Document Detail

Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized controlled trial.
MedLine Citation:
PMID:  22337679     Owner:  NLM     Status:  MEDLINE    
CONTEXT: Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking.
OBJECTIVE: To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m(2).
DESIGN, SETTING, AND PARTICIPANTS: Multinational, double-blind, randomized placebo-controlled trial among 227 patients with chronic kidney disease, mild to moderate left ventricular hypertrophy, and preserved left ventricular ejection fraction, conducted in 11 countries from July 2008 through September 2010.
INTERVENTION: Participants were randomly assigned to receive oral paricalcitol, 2 μg/d (n =115), or matching placebo (n = 112).
MAIN OUTCOME MEASURES: Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging. Secondary end points included echocardiographic changes in left ventricular diastolic function.
RESULTS: Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration. At 48 weeks, the change in left ventricular mass index did not differ between treatment groups (paricalcitol group, 0.34 g/m(2.7) [95% CI, -0.14 to 0.83 g/m(2.7)] vs placebo group, -0.07 g/m(2.7) [95% CI, -0.55 to 0.42 g/m(2.7)]). Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity (paricalcitol group, -0.01 cm/s [95% CI, -0.63 to 0.60 cm/s] vs placebo group, -0.30 cm/s [95% CI, -0.93 to 0.34 cm/s]) also did not differ. Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group.
CONCLUSION: Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease.
TRIAL REGISTRATION: Identifier: NCT00497146.
Ravi Thadhani; Evan Appelbaum; Yili Pritchett; Yuchiao Chang; Julia Wenger; Hector Tamez; Ishir Bhan; Rajiv Agarwal; Carmine Zoccali; Christoph Wanner; Donald Lloyd-Jones; Jorge Cannata; B Taylor Thompson; Dennis Andress; Wuyan Zhang; David Packham; Bhupinder Singh; Daniel Zehnder; Amil Shah; Ajay Pachika; Warren J Manning; Scott D Solomon
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  307     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-02-16     Completed Date:  2012-02-16     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  674-84     Citation Subset:  AIM; IM    
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MeSH Terms
Chronic Disease
Double-Blind Method
Ergocalciferols / pharmacology,  therapeutic use*
Glomerular Filtration Rate
Hypercalcemia / chemically induced
Hyperparathyroidism, Secondary / drug therapy
Hypertrophy, Left Ventricular / drug therapy*,  etiology
Kidney Diseases / complications*
Middle Aged
Parathyroid Hormone / blood
Treatment Outcome
Ventricular Function, Left / drug effects*
Vitamin D Deficiency / complications,  drug therapy*,  etiology
Vitamins / pharmacology,  therapeutic use*
Grant Support
PG/11/66/28982//British Heart Foundation
Reg. No./Substance:
0/Ergocalciferols; 0/Parathyroid Hormone; 0/Vitamins; 131918-61-1/paricalcitol
Comment In:
JAMA. 2012 Jun 6;307(21):2253; author reply 2254   [PMID:  22706819 ]
JAMA. 2012 Feb 15;307(7):722-3   [PMID:  22337683 ]
Int J Cardiol. 2013 Sep 1;167(5):2343-4   [PMID:  23176772 ]
JAMA. 2012 Jun 6;307(21):2253; author reply 2254   [PMID:  22706820 ]

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