched from an index DOAC prescription to an alternate anticoagulant and 27,409 (80.6%) remained on the DOAC [age: 68.5 ± 11.7 vs. 67.1 ± 12.7 years, p < 0.001; males: 3781 (57.2%) vs. 17,160 (62.6%), p < 0.001]. Amongst those that switched medication, 3196 (48.3%) did so within the first 6 months of therapy. Overall, 2945 (44.5%) patients switched to warfarin, 2912 (44.0%) switched to another DOAC and 756 (11.4%) switched to an injectable anticoagulant. The highest proportion of patients switched from dabigatran to warfarin (N = 2320; 42.5%) or rivaroxaban (N = 2252; 41.3%). The median time to switch from the index DOAC to another DOAC was 309.5 days versus 118.0 days (p < 0.001) to switch to warfarin. In NVAF patients newly initiated on DOAC therapy, one in five patients switch to an alternate anticoagulant and one of every two patients do so within the first 6 months of therapy. Switching from an initial DOAC prescription to traditional anticoagulants occurs as frequently as switching to an alternate DOAC.

Meeting the challenge of COPD care delivery in the USA: a multiprovider perspective.

The burden of chronic obstructive pulmonary disease (COPD) in the USA continues to grow. Although progress has been made in the the development of diagnostics, therapeutics, and care guidelines, whether patients' quality of life is improved will ultimately depend on the actual implementation of care and an individual patient's access to that care. In this Commission, we summarise expert opinion from key stakeholders-patients, caregivers, and medical professionals, as well as representatives from health systems, insurance companies, and industry-to understand barriers to care delivery and propose potential solutions. Health care in the USA is delivered through a patchwork of provider networks, with a wide variation in access to care depending on a patient's insurance, geographical location, and socioeconomic status. Furthermore, Medicare's complicated coverage and reimbursement structure pose unique challenges for patients with chronic respiratory disease who might need access to several types of services. Throughout this Commission, recurring themes include poor guideline implementation among health-care providers and poor patient access to key treatments such as affordable maintenance drugs and pulmonary rehabilitation. Although much attention has recently been focused on the reduction of hospital readmissions for COPD exacerbations, health systems in the USA struggle to meet these goals, and methods to reduce readmissions have not been proven. There are no easy solutions, but engaging patients and innovative thinkers in the development of solutions is crucial. Financial incentives might be important in raising engagement of providers and health systems. Lowering co-pays for maintenance drugs could result in improved adherence and, ultimately, decreased overall health-care spending. Given the substantial geographical diversity, health systems will need to find their own solutions to improve care coordination and integration, until better data for interventions that are universally effective become available.

Cost-utility of chelators in transfusion-dependent ß-thalassemia major patients: a review of the pharmacoeconomic literature.

In the inherited hematologic disorder ß-thalassemia major, patients receive regular, lifelong blood transfusions, which carry excess iron that the body is unable to eliminate. Chelation therapy (deferoxamine, deferiprone, deferasirox or deferoxamine-deferiprone combination) is required to reduce iron accumulation in target organs and the associated morbidity and mortality. Each chelation regimen has a distinct safety/efficacy profile and particular costs associated with its use. This review aims to provide an overview of published cost-utility analyses of currently used chelation regimens, and to comment on the potential relevance of their findings in the USA market, where deferiprone has recently been introduced.

Stakeholder priorities for comparative effectiveness research in chronic obstructive pulmonary disease: a workshop report.

Comparative effectiveness research (CER) is intended to address the expressed needs of patients, clinicians, and other stakeholders. Representatives of 54 stakeholder groups with an interest in chronic obstructive pulmonary disease (COPD) participated in workshops convened by the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT) over a 2-year period. Year 1 focused on chronic care and care coordination. Year 2 focused on acute care and transitions in care between healthcare settings. Discussions and provisional voting were conducted via teleconferences and e-mail exchanges before the workshop. Final prioritization votes occurred after in-person discussions at the workshop. We used a modified Delphi approach to facilitate discussions and consensus building. To more easily quantify preferences and to evaluate the internal consistency of rankings, the Analytic Hierarchy Process was incorporated in Year 2. Results of preworkshop and final workshop voting often differed, suggesting that prioritization efforts relying solely on requests for topics from stakeholder groups without in-person discussion may provide different research priorities. Research priorities varied across stakeholder groups, but generally focused on studies to evaluate different approaches to healthcare delivery (e.g., spirometry for diagnosis and treatment, integrated healthcare strategies during transitions in care) rather than head-to-head comparisons of medications. This research agenda may help to inform groups intending to respond to CER funding opportunities in COPD. The methodologies used, detailed in the online supplement, may also help to inform prioritization efforts for CER in other health conditions.

