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ABSTRACT: BACKGROUND: Diabetes is associated with a higher risk for adverse cardiovascular outcomes. To improve the health outcomes of patients with type 2 diabetes (T2DM), the American Diabetes Association (ADA) recommended target goals for the improvement of glycemic control and the reduction of cardiovascular risk factors associated with the disease. This retrospective analysis calculated the absolute benefit increase (ABI) of using exenatide once weekly (QW), a glucagon-like peptide-1 (GLP-1) receptor agonist, vs an oral glucose-lowering medication or insulin glargine to achieve ADA-recommended goals. The number needed to treat (NNT) to achieve these goals was also calculated and provides a useful clinical metric for comparing potential therapies from different drug classes. METHODS: Patient data from three double-blind or open label, 26-week, randomized, controlled trials were retrospectively analyzed separately. ABI and NNT were calculated by comparing the percentage of patients treated with exenatide QW (N = 641) vs metformin (N = 246), sitagliptin (N = 329), pioglitazone (N = 328), or insulin glargine (N = 223), who achieved a single glycemic, weight, blood pressure, or lipid goal or a composite of these recommended goals, during the DURATION-2, -3, and -4 clinical trials. RESULTS: Significant ABIs favoring exenatide QW over all four glucose-lowering medications were observed for at least one HbA1c glycemic goal. NNTs of 4 and 5 were calculated when exenatide QW was compared to sitagliptin for attaining HbA1c goals of <7.0% and <=6.5%, respectively. Additionally, significantly more patients using exenatide QW compared to sitagliptin, pioglitazone, or insulin glargine attained the composite goal of HbA1c <7% or <=6.5%, without weight gain or hypoglycemia. Exenatide QW was also favored over sitagliptin and insulin glargine for the achievement of the composite goals of HbA1c <7% (or <=6.5%), systolic blood pressure <130 mm Hg, and low-density lipoprotein <2.59 mmol/L. For most goals, exenatide QW and metformin had similar effects in treatment naive patients. CONCLUSIONS: This analysis assessed the between-therapy differences in achieving therapeutic goals with therapies commonly used for glycemic control in patients with T2DM. In clinical trials, exenatide QW assisted more patients in reaching the majority of ADA-recommended therapeutic goals than treatment with sitagliptin, pioglitazone, or insulin glargine.Trial registration: NCT00637273, NCT00641056, NCT00676338.
Cardiovascular Diabetology 03/2013; 12(1):48. · 3.35 Impact Factor
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ABSTRACT: Abstract Objective: The purpose of this study was to estimate the long-term cost-utility of treating type 2 diabetes mellitus (T2DM) patients with exenatide once weekly (EQW) compared with insulin glargine (IG) from a US payer perspective. Methods: A validated computer simulation model, the CORE Diabetes Model, was used to project lifetime clinical outcomes and direct medical costs. Direct medical costs included pharmacy costs and costs associated with the management of diabetes and its complications. The model was populated using patient characteristics (mean age: 57.9 years; mean diabetes duration: 7.9 years; mean HbA1(c): 8.3%; mean body mass index [BMI]: 32.3 kg/m(2)) and clinical data from a phase 3 clinical trial that compared EQW with IG in T2DM patients on a background of metformin alone or a combination of metformin and a sulphonylurea (DURATION-3). All EQW patients were assumed to have stayed on treatment for 3 years before switching to IG. Health outcomes and costs were discounted at 3% per year. Complication costs were derived from published sources. A range of sensitivity analyses was performed. Results: Over a lifetime horizon, and compared with IG, EQW was associated with an incremental cost of $3914 (SD = 2923). EQW was projected to increase life expectancy by 0.135 (SD = 0.216) years and to improve quality-adjusted life expectancy by 0.246 (SD = 0.147) quality-adjusted life years (QALYs), generating an incremental cost-effectiveness ratio (ICER) of $15,936/QALY. Assuming a payer's willingness to pay threshold of $50,000/QALY, EQW is therefore cost-effective compared to IG. One-way and probabilistic sensitivity analyses confirmed EQW's cost-effective profile. Limitations: Short-term changes (26 weeks) in surrogate end-points (e.g., HbA1(c,) weight, complications) from one clinical trial were used to project long-term future effects on clinical outcomes. Conclusions: Treatment with EQW is projected to be cost-effective compared to treatment with IG.
Journal of Medical Economics 07/2012;
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ABSTRACT: Exenatide once-weekly (ExQW) is a GLP-1 receptor agonist shown to lower glucose and cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM). The objective of this study was to estimate the clinical benefits and associated economic benefits of treatment with ExQW compared with sitagliptin or pioglitazone in the US.
The IMS CORE Diabetes Model, a validated computer simulation model, was used to project lifetime clinical outcomes and complication costs. The costs of glucose-lowering drugs were excluded as not all prices were available. Baseline patient characteristics (mean values: age, 52.5 years; diabetes duration, 6 years; HbA1(c), 8.51%; body mass index, 32.12 kg/m(2)) and clinical data were derived from a phase 3 clinical trial that compared ExQW with sitagliptin or pioglitazone in T2DM patients. At 6 months, patients treated with ExQW had greater improvements in HbA1(c) and body weight than those treated with sitagliptin or pioglitazone. Complication costs were extracted from published sources. Health outcomes and costs were discounted at 3% per year. Sensitivity analyses were performed.
Over 35 years, and compared with sitagliptin or pioglitazone, ExQW increased life expectancy by, respectively, 0.28 (13.76 ± 0.17 vs 13.48 ± 0.18) and 0.17 years (13.76 ± 0.17 vs 13.59 ± 0.17), and quality-adjusted life years by, respectively, 0.28 (9.56 ± 0.12 vs 9.28 ± 0.12) and 0.24 years (9.56 ± 0.12 vs 9.32 ± 0.12). ExQW was associated with lower lifetime complication costs: compared with sitagliptin or pioglitazone, ExQW saved, respectively US$2215 (US$55,647 ± 2039 vs US$57,862 ± 2159) and US$933 (US$55,647 ± 2039 vs US$56,580 ± 2007) direct cost per patient. Cost-savings resulted mainly from a lower projected cumulative incidence of cardiovascular diseases and neuropathic complications.
Short-term changes in surrogate end-points were used to project lifetime effects on clinical outcomes. Pharmacy costs were excluded from the analyses.
Over a patient's lifetime, ExQW was projected to improve health and decrease diabetes-related complication costs compared with sitagliptin or pioglitazone.
Journal of Medical Economics 02/2012; 15(4):654-63.
