Long-Term, Real-World Safety and Efficacy of Teneligliptin: A Post-Marketing Surveillance of More Than 10,000 Patients with Type 2 Diabetes in ... View Full Text


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Article Info

DATE

2019-12-23

AUTHORS

Takashi Kadowaki, Masakazu Haneda, Hiroshi Ito, Kazuyo Sasaki, Miyuki Matsukawa, Yuka Yamada

ABSTRACT

IntroductionTeneligliptin is a dipeptidyl peptidase 4 inhibitor that was approved for the treatment of type 2 diabetes mellitus (T2DM) in Japan in 2012. We performed a long-term post-marketing surveillance (RUBY) to obtain real-world evidence regarding the safety and efficacy of teneligliptin in Japan.MethodsThis 3-year follow-up RUBY surveillance registered patients with T2DM who started treatment with teneligliptin between May 2013 and February 2015 in Japan. Collected data included demographics, treatments, adverse drug reactions (ADRs) and laboratory variables. Data were evaluated in all patients and in patients divided according to baseline renal function across categories of estimated glomerular filtration rate (G1–G5) and dialysis. Safety was assessed as the incidence of ADRs and efficacy was assessed in terms of glycaemic control, for up to 3 years.ResultsOf 11,677 patients registered, 10,696 and 10,249 were evaluable for safety and efficacy analyses, respectively. The median duration of exposure was 1096 days. ADRs occurred in 412 patients (3.85%) and were serious in 117 patients (1.09%). The most frequent ADR class was gastrointestinal disorders (0.68%), which included constipation. There were no new ADRs warranting attention beyond those already described in teneligliptin’s package insert. ADRs and serious ADRs in renal function subgroups occurred in 3.24–7.14% and 0.65–5.36% in G1–G5, and 4.49% and 1.92% in patients on dialysis, respectively. Reduction in HbA1c was sustained for 3 years after starting teneligliptin (− 0.70% ± 1.36%, p < 0.001 at 3 years). The least-squares mean changes in HbA1c adjusted for baseline were − 0.76% to − 0.66% in G1–G5 at 3 years. Glycated albumin levels decreased in patients on dialysis (− 2.92% ± 4.78% at 3 years).ConclusionThere were no new safety or efficacy concerns about teneligliptin used in long-term, real-world, clinical settings in patients with T2DM with any stages of renal impairment.Trial registrationJapan Pharmaceutical Information Center clinical trials database identifier: Japic CTI-153047.Plain Language SummaryPlain language summary available for this article. More... »

PAGES

1065-1086

References to SciGraph publications

  • 2019-04-26. Real-World Data on the Incidence of Macrovascular Complications in Japanese Patients with Type 2 Diabetes: The Sitagliptin Registration Type 2 Diabetes-Juntendo Collaborating Project in DIABETES THERAPY
  • 2018-05-17. Relationship of Eating Patterns and Metabolic Parameters, and Teneligliptin Treatment: Interim Results from Post-marketing Surveillance in Japanese Type 2 Diabetes Patients in ADVANCES IN THERAPY
  • 2013-06. Report of the JDS/JCA Joint Committee on Diabetes and Cancer in DIABETOLOGY INTERNATIONAL
  • 2018-04-10. Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance in DIABETES THERAPY
  • 2015-05-06. β Cell Dysfunction Versus Insulin Resistance in the Pathogenesis of Type 2 Diabetes in East Asians in CURRENT DIABETES REPORTS
  • 2019-04-13. The Unique Pharmacological and Pharmacokinetic Profile of Teneligliptin: Implications for Clinical Practice in DRUGS
  • 2018-10-05. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) in DIABETOLOGIA
  • 2012-12-02. Achieving glycemic control in patients with type 2 diabetes and renal impairment in ACTA DIABETOLOGICA
  • 2018-02-12. Efficacy and Safety of Teneligliptin 40 mg in Type 2 Diabetes: A Pooled Analysis of Two Phase III Clinical Studies in DIABETES THERAPY
  • 2013-01-24. Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-analysis in DIABETOLOGIA
  • 2013-09-08. Safety and efficacy of teneligliptin: a novel DPP-4 inhibitor for hemodialysis patients with type 2 diabetes in INTERNATIONAL UROLOGY AND NEPHROLOGY
  • 2015-07-03. Two-year assessment of the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes: Post hoc analysis of the ASSET-K study in BMC ENDOCRINE DISORDERS
  • 2016-08-08. Systematic Literature Review of DPP-4 Inhibitors in Patients with Type 2 Diabetes Mellitus and Renal Impairment in DIABETES THERAPY
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    http://scigraph.springernature.com/pub.10.1007/s12325-019-01189-w

