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Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study

OBJECTIVE: To estimate the rate of lower limb amputation among adults newly prescribed canagliflozin according to age and cardiovascular disease. DESIGN: Population based, new user, cohort study. DATA SOURCES: Two commercial and Medicare claims databases, 2013-17. PARTICIPANTS: Patients newly prescr...

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Autores principales: Fralick, Michael, Kim, Seoyoung C, Schneeweiss, Sebastian, Everett, Brendan M, Glynn, Robert J, Patorno, Elisabetta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7445737/
https://www.ncbi.nlm.nih.gov/pubmed/32843476
http://dx.doi.org/10.1136/bmj.m2812
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author Fralick, Michael
Kim, Seoyoung C
Schneeweiss, Sebastian
Everett, Brendan M
Glynn, Robert J
Patorno, Elisabetta
author_facet Fralick, Michael
Kim, Seoyoung C
Schneeweiss, Sebastian
Everett, Brendan M
Glynn, Robert J
Patorno, Elisabetta
author_sort Fralick, Michael
collection PubMed
description OBJECTIVE: To estimate the rate of lower limb amputation among adults newly prescribed canagliflozin according to age and cardiovascular disease. DESIGN: Population based, new user, cohort study. DATA SOURCES: Two commercial and Medicare claims databases, 2013-17. PARTICIPANTS: Patients newly prescribed canagliflozin were propensity score matched 1:1 with patients newly prescribed a glucagon-like peptide-1 (GLP-1) receptor agonist. Hazard ratios and rate differences per 1000 person years were computed for the rate of lower limb amputation in the following four groups: group 1, patients aged less than 65 years without baseline cardiovascular disease; group 2, patients aged less than 65 with baseline cardiovascular disease; group 3, patients aged 65 or older without baseline cardiovascular disease; group 4, patients aged 65 or older with baseline cardiovascular disease. Within each group, pooled hazard ratio and rate difference per 1000 person years were calculated by meta-analysis. INTERVENTION: Canagliflozin versus a GLP-1 agonist. MAIN OUTCOME MEASURES: Lower limb amputation requiring surgery. RESULTS: Across the three databases, 310 840 propensity score matched adults who started canagliflozin or a GLP-1 agonist were identified. The hazard ratio and rate difference per 1000 person years for amputation in adults receiving canagliflozin compared with a GLP-1 agonist for each group was: group 1, hazard ratio 1.09 (95% confidence interval 0.83 to 1.43), rate difference 0.12 (−0.31 to 0.55); group 2, hazard ratio 1.18 (0.86 to 1.62), rate difference 1.06 (−1.77 to 3.89); group 3, hazard ratio 1.30 (0.52 to 3.26), rate difference 0.47 (−0.73 to 1.67); and group 4, hazard ratio 1.73 (1.30 to 2.29), rate difference 3.66 (1.74 to 5.59). CONCLUSIONS: The increase in rate of amputation with canagliflozin was small and most apparent on an absolute scale for adults aged 65 or older with baseline cardiovascular disease, resulting in a number needed to treat for an additional harmful outcome of 556 patients at six months (that is, 18 more amputations per 10 000 people who received canagliflozin). These results help to contextualize the risk of amputation with canagliflozin in routine care.
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spelling pubmed-74457372020-09-01 Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study Fralick, Michael Kim, Seoyoung C Schneeweiss, Sebastian Everett, Brendan M Glynn, Robert J Patorno, Elisabetta BMJ Research OBJECTIVE: To estimate the rate of lower limb amputation among adults newly prescribed canagliflozin according to age and cardiovascular disease. DESIGN: Population based, new user, cohort study. DATA SOURCES: Two commercial and Medicare claims databases, 2013-17. PARTICIPANTS: Patients newly prescribed canagliflozin were propensity score matched 1:1 with patients newly prescribed a glucagon-like peptide-1 (GLP-1) receptor agonist. Hazard ratios and rate differences per 1000 person years were computed for the rate of lower limb amputation in the following four groups: group 1, patients aged less than 65 years without baseline cardiovascular disease; group 2, patients aged less than 65 with baseline cardiovascular disease; group 3, patients aged 65 or older without baseline cardiovascular disease; group 4, patients aged 65 or older with baseline cardiovascular disease. Within each group, pooled hazard ratio and rate difference per 1000 person years were calculated by meta-analysis. INTERVENTION: Canagliflozin versus a GLP-1 agonist. MAIN OUTCOME MEASURES: Lower limb amputation requiring surgery. RESULTS: Across the three databases, 310 840 propensity score matched adults who started canagliflozin or a GLP-1 agonist were identified. The hazard ratio and rate difference per 1000 person years for amputation in adults receiving canagliflozin compared with a GLP-1 agonist for each group was: group 1, hazard ratio 1.09 (95% confidence interval 0.83 to 1.43), rate difference 0.12 (−0.31 to 0.55); group 2, hazard ratio 1.18 (0.86 to 1.62), rate difference 1.06 (−1.77 to 3.89); group 3, hazard ratio 1.30 (0.52 to 3.26), rate difference 0.47 (−0.73 to 1.67); and group 4, hazard ratio 1.73 (1.30 to 2.29), rate difference 3.66 (1.74 to 5.59). CONCLUSIONS: The increase in rate of amputation with canagliflozin was small and most apparent on an absolute scale for adults aged 65 or older with baseline cardiovascular disease, resulting in a number needed to treat for an additional harmful outcome of 556 patients at six months (that is, 18 more amputations per 10 000 people who received canagliflozin). These results help to contextualize the risk of amputation with canagliflozin in routine care. BMJ Publishing Group Ltd. 2020-08-25 /pmc/articles/PMC7445737/ /pubmed/32843476 http://dx.doi.org/10.1136/bmj.m2812 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. 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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Research
Fralick, Michael
Kim, Seoyoung C
Schneeweiss, Sebastian
Everett, Brendan M
Glynn, Robert J
Patorno, Elisabetta
Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study
title Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study
title_full Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study
title_fullStr Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study
title_full_unstemmed Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study
title_short Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study
title_sort risk of amputation with canagliflozin across categories of age and cardiovascular risk in three us nationwide databases: cohort study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7445737/
https://www.ncbi.nlm.nih.gov/pubmed/32843476
http://dx.doi.org/10.1136/bmj.m2812
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