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1.
Diabetes Obes Metab ; 22(7): 1024-1034, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32037647

RESUMO

Data from three completed cardiovascular outcome trials (CVOTs), EMPA-REG OUTCOME, CANVAS Program and DECLARE-TIMI 58, add to the evidence supporting the potential renoprotective effects of sodium-glucose linked transporter-2 (SGLT2) inhibitors in patients with type 2 diabetes. Despite recommendations in recent guidelines, it is difficult to support a view that definitive evidence for renoprotection exists from these SGLT2 inhibitor CVOT results. To date, the only dedicated trial to report definitive data on the renal impact of SGLT2 inhibition is CREDENCE. Notably, the total number of patient-relevant renal endpoint events (dialysis, transplant or renal death) observed in CREDENCE was significantly higher than the total for all three CVOTs collectively (183 events/4401 patients vs. 69 events/34 322 patients, respectively), which shows the increased statistical power of CREDENCE for these renal endpoints. Treatment with canagliflozin was associated with a 30% relative risk reduction (RRR) in the primary composite endpoint of end-stage kidney disease, doubling of serum creatinine, or death from renal or cardiovascular causes and a 34% RRR for the renal-specific elements of this primary endpoint (P <0.001). Canagliflozin has therefore become the first US-approved SGLT2 inhibitor to include an indication for RRR, in addition to type 2 diabetes glycaemic control and cardiovascular risk reduction. While confirmatory of the exploratory data from CVOTs, CREDENCE provides the first robust data on the effects of canagliflozin on patient-relevant renal endpoints. Extrapolation to a conclusion of a SGLT2 inhibitor class effect cannot be made until additional renal trials with other SGLT2 inhibitors are reported.

2.
Circulation ; 141(17): 1360-1370, 2020 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-32098501

RESUMO

BACKGROUND: EXSCEL (Exenatide Study of Cardiovascular Event Lowering) assessed the impact of once-weekly exenatide 2 mg versus placebo in patients with type 2 diabetes mellitus, while aiming for glycemic equipoise. Consequently, greater drop-in of open-label glucose-lowering medications occurred in the placebo group. Accordingly, we explored the potential effects of their unbalanced use on major adverse cardiovascular events (MACE), defined as cardiovascular death, nonfatal myocardial infarction or nonfatal stroke, and all-cause mortality (ACM), given that some of these agents are cardioprotective. METHODS: Cox hazard models were performed by randomized treatment for drug classes where >5% open-label drop-in glucose-lowering medication occurred, and for glucagon-like peptide-1 receptor agonists (GLP-1 RAs; 3.0%) using three methodologies: drop-in visit right censoring, inverse probability for treatment weighting (IPTW), and applying drug class risk reductions. RESULTS: Baseline glucose-lowering medications for the 14 752 EXSCEL participants (73.1% with previous cardiovascular disease) did not differ between treatment groups. During median 3.2 years follow-up, open-label drop-in occurred in 33.4% of participants, more frequently with placebo than exenatide (38.1% versus 28.8%), with metformin (6.1% versus 4.9%), sulfonylurea (8.7% versus 6.9%), dipeptidyl peptidase-4 inhibitors (10.6% versus 7.5%), SGLT-2i (10.3% versus 8.1%), GLP-1 RA (3.4% versus 2.4%), and insulin (13.8% versus 9.4%). The MACE effect size was not altered meaningfully by right censoring, but the favorable HR for exenatide became nominally significant in the sulfonylurea and any glucose-lowering medication groups, while the ACM HR and p-values were essentially unchanged. IPTW decreased the MACE HR from 0.91 (P=0.061) to 0.85 (P=0.008) and the ACM HR from 0.86 (P=0.016) to 0.81 (P=0.012). Application of literature-derived risk reductions showed no meaningful changes in MACE or ACM HRs or P values, although simulations of substantially greater use of drop-in cardioprotective glucose-lowering agents demonstrated blunting of signal detection. CONCLUSIONS: EXSCEL-observed HRs for MACE and ACM remained robust after right censoring or application of literature-derived risk reductions, but the exenatide versus placebo MACE effect size and statistical significance were increased by IPTW. Effects of open-label drop-in cardioprotective medications need to be considered carefully when designing, conducting, and analyzing cardiovascular outcome trials of glucose-lowering agents under the premise of glycemic equipoise. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01144338.

