Failure of monotherapy in clinical practice in patients with type 2 diabetes

The Korean National Diabetes Program

Ja Young Jeon, Soo Jin Lee, Sieun Lee, Soo Jin Kim, Seung Jin Han, Hae Jin Kim, Dae Jung Kim, Young Seol Kim, Jeong Taek Woo, Kyu Jeung Ahn, Moonsuk Nam, Sei-Hyun Baik, Yongsoo Park, Kwan Woo Lee

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Aims/Introduction: We investigated the failure of monotherapy in patients with type 2 diabetes mellitus in real practice settings. Materials and Methods: The Korean National Diabetes Program was a prospective, multicenter observational cohort study of type 2 diabetes mellitus patients in Korea. Of the 3,950 patients enrolled in the study, we studied 998 who were continuously maintained on monotherapy for at least 90 days at six participating centers. To balance the baseline characteristics of patients in each group, we used propensity matching at a 1:1 ratio (metformin vs sulfonylureas) and 4:1 ratio (metformin vs meglitinides and metformin vs alpha-glucosidase inhibitors [aGIs]). The hazard ratios (HRs) of treatments (compared with metformin) were determined by Cox's proportional hazards regression modeling. Results: The median follow-up time was 56 months, and monotherapy failed in 45% of all patients. The annual incidences of failure were 15.6%, 21.3%, 27% and 9.6% in the metformin, sulfonylurea, meglitinide and aGI groups. Compared with metformin, sulfonylureas and meglitinides were associated with higher risks of monotherapy failure (HR 1.39, 95% confidence interval [CI] 1.08-1.80; HR 1.92, 95% CI 1.13-3.27), and aGIs with risks similar to that of metformin (HR 0.80, 95% CI 0.44-1.45). When analyzed by failure type, sulfonylureas, meglitinides and aGIs were associated with a higher risk of a switch to other agents (HR 4.43, 95% CI 2.14-9.17; HR 18.80, 95% CI 6.21-56.93; HR 4.25, 95% CI 1.49-12.13), and aGIs with a lower risk of prescription of add-on second agents (HR 0.16, 95% CI 0.04-0.64). Conclusions: Metformin was associated with a lower failure risk than were sulfonylureas and meglitinides, but a comparable aGI failure rate.

Original languageEnglish
JournalJournal of Diabetes Investigation
DOIs
Publication statusAccepted/In press - 2018 Jan 1

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Metformin
Type 2 Diabetes Mellitus
Confidence Intervals
Korea
Observational Studies
Prescriptions
Cohort Studies
Glycoside Hydrolase Inhibitors
Incidence

Keywords

  • Cohort study
  • Monotherapy failure
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Failure of monotherapy in clinical practice in patients with type 2 diabetes : The Korean National Diabetes Program. / Jeon, Ja Young; Lee, Soo Jin; Lee, Sieun; Kim, Soo Jin; Han, Seung Jin; Kim, Hae Jin; Kim, Dae Jung; Kim, Young Seol; Woo, Jeong Taek; Ahn, Kyu Jeung; Nam, Moonsuk; Baik, Sei-Hyun; Park, Yongsoo; Lee, Kwan Woo.

In: Journal of Diabetes Investigation, 01.01.2018.

Research output: Contribution to journalArticle

Jeon, JY, Lee, SJ, Lee, S, Kim, SJ, Han, SJ, Kim, HJ, Kim, DJ, Kim, YS, Woo, JT, Ahn, KJ, Nam, M, Baik, S-H, Park, Y & Lee, KW 2018, 'Failure of monotherapy in clinical practice in patients with type 2 diabetes: The Korean National Diabetes Program', Journal of Diabetes Investigation. https://doi.org/10.1111/jdi.12801
Jeon, Ja Young ; Lee, Soo Jin ; Lee, Sieun ; Kim, Soo Jin ; Han, Seung Jin ; Kim, Hae Jin ; Kim, Dae Jung ; Kim, Young Seol ; Woo, Jeong Taek ; Ahn, Kyu Jeung ; Nam, Moonsuk ; Baik, Sei-Hyun ; Park, Yongsoo ; Lee, Kwan Woo. / Failure of monotherapy in clinical practice in patients with type 2 diabetes : The Korean National Diabetes Program. In: Journal of Diabetes Investigation. 2018.
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abstract = "Aims/Introduction: We investigated the failure of monotherapy in patients with type 2 diabetes mellitus in real practice settings. Materials and Methods: The Korean National Diabetes Program was a prospective, multicenter observational cohort study of type 2 diabetes mellitus patients in Korea. Of the 3,950 patients enrolled in the study, we studied 998 who were continuously maintained on monotherapy for at least 90 days at six participating centers. To balance the baseline characteristics of patients in each group, we used propensity matching at a 1:1 ratio (metformin vs sulfonylureas) and 4:1 ratio (metformin vs meglitinides and metformin vs alpha-glucosidase inhibitors [aGIs]). The hazard ratios (HRs) of treatments (compared with metformin) were determined by Cox's proportional hazards regression modeling. Results: The median follow-up time was 56 months, and monotherapy failed in 45{\%} of all patients. The annual incidences of failure were 15.6{\%}, 21.3{\%}, 27{\%} and 9.6{\%} in the metformin, sulfonylurea, meglitinide and aGI groups. Compared with metformin, sulfonylureas and meglitinides were associated with higher risks of monotherapy failure (HR 1.39, 95{\%} confidence interval [CI] 1.08-1.80; HR 1.92, 95{\%} CI 1.13-3.27), and aGIs with risks similar to that of metformin (HR 0.80, 95{\%} CI 0.44-1.45). When analyzed by failure type, sulfonylureas, meglitinides and aGIs were associated with a higher risk of a switch to other agents (HR 4.43, 95{\%} CI 2.14-9.17; HR 18.80, 95{\%} CI 6.21-56.93; HR 4.25, 95{\%} CI 1.49-12.13), and aGIs with a lower risk of prescription of add-on second agents (HR 0.16, 95{\%} CI 0.04-0.64). Conclusions: Metformin was associated with a lower failure risk than were sulfonylureas and meglitinides, but a comparable aGI failure rate.",
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T1 - Failure of monotherapy in clinical practice in patients with type 2 diabetes

