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See detailGLP-1 receptor agonists and heart failure in diabetes.
Scheen, André ULg

in Diabètes & Métabolism (2017), 43 Suppl 1

The prevalence of heart failure (HF) is increasing in patients with type 2 diabetes (T2D), and glucose-lowering agents have distinctive effects on the risk of developing HF that requires hospitalization ... [more ▼]

The prevalence of heart failure (HF) is increasing in patients with type 2 diabetes (T2D), and glucose-lowering agents have distinctive effects on the risk of developing HF that requires hospitalization. Such an increased risk has been consistently reported with thiazolidinediones (glitazones) and perhaps also with the dipeptidyl peptidase (DPP)-4 inhibitor saxagliptin (at least in SAVOR - TIMI 53), whereas a markedly decreased risk was highlighted with the sodium - glucose cotransporter type 2 (SGLT2) inhibitor empagliflozin in EMPA-REG OUTCOME. Yet, the effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on myocardial function remain controversial. Whereas some promising observations have been reported in various animal models, the effects of GLP-1RAs on myocardial function in humans are more heterogeneous, while the positive effect on left ventricular ejection fraction (LVEF), if any, appears to be inconsistent and rather modest in most patients with HF. However, no increased risk of hospitalization for HF has been reported with GLP-1RAs in meta-analyses of phase-II/III trials (exenatide, albiglutide, dulaglutide, liraglutide), demonstrating the safety of this pharmacological class, and such findings have been confirmed by three large prospective cardiovascular outcome trials (ELIXA with lixisenatide, LEADER with liraglutide and SUSTAIN-6 with semaglutide). In particular, LEADER reported a trend towards a reduction in HF hospitalization (-13%, P = 0.14), together with a significant reduction in cardiovascular and all-cause mortality in patients with T2D at risk of cardiovascular disease. These results are reassuring in the face of the somewhat negative results of the FIGHT trial, which evaluated the effects of liraglutide in patients with advanced HF and low LVEF, such that further studies and caution are now required when using this agent to treat such patients in clinical practice. [less ▲]

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See detailCardiovascular outcome studies with incretin-based therapies: Comparison between DPP-4 inhibitors and GLP-1 receptor agonists.
Scheen, André ULg

in Diabetes Research & Clinical Practice (2017), 127

Dipeptidyl peptidase-4 inhibitors (DPP-4is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) represent two distinct classes of incretin-based therapies used for the treatment of type 2 diabetes ... [more ▼]

Dipeptidyl peptidase-4 inhibitors (DPP-4is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) represent two distinct classes of incretin-based therapies used for the treatment of type 2 diabetes. Non-inferiority versus placebo was shown in large prospective cardiovascular outcome trials in patients with high cardiovascular risk: SAVOR-TIMI 53 (saxagliptin), EXAMINE (alogliptin), and TECOS (sitagliptin); ELIXA (lixisenatide), LEADER (liraglutide) and SUSTAIN 6 (semaglutide). The promises raised by meta-analyses of phase 2-3 trials with DPP-4is were non confirmed as no cardiovascular protection could be evidenced. However, LEADER showed a significant reduction in major cardiovascular events, myocardial infarction, cardiovascular and all-cause mortality in patients treated by liraglutide compared to placebo. These positive results contrasted with the non-inferiority results with lixisenatide in ELIXA. They were partially confirmed with semaglutide in SUSTAIN 6 despite the absence of reduction in cardiovascular mortality. Hospitalisation for heart failure was not increased except with saxagliptin in SAVOR-TIMI 53. The reasons for different outcomes between trials remain largely unknown as well as the precise underlying mechanisms explaining the cardiovascular protection by liraglutide. The clinical relevance of results with DPP-4is and GLP-1RAs is discussed. Ongoing trials with linagliptin and several once-weekly GLP-1RAs should provide new insights into remaining fundamental questions. [less ▲]

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See detailVignette therapeutique de l'etudiant. Optimisation d'un traitement par insuline basale chez le patient diabetique de type 2.
Scheen, André ULg; Paquot, Nicolas ULg

in Revue Médicale de Liège (2017), 72(3), 156-161

Because of the natural history of type 2 diabetes and the increasing life expectancy, more and more patients are treated with insulin after failure of oral therapy. International guidelines give the ... [more ▼]

