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PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness

INTRODUCTION: Sitagliptin is a dipeptidyl peptidase 4 inhibitor for the treatment of type 2 diabetes (T2D). Limited real-world data on its effectiveness and safety are available from an Italian population. RESEARCH DESIGN AND METHODS: We evaluated long-term clinical data from the single-arm PERsiste...

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Autores principales: Bossi, Antonio Carlo, De Mori, Valentina, Galeone, Carlotta, Bertola, Davide Pietro, Gaiti, Margherita, Balini, Annalisa, Berzi, Denise, Forloni, Franco, Meregalli, Giancarla, Turati, Federica
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
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Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7478001/
https://www.ncbi.nlm.nih.gov/pubmed/32900698
http://dx.doi.org/10.1136/bmjdrc-2020-001507
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author Bossi, Antonio Carlo
De Mori, Valentina
Galeone, Carlotta
Bertola, Davide Pietro
Gaiti, Margherita
Balini, Annalisa
Berzi, Denise
Forloni, Franco
Meregalli, Giancarla
Turati, Federica
author_facet Bossi, Antonio Carlo
De Mori, Valentina
Galeone, Carlotta
Bertola, Davide Pietro
Gaiti, Margherita
Balini, Annalisa
Berzi, Denise
Forloni, Franco
Meregalli, Giancarla
Turati, Federica
author_sort Bossi, Antonio Carlo
collection PubMed
description INTRODUCTION: Sitagliptin is a dipeptidyl peptidase 4 inhibitor for the treatment of type 2 diabetes (T2D). Limited real-world data on its effectiveness and safety are available from an Italian population. RESEARCH DESIGN AND METHODS: We evaluated long-term clinical data from the single-arm PERsistent Sitagliptin Treatment & Outcomes (PERS&O) study, which collected information on 440 patients with TD2 (275 men, 165 women; mean age 64.1 years; disease median duration: 12 years) treated with sitagliptin ‘add-on’. For each patient, we estimated the 10-year cardiovascular (CV) risk using the UK Prospective Diabetes Study (UKPDS) Risk Engine (RE). Drug survival was evaluated using Kaplan-Meier survival curves; repeated measures mixed effects models were used to evaluate the evolution of glycated hemoglobin (HbA1c) and CV risk during sitagliptin treatment. RESULTS: At baseline, most patients were overweight or obese (median body mass index (BMI) (kg/m(2)) 30.2); median HbA1c was 8.4%; median fasting plasma glucose: 172 mg/dL; median UKPDS RE score: 24.8%, being higher in men (median 30.2%) than in women (median 17.0%) as expected. Median follow-up from starting sitagliptin treatment was 5.6 years. From Kaplan-Meier curves, the estimated median drug survival was 32.8 months when considering discontinuation for any cause and 58.4 months when considering discontinuation for loss of efficacy. A significant improvement in HbA1c was evident during treatment with sitagliptin (p<0.01): the reduction was rapid (median HbA1c after 4–6 months: 7.5%) and continued at longer follow-up. When comparing patients treated with sitagliptin versus those stopping sitagliptin and switching to another antihyperglycemic drug, we detected a significant difference in the evolution of HbA1c in favor of patients who continued sitagliptin treatment. The UKPDS RE score at 10 years and the BMI significantly improved during treatment with sitagliptin (p<0.001). Adverse events were relatively uncommon. CONCLUSION: Patients with T2D treated with sitagliptin achieved an improvement in metabolic control and a reduction in CV risk and did not experience relevant adverse events.
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spelling pubmed-74780012020-09-21 PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness Bossi, Antonio Carlo De Mori, Valentina Galeone, Carlotta Bertola, Davide Pietro Gaiti, Margherita Balini, Annalisa Berzi, Denise Forloni, Franco Meregalli, Giancarla Turati, Federica BMJ Open Diabetes Res Care Cardiovascular and Metabolic Risk INTRODUCTION: Sitagliptin is a dipeptidyl peptidase 4 inhibitor for the treatment of type 2 diabetes (T2D). Limited real-world data on its effectiveness and safety are available from an Italian population. RESEARCH DESIGN AND METHODS: We evaluated long-term clinical data from the single-arm PERsistent Sitagliptin Treatment & Outcomes (PERS&O) study, which collected information on 440 patients with TD2 (275 men, 165 women; mean age 64.1 years; disease median duration: 12 years) treated with sitagliptin ‘add-on’. For each patient, we estimated the 10-year cardiovascular (CV) risk using the UK Prospective Diabetes Study (UKPDS) Risk Engine (RE). Drug survival was evaluated using Kaplan-Meier survival curves; repeated measures mixed effects models were used to evaluate the evolution of glycated hemoglobin (HbA1c) and CV risk during sitagliptin treatment. RESULTS: At baseline, most patients were overweight or obese (median body mass index (BMI) (kg/m(2)) 30.2); median HbA1c was 8.4%; median fasting plasma glucose: 172 mg/dL; median UKPDS RE score: 24.8%, being higher in men (median 30.2%) than in women (median 17.0%) as expected. Median follow-up from starting sitagliptin treatment was 5.6 years. From Kaplan-Meier curves, the estimated median drug survival was 32.8 months when considering discontinuation for any cause and 58.4 months when considering discontinuation for loss of efficacy. A significant improvement in HbA1c was evident during treatment with sitagliptin (p<0.01): the reduction was rapid (median HbA1c after 4–6 months: 7.5%) and continued at longer follow-up. When comparing patients treated with sitagliptin versus those stopping sitagliptin and switching to another antihyperglycemic drug, we detected a significant difference in the evolution of HbA1c in favor of patients who continued sitagliptin treatment. The UKPDS RE score at 10 years and the BMI significantly improved during treatment with sitagliptin (p<0.001). Adverse events were relatively uncommon. CONCLUSION: Patients with T2D treated with sitagliptin achieved an improvement in metabolic control and a reduction in CV risk and did not experience relevant adverse events. BMJ Publishing Group 2020-09-07 /pmc/articles/PMC7478001/ /pubmed/32900698 http://dx.doi.org/10.1136/bmjdrc-2020-001507 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/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 Cardiovascular and Metabolic Risk
Bossi, Antonio Carlo
De Mori, Valentina
Galeone, Carlotta
Bertola, Davide Pietro
Gaiti, Margherita
Balini, Annalisa
Berzi, Denise
Forloni, Franco
Meregalli, Giancarla
Turati, Federica
PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness
title PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness
title_full PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness
title_fullStr PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness
title_full_unstemmed PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness
title_short PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness
title_sort persistent sitagliptin treatment & outcomes (pers&o 2.0) study, long-term results: a real-world observation on dpp4-inhibitor effectiveness
topic Cardiovascular and Metabolic Risk
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7478001/
https://www.ncbi.nlm.nih.gov/pubmed/32900698
http://dx.doi.org/10.1136/bmjdrc-2020-001507
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