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    http://dx.doi.org/10.1007/s12325-019-01189-w

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    36 schema:description IntroductionTeneligliptin is a dipeptidyl peptidase 4 inhibitor that was approved for the treatment of type 2 diabetes mellitus (T2DM) in Japan in 2012. We performed a long-term post-marketing surveillance (RUBY) to obtain real-world evidence regarding the safety and efficacy of teneligliptin in Japan.MethodsThis 3-year follow-up RUBY surveillance registered patients with T2DM who started treatment with teneligliptin between May 2013 and February 2015 in Japan. Collected data included demographics, treatments, adverse drug reactions (ADRs) and laboratory variables. Data were evaluated in all patients and in patients divided according to baseline renal function across categories of estimated glomerular filtration rate (G1–G5) and dialysis. Safety was assessed as the incidence of ADRs and efficacy was assessed in terms of glycaemic control, for up to 3 years.ResultsOf 11,677 patients registered, 10,696 and 10,249 were evaluable for safety and efficacy analyses, respectively. The median duration of exposure was 1096 days. ADRs occurred in 412 patients (3.85%) and were serious in 117 patients (1.09%). The most frequent ADR class was gastrointestinal disorders (0.68%), which included constipation. There were no new ADRs warranting attention beyond those already described in teneligliptin’s package insert. ADRs and serious ADRs in renal function subgroups occurred in 3.24–7.14% and 0.65–5.36% in G1–G5, and 4.49% and 1.92% in patients on dialysis, respectively. Reduction in HbA1c was sustained for 3 years after starting teneligliptin (− 0.70% ± 1.36%, p < 0.001 at 3 years). The least-squares mean changes in HbA1c adjusted for baseline were − 0.76% to − 0.66% in G1–G5 at 3 years. Glycated albumin levels decreased in patients on dialysis (− 2.92% ± 4.78% at 3 years).ConclusionThere were no new safety or efficacy concerns about teneligliptin used in long-term, real-world, clinical settings in patients with T2DM with any stages of renal impairment.Trial registrationJapan Pharmaceutical Information Center clinical trials database identifier: Japic CTI-153047.Plain Language SummaryPlain language summary available for this article.
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    43 G1-G5
    44 HbA1c
    45 Japan
    46 Language Summary
    47 MethodsThis
    48 T2DM
    49 World Safety
    50 adverse drug reactions
    51 albumin levels
    52 analysis
    53 article
    54 attention
    55 baseline
    56 baseline renal function
    57 categories
    58 changes
    59 class
    60 clinical setting
    61 concern
    62 constipation
    63 control
    64 data
    65 days
    66 demographics
    67 diabetes
    68 diabetes mellitus
    69 dialysis
    70 dipeptidyl peptidase
    71 disorders
    72 drug reactions
    73 duration
    74 efficacy
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    76 efficacy concerns
    77 efficacy of teneligliptin
    78 evidence
    79 exposure
    80 filtration rate
    81 follow
    82 function
    83 gastrointestinal disorders
    84 glomerular filtration rate
    85 glycaemic control
    86 glycated albumin levels
    87 impairment
    88 incidence
    89 incidence of ADRs
    90 inhibitors
    91 inserts
    92 laboratory variables
    93 levels
    94 long-term post-marketing surveillance
    95 median duration
    96 mellitus
    97 new adverse drug reactions
    98 new safety
    99 package inserts
    100 patients
    101 peptidase
    102 post-marketing surveillance
    103 rate
    104 reaction
    105 real-world evidence
    106 reduction
    107 renal function
    108 renal function subgroups
    109 renal impairment
    110 safety
    111 serious adverse drug reactions
    112 setting
    113 stage
    114 subgroups
    115 summary
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    117 teneligliptin
    118 terms
    119 treatment
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    121 type 2 diabetes
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