Because of the natural history of type 2 diabetes and the increasing life expectancy, more and more patients are treated with insulin after failure of oral therapy. International guidelines give the preference to basal insulin, most often while maintaining metformin. If this treatment does not allow to reach the glycaemic objectives, optimizing therapy is mandatory. This clinical case offers the opportunity of discussing both advantages and disadvantages of three therapeutic options : the shift from basal insulin to a basal-plus or a basal-bolus insulin regimen, the addition of another oral glucose-lowering agent, either a dipeptidyl peptidase-4 inhibitor (gliptin) or an inhibitor of cotransporters sodium-glucose type 2 cotransporters (gliflozin), or the combination of basal insulin and a glucagon-like peptide-1 receptor agonist. [less ▲]

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See detailPharmacokinetic drug evaluation of saxagliptin plus dapagliflozin for the treatment of type 2 diabetes.
Scheen, André ULg

in Expert Opinion on Drug Metabolism & Toxicology (2017), 13(5), 583-592

INTRODUCTION: Combining a dipeptidyl peptidase-4 inhibitor and a sodium-glucose cotransporter type 2 inhibitor is an attractive option to treat hyperglycaemia in type 2 diabetes. Areas covered: The ... [more ▼]

INTRODUCTION: Combining a dipeptidyl peptidase-4 inhibitor and a sodium-glucose cotransporter type 2 inhibitor is an attractive option to treat hyperglycaemia in type 2 diabetes. Areas covered: The saxagliptin plus dapagliflozin combination is carefully analysed, focusing on: 1) pharmacokinetic properties, 2) pharmacodynamics data, and 3) results of randomised controlled trials (dual combination versus either monotherapy, sequential therapy saxagliptin added to dapagliflozin or dapagliflozin added to saxagliptin). Expert opinion: Pharmacokinetic findings demonstrate the absence of drug-drug interaction and the bioequivalence of the FDC compared with separated tablets. Pharmacodynamic observations confirm a complementary mode of action of the two agents. Dual saxagliptin-dapagliflozin therapy is more potent than either monotherapy. It may be used as an initial combination, although this approach remains debatable and should probably be reserved in case of high glycated hemoglobin, or a stepwise strategy, according to a personalized approach. The developed saxagliptin-dapagliflozin FDC may simplify anti-hyperglycemic therapy and improve drug compliance. [less ▲]

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See detailFactors associated with reaching or not reaching target HbA1c after initiation of basal or premixed insulin in patients with type 2 diabetes.
Scheen, André ULg; Schmitt, H.; Jiang, H. H. et al

in Diabètes & Métabolism (2017), 43(69-78),

AIMS: To evaluate factors associated with reaching or not reaching target glycated haemoglobin (HbA1c) levels by analysing the respective contributions of fasting hyperglycaemia (FHG), also referred to as ... [more ▼]

AIMS: To evaluate factors associated with reaching or not reaching target glycated haemoglobin (HbA1c) levels by analysing the respective contributions of fasting hyperglycaemia (FHG), also referred to as basal hyperglycaemia, vs postprandial hyperglycaemia (PHG) before and after initiation of a basal or premixed insulin regimen in patients with type 2 diabetes. METHODS: This post-hoc analysis of insulin-naive patients in the DURABLE study randomised to receive either insulin glargine or insulin lispro mix 25 evaluated the percentages of patients achieving a target HbA1c of <7.0% (<53mmol/mol) per baseline HbA1c quartiles, and the effect of each insulin regimen on the relative contributions of PHG and FHG to overall hyperglycaemia. RESULTS: Patients had comparable demographic characteristics and similar HbA1c and FHG values at baseline in each HbA1c quartile regardless of whether they reached the target HbA1c. The higher the HbA1c quartile, the greater was the decrease in HbA1c, but also the smaller the percentage of patients achieving the target HbA1c. HbA1c and FHG decreased more in patients reaching the target, resulting in significantly lower values at endpoint in all baseline HbA1c quartiles with either insulin treatment. Patients not achieving the target HbA1c had slightly higher insulin doses, but lower total hypoglycaemia rates. CONCLUSION: Smaller decreases in FHG were associated with not reaching the target HbA1c, suggesting a need to increase basal or premixed insulin doses to achieve targeted fasting plasma glucose and improve patient response before introducing more intensive prandial insulin regimens. [less ▲]

