gms | German Medical Science

28. Wissenschaftlicher Kongress der Deutschen Hochdruckliga

24. bis 27.11.2004, Hannover

Study on the Evaluation of Candesartan cilexetil after Renal Transplantation (SECRET-Study).

Effekt von Candesartan Cilexetil auf Nierenfunktion und kardiovaskuläre Morbidität nach Nierentransplantation

Meeting Abstract (Hypertonie 2004)

  • T. Philipp - Universitätsklinikum Essen (Essen, D)
  • C. Legendre - Universitätsklinikum Essen (Essen, D; Paris, F)
  • H. Geiger - Universitätsklinikum Frankfurt (Frankfurt, D)
  • F. Girat - Universitätsklinikum Frankfurt (Frankfurt, D)
  • R. Hübner - Universitätsklinikum Aachen (Aachen, D)
  • R. Lievre - (Lyon, D)
  • S. Nisse-Durgat - (Lyon, F)
  • R.E. Schmieder - Universitätsklinikum Erlangen (Erlangen, D)

Hypertonie 2004. 28. Wissenschaftlicher Kongress der Deutschen Hochdruckliga. Hannover, 24.-27.11.2004. Düsseldorf, Köln: German Medical Science; 2005. Doc04hochP126

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/hoch2004/04hoch126.shtml

Veröffentlicht: 10. August 2005

© 2005 Philipp et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Chronic allograft nephropathy and cardiovascular (CV) complications limit the long-term success of renal transplantation (RT). Animal experiments have shown that AR-B can lower the rate of graft failure (GF). Moreover it has been suggested that AR-B might lower CV mortality as well.

We therefore designed a controlled trial (SECRET) in pts. following RT to evaluate whether the AR-B candesartan(CC) (4 - 16mg/day) vs. placebo (PL) can reduce GF(exp.5%/y) and CV morbidity (exp.3%/y). 700 pts. were to be included who were to be followed up for 3 years. During that time we expected to observe the primary endpoints GF and CV morbidity in more than 150 pts..

Results: Following an interim analysis after 18 months, the study was discontinued since the observed event rate (26 primary endpoints) was only 25 % of what had been expected. At that

time data of 502 pts. with a median follow-up of 23 month were available (11500 pts.months).

CV morbidity and mortality (CC 9 pts., PL 8 pts.), GF (CC 1 pt., PL 6 pts.),Creatinine doubling (CC 7 pts., PL 4 pts.) did not differ between both groups. Median proteinuria was (p< 0.0001) decreased by CC (-29.2%) compared to PL (+13.8%).

Although all concomitant antihypertensive drugs (except ACE-inhibitors) were allowed in order to lower blood pressure (BP) below 135/80 mmHg BP was lowered more markedly in the CC group from 137.9/84.4 to 131.2/79.6 mmHg (p<0.001) compared to PL (137.8/84.6 to 137.2/83.4 mmHg).

Early treatment discontinuation was more often observed (p<0.001) in the PL group esp. due to lack of antihypertensive efficacy (CC 2 pts., PL 17 pts.) and due to consent withdrawal (CC 9 pts., PL 19 pts.).

Summary: The study failed to show the superiority of the CC in lowering GF and CV morbidity in RT pts.. This may be due to the excellent BP control in both groups. However, treatment with CC in these pts. was more effective in lowering BP and in reducing proteinuria, which can be an early sign of chronic allograft nephropathy.