Cargando…
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...
Autores principales: | , , , , , |
---|---|
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 |
_version_ | 1783475040953565184 |
---|---|
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 |
format | Online Article Text |
id | pubmed-6887507 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT patelsapna effectofmedicationadherenceonclinicaloutcomesintype2diabetesanalysisofthesimplestudy AT abreumarconi effectofmedicationadherenceonclinicaloutcomesintype2diabetesanalysisofthesimplestudy AT tumyananna effectofmedicationadherenceonclinicaloutcomesintype2diabetesanalysisofthesimplestudy AT adamshuetbeverley effectofmedicationadherenceonclinicaloutcomesintype2diabetesanalysisofthesimplestudy AT lixilong effectofmedicationadherenceonclinicaloutcomesintype2diabetesanalysisofthesimplestudy AT lingvayildiko effectofmedicationadherenceonclinicaloutcomesintype2diabetesanalysisofthesimplestudy |