Abstract
BackgroundPoor control of type 2 diabetes results in substantial long-term consequences. Studies of new diabetes treatments are rarely designed to assess mortality, complication rates and costs. We sought to estimate the long-term consequences of liraglutide and rosiglitazone both added to glimepiride.MethodsTo estimate long-term clinical and economic consequences, we used the CORE diabetes model, a validated cohort model that uses epidemiologic data from long-term clinical trials to simulate morbidity, mortality and costs of diabetes. Clinical data were extracted from the LEAD-1 trial evaluating two doses (1.2 mg and 1.8 mg) of a once daily GLP-1 analog liraglutide, or rosiglitazone 4 mg, on a background of glimepiride in type 2 diabetes. CORE was calibrated to the LEAD-1 baseline patient characteristics. Survival, cumulative incidence of cardiovascular, ocular and renal events and healthcare costs were estimated over three periods: 10, 20 and 30 years.ResultsIn a hypothetical cohort of 5000 patients per treatment followed for 30 years, liraglutide 1.2 mg and 1.8 mg had higher survival rates compared to the group treated with rosiglitazone (15.0% and 16.0% vs. 12.6% after 30 years), and fewer cardiovascular, renal, and ocular events. Cardiovascular death rates after 30 years were 69.7%, 68.4% and 72.5%, for liraglutide 1.2 mg, 1.8 mg, and rosiglitazone, respectively. First and recurrent amputations were lower in the rosiglitazone group, probably due to a 'survival paradox' in the liraglutide arms (number of events: 565, 529, and 507, respectively). Overall cumulative costs per patient, were lower in both liraglutide groups compared to rosiglitazone (US$38,963, $39,239, and $40,401 for liraglutide 1.2 mg, 1.8 mg, and rosiglitazone, respectively), mainly driven by the costs of cardiovascular events in all groups.ConclusionUsing data from LEAD-1 and epidemiologic evidence from the CORE diabetes model, projected rates of mortality, diabetes complications and healthcare costs over the long term favor liraglutide plus glimepiride over rosiglitazone plus glimepiride.Trial registrationLEAD-1 NCT00318422; LEAD-2 NCT00318461; LEAD-3 NCT 00294723; LEAD-4 NCT00333151; LEAD-5 NCT00331851; LEAD-6 NCT00518882.
Highlights
Poor control of type 2 diabetes results in substantial long-term consequences
The American Diabetes Association (ADA) reported that, in the USA in 2007, 17.5 million people were diagnosed with diabetes
The results of the study showed that all doses of liraglutide plus glimepiride were associated with an improvement in HbA1c and fasting plasma glucose (FPG) levels compared to placebo, and that higher doses of liraglutide (1.2 mg and 1.8 mg) resulted in significantly greater reductions in HbA1c and greater bodyweight loss compared to rosiglitazone
Summary
Poor control of type 2 diabetes results in substantial long-term consequences. Studies of new diabetes treatments are rarely designed to assess mortality, complication rates and costs. We sought to estimate the long-term consequences of liraglutide and rosiglitazone both added to glimepiride. The American Diabetes Association (ADA) reported that, in the USA in 2007, 17.5 million people were diagnosed with diabetes. Estimates from the Centers for Disease Control and Prevention (CDC), which include persons with both diagnosed and undiagnosed diabetes, place the number of Americans with diabetes at 23.6 million [5]. The impact of diabetes on the US economy is alarming, with a total estimated cost of US$174 billion in 2007. A majority of these costs are for treatment of complications of the disease [8,9,10,11]
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