Effectiveness of Liraglutide and Lixisenatide in the Treatment of Type 2 Diabetes: Real-World Evidence from The Health Improvement Network (THIN) Database in the United Kingdom.

INTRODUCTION: The glucagon-like peptide-1 receptor agonists liraglutide and lixisenatide are effective at reducing glycated hemoglobin (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Although liraglutide has demonstrated superior efficacy in head-to-head clinical trials, real-world evidence of comparative effectiveness is lacking. This observational study aimed to assess the effectiveness of liraglutide versus lixisenatide in UK clinical practice. METHODS: Electronic medical records from The Health Improvement Network (THIN) UK primary care database were analyzed. Patients aged ≥18 years, diagnosed with T2DM, and prescribed liraglutide or lixisenatide between 01 May 2013 and 31 December 2015 were included in the study. Adjusted linear regression models compared the difference in mean change in HbA1c, body mass index (BMI), and systolic blood pressure (SBP) after 12-month follow-up. The proportion of patients achieving glycemic control (HbA1c 1%; and weight reduction ≥3% within 12 months were determined. Cox proportional hazards modeling was used to evaluate the effect of treatment on time to achieving HbA1c and weight reduction targets. Healthcare resource use (HCRU) (GP, secondary care, hospitalizations) was compared using analysis of covariance. RESULTS: The primary outcome was assessed in 579 liraglutide and 213 lixisenatide new users. Fully adjusted linear regression indicated that liraglutide reduced HbA1c significantly more than lixisenatide (mean treatment difference -0.30; 95% CI -0.56, -0.04; p = 0.025). Compared to lixisenatide, liraglutide recipients were 2.5 times more likely to achieve HbA1c 1% HbA1c reduction (HR 1.29; p = 0.0002). BMI and SBP reductions were greater for the liraglutide group but results were not significant. HCRU was comparable between treatment groups. CONCLUSION: These results from the THIN database indicate that liraglutide treatment provided better outcomes related to glycemic control. FUNDING: Novo Nordisk

Treating iron deficiency in patients with gastrointestinal disease: Risk of re-attendance in secondary care.

Patients with gastrointestinal disease may have comorbid iron deficiency anaemia (IDA) and an increased risk of hospitalisation and re-attendance in hospital. The purpose of this study was to determine if oral and intravenous (IV) treatment of IDA in patients with gastrointestinal disease attending hospital were associated with differential rates of subsequent re-attendance.Data from the Clinical Practice Research Datalink (primary care) and Hospital Treatment Insights (secondary care) databases in England were used to conduct this retrospective cohort study. Patients with a coded gastrointestinal disease and IDA who attended hospital (inpatient or outpatient) and were dispensed oral or IV iron between 01/01/2010-31/10/2013 were included. Elective and emergency re-attendances in secondary care within 30 days of the initial attendance were determined. Demographics, medical diagnoses and treatments were extracted. Re-attendance rates following oral or IV iron were compared using chi-square tests and a step-wise logistic regression model to adjust for confounders. 2,844 patients contributed 6,294 initial attendances; 80% of patients received oral iron, 14% received intravenous iron, and 6% received both. Of initial attendances recording oral iron, 77% resulted in re-attendance in hospital, compared to 34% of those recording IV iron (unadjusted odds ratio [OR]: 0.16; adjusted OR: 0.52 [95% CI: 0.44-0.61]). Initial attendances using IV treatment were more likely to result in elective re-attendance (84%) than those recording oral treatment (43%) (p<0.001). Median length of stay in hospital tended to be shorter for patients using IV iron (1.4 days; interquartile range 0.5-3.6 days; oral iron: 5.1 days; interquartile range: 2.2-9.6 days).Patients with gastrointestinal disease and IDA who received IV iron were less likely to re-attend hospital, more likely to re-attend electively, and tended to have a shorter length of stay in hospital. The mode of IDA treatment could have a real-world impact on healthcare utilisation

Schematic overview of study design.

