title: 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: BACKGROUND
  Patients 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.
  
  
  METHODS
  DIALOGUE 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Stiftung Institut für Herzinfarktforschung Ludwigshafen, Bremser Strasse 79, 67063, Ludwigshafen, Germany. gitta@klilu.de
authors.forename: Anselm K
authors.initials: AK
authors.lastname: Gitt
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
authors.forename: Eva
authors.initials: E
authors.lastname: Duetting
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
authors.forename: Steffen
authors.initials: S
authors.lastname: Schneider
authors.forename: Diethelm
authors.initials: D
authors.lastname: Tschöpe
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D001794:Blood Pressure / Q000187:drug effects*; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control; D002561:Cerebrovascular Disorders / Q000453:epidemiology / Q000517:prevention & control; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D005858:Germany / Q000453:epidemiology; D006442:Glycated Hemoglobin / Q000378:metabolism; D019983:Guideline Adherence; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human