Dataset Information

An estimation of the long-term clinical and economic benefits of insulin lispro in Type 1 diabetes in the UK.

ABSTRACT:

Aims

To determine the long-term health economic benefits associated with lispro vs. regular human insulin (RHI) in UK Type 1 diabetic (T1DM) patients using the previously published and validated CORE Diabetes Model.

Methods

A literature review designed to capture clinical benefits associated with lispro and T1DM cohort characteristics specific to UK was undertaken. Clinical benefits were derived from a Cochrane meta-analysis. The estimated difference (weighted mean) in glycated haemoglobin (HbA(1c)) was -0.1% (95% confidence interval -0.2 to 0.0%) for lispro vs. RHI. Severe hypoglycaemia rates for lispro and RHI were 21.8 and 46.1 events per 100 patient years, respectively. Costs and disutilities were accounted for severe hypoglycaemia rates. All costs were accounted in 2007 poundUK from a National Health Service (NHS) perspective. Future costs and clinical benefits were discounted at 3.5% annually.

Results

In the base-case analysis, lispro was projected to be dominant compared with RHI. Lispro was associated with improvements in quality-adjusted life expectancy (QALE) of approximately 0.10 quality-adjusted life years (QALYs) vs. RHI (7.60 vs. 7.50 QALYs). Lifetime direct medical costs per patient were lower with lispro treatment, pound70 576 vs. pound72 529. Severe hypoglycaemia rates were the key driver in terms of differences in QALE and lifetime costs. Sensitivity analyses with assumptions around time horizon, discounting rates and benefits in terms of glycaemic control or hypoglycaemic event rates revealed that lispro remained dominant.

Conclusions

Our findings suggest that lispro is likely to improve QALE, reduce frequency of diabetes-related complications and lifetime medical costs compared with RHI.

SUBMITTER: Pratoomsoot C

PROVIDER: S-EPMC3228293 | biostudies-literature | 2009 Aug

REPOSITORIES: biostudies-literature

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Publications

An estimation of the long-term clinical and economic benefits of insulin lispro in Type 1 diabetes in the UK.

Pratoomsoot C C Smith H T HT Kalsekar A A Boye K S KS Arellano J J Valentine W J WJ

Diabetic medicine : a journal of the British Diabetic Association 20090801 8

<h4>Aims</h4>To determine the long-term health economic benefits associated with lispro vs. regular human insulin (RHI) in UK Type 1 diabetic (T1DM) patients using the previously published and validated CORE Diabetes Model.<h4>Methods</h4>A literature review designed to capture clinical benefits associated with lispro and T1DM cohort characteristics specific to UK was undertaken. Clinical benefits were derived from a Cochrane meta-analysis. The estimated difference (weighted mean) in glycated ha ...[more]

PMID: 19709151

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Project description:IntroductionThe PRONTO-T1D study, which evaluated the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes (T1D), met the primary endpoint of noninferiority of HbA1c change from baseline compared to lispro at 26 weeks. We present results of an additional 26-week treatment phase evaluating long-term efficacy and safety of URLi.MethodsIn this phase 3, treat-to-target study, subjects were randomized to double-blind mealtime URLi, lispro, or open-label postmeal URLi with insulin degludec or glargine for 26 weeks. Subjects in the double-blind URLi (n = 451) and lispro (n = 442) groups continued for another 26 weeks to assess long-term efficacy and safety.ResultsHbA1c increased marginally during the long-term maintenance period (week 26-52) in both groups to 7.47% (URLi) and 7.54% (lispro). At week 52, there were no statistically significant treatment differences in change from baseline HbA1c with a least-squares mean treatment difference (95% confidence interval) of - 0.06% (- 0.16, 0.03). Proportions of patients with HbA1c < 7% at week 52 were similar (URLi, 26.8%; lispro, 24.5%). Self-monitored blood glucose (SMBG) showed that 1-h (9.23 versus 10.14 mmol/L) and 2-h (8.40 versus 9.53 mmol/L) postmeal daily mean glucose was statistically significantly (p < 0.001) lower with URLi than lispro. The rate and incidence of severe, documented, and postprandial hypoglycemia (< 54 mg/dl [3.0 mmol/L]) were similar between treatments, but URLi demonstrated a 31% lower rate in the period more than 4 h after meals, (p = 0.023). Injection site reactions were reported by 3.3% of patients on URLi and 0.9% on lispro. The incidence of treatment-emergent adverse events was similar between treatments.ConclusionOverall glycemic control and improved postprandial glucose via SMBG were maintained after 52 weeks with URLi versus lispro, suggesting that the efficacy of URLi is preserved during long-term treatment in patients with T1D. No long-term safety issues were identified with URLi.Trial registrationClinicalTrials.gov, NCT03214367.

Dataset Information

An estimation of the long-term clinical and economic benefits of insulin lispro in Type 1 diabetes in the UK.

Aims

Methods

Results

Conclusions

Publications

An estimation of the long-term clinical and economic benefits of insulin lispro in Type 1 diabetes in the UK.

Similar Datasets

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