Life-years gained with meropenem over ciprofloxacin in penicillin-allergic patients with gram-negative bacilli sepsis: results of a probabilistic model.

STUDY OBJECTIVE: To compare meropenem with ciprofloxacin for treatment of gram-negative bacilli sepsis in penicillin-allergic patients in the intensive care unit (ICU) to determine if increased anaphylaxis risk with meropenem precluded its use when weighed against risks of inactive therapy with ciprofloxacin. DESIGN: A decision model constructed from probability distributions from the literature and data from a local ICU antibiogram. A probabilistic sensitivity analysis was performed to evaluate uncertainty in variable estimates by using one-way analyses, two-way analyses, and Monte Carlo simulation. MEASUREMENTS AND MAIN RESULTS: Microbiologic activity of treatment, anaphylaxis according to treatment regimen, curability of infection according to patient morbidity status, risk of superinfection, and recovery from gram-negative bacilli sepsis were the variables modeled. Effectiveness was defined by long-term survival and was modeled as life-years (LYs) and quality-adjusted life-years (QALYs) gained according to treatment group. Base case results were the incremental differences between the average effectiveness of each strategy calculated from the Monte Carlo simulation. Mean LYs and QALYs gained with meropenem were 9.9 (95% confidence interval [CI] 8.9-10.8) and 5.9 (95% CI 4.8-6.7), respectively. Mean LYs and QALYs gained with ciprofloxacin were 8.9 (95% CI 8.1-9.6) and 5.3 (95% CI 4.4-6.3), respectively. The incremental difference in effectiveness-or average benefit expected by selecting meropenem over ciprofloxacin-was 1.0 LY (95% CI 0.3-1.7 LYs) and 0.6 QALY (95% CI 0.2-1.1 QALYs) favoring meropenem. CONCLUSION: Use of empiric meropenem over ciprofloxacin may be justified in patients in the ICU who are allergic to penicillin.

Vitamin d deficiency/insufficiency practice patterns in a veterans health administration long-term care population: a retrospective analysis.

OBJECTIVES: To evaluate the prevalence of vitamin D deficiency/insufficiency in long-term care patients at a Veterans Health Administration (VHA) hospital and to assess treatment and follow-up of low vitamin D levels. DESIGN: Observational cohort study. SETTING: VA hospital extended care center (ECC). PARTICIPANTS: 2218 ECC patients between January 2001 and December 2006 were screened. MEASUREMENT: Serum 25-hydroxyvitamin D (25[OH]D) level, vitamin D therapy regimen, time to follow-up, documented adverse event to vitamin D therapy. RESULTS: Of 2218 patients admitted to the ECC during the study period, 229 (10%) had a vitamin D level measured. Among these 229 patients, 49% were vitamin D sufficient (25[OH]D > or =30 ng/mL), 14% were insufficient (25[OH]D=21-29 ng/mL), and 37% were deficient (25[OH]D < or =20 ng/mL). Sixty-nine percent of patients with low vitamin D levels received some form of vitamin D therapy, whereas 43% received treatment as well as follow-up evaluation of vitamin D status within 3 months. Only 13% received a formulation of vitamin D appropriate for the severity of their deficiency/insufficiency with concurrent calcium supplementation and had a repeat vitamin D level within 3 months. CONCLUSION: Vitamin D levels were measured infrequently in long-term care patients. Among those monitored, the rate of vitamin D deficiency/insufficiency is high. Few patients with low vitamin D status received proper treatment and follow-up. These data support the need to educate physicians regarding the high prevalence of vitamin D insufficiency/deficiency among long-term care patients to ensure that patients with low vitamin D levels are identified and treated appropriately.