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See detailEffects of reducing blood pressure on renal outcomes in patients with type 2 diabetes: Focus on SGLT2 inhibitors and EMPA-REG OUTCOME.
Scheen, André ULg; Delanaye, P.

in Diabètes & Métabolism (2017), (epub ahead of print),

Empagliflozin, a sodium-glucose cotransporter type 2 (SGLT2) inhibitor, has enabled remarkable reductions in cardiovascular and all-cause mortality as well as in renal outcomes in patients with type 2 ... [more ▼]

Empagliflozin, a sodium-glucose cotransporter type 2 (SGLT2) inhibitor, has enabled remarkable reductions in cardiovascular and all-cause mortality as well as in renal outcomes in patients with type 2 diabetes (T2D) and a history of cardiovascular disease in the EMPA-REG OUTCOME. These results have been attributed to haemodynamic rather than metabolic effects, in part due to the osmotic/diuretic action of empagliflozin and the reduction in arterial blood pressure (BP). The present narrative review includes the results of meta-analyses of trials evaluating the effects on renal outcomes of lowering BP in patients with T2D, with a special focus on the influence of baseline and achieved systolic BP, and compares the renal outcome results of the EMPA-REG OUTCOME with those of other major trials with inhibitors of the renin-angiotensin system in patients with T2D and the preliminary findings with other SGLT2 inhibitors, and also evaluates post hoc analyses from the EMPA-REG OUTCOME of special interest as regards the BP-lowering hypothesis and renal function. While systemic BP reduction associated to empagliflozin therapy may have contributed to the renal benefits reported in EMPA-REG OUTCOME, other local mechanisms related to kidney homoeostasis most probably also played a role in the overall protection observed in the trial. [less ▲]

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See detailPharmacotherapy of 'treatment resistant' type 2 diabetes.
Scheen, André ULg

in Expert Opinion on Pharmacotherapy (2017), 1

INTRODUCTION: Despite type 2 diabetes (T2D) management offers a variety of pharmacological interventions targeting different defects, numerous patients remain with persistent hyperglycaemia responsible ... [more ▼]

INTRODUCTION: Despite type 2 diabetes (T2D) management offers a variety of pharmacological interventions targeting different defects, numerous patients remain with persistent hyperglycaemia responsible for severe complications. Unlike resistant hypertension, treatment resistant T2D is not a classical concept although it is a rather common observation in clinical practice. Areas covered: This article proposes a definition for 'treatment resistant diabetes', analyses the causes of poor glucose control despite standard therapy, briefly considers the alternative approaches to glucose-lowering pharmacotherapy and finally describes how to overcome poor glycaemic control, using innovative oral or injectable combination therapies. Expert opinion: Before considering intensifying the pharmacotherapy of a patient with poorly controlled T2D, it is important to verify treatment adherence, target obesity and consider various non pharmacological improvement quality interventions. If treatment resistant diabetes is defined as not achieving glycated haemoglobin target despite oral triple therapy with a third glucose-lowering agent added to metformin-sulfonylurea dual treatment, the combination of a dipeptidyl peptidase-4 (DPP-4) inhibitor and a sodium glucose cotransporter type 2 (SGLT2) inhibitor may offer new opportunities before considering injectable therapies. Insulin basal therapy (+/- metformin) may be optimized by the addition of a SGLT2 inhibitor or a glucagon-like peptide-1 (GLP-1) receptor agonist. [less ▲]

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See detailDulaglutide for the treatment of type 2 diabetes.
Scheen, André ULg

in Expert Opinion on Biological Therapy (2017), 17(4), 485-496

INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are injectable agents used for the treatment of hyperglycemia in type 2 diabetes. The interest for this pharmacological class is rising ... [more ▼]

INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are injectable agents used for the treatment of hyperglycemia in type 2 diabetes. The interest for this pharmacological class is rising with the development of once weekly compounds and the demonstration of a potential reduction in cardiorenal outcomes. Areas covered: The paper describes the main pharmacokinetic/pharmacodynamic characteristics of dulaglutide, a new once-weekly GLP-1 RA. Dulaglutide was extensively investigated in the phase-3 AWARD program, which demonstrated its safety and efficacy when compared to placebo or active glucose-lowering agents in patients treated with diet alone, metformin or sulfonylurea monotherapy, oral dual therapies and basal insulin. In both Caucasian and Japanese patients, comparative trials showed better glucose control with dulaglutide, with a minimal risk of hypoglycemia and weight loss, but at the expense of an increased dropout rate due to side effects, mostly transient gastrointestinal disturbances. Dulaglutide proved its non-inferiority versus liraglutide and the safety and tolerance profile is similar to that of other GLP-1 RAs. Expert opinion: The once-weekly formulation and the combined positive effects on both glucose control and weight improves patient satisfaction despite nausea. Dulaglutide must prove its capacity to reduce cardiovascular and diabetic complications in the ongoing prospective REWIND trial. [less ▲]

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See detailUnderstanding and overcoming metformin gastrointestinal intolerance.
Bonnet, Fabrice; Scheen, André ULg

in Diabetes, Obesity & Metabolism (2017), 19(473-481),

Metformin is the most widely prescribed drug for patients with type 2 diabetes mellitus and the first-line pharmacologic option as supported by multiple international guidelines, yet a rather large ... [more ▼]

Metformin is the most widely prescribed drug for patients with type 2 diabetes mellitus and the first-line pharmacologic option as supported by multiple international guidelines, yet a rather large proportion of patients cannot tolerate metformin in adequate amounts because of its associated gastrointestinal (GI) adverse events (AEs). GI AEs typically encountered with metformin therapy include diarrhoea, nausea, flatulence, indigestion, vomiting, and abdominal discomfort, with diarrhoea and nausea being the most common. Although starting at a low dose and titrating slowly may help prevent some of metformin's GI AEs, some patients are unable to tolerate metformin at all and it may also be difficult to convince patients to start metformin again after a bout of GI AEs. Despite this clinical importance the underlying mechanisms of metformin's GI intolerance are poorly known. This review discusses the epidemiology of metformin GI intolerance; its underlying mechanisms; genotype variability and associated factors affecting metformin GI intolerance, such as comorbidities, co-medications, and bariatric surgery; clinical consequences, and therapeutic strategies to overcome metformin GI intolerance. These strategies include appropriate titration of immediate-release metformin, use of extended-release metformin, the promise of delayed-release metformin and gut microbiome modulators, and alternative pharmacological therapies when metformin cannot be tolerated at all. Given the available data, all efforts should be made to maintain metformin before considering a shift to another drug therapy. [less ▲]

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See detailSemaglutide: a promising new glucagon-like peptide-1 receptor agonist.
Scheen, André ULg

in Lancet Diabetes & Endocrinology (2017)

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See detailLa vignette thérapeutique de l'étudiant. Le choix entre un inhibiteur de la DPP-4 et un inhibiteur des SGLT2 pour traiter le diabète de type 2 (2016)
SCHEEN, André ULg; PAQUOT, Nicolas ULg

in Revue Médicale de Liège (2016), 71(12), 579-585

Summary : Two new classes of oral antidiabetic agents play an increasing role in the management of type 2 diabetes, dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins) and sodiumglucose cotransporters ... [more ▼]

Summary : Two new classes of oral antidiabetic agents play an increasing role in the management of type 2 diabetes, dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins) and sodiumglucose cotransporters type 2 (SGLT2) inhibitors (gliflozins). After failure of a monotherapy with metformin (first pharmacological choice in type 2 diabetes), both may offer an alternative to the add-on of a sulphonylurea, especially in patients at risk of hypoglycaemia. However, the choice between a DPP-4 inhibitor and a SGLT2 inhibitor is not easy and should be oriented based upon the individual patient characteristics. The arguments in favour of one or another pharmacological class are discussed, considering a clinical case of a patient with coronary heart disease and type 2 diabetes not well controlled with metformin. [less ▲]

