Journal article

Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study

Pablo A Urena-Torres, Juergen Floege, Carmel M Hawley, Eugenie Pedagogos, William G Goodman, Frank Petavy, Maureen Reiner, Paolo Raggi

Nephrology, Dialysis, Transplantation | OXFORD UNIV PRESS | Published : 2013


BACKGROUND: The ADVANCE study assessed the progression of vascular and cardiac valve calcification in 360 hemodialysis patients with secondary hyperparathyroidism (sHPT) assigned randomly to treatment either with cinacalcet plus low-dose vitamin D (≤ 6 µg/week of intravenous paricalcitol equivalent) or with varying doses of vitamin D alone for 52 weeks. The primary efficacy endpoint was progression of coronary artery calcification (CAC). METHODS: In this post-hoc analysis, we compared CAC progression among 70 protocol-adherent subjects given cinacalcet and low doses of vitamin D (CPA) as specified in the study protocol and 120 control subjects given vitamin D sterols. RESULTS: Baseline patie..

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Funding Acknowledgements

These data have not been published previously, except in abstract form at the American Society of Nephrology Kidney Week 2010 and the Australia and New Zealand Society of Nephrology Annual Scientific Meeting 2011. The ADVANCE study was sponsored by Amgen, Inc. Medical writing assistance was provided by Roger Nutter of Bioscript Stirling, with funding from Amgen (Europe) GmbH, and editorial assistance by Caterina Hatzifoti and Lucy Hyatt, both of Amgen (Europe) GmbH.P.U.T. has received fees for clinical research, speaking and expert consultancy from Amgen, Shire, Novartis, Roche, Fresenius and Hemotech. J.F. has received consultancy and lecture fees from Amgen and lecture fees from Abbott, Genzyme, Shire and Fresenius. C.H. has received travel and research grants from Amgen. E.P. has nothing to declare. W.G.G. and M.R. are employees and stockholders in Amgen. F.P. has worked on behalf of Amgen. P.R. has received research grants from Amgen and Genzyme.