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

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...

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Autores principales: Patel, Sapna, Abreu, Marconi, Tumyan, Anna, Adams-Huet, Beverley, Li, Xilong, Lingvay, Ildiko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6887507/
https://www.ncbi.nlm.nih.gov/pubmed/31803482
http://dx.doi.org/10.1136/bmjdrc-2019-000761
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author Patel, Sapna
Abreu, Marconi
Tumyan, Anna
Adams-Huet, Beverley
Li, Xilong
Lingvay, Ildiko
author_facet Patel, Sapna
Abreu, Marconi
Tumyan, Anna
Adams-Huet, Beverley
Li, Xilong
Lingvay, Ildiko
author_sort Patel, Sapna
collection PubMed
description 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
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spelling pubmed-68875072019-12-04 Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study Patel, Sapna Abreu, Marconi Tumyan, Anna Adams-Huet, Beverley Li, Xilong Lingvay, Ildiko BMJ Open Diabetes Res Care Clinical care education/Nutrition 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 BMJ Publishing Group 2019-11-18 /pmc/articles/PMC6887507/ /pubmed/31803482 http://dx.doi.org/10.1136/bmjdrc-2019-000761 Text en © 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. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Clinical care education/Nutrition
Patel, Sapna
Abreu, Marconi
Tumyan, Anna
Adams-Huet, Beverley
Li, Xilong
Lingvay, Ildiko
Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study
title Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study
title_full Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study
title_fullStr Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study
title_full_unstemmed Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study
title_short Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study
title_sort effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the simple study
topic Clinical care education/Nutrition
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6887507/
https://www.ncbi.nlm.nih.gov/pubmed/31803482
http://dx.doi.org/10.1136/bmjdrc-2019-000761
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