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See detailEtude transfrontalière des besoins de formation en Education Thérapeutique du Patient souffrant de diabète et/ou d’obésité pour le personnel médical et paramédical : enquête par méthode du groupe nominal
Pétré, Benoît ULg; Ketterer, Frédéric ULg; Vanmeerbeek, Marc ULg et al

in Presse Médicale (2016), 45(10), 351-361

INTRODUCTION: The design of continuous training programs in therapeutic patient education (ETP) should be inspired by needs shown by the professionals concerned in terms of mobilization or acquisition of ... [more ▼]

INTRODUCTION: The design of continuous training programs in therapeutic patient education (ETP) should be inspired by needs shown by the professionals concerned in terms of mobilization or acquisition of skills in this domain. The objective of this study is to analyze needs expressed by healthcare professionals (HP) involved in patients' management presenting a type 2 diabetes (T2D) and/or obesity and to compare them with the existing recommendations. METHODS: One hundred and five PS (general practitioners, dietitians and nurses) of 3 frontier regions of French-speaking European countries (France, Belgium and Grand duchy of Luxembourg) were questioned in 12 monodisciplinary groups according to the technique of the nominal group. Needs expressed by the participants were classified in the categories of the reference table of skills to dispense TPE (National Institute for Health Prevention and Education [INPES], 2013). RESULTS/DISCUSSION: Among needs expressed by HP, 52 % of the votes targeted relational skills, 10 % of the skills relative to the biomedical techniques, 20 % of the skills relative to the educational techniques and 11 %, those of organization and the coordination. Seven percent of the proposals were out of the categories of the INPES. Results do not allow to establish profiles of skills according to the studied region or profession. The recognition of the TPE by the French legislation does not seem to influence in a major way the data. CONCLUSION: The needs expressed by PS in the context of this study are focused on the relation HP/patient that is the heart of the TPE. It would however be necessary to raise awareness among HP in the acquisition of the other skills which concern in particular the animation of group, the interprofessional coordination, the consideration of the environment or more generally the procedures. [less ▲]

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See detailLE MÉDICAMENT DU MOIS Dapagliflozine (Forxiga®) Inhibiteur des cotransporteurs rénaux SGLT2, nouvel agent anti-hyperglycémiant dans le diabète de type 2
SCHEEN, André ULg

in Revue Médicale de Liège (2016), 71(10), 463-469

Résumé : La dapagliflozine, un inhibiteur spécifique des cotransporteurs sodium-glucose de type 2 (SGLT2), inhibe la réabsorption tubulaire rénale du glucose et accroît la gluco¬surie. Il en résulte une ... [more ▼]

Résumé : La dapagliflozine, un inhibiteur spécifique des cotransporteurs sodium-glucose de type 2 (SGLT2), inhibe la réabsorption tubulaire rénale du glucose et accroît la gluco¬surie. Il en résulte une diminution de la glycémie et du taux d’hémoglobine glyquée (HbA1c), avec un risque faible d’hypo¬glycémie, une perte pondérale et une diminution de la pression artérielle. L’efficacité sur la réduction du taux d’HbA1c est d’autant plus importante que l’hyperglycémie est élevée, mais elle diminue en cas d’insuffisance rénale. Les infections géni¬tales mycotiques sont plus fréquentes, surtout chez la femme, alors que l’augmentation des infections urinaires basses n’est que marginale. La dapagliflozine (Forxiga®), commercialisée à la dose de 10 mg une fois par jour, est indiquée pour le trai¬tement du diabète de type 2 et remboursée en Belgique, sous conditions, en ajout à la metformine, un sulfamide ou le répa-glinide, une association metformine-sulfamide/répaglinide ou une insuline basale avec au moins un antidiabétique oral. Des données préliminaires ne démontrent pas d’augmentation du risque cardiovasculaire par rapport au comparateur et suggèrent même une protection cardiovasculaire et rénale, à confirmer dans l’essai DECLARE, une grande étude prospec¬tive contrôlée actuellement en cours chez des patients diabé¬tiques de type 2 à haut risque cardiovasculaire. [less ▲]

