Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study

Sapna Patel, Marconi Abreu, Anna Tumyan, Beverley Adams-Huet, Xilong Li, Ildiko Lingvay, Sapna Patel, Marconi Abreu, Anna Tumyan, Beverley Adams-Huet, Xilong Li, Ildiko Lingvay

Abstract

Objective: Medication adherence is impacted by regimen complexity. The SIMPLE (Simple basal Insulin titration, Metformin Plus Liraglutide for type 2 diabetes with very Elevated HbA1c) study compared GLP1RA plus basal insulin (GLP1RA+BI) to basal-bolus insulin (BBI) regimen in participants with very uncontrolled type 2 diabetes mellitus (T2DM). This analysis aimed to evaluate medication adherence to GLP1RA+BI compared with BBI, the effect of adherence on clinical and patient-reported outcomes, and baseline predictors of adherence.

Research design and methods: This was an analysis of the SIMPLE study based on prespecified outcome. The study took place in pragmatic, real-world setting. A total of 120 adults with T2DM and HgbA1c≥10% were randomized to detemir plus liraglutide, or detemir plus aspart before each meal; 6-month follow-up. The main outcomes evaluated were: adherence, HgbA1c, weight, quality of life, and hypoglycemia. Adherence rate was calculated for each study medication at each follow-up visit; participants were classified as ≥80% or <80% adherent.

Result: A higher percentage of participants in the GLP1RA+BI compared with the BBI group had ≥80% adherence to detemir (59.3% vs 35.7%, p=0.02) as well as liraglutide versus aspart (57.4% vs 30.4%, p=0.007). Higher age was predictive of ≥80% adherence (OR per 5-year increment=1.48, 95% CI 1.09 to 2.0, p=0.01). Higher adherence led to greater improvement in HbA1c and weight in both groups. Treatment with GLP1RA+BI compared with BBI led to greater improvement in HbA1c, weight, and quality of life and lower risk of hypoglycemia even after adjusting for the difference in adherence between groups.

Conclusions: Adherence was higher with the simplified regimen of GLP1RA+BI compared with BBI. Greater adherence to the simpler regimen amplified the treatment effect on HbA1c, weight, quality of life, and risk of hypoglycemia, yet statistically significant greater benefits were noted even when adjusted for adherence.

Trial registration number: NCT01966978.

Keywords: adherence to medications; glycemic control; hypoglycemia; weight.

Conflict of interest statement

Competing interests: IL received honoraria for consulting/advising boards from Novo Nordisk, Eli Lilly, Sanofi, Intarcia Therapeutics, AstraZeneca, Valeritas, MannKind, TARGET Pharma, Boehringer Ingelheim and research grants from Novo Nordisk, Merck, GI Dynamics, Pfizer, Novartis, and Mylan. BAH has consulted for Valeritas outside the submitted work. MA has consulted for Novo Nordisk outside the submitted work.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Baseline characteristics as predictors of ≥80% adherence. The units for the baseline variables associated with the ORs for adherence ≥80% are age per 5 years, median income per $10 000, insulin TDD/kg per 0.1 unit, weight per 5 kg and HbA1c per 1%. TDD, total daily dose.

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Source: PubMed

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