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Journal of Toxicology
Volume 2013, Article ID 463595, 5 pages
http://dx.doi.org/10.1155/2013/463595
Clinical Study

Analysis of Safety from a Human Clinical Trial with Pterostilbene

1Department of Pharmacy Practice, The University of Mississippi School of Pharmacy, 2500 North State Street, Jackson, MS 39216, USA
2Department of Medicine, The University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216, USA
3Department of Pharmacy, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA
4Department of Pharmacy, St. Dominic Hospital, 969 Lakeland Drive, Jackson, MS 39216, USA

Received 14 December 2012; Accepted 5 January 2013

Academic Editor: Lucio Guido Costa

Copyright © 2013 Daniel M. Riche et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objectives. The purpose of this trial was to evaluate the safety of long-term pterostilbene administration in humans. Methodology. The trial was a prospective, randomized, double-blind placebo-controlled intervention trial enrolling patients with hypercholesterolemia (defined as a baseline total cholesterol ≥200 mg/dL and/or baseline low-density lipoprotein cholesterol ≥100 mg/dL). Eighty subjects were divided equally into one of four groups: (1) pterostilbene 125 mg twice daily, (2) pterostilbene 50 mg twice daily, (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily, and (4) matching placebo twice daily for 6–8 weeks. Safety markers included biochemical and subjective measures. Linear mixed models were used to estimate primary safety measure treatment effects. Results. The majority of patients completed the trial (91.3%). The average age was 54 years. The majority of patients were females (71%) and Caucasians (70%). There were no adverse drug reactions (ADRs) on hepatic, renal, or glucose markers based on biochemical analysis. There were no statistically significant self-reported or major ADRs. Conclusion. Pterostilbene is generally safe for use in humans up to 250 mg/day.