3.
Diabetes Res Clin Pract ; 159: 107946, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31778746

RESUMO

Metformin is the most widely used glucose lowering drug worldwide in the treatment of patients with type 2 diabetes, since we have experience with this drug for more than 60 years about the efficacy and safety. Metformin is very effective in HbA1c lowering associated with some weight loss, but does not increase risk for hypoglycemia. At the moment all guidelines in the world recommend to use metformin in monotherapy in patients with newly diagnosed diabetes or in combination with other antidiabetic drugs with documented CV (and renal) benefit in cardiovascular outcome trials (CVOT). Although a randomized placebo controlled CVOT with metformin is lacking, many observational studies in patients with coronary heart disease, heart failure and chronic kidney disease have demonstrated consistent beneficial effects. A recent metanalysis of 26 observational studies including 815 839 patients showed that metformin use was associated with a significantly lower rate of all-cause mortality (HR: 0.74; 95% CI: 0.68-0.81). Whether this very consistent reduction of all-cause mortality is related to the incidence/outcome of several cancers has still to be investigated. In the future early combination therapy of metformin e.g. with SGLT-2 inhibitors should be more often used.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Humanos , Hipoglicemiantes/farmacologia , Metformina/farmacologia , Pessoa de Meia-Idade
4.
Cardiovasc Diabetol ; 18(1): 115, 2019 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-31472683

RESUMO

EMPA-REG OUTCOME is recognised by international guidelines as a landmark study that showed a significant cardioprotective benefit with empagliflozin in patients with type 2 diabetes (T2D) and cardiovascular disease. To assess the impact of empagliflozin in routine clinical practice, the ongoing EMPRISE study is collecting real-world evidence to compare effectiveness, safety and health economic outcomes between empagliflozin and DPP-4 inhibitors. A planned interim analysis of EMPRISE was recently published, confirming a substantial reduction in hospitalisation for heart failure with empagliflozin across a diverse patient population. In this commentary article, we discuss the new data in the context of current evidence and clinical guidelines, as clinicians experienced in managing cardiovascular risk in patients with T2D. We also look forward to what future insights EMPRISE may offer, as evidence is accumulated over the next years to complement the important findings of EMPA-REG OUTCOME.


Assuntos
Compostos Benzidrílicos/uso terapêutico , Doenças Cardiovasculares/terapia , Ensaios Clínicos como Assunto/métodos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Medicina Baseada em Evidências , Glucosídeos/uso terapêutico , Projetos de Pesquisa , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Compostos Benzidrílicos/efeitos adversos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/mortalidade , Tomada de Decisão Clínica , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/mortalidade , Glucosídeos/efeitos adversos , Hospitalização , Humanos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica , Fatores de Proteção , Medição de Risco , Fatores de Risco , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Resultado do Tratamento
5.
Artigo em Inglês | MEDLINE | ID: mdl-31495881

