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Am J Respir Crit Care Med. 2010 May 15;181(10):1106-13. doi: 10.1164/rccm.2009111-699OC.

Simvastatin as a treatment for pulmonary hypertension trial.

Author information

1
Experimental Medicine, Imperial College London, Hammersmith Hospital, Du Cane Road, London, United Kingdom. m.wilkins@imperial.ac.uk

Abstract

RATIONALE:

In animal models of pulmonary hypertension, simvastatin has been shown to reduce pulmonary artery pressure and induce regression of associated right ventricular (RV) hypertrophy.

OBJECTIVES:

To assess the therapeutic value of simvastatin in patients with pulmonary arterial hypertension (PAH).

METHODS:

Forty-two patients with PAH were randomized to receive either simvastatin (80 mg/d) or placebo in addition to current care for 6 months, and thereafter offered open-label simvastatin. The primary outcome was change in RV mass, assessed by cardiac magnetic resonance (CMR).

MEASUREMENTS AND MAIN RESULTS:

At 6 months, RV mass decreased by 5.2 +/- 11 g in the statin group (P = 0.045) and increased 3.9 +/- 14 g in the placebo group. The treatment effect was -9.1 g (P = 0.028). N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels decreased significantly in the statin group (-75 +/- 167 fmol/ml; P = 0.02) but not the placebo group (49 +/- 224 fmol/ml; P = 0.43; overall treatment effect -124 fmol/ml; P = 0.041). There were no significant changes in other outcome measures (including 6-minute walk test, cardiac index, and circulating cytokines). From 6 to 12 months, both RV mass and NT-proBNP increased toward baseline values in 16 patients on active treatment who continued with simvastatin but remained stable in 18 patients who switched from placebo to simvastatin. Two patients required a reduction in dose but not cessation of simvastatin.

CONCLUSIONS:

Simvastatin added to conventional therapy produces a small and transient early reduction in RV mass and NT-proBNP levels in patients with PAH, but this is not sustained over 12 months.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00180713.

PMID:
20460548
PMCID:
PMC2874452
DOI:
10.1164/rccm.200911-1699OC
[Indexed for MEDLINE]
Free PMC Article

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