T2 - The Korean National Diabetes Program

AU - Jeon, Ja Young

AU - Lee, Soo Jin

AU - Lee, Sieun

AU - Kim, Soo Jin

AU - Han, Seung Jin

AU - Kim, Hae Jin

AU - Kim, Dae Jung

AU - Kim, Young Seol

AU - Woo, Jeong Taek

AU - Ahn, Kyu Jeung

AU - Nam, Moonsuk

AU - Baik, Sei-Hyun

AU - Park, Yongsoo

AU - Lee, Kwan Woo

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Aims/Introduction: We investigated the failure of monotherapy in patients with type 2 diabetes mellitus in real practice settings. Materials and Methods: The Korean National Diabetes Program was a prospective, multicenter observational cohort study of type 2 diabetes mellitus patients in Korea. Of the 3,950 patients enrolled in the study, we studied 998 who were continuously maintained on monotherapy for at least 90 days at six participating centers. To balance the baseline characteristics of patients in each group, we used propensity matching at a 1:1 ratio (metformin vs sulfonylureas) and 4:1 ratio (metformin vs meglitinides and metformin vs alpha-glucosidase inhibitors [aGIs]). The hazard ratios (HRs) of treatments (compared with metformin) were determined by Cox's proportional hazards regression modeling. Results: The median follow-up time was 56 months, and monotherapy failed in 45% of all patients. The annual incidences of failure were 15.6%, 21.3%, 27% and 9.6% in the metformin, sulfonylurea, meglitinide and aGI groups. Compared with metformin, sulfonylureas and meglitinides were associated with higher risks of monotherapy failure (HR 1.39, 95% confidence interval [CI] 1.08-1.80; HR 1.92, 95% CI 1.13-3.27), and aGIs with risks similar to that of metformin (HR 0.80, 95% CI 0.44-1.45). When analyzed by failure type, sulfonylureas, meglitinides and aGIs were associated with a higher risk of a switch to other agents (HR 4.43, 95% CI 2.14-9.17; HR 18.80, 95% CI 6.21-56.93; HR 4.25, 95% CI 1.49-12.13), and aGIs with a lower risk of prescription of add-on second agents (HR 0.16, 95% CI 0.04-0.64). Conclusions: Metformin was associated with a lower failure risk than were sulfonylureas and meglitinides, but a comparable aGI failure rate.

AB - Aims/Introduction: We investigated the failure of monotherapy in patients with type 2 diabetes mellitus in real practice settings. Materials and Methods: The Korean National Diabetes Program was a prospective, multicenter observational cohort study of type 2 diabetes mellitus patients in Korea. Of the 3,950 patients enrolled in the study, we studied 998 who were continuously maintained on monotherapy for at least 90 days at six participating centers. To balance the baseline characteristics of patients in each group, we used propensity matching at a 1:1 ratio (metformin vs sulfonylureas) and 4:1 ratio (metformin vs meglitinides and metformin vs alpha-glucosidase inhibitors [aGIs]). The hazard ratios (HRs) of treatments (compared with metformin) were determined by Cox's proportional hazards regression modeling. Results: The median follow-up time was 56 months, and monotherapy failed in 45% of all patients. The annual incidences of failure were 15.6%, 21.3%, 27% and 9.6% in the metformin, sulfonylurea, meglitinide and aGI groups. Compared with metformin, sulfonylureas and meglitinides were associated with higher risks of monotherapy failure (HR 1.39, 95% confidence interval [CI] 1.08-1.80; HR 1.92, 95% CI 1.13-3.27), and aGIs with risks similar to that of metformin (HR 0.80, 95% CI 0.44-1.45). When analyzed by failure type, sulfonylureas, meglitinides and aGIs were associated with a higher risk of a switch to other agents (HR 4.43, 95% CI 2.14-9.17; HR 18.80, 95% CI 6.21-56.93; HR 4.25, 95% CI 1.49-12.13), and aGIs with a lower risk of prescription of add-on second agents (HR 0.16, 95% CI 0.04-0.64). Conclusions: Metformin was associated with a lower failure risk than were sulfonylureas and meglitinides, but a comparable aGI failure rate.

KW - Cohort study

KW - Monotherapy failure

KW - Type 2 diabetes

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