RESUMO

BACKGROUND: Doubling of serum creatinine [equivalent to 57% reduction in estimated glomerular filtration rate (eGFR)] is an established surrogate for end-stage kidney disease (ESKD); however, this endpoint necessitates lengthy follow-up and large sample sizes in clinical trials. We explored whether alternative eGFR decline thresholds provide more feasible surrogate kidney endpoints. METHODS: The study involved post hoc analysis of the EMPA-REG OUTCOME® trial. Adults with type 2 diabetes, high cardiovascular risk and eGFR ≥30 mL/min/1.73 m2 were assigned empagliflozin 10 mg or 25 mg (n = 4687) or placebo (n = 2333), on top of standard of care. We assessed composite endpoints incorporating different eGFR decline thresholds (≥30, ≥40, ≥50 or ≥57%) combined with initiation of renal replacement therapy (RRT) or renal death. This trial is registered with ClinicalTrials.gov (NCT01131676). RESULTS: Empagliflozin versus placebo significantly lowered the risk of decline in eGFR for each threshold listed above, combined with initiation of RRT or renal death, ranging from a hazard ratio (HR) of 0.81 [95% confidence interval (CI) 0.72-0.91] for endpoints based on 30% eGFR decline to an HR of 0.37 (0.23-0.61) for endpoints based on 57% eGFR decline. Lower thresholds (e.g. 30%) were associated with higher event rates but weaker treatment effects. The time to the 95% CI of the HR falling to <1.0 decreased with increasing eGFR threshold. CONCLUSIONS: The composite of 40% decline in eGFR, ESKD or renal death appears to provide reliable results similar to the traditional 57% decline in eGFR.

6.
Obes Surg ; 29(11): 3581-3588, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31240536

RESUMO

BACKGROUND AND OBJECTIVES: Patients with morbid obesity are at an increased risk for cardiovascular and renal complications, which are not only linked to traditional cardiovascular risk factors. Thus, we evaluated (a) the prevalence of albuminuria in non-diabetic and diabetic morbidly obese patients and (b) the effect of weight loss following bariatric surgery. MATERIAL AND METHODS: We included 1307 patients (77% women, mean age 40 ± 12 years, BMI 45.6 ± 6.6 kg/m2) in a cross-sectional study. A subgroup (n = 318) was followed up for 2 years after bariatric surgery. Weight, cardiovascular risk markers and a 75-g glucose tolerance test were determined. Albuminuria was assessed by collecting 24-h urine on three consecutive days. RESULTS: In the cross-sectional study, the prevalence of microalbuminuria was 16.0% (n = 209), of macroalbuminuria 3.1% (n = 41). The chi-square for the association of albuminuria and diabetes was 31.937 (p < 0.001). Of all patients with albuminuria, 42.0% exhibited normal glucose tolerance. In a multivariate regression analysis, systolic blood pressure (beta = 0.236; p < 0.001), log fasting insulin (beta = 0.309; p < 0.001) and log 2-h postprandial insulin (beta = - 0.173; p = 0.033) were predictive risk factors for albuminuria. Longitudinally, albumin excretion decreased significantly from 11.1 (6.4, 18.4 mg/24 h) to 7.8 mg/24 h (4.9, 13.0 mg/24 h; p < 0.001). In the group with albuminuria preoperatively, albumin excretion decreased from 65.7 (38.2, 147.1 mg/24 h) to 13.5 mg/24 h (8.4, 36.8 mg/24 h; p < 0.001). After adjusting for age, sex and baseline albuminuria, patients with lower creatinine clearance showed a smaller decrease of albuminuria (beta = 0.117; p = 0.021). CONCLUSION: A substantial portion of patients with morbid obesity exhibits microalbuminuria, nearly half of those present with normal glucose tolerance. After weight loss, we found a significant decrease of albuminuria, potentially indicating or even contributing to the known reduction of cardiovascular mortality after bariatric surgery.

