title: Effect of the moderate consumption of olestra in patients receiving long-term warfarin therapy.
abstract: We conducted a prospective, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of the moderate consumption of snacks containing olestra on the international normalized ratio (INR) in 40 patients receiving long-term warfarin therapy. Patients continued their warfarin regimen and were assigned to receive 1.5 servings/day (42 g) for 2 weeks of Pringles Original Flavor Fat Free Potato Crisps with Olean (12 g olestra/1.5 servings) or Pringles Original Flavor Potato Crisps (placebo group). Patients' INRs were measured weekly for 2 weeks. Thirty-six patients completed the first week of the trial. After 1 week, the mean change in the INR from baseline increased by 0.02 +/- 0.5 in the olestra group and by 0.17 +/-0.4 in the placebo group (p= 0.327). Ten patients in the olestra group and 12 in the placebo group completed the second week of the study. Mean change in the INR from baseline was similar at week 2, -0.18 +/- 0.38 and 0.09 +/- 0.53 (p=0.193), respectively. Gastrointestinal side effects (diarrhea, gas, bloating) occurred in three patients in the olestra group and five in the placebo group (p=0.3). Moderate consumption of snacks containing olestra did not significantly affect the INR (> 0.3 U) at 1 week in patients receiving long-term anticoagulation with warfarin. It does not appear that moderate consumption of these snacks would affect the INR after 2 weeks, but this must be confirmed in a larger sample with adequate power at 2 weeks.
authors.affiliation: Department of Clinical Pharmacy, University of Florida College of Pharmacy, West Palm Beach 33410, USA.
authors.forename: N P
authors.initials: NP
authors.lastname: Beckey
authors.forename: L B
authors.initials: LB
authors.lastname: Korman
authors.forename: D
authors.initials: D
authors.lastname: Parra
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D004311:Double-Blind Method; D004347:Drug Interactions; D019358:Fat Substitutes / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*; D005227:Fatty Acids / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D010919:Placebos; D013395:Sucrose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D013997:Time Factors; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D019358:Fat Substitutes; D005227:Fatty Acids; D010919:Placebos; D013395:Sucrose; D014859:Warfarin; C013692:sucrose polyester