AimIn the EMPA‐REG OUTCOME trial, empagliflozin therapy reduced cardiovascular death by 38% compared with placebo when added to standard of care. Using the trial results, we created a discrete‐event simulation model to assess lifetime health economic outcomes in people with Type 2 diabetes and established cardiovascular disease.MethodsTime‐dependent survival regression analysis was performed on data from EMPA‐REG OUTCOME for 10 cardiovascular and renal events (e.g. stroke, heart failure hospitalization, macroalbuminuria, cardiovascular mortality) to capture event rates over time, and interaction between events. Model performance was assessed by comparing predicted and observed outcomes at 3 years. Costs in the United Kingdom (UK) and health utilities were obtained from published literature. Outcomes included cumulative event rates, life‐years, costs and quality‐adjusted life‐years (QALYs).ResultsThe model predicted an 18% relative increase (by 2.1 life‐years) in survival for empagliflozin (14.0 life‐years) vs. standard of care (11.9 life‐years), attributable to direct treatment effect on cardiovascular mortality, and to indirect effect via reductions in other events. Participants treated with empagliflozin may experience improved quality of life (1.0 QALY) and higher costs (£3737/participant), yielding an incremental cost‐effectiveness ratio (ICER) of £4083/QALY. Sensitivity analyses confirmed the robustness of these results to changes in input parameters.ConclusionsBased on extrapolation of EMPA‐REG OUTCOME trial data using a participant‐level simulation model, empagliflozin in addition to standard of care is projected to be highly cost‐effective using UK healthcare costs. The impact in other countries will vary due to differences in drug pricing and accrual of other costs. (Clinical Trial Registry No: NCT01131676)

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This model makes a strong economic case for the introduction of rapid onsite assessment of thyroid FNA across cancer networks, to improve the diagnostic efficacy of thyroid FNA.

To examine the efficacy and potential cost implications of acetic acid (AA) chromoendoscopy in the assessment of Barrett's neoplasia. Our prospective database of patients referred between 2005 and 2010 with suspected early neoplasia was reviewed. High-resolution Fujinon gastroscopes and EPX-4400 processor were used. Inspection of Barrett's neoplasia was carried out using white light followed by AA. Neoplastic areas were noted, and targeted biopsy was carried out. This was followed by quadrantic biopsies of the remaining Barrett's neoplasia. The cost of protocol-guided biopsies was compared with AA-guided biopsy protocols. Two hundred sixty-three procedures on 197 patients were examined. High-risk neoplasia was found during 143 procedures. In 96% of cases it was identified with AA. The cost of histological evaluation by Cleveland protocol would be £139,416.30. The cost by AA-targeted biopsy followed by random biopsies in one pot would be £25,032.50. For AA-targeted biopsies alone the cost would be £9,541.8 but results in a 4% miss rate. AA localizes neoplastic lesions in the majority of patients and could potentially represent a significant cost saving in patients with suspected neoplasia.

mean of age for 400 patients was (52.3±14.8) years and 60% of them had DFCs. DFCs were (43.5%) diminishing or/and loss of protective sensation, (34.5%) foot deformity and callosity, (5.8%) foot fungal infection, (5.8%) foot ulcer, and (3.5%) amputation. Of 223 patients with HbA1c% >7, about 148 (66.4%) cases had DFCs, 0.66 (95% CI: 0.6 e 0.73). However, from 177 patients with HbA1c 7, only 92 (52%) subjects had DFCs, 0.52 (95% CI: 0.45 e 0.59). The relative risk of HbA1c% >7, for the incidence of DFCs, is (RR: 1.28, 95% CI: 1.1 e 1.5) and excess relative risk is (27.7%). The absolute risk is (14.4%), and number needed to harm is 7. Chi-square test indicated a significant difference between the means of two cohorts in DFCs incidence (P-value: 0.001). Spearman's correlation is significant, (r: 0.146, p-value: 0.003). Multinomial logistic regression indicated HbA1c >7% as a significant predictor of DFCs (rs: 0.021, p-value: 0.004). CONCLUSIONS: This analysis demonstrated that more than half of the patients have DFCs. Patients with HbA1c >7 have a higher risk of DFCs.