7.
Obes Facts ; 12(4): 397-406, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31234171

RESUMO

OBJECTIVES: The frequency of postprandial hypoglycaemia after different operative procedures of bariatric surgery (BS) is unknown, although this complication is potentially dangerous. Predictors and severity of hypoglycaemia after Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy, and gastric banding were investigated in a large prospective study. METHODS: This study was performed at an excellence centre for BS at a tertiary care institution. Data of 333 patients (mean BMI: 44.9 ± 9.6 kg/m2; mean age: 40 ± 10 years; 80.7% women) were analysed in a prospective study with a 2-year observation period after BS. All patients underwent a 2-hour oral glucose tolerance test (OGTT) with measurements of blood glucose (BG) and insulin. For the purpose of this study, hypoglycaemia was defined as a post-challenge BG <2.8 mmol/L during the OGTT. RESULTS: 72 (25.6%) of 281 patients showed post-challenge hypoglycaemia after surgery. Hypoglycaemia was different after various procedures: 32.6% of patients after RYGB, 22.6% after sleeve gastrectomy, but only 2.3% after gastric banding had hypoglycaemia. In the whole group, patients with hypoglycaemia had lost more weight (p = 0.013), had a slightly greater decrease in BMI (p = 0.037), a greater change in 2-hour post-challenge BG (p = 0.001), and a smaller change in 1-hour post-challenge insulin (p = 0.004) compared to patients without hypoglycaemia. CONCLUSION: This prospective study shows a higher prevalence of severe hypoglycaemia (25.6%) after BS than anticipated from retrospective registers. A systematic evaluation of glucose and insulin levels by OGTT 2 years post-surgery may help to identify patients at increased risk for symptomatic and asymptomatic hypoglycaemia.


Assuntos
Cirurgia Bariátrica/métodos , Cirurgia Bariátrica/estatística & dados numéricos , Hipoglicemia/epidemiologia , Obesidade Mórbida/epidemiologia , Obesidade Mórbida/cirurgia , Adulto , Cirurgia Bariátrica/efeitos adversos , Glicemia/metabolismo , Feminino , Gastrectomia/efeitos adversos , Gastrectomia/estatística & dados numéricos , Derivação Gástrica/efeitos adversos , Derivação Gástrica/estatística & dados numéricos , Teste de Tolerância a Glucose , Humanos , Hipoglicemia/etiologia , Insulina/sangue , Resistência à Insulina , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/sangue , Prevalência , Estudos Prospectivos
8.
BMC Endocr Disord ; 19(1): 64, 2019 Jun 17.
Artigo em Inglês | MEDLINE | ID: mdl-31208401

RESUMO

BACKGROUND: For patients with type 2 diabetes (T2D), cardiovascular disease (CVD) is the single most common cause of mortality. In 2008 and 2012, the Federal Drug Administration (FDA) and the European Medicines Agency (EMA) respectively mandated cardiovascular outcomes trials (CVOTs) on all new anti-diabetic agents, as prospective trials statistically powered to rule out excess cardiovascular risk in patients with T2D. Unexpectedly, some of these CVOTs have demonstrated not only cardiovascular safety, but also cardioprotective effects, as was first shown for the SGLT2 inhibitor empagliflozin in EMPA-REG OUTCOME. EXPERT OPINION: To debate newly available CVOT data and to put them into context, we convened as a group of medical experts from the Central and Eastern European Region. Here we describe our discussions, focusing on the conclusions we can draw from EMPA-REG OUTCOME and other SGLT2 inhibitor CVOTs, including when considered alongside real-world evidence. CONCLUSION: CVOTs investigating SGLT2 inhibitors have suggested benefits beyond glucose lowering that have been confirmed in real-world evidence studies.


Assuntos
Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Doenças Cardiovasculares/etiologia , Comorbidade , Humanos , Incidência , Prognóstico
9.
Diabetes Res Clin Pract ; 153: 30-40, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31121272

