Original InvestigationDialysisThyroid Function, Cardiovascular Events, and Mortality in Diabetic Hemodialysis Patients
Section snippets
Study Design and Participants
The study protocol and methodology of 4D (registered at the German medical authority [BfArM], registration no. 401 3206) have been reported previously in detail.27 Briefly, 4D was a prospective randomized controlled trial investigating atorvastatin in 1,255 patients with type 2 diabetes mellitus, aged 18-80 years, and undergoing hemodialysis for less than 2 years. Between March 1998 and October 2002, patients were recruited in 178 dialysis centers in Germany. At each follow-up visit and until
Patient Characteristics and Prevalence of Thyroid Dysfunction
Of 1,255 patients included in 4D, 255 had to be excluded due to incomplete or implausible thyroid test results or the use of amiodarone, thyrostatic agents, or glucocorticoids (equivalent to prednisone ≥ 10 mg/d). A flow chart showing the respective numbers of patients with reasons for exclusion is provided in Fig 1. Regarding the concomitant medication for diabetes mellitus in the final study population (n = 1,000), 186 patients did not take diabetes medication, 633 patients received insulin, 124
Discussion
This prospective follow-up study in 1,000 well-characterized diabetic hemodialysis patients analyzes the impact of subclinical thyroid dysfunction on cardiac death. We found a borderline effect in risk of sudden cardiac death in patients with subclinical hyperthyroidism. However, we could not find a significant association between subclinical thyroid dysfunction and MI, stroke, and all-cause mortality. Further, we confirm earlier data of increased mortality in hemodialysis patients with
Acknowledgements
We thank all patients who participated in 4D; all investigators, study nurses, and collaborators involved in patient recruitment and sample and data handling; the laboratory staffs at the Universities of Freiburg, Würzburg, and Graz; and Katja Blouin, Sonja Steinhauer, and Paul Pömpel for support in laboratory work.
Support: Dr Drechsler is grateful to the Medical Faculty of the University of Würzburg for the support with a research fellowship. This work has also been supported by grants from
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