Abstract
AimsMetformin is the first line drug for patients diagnosed with type-2 diabetes; however, the impact of different treatment escalation strategies after metformin failure has thus far not been investigated in a real world situation. The registry described herein goes some way to clarifying treatment outcomes in such patients.MethodsDiaRegis is a multicentre registry including 3,810 patients with type-2 diabetes. For the present analysis we selected patients being treated with metformin monotherapy at baseline (n = 1,373), with the subsequent addition of incretin-based drugs (Met/Incr; n = 783), sulfonylureas (Met/SU; n = 255), or insulin (n = 220).ResultsAfter two years 1,110 of the initial 1,373 patients had a complete follow-up (80.8%) and 726 of these were still on the initial treatment combination (65.4%). After treatment escalation, compared to Met/Incr (n = 421), Met/SU (n = 154) therapy resulted in a higher HbA1c reduction vs. baseline (−0.6 ± 1.4% vs. −0.5 ± 1.0%; p = 0.039). Insulin (n = 151) resulted in a stronger reduction in HbA1c (−0.9 ± 2.0% vs. −0.5 ± 1.0%; p = 0.003), and fasting plasma glucose (−24 ± 70 mg/dl vs. −19 ± 42 mg/dl; p = 0.001), but was associated with increased bodyweight (0.8 ± 9.0 kg vs. −1.5 ± 5.0 kg; p = 0.028). Hypoglycaemia rates (any with or without help and symptoms) were higher for patients receiving insulin (Odds Ratio [OR] 8.35; 95% Confidence Interval [CI] 4.84-14.4) and Met/SU (OR 2.70; 95% CI 1.48-4.92) versus Met/Incr. While there was little difference in event rates between Met/Incr and Met/SU, insulin was associated with higher rates of death, major cardiac and cerebrovascular events, and microvascular disease.ConclusionsTaking the results of DiaRegis into consideration it can be concluded that incretin-based treatment strategies appear to have a favourable balance between glycemic control and treatment emergent adverse effects.Electronic supplementary materialThe online version of this article (doi:10.1186/s12933-015-0172-9) contains supplementary material, which is available to authorized users.
Highlights
Metformin is generally the first choice antidiabetic treatment option for patients not achieving adequate blood glucose control using dietary restrictions alone [1,2,3]
Patient characteristics A total of 3,810 patients were included in DiaRegis, of which 2,064 received metformin monotherapy at baseline (Figure 1) and 1,373 of these had an incretin-based treatment strategy (DPP-4 I or glucagon-like protein-1 agonists (GLP-1 A)) (38.0% of patients; n = 783), or SU (15.7%; n = 324), and an insulinbased treatment strategy (12.9%; n = 266) added
Patients receiving insulin had a higher prevalence of microvascular disease than patients receiving Met/Incr (22.9 vs. 14.7%; p = 0.002)
Summary
Metformin is generally the first choice antidiabetic treatment option for patients not achieving adequate blood glucose control using dietary restrictions alone [1,2,3]. Sulfonylurea (SU), glitazones, incretin-based treatments, and insulin are potential subsequent treatment steps according to the recent consensus statement of the European Association for the Study of Diabetes and the American Diabetes Association [3]. These are considered when monotherapy with metformin alone does not maintain. In the present analysis we aimed to 1) describe treatment utilisation and patient characteristics of sulfonylurea (SU) and insulin vs incretin-based treatment in a real world setting, 2) identify patients with stable treatment throughout a two year follow-up, and 3) to compare blood glucose control, body weight, rates of hypoglycaemia and incident co-morbidity/vascular events among the different treatment strategies in those with stable drug treatment.
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