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2 results on '"Canivell S"'

1. Glycaemic control after treatment intensification in patients with type 2 diabetes uncontrolled on two or more non-insulin antidiabetic drugs in a real-world setting

Author

Canivell, S, Mata-Cases, M, Real, J, Franch-Nadal, J, Vlacho, B, Khunti, K, Gratacos, M, Mauricio, D, Canivell, S, Mata-Cases, M, Real, J, Franch-Nadal, J, Vlacho, B, Khunti, K, Gratacos, M, and Mauricio, D

Abstract

AIM: To assess glycaemic control after treatment intensification in patients with type 2 diabetes uncontrolled on ≥2 non-insulin antidiabetic drugs (NIADS). METHODS: A retrospective cohort study, using electronic health records from the SIDIAP database (2010-2014), was conducted. Intensification was defined as the prescription of any new antidiabetic drug in patients treated with ≥2 NIADS and HbA1c >7%. The primary outcome was the absolute change in HbA1c 6-12 months after any intensification. Secondary analyses included the percentage of patients reaching HbA1c <7%, HbA1c <8%, and a reduction of HbA1c >1% after the first intensification. RESULTS: There were 21 241 intensifications in 15 205 patients with a mean (SD) HbA1c of 9.02% (±1.35). Insulin and dipeptidyl peptidase-4 inhibitors (DPP4i) were the most frequently added therapies. The mean baseline-adjusted HbA1c reduction was 0.78% (95% CI, -0.80 to -0.76), varying from -0.69% with DPP4i to -0.85% with glucagon-like peptide-1 receptor agonists while the addition of insulin was associated with a reduction >1%. After the first intensification, 48.9% of patients achieved HbA1c <8%, 16.2% HbA1c <7%, and 43.1% a reduction >1%. High previous HbA1c was positively associated with the reduction of HbA1c >1% [odds ratio (OR) 2.13 (95% CI: 2.05-2.21)], but inversely associated with the attainment of HbA1c <7% [OR 0.64 (0.61-0.67)] or < 8% [OR 0.63 (0.60-0.65)]. Older age, male gender, higher Charlson index, and short diabetes duration were associated with achievement of HbA1c <7%. CONCLUSIONS: Despite intensification, most patients failed the glycaemic goal of HbA1c <7%. The reduction depended mainly on preintensification HbA1c values, with small differences between drugs.

Published
2019

2. How Many Patients with Type 2 Diabetes Meet the Inclusion Criteria of the Cardiovascular Outcome Trials with SGLT2 Inhibitors? Estimations from a Population Database in a Mediterranean Area.

Author

Canivell S, Mata-Cases M, Vlacho B, Gratacòs M, Real J, Mauricio D, and Franch-Nadal J

Subjects
Aged, Aged, 80 and over, Benzhydryl Compounds therapeutic use, Canagliflozin therapeutic use, Cardiovascular Diseases prevention & control, Cross-Sectional Studies, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 metabolism, Female, Glucosides therapeutic use, Glycated Hemoglobin metabolism, Humans, Male, Middle Aged, Reproducibility of Results, Retrospective Studies, Spain epidemiology, Cardiovascular Diseases epidemiology, Clinical Trials as Topic, Diabetes Mellitus, Type 2 epidemiology, Eligibility Determination, Renal Insufficiency, Chronic epidemiology, Sodium-Glucose Transporter 2 Inhibitors therapeutic use
Abstract

Objective: Regulatory agencies require the assessment of cardiovascular (CV) safety for new type 2 diabetes (T2D) therapies through CV outcome trials (CVOTs). However, patients included in CVOTs assessing sodium-glucose cotransporter-2 inhibitors (SGLT2i) might not be representative of those seen in clinical practice. This study examined the proportion of patients that would have been enrolled into three main SGLT2i CVOTs to determine whether these trials' eligibility criteria can be applied to a real-world Mediterranean T2D population., Methods: Cross-sectional, retrospective, cohort study of T2D patients registered in primary care centres of the Catalan Institute of Health using medical records from a population database (SIDIAP) that includes approximately 74% of the population in Catalonia (Spain). Eligibility criteria were according to those of three SGLT2i CVOTs: EMPA-REG OUTCOME (empagliflozin), CANVAS (canagliflozin), and DECLARE-TIMI 58 (dapagliflozin)., Results: By the end of 2016, the database included 373,185 patients with T2D with a mean age of 70 ± 12 years, 54.9% male, with a mean duration of T2D of 9 ± 6 years, and a mean glycated haemoglobin (HbA1c) of 7.12% ± 1.32 (59% with HbA1c < 7%). Of these, 86,534 (23%) had established CV disease and 28% chronic renal failure (estimated glomerular filtration < 60 ml/min/1.73m 2 ). Among all included patients, only 8.2% would have qualified for enrolment into the EMPA-REG OUTCOME trial, 29.6% into the CANVAS program, and 38% into the DECLARE-TIMI 58 trial. The main limiting factors for inclusion would have been a previous history of CV disease and the baseline HbA1c value., Conclusion: The external validity of the analysed CVOTs is clearly limited when applying the same eligibility criteria to a T2D Mediterranean population., Competing Interests: M.M.-C. has received advisory honorarium from Astra-Zeneca, Bayer, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received speaker honorarium from Astra-Zeneca, Bayer, Boehringer Ingelheim, GSK, Lilly, Menarini, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the institution from Astra-Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi. J.F.-N. has received advisory and/or speaking fees from Astra-Zeneca, Ascensia, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the institution from Astra-Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, Sanofi, and Boehringer. D.M. has received advisory and/or speaking fees from Astra-Zeneca, Ascensia, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the institution from Astra-Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, Sanofi, and Boehringer. S.C., J.R., B.V., and M.G. have no conflicts of interest to declare., (Copyright © 2019 Silvia Canivell et al.)

Published
2019
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