Long-acting insulin analogs: a review of "real-world" effectiveness in patients with type 2 diabetes.

A systematic review was conducted to evaluate the effectiveness of initiating insulin treatment with insulin glargine or insulin detemir for type 2 diabetes in a routine clinical practice setting. Medline, EMBASE and Cochrane literature databases were searched to identify published "real world" reports. Studies were included in the review if they reported the following; insulin dose, change in HbA1c, change in body weight and hypoglycemic events. In routine practice, decreases inHbA1c associated with insulin glargine and insulin detemir were variable and ranged between approximately -0.3% to -1.5% depending on prior treatment, but switching to insulin analogs was associated with less weight gain than previously reported. Compared with data reported in published trials, hypoglycemic event rates associated with basal analog insulin use in clinical practice were lower in patients initiating insulin and comparable in patients using basal-bolus regimens. Most patients were treated with low doses of insulin analog administered as once daily injections. In routine clinical practice most patients stopped concomitant use of sulfonylureas when initiating insulin analogs and it is likely that this together with the lower dose of insulin influenced outcomes. Nevertheless, despite initiating insulin therapy, it was also apparent that for many patients in routine clinical practice attainment of glycemic goals remains elusive.

Cost-effectiveness of pioglitazone in type 2 diabetes patients with a history of macrovascular disease: a German perspective.

BACKGROUND: The aim of this study was to project health-economic outcomes relevant to the German setting for the addition of pioglitazone to existing treatment regimens in patients with type 2 diabetes, evidence of macrovascular disease and at high risk of cardiovascular events. METHODS: Event rates corresponding to macrovascular outcomes from the Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) study of pioglitazone were used with a modified version of the CORE Diabetes Model to simulate outcomes over a 35-year time horizon. Direct medical costs were accounted from a healthcare payer perspective in year 2005 values. Germany specific costs were applied for patient treatment, hospitalization and management. Both costs and clinical benefits were discounted at 5.0% per annum. RESULTS: Over patient lifetimes pioglitazone treatment improved undiscounted life expectancy by 0.406 years and improved quality-adjusted life expectancy by 0.120 quality-adjusted life years (QALYs) compared to placebo. Direct medical costs (treatment plus complication costs) were marginally higher for pioglitazone treatment and calculation of the incremental cost-effectiveness ratio (ICER) produced a value of euro13,294 per QALY gained with the pioglitazone regimen versus placebo. Acceptability curve analysis showed that there was a 78.2% likelihood that pioglitazone would be considered cost-effective in Germany, using a "good value for money" threshold of euro50,000 per QALY gained. Sensitivity analyses showed that the results were most sensitive to changes in the simulation time horizon. After adjustment for the potential stabilization of pancreatic beta-cell function with pioglitazone treatment, the ICER was euro6,667 per QALY gained for pioglitazone versus placebo. CONCLUSION: The findings of this modelling analysis indicated that, for patients with a history of macrovascular disease, addition of pioglitazone to existing therapy reduces the long-term cumulative incidence of diabetes-complications at a cost that would be considered to represent good value for money in the German setting.

Cost-effectiveness of basal insulin from a US health system perspective: comparative analyses of detemir, glargine, and NPH.

The purpose of this study was to compare in clinical and economic terms the long-acting insulin analogue detemir with intermediate-acting Neutral Protamine Hagedorn (NPH) insulin and with long-acting insulin glargine. Investigators used the validated Center for Outcomes Research (CORE) Diabetes Model to project clinical and cost outcomes over a 35-year base case time horizon; outcome data were extracted directly from randomized, controlled trials designed to compare detemir with NPH and with insulin glargine. Modeled patient characteristics were derived from corresponding trials, and simulations incorporated published quality-of-life utilities with cost data obtained from a Medicare perspective. Detemir, when compared with NPH, increased quality-adjusted life expectancy by 0.698 quality-adjusted life-years (QALYs). Lifetime direct medical costs were increased by 10,451 dollars per patient, although indirect costs were reduced by 4688 dollars. On the basis of direct costs, the cost per QALY gained with detemir was 14,974 dollars. In comparison with glargine, detemir increased quality-adjusted life expectancy by 0.063 QALYs, reduced direct medical costs by 2072 dollars per patient, and decreased indirect costs by 3103 dollars (dominant). Reductions in diabetes-related comorbidities were also associated with detemir in both instances, most notably in the complications of retinopathy and nephropathy. Relative reductions in rates of complications were greatest in the comparison of detemir with NPH. Results were most sensitive to variation in hemoglobin A1c (HbA1c) levels. However, variation among any of the key assumptions, including HbA1c, did not alter the relative results. Detemir represents an attractive clinical and economic intervention in the US health care setting compared with both NPH insulin and insulin glargine.