RESUMO

Dipeptidyl peptidase-4 (DPP-4) inhibitors are a class of glucose-lowering agent for type 2 diabetes (T2D) that are commonly used in clinical practice. With the recent disclosure of data from the CARMELINA cardiovascular outcomes trial (CVOT), which investigated linagliptin, CV and renal outcomes data are now available for four agents in the DPP-4 inhibitor class that are approved in most markets. To consider how the CARMELINA study may be interpreted, and the relevance for our clinical practice, we convened as an expert group of diabetes specialists from the Central and Eastern Europe region to discuss the new disclosures. Our discussions revealed a general confidence in safety across the class that is further supported by CARMELINA. However, we also concluded that there are important differences in the available evidence level between agents in the setting of heart failure and data on renal outcomes. Here, we noted the clinical relevance to our practice of the study population in CARMELINA, which is unique among CVOTs in including a majority of patients with chronic kidney disease (CKD). Given the risk for future development of renal impairment that is associated with T2D even in patients without current overt CKD, we believe that the CARMELINA study provides important new insights that are clinically relevant for a broad range of patients. Finally, we discuss how these insights can be integrated into the approach to the pharmacotherapeutic management of hyperglycaemia that is recommended in newly updated guidelines.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Hipoglicemiantes/uso terapêutico , Inibidores da Dipeptidil Peptidase IV/farmacologia , Feminino , Humanos , Hipoglicemiantes/farmacologia , Masculino
10.
Wien Klin Wochenschr ; 131(Suppl 1): 124-135, 2019 May.
Artigo em Alemão | MEDLINE | ID: mdl-30980142

RESUMO

Hypertension is one of the most important comorbidities of diabetes, contributing significantly to death and leads to macrovascular and microvascular complications. When assessing the medical priorities for patients with diabetes, treating hypertension should be a primary consideration. In the present review practical approaches to hypertension in diabetes, including individualized targets for preventing specific complications are discussed according to current studies and guidelines. According to recent studies, blood pressure values of about 130/80 mm Hg are associated with the best outcome. Angiotensin converting enzyme inhibitors and angiotensin receptor blockers are the most effective drugs for treating hypertension in diabetes. Calcium antagonists or diuretics are acceptable as second-line agents. Once the target is achieved, antihypertensive drugs should be continued. Newer antidiabetic medications such as SGLT-2-inhibitors or GLP1-receptor agonists have also antihypertensive effects.


Assuntos
Anti-Hipertensivos/uso terapêutico , Diabetes Mellitus , Hipertensão , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Áustria , Humanos , Hipertensão/tratamento farmacológico , Guias de Prática Clínica como Assunto
11.
Wien Klin Wochenschr ; 131(Suppl 1): 151-163, 2019 May.
Artigo em Alemão | MEDLINE | ID: mdl-30980144

RESUMO

Recent epidemiological investigations have shown that approximately 2-3% of all Austrians suffer from diabetes with renal involvement, i. e. 250,000 people in Austria are affected. The risk of occurrence and progression of this disease can be ameliorated by life style interventions as well as optimization of blood pressure, blood glucose levels and special drug classes. The present article represents the joint recommendations of the Austrian Diabetes Association and the Austrian Society for Nephrology for the diagnostics and treatment strategies of diabetic kidney disease.


Assuntos
Nefropatias Diabéticas , Dietoterapia/normas , Terapia por Exercício/normas , Guias de Prática Clínica como Assunto , Áustria , Pressão Sanguínea , Nefropatias Diabéticas/diagnóstico , Nefropatias Diabéticas/terapia , Humanos , Estilo de Vida , Comportamento de Redução do Risco , Resultado do Tratamento
14.
Wien Klin Wochenschr ; 131(Suppl 1): 27-38, 2019 May.
Artigo em Alemão | MEDLINE | ID: mdl-30980148

RESUMO

Hyperglycemia significantly contributes to complications in patients with diabetes mellitus. While lifestyle interventions remain cornerstones of disease prevention and treatment, most patients with type 2 diabetes will eventually require pharmacotherapy for glycemic control. The definition of individual targets regarding optimal therapeutic efficacy and safety as well as cardiovascular effects is of great importance. In this guideline we present the most current evidence-based best clinical practice data for healthcare professionals.


