Optimal type 2 diabetes mellitus management: the randomised controlled OPTIMISE benchmarking study: baseline results from six European countries

Hermans, Michel P.; Brotons, Carlos; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank

doi:10.1177/2047487312449414

Cited by 26 publications

(21 citation statements)

References 61 publications

(60 reference statements)

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“…These drugs target various facets of metabolic pathways involved in the pathophysiology of the disease [1]. Despite this, fewer than 50 % of the patients achieve glycemic treatment goals predefined by expert societies [2][3][4]. Additionally, concerns such as progressive deterioration of b-cell function, weight gain, and hypoglycemia limit the clinical utility of some of these drugs.…”

Section: Introductionmentioning

confidence: 99%

Clinical Pharmacokinetic, Pharmacodynamic, and Drug–Drug Interaction Profile of Canagliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor

Devineni

Polidori

2015

Clin Pharmacokinet

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The sodium-glucose co-transporter 2 (SGLT2) inhibitors represent novel therapeutic approaches in the management of type 2 diabetes mellitus; they act on kidneys to decrease the renal threshold for glucose (RTG) and increase urinary glucose excretion (UGE). Canagliflozin is an orally active, reversible, selective SGLT2 inhibitor. Orally administered canagliflozin is rapidly absorbed achieving peak plasma concentrations in 1-2 h. Dose-proportional systemic exposure to canagliflozin has been observed over a wide dose range (50-1600 mg) with an oral bioavailability of 65 %. Canagliflozin is glucuronidated into two inactive metabolites, M7 and M5 by uridine diphosphate-glucuronosyltransferase (UGT) 1A9 and UGT2B4, respectively. Canagliflozin reaches steady state in 4 days, and there is minimal accumulation observed after multiple dosing. Approximately 60 % and 33 % of the administered dose is excreted in the feces and urine, respectively. The half-life of orally administered canagliflozin 100 or 300 mg in healthy participants is 10.6 and 13.1 h, respectively. No clinically relevant differences are observed in canagliflozin exposure with respect to age, race, sex, and body weight. The pharmacokinetics of canagliflozin remains unaffected by mild or moderate hepatic impairment. Systemic exposure to canagliflozin is increased in patients with renal impairment relative to those with normal renal function; however, the efficacy is reduced in patients with renal impairment owing to the reduced filtered glucose load. Canagliflozin did not show clinically relevant drug interactions with metformin, glyburide, simvastatin, warfarin, hydrochlorothiazide, oral contraceptives, probenecid, and cyclosporine, while co-administration with rifampin modestly reduced canagliflozin plasma concentrations and thus may necessitate an appropriate monitoring of glycemic control. Canagliflozin increases UGE and suppresses RTG in a dose-dependent manner, thereby lowering the plasma glucose levels and reducing the glycosylated hemoglobin levels through an insulin-independent mechanism of action. The 300-mg dose provides near-maximal effects on RTG throughout the full 24-h dosing interval, whereas the effect of the 100-mg dose on RTG is near-maximal for approximately 12 h and is modestly attenuated during the overnight period. The observed pharmacokinetic/pharmacodynamic profile of canagliflozin in patients with type 2 diabetes mellitus supports a once-daily dosing regimen.

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Section: Introductionmentioning

confidence: 99%

Clinical Pharmacokinetic, Pharmacodynamic, and Drug–Drug Interaction Profile of Canagliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor

Devineni

Polidori

2015

Clin Pharmacokinet

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“…Los hallazgos más saltantes en un estudio canadiense (26) muestran que, a pesar de que la mayoría de sus pacientes era diabético y tenía factores de riesgo cardiovascular, solo 46% recibía bloqueadores del sistema renina angiotensina aldosterona y solo 32% tomaba estatinas. En el estudio de Kanter (27) , 71% tenía HTA y aunque 32,4% sufría de dislipidemia, solo 22,4% recibía estatinas.…”