<p>Following the start of the study period, 1^st January 2010, 4 theoretical qualifying events are shown. Within the 30 day follow up period, a re-attendance in hospital is observed for 1) an episode with oral treatment and 2) an episode with IV treatment. Each initial attendance enters into either the oral or IV group and a subsequent re-attendance may or may not occur during the 30 day follow-up period.</p

Baseline characteristics for patients at initial attendance.

<p>Baseline characteristics for patients at initial attendance.</p

The economic burden of tuberous sclerosis complex in the UK: A retrospective cohort study in the Clinical Practice Research Datalink

Background: Tuberous sclerosis complex (TSC) is a multi-system genetic disorder characterized by the development of diverse clinical manifestations. The complexity of this disease is likely to result in substantial challenges and costs in disease management throughout the patient’s lifetime. This retrospective database study aims to quantify healthcare resources utilized by TSC patients. Methods: TSC patients in the Clinical Practice Research Datalink linked to the Hospital Episodes Statistics database were identified between January 1987 and June 2013. Analyses were conducted over the most recent 3-year period of data and stratified by pediatric (< 18) and adult patients. Prescriptions, procedures, diagnostic tests, and healthcare encounters were reported in comparison with a matched comparator cohort. Costs and key economic drivers by primary organ system manifestations were also examined. Results: A total of 286 patients with TSC were identified and consistently reported 2-fold greater resource use than the matched presumably healthy controls. Despite this comparatively greater resource use, half of TSC patients did not record any procedures, and 20% of patients did not record any diagnostic tests; however, inpatient hospitalizations were greater for the TSC cohort (3.1 vs 1.3), but length of stay was comparable. TSC patients had costs totaling £12,681 per patient over the 3-year period, a figure 2.7-fold greater than the total costs in the comparator cohort (£4,777). Costs for patients with specific primary manifestations were even greater, with brain manifestations incurring £22,139 per affected patient. Kidney and nervous system manifestations were the main cost drivers. Conclusions: The economic burden of TSC and its impact on NHS healthcare resources is mostly attributable to the broad spectrum of manifestations that develop within multiple organ systems. TSC patients may benefit from co-ordinated care based on their requirement for high numbers of healthcare visits across specialties

Using Climate-HIV to describe real-world clinical outcomes for people living with HIV taking dolutegravir-based regimens.

OBJECTIVES The objective of this study was to describe the real-world use and effectiveness of dolutegravir-based regimens (DBRs) in routine clinical practice in the United Kingdom. METHODS Retrospective analysis was conducted using data from four National Health Service trusts using Climate-HIV, an electronic case record system. Eligible patients were aged ≥18 years with HIV-1 infection who were prescribed a DBR from December 2012 to March 2018. Outcome measurements were accessed at DBR initiation and at weeks 24, 48 and 96 and the last recorded visit up to the extraction date (last measurement). The primary endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL at Week 48. RESULTS The study cohort included 934 patients; 337 (36%) were female, 414 (47%) were white and 717 (77%) were treatment experienced (TE). The Kaplan-Meier estimated probability of achieving HIV-1 RNA <50 copies/mL at 48 weeks was 96% for treatment-naive (TN) patients and 86% for TE patients. Median times to viral suppression (<50 copies/mL) were 49 and 57 days for TN and TE patients with detectable baseline viral load, respectively, according to Kaplan-Meier analysis. Median follow-up time was 377 days (interquartile range: 131-683). At last measurement, 87% (809/934) of patients remained on a DBR; among those patients, 681 (84%) had HIV-1 RNA <50 copies/mL. CONCLUSIONS High levels of virologic suppression and low rates of discontinuation of DBRs were seen in a large, diverse, UK-based population with HIV-1 infection. These findings are broadly consistent with efficacy data from phase III studies

Effectiveness of Liraglutide and Lixisenatide in the Treatment of Type 2 Diabetes: Real-World Evidence from The Health Improvement Network (THIN) Database in the United Kingdom

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