Assuntos
Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2 , Hipoglicemiantes/uso terapêutico , Guias de Prática Clínica como Assunto , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/tratamento farmacológico , Humanos , Hiperglicemia/tratamento farmacológico , Estilo de Vida
16.
Cardiovasc Diabetol ; 17(1): 145, 2018 11 21.
Artigo em Inglês | MEDLINE | ID: mdl-30463621

RESUMO

Cardiovascular disease (CVD) is the most significant prognostic factor in individuals with type 2 diabetes (T2D). However, a significant number of individuals may develop CVD that does not present with the classic angina-related or heart failure symptoms. In these cases, CVD may seem to be 'silent' or 'asymptomatic', but may be more accurately characterised as unrecognised diabetic cardiac impairment. An initial step to raise awareness of unrecognised CVD in individuals with T2D would be to reach a consensus regarding the terminology used to describe this phenomenon. By standardising the terminologies, and agreeing on the implementation of an efficient screening program, it is anticipated that patients will receive an earlier diagnosis and appropriate and timely treatment. Given the availability of anti-diabetic medications that have been shown to concomitantly reduce CV risk and mortality, it is imperative to improve early identification and initiate treatment as soon as possible in order to enable as many patients with T2D as possible to benefit.


Assuntos
Doenças Cardiovasculares/terapia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Doenças Assintomáticas , Biomarcadores/sangue , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/mortalidade , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/mortalidade , Diagnóstico Precoce , Humanos , Programas de Rastreamento , Valor Preditivo dos Testes , Prognóstico , Medição de Risco , Fatores de Risco
17.
Diabetologia ; 61(7): 1503-1516, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29417185

RESUMO

Owing to the worldwide increase in life expectancy, the high incidence of diabetes in older individuals and the improved survival of people with diabetes, about one-third of all individuals with diabetes are now older than 65 years. Evidence is accumulating that type 2 diabetes is associated with cognitive impairment, dementia and frailty. Older people with diabetes have significantly more comorbidities, such as myocardial infarction, stroke, peripheral arterial disease and renal impairment, compared with those without diabetes. However, as a consequence of the increased use of multifactorial risk factor intervention, a considerable number of older individuals can now survive for many years without any vascular complications. Given the heterogeneity of older individuals with type 2 diabetes, an individualised approach is warranted, which must take into account the health status, presence or absence of complications, and life expectancy. In doing so, undertreatment of otherwise healthy older individuals and overtreatment of those who are frail may be avoided. Specifically, overtreatment of hyperglycaemia in older patients is potentially harmful; in particular, insulin and sulfonylureas should be avoided or, if necessary, used with caution. Instead, glucose-dependent drugs that do not induce hypoglycaemia are preferable since older patients with diabetes and impaired kidney function are especially vulnerable to this adverse event.


Assuntos
Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Assistência Centrada no Paciente , Fatores Etários , Idoso , Biomarcadores/sangue , Glicemia/metabolismo , Tomada de Decisão Clínica , Comorbidade , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Nível de Saúde , Humanos , Hiperglicemia/sangue , Hiperglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Masculino , Pessoa de Meia-Idade , Polimedicação , Fatores de Risco , Resultado do Tratamento
18.
Endocrinol Diabetes Metab ; 1(2): e00016, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30815552

RESUMO

Aims: To analyse the effect of baseline glycated haemoglobin (HbA1c) on the reduction in HbA1c with empagliflozin compared with sitagliptin or glimepiride in patients with type 2 diabetes. Materials and methods: Using regression analyses of individual patient data from two Phase III studies, we compared the change in HbA1c according to a unit change in baseline HbA1c (the slope) with empagliflozin 10 mg or 25 mg vs sitagliptin (monotherapy) after 24 weeks, and with empagliflozin 25 mg vs glimepiride (as add-on to metformin) after 52 weeks. Results: Steeper slopes of HbA1c decline were observed with empagliflozin 10 or 25 mg vs sitagliptin monotherapy at week 24. Regression analysis showed slopes of -0.59 (95% CI -0.70, -0.47), -0.49 (95% CI -0.62, -0.37) and -0.29 (95% CI -0.42, -0.15) for empagliflozin 10 mg, empagliflozin 25 mg and sitagliptin, respectively (P < .001 and P < .05 for empagliflozin 10 mg and empagliflozin 25 mg, respectively, vs sitagliptin). Similarly, a steeper slope of HbA1c decline was observed with empagliflozin 25 mg vs glimepiride as add-on to metformin at week 52. Regression analysis showed slopes of - 0.52 (95% CI -0.59, -0.44) and -0.32 (95% CI -0.39, -0.25) for empagliflozin 25 mg and glimepiride, respectively (P < .001 for empagliflozin 25 mg vs glimepiride). Conclusions: Incremental reductions in HbA1c with increasing baseline HbA1c are greater with empagliflozin compared with sitagliptin or glimepiride in patients with type 2 diabetes.