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See detailLa vignette diagnostique de l’étudiant Mise au point d’une suspicion de malaise hypoglycémique chez une personne adulte non diabétique
SCHEEN, André ULg; PAQUOT, Nicolas ULg; LEFEBVRE, Pierre ULg

in Revue Médicale de Liège (2016), 71(09), 407-413

Résumé : La survenue de malaises est souvent attribuée à une hypoglycémie chez des personnes non diabétiques et, a priori, sans autre problème de santé. Ce diagnostic est, cependant, souvent galvaudé, car ... [more ▼]

Résumé : La survenue de malaises est souvent attribuée à une hypoglycémie chez des personnes non diabétiques et, a priori, sans autre problème de santé. Ce diagnostic est, cependant, souvent galvaudé, car habituellement non clairement démontré. Le diagnostic d’hypoglycémie doit se faire de façon structurée en se basant sur la triade de Whipple. Tout d’abord, l’anamnèse doit rechercher les symptômes évocateurs d’hypoglycémie, adrénergiques et neuroglucopéniques. Ensuite, l’hypoglycémie doit être authentifiée par une mesure d’une valeur basse au moment d’un malaise. Enfin, s’il s’agit bien d’une hypoglycémie, le malaise doit disparaître rapidement après resucrage. Une fois le diagnostic posé sur la base de cette triade, l’anamnèse doit faire préciser, outre la sévérité des malaises, leur chronologie, après les repas ou à jeun, ce qui oriente vers une hypoglycémie réactive, fonctionnelle, ou vers une hypoglycémie d’origine organique (insulinome). Des examens complémentaires, faisant d’abord appel à la biologie clinique, ensuite éventuellement à l’imagerie médicale, permettront de, non seulement confirmer le diagnostic d’hypoglycémie, mais aussi d’en préciser l’origine, ce qui orientera la stratégie thérapeutique. [less ▲]

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See detailProtection cardiovasculaire et rénale du patient diabétique de type 2 : le point après EMPA-REG OUTCOME et LEADER
SCHEEN, André ULg; PIERARD, Luc ULg; KRZESINSKI, Jean-Marie ULg et al

in Revue Médicale de Liège (2016), 71(09), 376-381

Summary : Type 2 diabetes (T2D), often associated with arterial hypertension, represents a high risk of cardiovascular disease and nephropathy. Two clinical trials demonstrate the superiority versus a ... [more ▼]

Summary : Type 2 diabetes (T2D), often associated with arterial hypertension, represents a high risk of cardiovascular disease and nephropathy. Two clinical trials demonstrate the superiority versus a placebo of two antidiabetic drugs in patients with T2D and high cardiovascular risk : empagliflozin, an inhibitor of sodium-glucose type 2 (SGLT2) cotransporters, in EMPA-REG OUTCOME and liraglutide, an agonist of glucagon-like peptide-1 (GLP-1) receptors, in LEADER. Both medications showed a significant reduction in major cardiovascular events (-14 and -13 %, respectively), cardiovascular mortality (-38 and -22%), all-cause mortality (-32 and -15 %) and renal events (-39 et -22 %). The underlying protective mechanisms remain controverted. Ongoing studies should allow to decide whether the benefits are specific to each molecule or may be attributed to a class effect. [less ▲]

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See detailThe role of biochemical of bone turnover markers in osteoporosis and metabolic bone disease: a consensus paper of the Belgian Bone Club.
Cavalier, Etienne ULg; Bergmann, P.; Bruyère, Olivier ULg et al

in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA (2016), 27

The exact role of biochemical markers of bone turnover in the management of metabolic bone diseases remains a topic of controversy. In this consensus paper, the Belgian Bone Club aimed to provide a state ... [more ▼]

The exact role of biochemical markers of bone turnover in the management of metabolic bone diseases remains a topic of controversy. In this consensus paper, the Belgian Bone Club aimed to provide a state of the art on the use of these biomarkers in different clinical or physiological situations like in postmenopausal women, osteoporosis in men, in elderly patients, in patients suffering from bone metastasis, in patients with chronic renal failure, in pregnant or lactating women, in intensive care patients, and in diabetics. We also gave our considerations on the analytical issues linked to the use of these biomarkers, on potential new emerging biomarkers, and on the use of bone turnover biomarkers in the follow-up of patients treated with new drugs for osteoporosis. [less ▲]

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