Achievement of recommended glucose and blood pressure targets in patients with type 2 diabetes and hypertension in clinical practice -- study rationale and protocol of DIALOGUE

Abstract

BackgroundPatients with type 2 diabetes have 2–4 times greater risk for cardiovascular morbidity and mortality than those without, and this is even further aggravated if they also suffer from hypertension. Unfortunately, less than one third of hypertensive diabetic patients meet blood pressure targets, and more than half fail to achieve target HbA1c values. Thus, appropriate blood pressure and glucose control are of utmost importance. Since treatment sometimes fails in clinical practice while clinical trials generally suggest good efficacy, data from daily clinical practice, especially with regard to the use of newly developed anti-diabetic and anti-hypertensive compounds in unselected patient populations, are essential. The DIALOGUE registry aims to close this important gap by evaluating different treatment approaches in hypertensive type 2 diabetic patients with respect to their effectiveness and tolerability and their impact on outcomes. In addition, DIALOGUE is the first registry to determine treatment success based on the new individualized treatment targets recommended by the ADA and the EASD.MethodsDIALOGUE is a prospective observational German multicentre registry and will enrol 10,000 patients with both diabetes and hypertension in up to 700 sites. After a baseline visit, further documentations are scheduled at 6, 12 and 24 months. There are two co-primary objectives referring to the most recent guidelines for the treatment of diabetes and hypertension: 1) individual HbA1c goal achievement with respect to anti-diabetic pharmacotherapy and 2) individual blood pressure goal achievement with different antihypertensive treatments. Among the secondary objectives the rate of major cardio-vascular and cerebro-vascular events (MACCE) and the rate of hospitalizations are the most important.ConclusionThe registry will be able to gain insights into the reasons for the obvious gap between the demonstrated efficacy and safety of anti-diabetic and anti-hypertensive drugs in clinical trials and their real world balance of effectiveness and safety.

Individualised treatment targets in patients with type-2 diabetes and hypertension

“…Diabetologists and primary care physicians were responsible for patient enrolment at centres selected in order to provide a representation of ambulatory care for patients with comorbid diabetes and hypertension. The study protocol, as well as primary and secondary objectives of DIALOGUE, have been previously published in detail [ 11 , 12 ]. DIALOGUE was registered in the database of the Verband forschender Arzneimittelhersteller ( http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb ).…”

“…The DIALOGUE registry was established in order to evaluate differences in treatment strategies for patients with T2DM and comorbid hypertension, and to elucidate what factors influence the setting of individual targets in clinical practice [ 11 ]. In previous registry analysis, it was found that patients who had been set stricter target HbA1c levels were younger and less comorbid, while those with more lenient targets had a longer diabetes duration and were more likely to have heart failure (HF), peripheral artery disease (PAD), or neuropathy [ 12 ].…”

Blood pressure elevation in patients assisted in an emergency unit: cross-sectional study

“…Ainda na presente pesquisa, observou--se que a comorbidade mais comumente encontrada foi o DM. A literatura aponta que a prevalência de hipertensos com DM é pelo menos duas vezes maior do que na população em geral e que devido às complicações agudas e crônicas as chances de o indivíduo sofrer com problemas cardiovasculares se elevam (16) . Outro agravante observado é que ocorre uma maior propensão do hipertenso ter dificuldade para aderir ao tratamento, pois aumenta o número de medicamentos prescritos e os cuidados com a dieta (17) .…”

A higher TyG index level is more likely to have enhanced incidence of T2DM and HTN comorbidity in elderly Chinese people: a prospective observational study from the reaction study

“…The number of diabetic patients in China currently ranks first in the world according to the diabetes atlas of the International Diabetes Federation [ 2 ]. DM is a well-known risk factor for any form of cardiovascular disease (CVD) [ 3 ] and the risk for CVD of subjects with type 2 diabetes (T2DM) is 2 ~ fourfold higher than those without [ 4 ]. Hypertension (HTN) is prevailing in the complications of diabetes [ 5 ] and constitutes a critical challenge to the health burden as it elevates the prevalence of CVD, and this is even further aggravated if patients with concomitant T2DM [ 6 ].…”