19.
Obes Surg ; 28(3): 643-648, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-28849358

RESUMO

BACKGROUND: Postoperative micronutrient deficiency is a known side effect of bariatric surgery. In this study, we examined the prevalence of micronutrient deficiency in patients with morbid obesity (MO) preoperatively. METHODS: A total of 1732 patients with MO wishing to undergo bariatric surgery (age: 40 ± 12 years, mean BMI: 44 ± 9 kg/m2, means ± SD, 77.3% female) were analyzed in this cross-sectional examination. Iron state, vitamin B12, folic acid, 25hydroxy(OH)-vitamin D, PTH, vitamin A, and vitamin E levels were determined. Subsequently, patients underwent nutritional counseling and were substituted accordingly. RESULTS: A total of 63.2% (n = 1094) of the patients had a deficit in folic acid (< 5.3 ng/ml), 97.5% (n = 1689) in 25OHvitamin D (< 75 nmol/l), and 30.2% (n = 523) had a PTH elevation (> 56.9 pg/ml). A total of 5.1% (n = 88) of the patients presented with a deficit in vitamin B12 (< 188 pg/ml) and 6.2% (n = 107) in vitamin A (< 1.05 µmol/l). A total of 9.6% (n = 166) exhibited iron deficiency (ferritin < 15 µg/l). None of the patients had a deficit in vitamin E. There were no gender differences except for ferritin deficiency (women 11.8% vs. men 1.5%, p < 0.001). Patients in the highest BMI tertile had significantly more often a deficit in vitamin D (p = 0.033) and folic acid (p < 0.001). Patients in the lowest age tertile had significantly more often a deficit in folic acid (p < 0.001). CONCLUSIONS: Our data show a high prevalence of micronutrient deficiency in patients with morbid obesity preoperatively and emphasize the importance of exact preoperative evaluation and adequate substitution as well as postoperative surveillance.


Assuntos
Deficiências Nutricionais/complicações , Deficiências Nutricionais/epidemiologia , Micronutrientes/deficiência , Obesidade Mórbida/complicações , Obesidade Mórbida/epidemiologia , Adulto , Áustria/epidemiologia , Cirurgia Bariátrica , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/cirurgia , Período Pré-Operatório , Prevalência , Adulto Jovem
20.
Ther Clin Risk Manag ; 13: 1569-1576, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29276388

RESUMO

Type 2 diabetes (T2D) imposes a substantial disease burden, predominantly from cardiovascular disease (CVD), which accounts for >50% of deaths in this population and leads to a 12-year reduction in the life expectancy of a 60-year-old male patient with T2D and CVD compared with the general population. The results from mandatory cardiovascular outcome trials (CVOTs) are therefore of great interest in the field. The Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes meeting program aims to bring together experts from several associated disciplines to provide fair and balanced resources for those involved in the management of patients with T2D. This publication represents the opinions of the faculty on the key learnings from the meeting held in Vienna in the spring of 2017. In particular, we detail how data from the EMPA-REG OUTCOME® [cardiovascular outcomes trial of empagliflozin] and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER®) (liraglutide) CVOTs can be practically interpreted across clinical specialities. It is hoped that this translation of CVOT data will achieve a dual treatment paradigm for the management of both raised glucose levels and CV risk in patients with T2D.

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