Section: Discussionunclassified

Características clínicas de los pacientes diabéticos que acuden por primera vez a una consulta nefrológica en hospitales públicos de Lima

et al. 2014

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Introducción: La diabetes mellitus es la principal causa de enfermedad renal crónica y se recomienda una referencia temprana al nefrólogo, ya que se ha reportado peores resultados en pacientes con referencia tardía. Objetivos: Determinar las características de los pacientes diabéticos en su primera consulta nefrológica. Diseño: Estudio multicéntrico, observacional y analítico. Lugar: Hospital Nacional 2 de Mayo, Hospital Nacional Arzobispo Loayza, Hospital Daniel Alcides Carrión y Hospital María Auxiliadora. Participantes: Pacientes diabéticos. Intervenciones: Se estudió a los pacientes en su primera consulta nefrológica entre septiembre 2011 y febrero 2012. Para la descripción se utilizó porcentajes, frecuencias y desviaciones estándar. Principales medidas de resultados: Características clínicas de los pacientes diabéticos. Resultados: Se estudió 200 pacientes diabéticos, con tiempo de diagnóstico promedio de 12,9 años. El 73% recibió educación para autocuidados. El 40% refería que no tomaba sus medicamentos y 57% no seguía su dieta regularmente. El 70% era hipertenso con tiempo de diagnóstico promedio de 4,2 años; 36,5% era obeso, 52,8% sufría de dislipidemia, 10,5% tenía antecedente de enfermedad cardiovascular. El 81,5% refería no haber tenido una evaluación previa de la función renal. El 39,5% tenía hemoglobina glicosilada (HbA1c) >7%, 48,5% colesterol >200 mg/dL, 54,5% cLDL>100 mg/dL y 46,5% triglicéridos >150 mg/dL; 57% un tiempo de filtración glomerular<60 mL/min y 37% presentó albuminuria de 300 mg/d o más. Conclusiones: Casi la mitad de los pacientes no seguía las recomendaciones de autocuidados. Debido a los factores de riesgo cardiovascular involucrados en este grupo, se debería reforzar su educación.

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“…A reduction in glycated hemoglobin (HbA1c) remains the cornerstone of diabetes management [2] and until recently the HbA1c goal in most T2D patients was <7% [3]. However, observational studies in various groups of patients with T2D reported that attaining the HbA1c target remained unsatisfactory [4][5][6][7], although an improvement in the percentage of patients at target from 1999 through 2010 was shown in one study [8]. One of the main barriers in maintaining long-term glycemic control in T2D is the progressive nature of the disease attributed to a continuous decline in beta-cell function [9] and many patients require insulin after a number of years since diagnosis [10].…”

Section: Background and Aimsmentioning

confidence: 99%

The Impact of Structured Diabetes Education on Glycemic Control in Patients with Type 2 Diabetes at Initiation of Basal Insulin – The Basal-EDUC-RO Study: A Randomized Prospective Study

Bala

Rusu

Moise³

et al. 2019

Romanian Journal of Diabetes Nutrition and Metabolic Diseases

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Background: Basal-EDUC-RO Study evaluated the impact of structured education provided at the initiation of basal insulin therapy on glycaemic control in patients with uncontrolled type 2 diabetes mellitus (T2D). Methods: This was a prospective, multicenter, randomized, parallel group study (ACTRN12616001273471) which enrolled 711 patients initiated on insulin therapy with a basal insulin analogue. The subjects were randomized (1:1) to either structured education (structured education group; 353 patients) or standard education (control group; 358 patients) and followed for 6 months. Results: The median HbA1c levels at 6 months after start of basal insulin were significantly lower in the structured education group than in the control group (7.2% vs. 7.4%, p <0.001). In the structured education group, 49.4% of subjects achieved HbA1c targets vs. 34.4% in the control group, p <0.001. Number of documented symptomatic hypoglycemic episodes (all and nocturnal) was lower in the intervention group (139 vs. 217 for all episodes and 13 vs. 26 for nocturnal hypoglycemia) but with no statistical significance. No effect of intervention was seen on body weight, but there was no weight gain in any of the groups at 6 months. Conclusions: A structured diabetes education program delivered to patients with T2D started on a basal insulin analogue significantly improved glucose control at 6 months compared to a less intense education strategy. The positive effect was mainly seen on the percentage of patients who achieved individualized HbA1c pre-set targets, with a non-significant reduction in episodes of overall and nocturnal documented symptomatic hypoglycemia.

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Optimal type 2 diabetes mellitus management: the randomised controlled OPTIMISE benchmarking study: baseline results from six European countries

Cited by 26 publications

References 61 publications

Clinical Pharmacokinetic, Pharmacodynamic, and Drug–Drug Interaction Profile of Canagliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor

Clinical Pharmacokinetic, Pharmacodynamic, and Drug–Drug Interaction Profile of Canagliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor

Características clínicas de los pacientes diabéticos que acuden por primera vez a una consulta nefrológica en hospitales públicos de Lima

The Impact of Structured Diabetes Education on Glycemic Control in Patients with Type 2 Diabetes at Initiation of Basal Insulin – The Basal-EDUC-RO Study: A Randomized Prospective Study

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