LETTRE
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Thérapie 2013 Novembre-Décembre; 68 (6): 415–417 DOI: 10.2515/therapie/2013063
RÉDACTION
© 2013 Société Française de Pharmacologie et de Thérapeutique
Clinically Relevant Efficacy of Insulin Therapy in Patients with Type 2 Diabetes Efficacité cliniquement pertinente de l’insulinothérapie chez les patients diabétiques de type 2 Rémy Boussageon1, John-Michael Gamble2, François Gueyffier4,5,6 and Catherine Cornu3,4,5,6 1 Faculty of Poitiers, Department of General Practice, Poitiers, France 2 School of Pharmacy, Memorial University of Newfoundland, St. John’s, Newfoundland and Labrador, Canada 3 Inserm, Clinical Investigation Centre (CIC201), Lyon 4 Lyon University, Lyon, France 5 CHU Lyon, Louis Pradel Hospital, Clinical pharmacology, Lyon, France; 6 CNRS, UMR5558, Lyon, France Text received July 5th, 2013; accepted september 3rd, 2013 Keywords: insulin; randomized controlled trial; type 2 diabetes mellitus Mots clés : diabète sucré de type 2 ; essai clinique randomisé ; insuline Abbreviations: see end of article.
The aim of type 2 diabetes (T2D) treatment is supposed to be glycaemic control. This is often described as a glucocentric approach or “treat-to-target” model. Treatment success is based on how close we can get to and maintain euglycemia and is usually measured by HbA1c. Hyperglycemia is often considered to be a causal factor responsible for micro- and macrovascular complications. In other words, any intervention that lowers HbA1c is expected to reduce the risk of developing chronic complications. However, several large randomized controlled trials (RCTs) have failed to provide convincing evidence supporting this hypothesis, regardless of treatment option.[1] No oral antidiabetic drug, including metformin,[2] has demonstrated efficacy on patient-centered outcomes (e.g. blindness, leg amputations, or cardiovascular mortality) in a double-blind placebo-controlled RCT. High-quality trials demonstrating superior efficacy of insulin versus placebo for patient-centered outcomes are suprisingly absent. In this analysis, we discuss the current state of clinical trial evidence on insulin treatment for T2D and provide a summary of the data for patient-centered outcomes.
About 28% of patients with T2D take insulin in the United States[3] and France.[4] The American diabetes association and the European association for the study of diabetes (EASD) issued a consensus statement recommending insulin as a well-validated tier 1 option for the metabolic management of hyperglycemia in T2D.[5] But what is the evidence supporting the efficacy of insulin therapy on micro- and macrovascular complications? To answer this question, we present appropriate studies from our systematic review that was published in BMJ in July 2011.[1] Out of the 13 studies that were included in our systematic review, only two can be used to evaluate the clinical efficacy of insulin therapy in patients with T2D: the University group diabetes program (UGDP)[6] and the United Kingdom prospective diabetes study (UKPDS 33).[7] The UGDP trial randomized patients into a fixedinsulin dosage arm (ISTD) vs a variable-insulin arm (IVAR) [aim: maintain blood glucose at normal levels]. UKPDS randomized patients to insulin (aim: fasting plasma glucose (FPG)
À LA
Thérapie 2013 Novembre-Décembre; 68 (6): 415–417 DOI: 10.2515/therapie/2013063
RÉDACTION
© 2013 Société Française de Pharmacologie et de Thérapeutique
Clinically Relevant Efficacy of Insulin Therapy in Patients with Type 2 Diabetes Efficacité cliniquement pertinente de l’insulinothérapie chez les patients diabétiques de type 2 Rémy Boussageon1, John-Michael Gamble2, François Gueyffier4,5,6 and Catherine Cornu3,4,5,6 1 Faculty of Poitiers, Department of General Practice, Poitiers, France 2 School of Pharmacy, Memorial University of Newfoundland, St. John’s, Newfoundland and Labrador, Canada 3 Inserm, Clinical Investigation Centre (CIC201), Lyon 4 Lyon University, Lyon, France 5 CHU Lyon, Louis Pradel Hospital, Clinical pharmacology, Lyon, France; 6 CNRS, UMR5558, Lyon, France Text received July 5th, 2013; accepted september 3rd, 2013 Keywords: insulin; randomized controlled trial; type 2 diabetes mellitus Mots clés : diabète sucré de type 2 ; essai clinique randomisé ; insuline Abbreviations: see end of article.
The aim of type 2 diabetes (T2D) treatment is supposed to be glycaemic control. This is often described as a glucocentric approach or “treat-to-target” model. Treatment success is based on how close we can get to and maintain euglycemia and is usually measured by HbA1c. Hyperglycemia is often considered to be a causal factor responsible for micro- and macrovascular complications. In other words, any intervention that lowers HbA1c is expected to reduce the risk of developing chronic complications. However, several large randomized controlled trials (RCTs) have failed to provide convincing evidence supporting this hypothesis, regardless of treatment option.[1] No oral antidiabetic drug, including metformin,[2] has demonstrated efficacy on patient-centered outcomes (e.g. blindness, leg amputations, or cardiovascular mortality) in a double-blind placebo-controlled RCT. High-quality trials demonstrating superior efficacy of insulin versus placebo for patient-centered outcomes are suprisingly absent. In this analysis, we discuss the current state of clinical trial evidence on insulin treatment for T2D and provide a summary of the data for patient-centered outcomes.
About 28% of patients with T2D take insulin in the United States[3] and France.[4] The American diabetes association and the European association for the study of diabetes (EASD) issued a consensus statement recommending insulin as a well-validated tier 1 option for the metabolic management of hyperglycemia in T2D.[5] But what is the evidence supporting the efficacy of insulin therapy on micro- and macrovascular complications? To answer this question, we present appropriate studies from our systematic review that was published in BMJ in July 2011.[1] Out of the 13 studies that were included in our systematic review, only two can be used to evaluate the clinical efficacy of insulin therapy in patients with T2D: the University group diabetes program (UGDP)[6] and the United Kingdom prospective diabetes study (UKPDS 33).[7] The UGDP trial randomized patients into a fixedinsulin dosage arm (ISTD) vs a variable-insulin arm (IVAR) [aim: maintain blood glucose at normal levels]. UKPDS randomized patients to insulin (aim: fasting plasma glucose (FPG)