IntroductionClinical trials conducted in patients with type 2 diabetes (T2DM) treated with glucose-lowering drugs and examining cardiovascular-related outcomes have yielded mixed results. In this work, we aimed to assess the relative treatment effects of empagliflozin versus sitagliptin and saxagliptin (dipeptidyl peptidase-4 (DPP-4) inhibitors) on cardiovascular-related outcomes in patients with T2DM.MethodsWe conducted a systematic literature review to identify clinical trials assessing cardiovascular-related outcomes for sitagliptin-, saxagliptin-, and empagliflozin-treated patients with T2DM. A network meta-analysis of indirect treatment comparisons was conducted in a Bayesian framework. Hazard ratios (HR) and 95% credible intervals (CrI) were computed for six cardiovascular-related outcomes to estimate the relative efficacies of these agents.ResultsEmpagliflozin showed a statistically significant superiority over saxagliptin (HR 0.60; 95% CrI 0.46–0.80) and sitagliptin (HR 0.60; 95% CrI 0.46–0.79) to reduce the risk for cardiovascular-related mortality. For all-cause mortality, empagliflozin showed a statistically significant risk reduction compared to saxagliptin (HR 0.61; 95% CrI 0.49–0.76) and sitagliptin (HR 0.67; 95% CrI 0.54–0.83). A similar pattern was observed in the risk reduction for hospitalization due to heart failure, where empagliflozin was found to be statistically significantly superior to saxagliptin (HR 0.51; 95% CrI 0.37–0.70) and sitagliptin (HR 0.65; 95% CrI 0.47–0.90). Empagliflozin was not statistically significantly different to sitagliptin and saxagliptin with regard to the risk of a composite endpoint composed of death, stroke or myocardial infarction.ConclusionIn this indirect comparison to the DPP-4 inhibitors saxagliptin and sitagliptin, empagliflozin significantly lowered the risk of cardiovascular-related mortality, all-cause mortality and hospitalizations due to heart failure.FundingBoehringer Ingelheim GmbH.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0456-7) contains supplementary material, which is available to authorized users.

A 3 4 7 -A 7 6 6 reported clinical inputs utilised in economic models: reduction in HbA1c levels (49 studies), hypoglycaemic events (39 studies), change in BMI (30 studies), change in systolic blood pressure (SBP, 23 studies), change in body weight (19 studies), and change in lipid biomarkers (17 studies); 28 studies reported utility inputs: hypoglycaemia (20 studies), BMI (12 studies), and T2DM-related cardiovascular-(12 studies), renal-(11 studies), and eye-complications (11 studies). Six studies for SGLT-2 inhibitors considered urinary tract and genital infections (key SGLT-2 inhibitors adverse events [AEs]), which indicate increased interest in treatment-related AEs besides the regular clinical effectiveness inputs. Among assessed studies, key cost drivers for insulins were HbA1c change (9 studies), hypoglycaemia event rate (10 studies), and T2DM-related complications (5 studies). For GLP-1 analogues, key cost drivers were changes in utilities associated with weight change, BMI, and nausea. For SGLT-2 inhibitors, key cost drivers were weight/BMI change, HbA1c change, and SBP change. ConClusions: HbA1c levels and hypoglycaemic event rates dominate economic evaluations for T2DM and with T2DM-related complications were found to be key cost-drivers for insulin-based regimens. However, weight/BMI were identified as key cost-drivers for GLP-1 analogues and SGLT-2 inhibitors.objeCtives: Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodiumglucose co-transporter 2 inhibitors (SGLT-2i) are both indicated for the treatment of Type 2 diabetes mellitus (T2DM). Liraglutide and dapagliflozin are the most commonly prescribed GLP-1RA and SGLT-2i treatments in Spain, respectively. This study investigated the cost-effectiveness of liraglutide versus dapagliflozin for the treatment of T2DM in Spain. Methods: The IMS CORE Diabetes Model (CDM), a validated simulation model, was used to estimate expected costs and outcomes. Patients with T2DM who had failed prior therapy with metformin received liraglutide 1.2mg or 1.8mg as interventions versus dapagliflozin 10mg as comparator, in addition to continuing metformin (dual therapy). Comparative efficacy was extracted from a network meta-analysis. Utility inputs came from a systematic literature review. A Spanish national payer perspective was assumed and analysis run over a lifetime time horizon. Sensitivity analysis considered a cohort receiving liraglutide or dapagliflozin in combination with two other anti-diabetic drugs (triple therapy). Results: In dual therapy, liraglutide 1.2mg resulted in a QALY gain of 0.07 vs dapagliflozin 10mg at an additional cost of € 421 (ICER: € 6,486 per QALY gained), whereas results for liraglutide 1.8mg found a QALY gain of 0.08 at an additional cost of € 1,480 (ICER: € 17,966 per QALY gained). In triple therapy, QALY gain with liraglutide 1.2mg vs dapagliflozin 10mg was similar (0.07) and incremental cost was € 578 (ICER: € 8,932 per QALY gained), while increases in efficacy and costs were observed for liraglutide 1.8mg (ICER: € 17,703 per ...