Abstract 12868: Morphine Decreases Ticagrelor Concentrations but Not Its Effects: A Randomized, Double-Blind, Placebo-Controlled Trial

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Eva-Luise Hobl ◽  
Birgit Reiter ◽  
Thomas Stimpfl ◽  
Christian Schoergenhofer ◽  
Michael Schwameis ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Active Metabolite ◽  
Drug Exposure ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Area Under The Curve ◽  
Blood Platelet ◽  
Loading Dose ◽  
Double Blind ◽  
Double Blind Placebo

Introduction: Our recent drug interaction trial with clopidogrel showed that morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in susceptible individuals. This study examined possible drug-drug interactions between ticagrelor and morphine. Hypothesis: We hypothesized that the pharmacodynamic consequences of drug-drug interactions would be less between morphine and ticagrelor. Methods: Twenty-four healthy subjects received a loading dose of 180mg ticagrelor together with placebo or 5mg morphine intravenously in a randomized, double-blind, placebo-controlled, cross-over trial. Pharmacokinetics were determined by liquid chromatography tandem mass spectrometry, and ticagrelor effects were measured by platelet function tests. Results: Concomitant i.v. injection of morphine slows drug resorption of ticagrelor and its active metabolite (p<0.05) by one hour and decreases plasma levels of ticagrelor and its active metabolite (by 25-31%; p < 0.03) and the drug exposure (area under the curve by 22-23%; p < 0.01). Importantly, however, the effects of ticagrelor on platelet aggregation in whole blood, platelet plug formation, and vasodilator-stimulated phosphoprotein (VASP) phosphorylation are not affected by morphine. Conclusions: Morphine co-administration moderately decreases ticagrelor plasma concentrations but does not inhibit ist effects. Therefore, a 180 mg loading dose of ticagrelor appears to provide consistent and reliable platelet inhibition when morphine has to be given for pain relief.

scholarly journals Ergothioneine supplementation in people with metabolic syndrome (ErgMS): protocol for a randomised, double-blind, placebo-controlled pilot study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Xiaoying Tian ◽  
Giorgia Cioccoloni ◽  
Joanna H. Sier ◽  
Khalid M. Naseem ◽  
James L. Thorne ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Benefits ◽  
Blood Platelet ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Study Results ◽  
Randomised Controlled

Abstract Background Ergothioneine is a naturally occurring metabolite of histidine found in many foods and in high amounts in mushrooms. In vivo, ergothioneine acts as an antioxidant and is widely distributed in most mammalian tissues. While ergothioneine is sold as a dietary supplement for its antioxidant and anti-inflammatory properties, to date there are no published intervention trials examining its health benefits in humans. The aim of this work was to develop a study protocol for a pilot interventional trial that will establish the primary and secondary outcomes, and the power required, for a definitive randomised controlled trial to test the hypothesis that ergothioneine supplementation is beneficial for people with metabolic syndrome. Methods We have designed the ErgMS study as a single-centre, randomised, double-blind, placebo-controlled, 3-arm parallel, pilot intervention trial, which aims to supplement participants with either placebo, 5 or 30 mg/day ergothioneine for 12 weeks. Measurements of metabolic syndrome risk factors, serum markers of oxidative stress (lipid peroxidation), inflammation, blood platelet function and liver function will take place at baseline, and after 6 weeks and 12 weeks of supplementation. In addition, we will examine if there are any changes in the serum metabolome in response to ergothioneine supplementation. Linear regression and two-way ANOVA will be utilised to analyse the association between ergothioneine and measured variables. Discussion The ErgMS study will be the first study to address the question does ergothioneine supplementation have health benefits for people with metabolic syndrome. Study results will provide preliminary data as to which dose may improve inflammatory markers in adults with metabolic syndrome and will inform dose and primary outcome selection for a definitive randomised controlled trial. Trial registration ISRCTN, ISRCTN25890011 Registered February 10th, 2021

scholarly journals Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial

2017 ◽  
Vol 45 (2) ◽  
pp. 647-661 ◽  
Author(s):  
Pamela M. Lai ◽  
Agron Collaku ◽  
Kenneth Reed
Keyword(s):  
Ankle Sprain ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Complete Recovery ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Application Site ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Adolescents And Adults

Purpose This study was performed to evaluate topical 1% diclofenac/3% menthol gel in treating ankle sprain. Design In this randomized, double-blind, placebo-controlled trial, adolescents and adults with acute ankle sprain (N = 385) applied 4 g of gel containing 1% diclofenac/3% menthol (n = 117), 1% diclofenac (n = 112), 3% menthol (n = 77), or placebo (n = 75) four times daily. The primary outcome was the area under the curve of pain intensity (PI) on movement [0 (no pain) to 10 (extreme pain)] from 24 to 72 hours post-application (AUC1–3 days). Secondary outcomes included pain relief (PR); PI; time to onset of PR, meaningful PR, cooling, and complete recovery; PI difference; sum of PI difference; total PR; reduction in ankle swelling; and the patient’s global assessment of response to treatment. Results There were no statistically significant differences in AUC1–3 between 1% diclofenac/3% menthol and placebo, diclofenac, or menthol gels and no meaningful advantages of 1% diclofenac/3% menthol for any secondary outcome. There was a higher incidence of skin and application-site events with 1% diclofenac/3% menthol than with placebo or 1% diclofenac. Conclusion No significant improvement was observed with topical 1% diclofenac/3% menthol gel compared with placebo, 1% diclofenac, or 3% menthol gel in treating pain from ankle sprain. ClinicalTrials.Gov Identifier: NCT02100670

Clinical efficacy of specific immunotherapy to cat dander: a double-blind placebo-controlled trial

1997 ◽  
Vol 27 (8) ◽  
pp. 860-867 ◽  
Author(s):  
V.A. VARNEY ◽  
J. EDWARDS ◽  
K. TABBAH ◽  
H. BREWSTER ◽  
G. MAVROLEON ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Specific Immunotherapy ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

A randomized double blind, placebo controlled trial of a Chinese herbal preparation (CH100) in chronic Hepatitis C

2001 ◽  
Vol 120 (5) ◽  
pp. A384-A384
Author(s):  
L MOLLISON ◽  
L TOTTEN ◽  
C HOVELL ◽  
K THAYNE ◽  
C CONNELLY ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Controlled Trial ◽  
Herbal Preparation ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Chinese Herbal

40: Oral Ketoconazole for Prevention of Postoperative Penile Erection, a Prospective, Randomized, Double Blind, Placebo Controlled Trial

2007 ◽  
Vol 177 (4S) ◽  
pp. 14-15
Author(s):  
Brian J. DeCastro ◽  
Jack R. Walter ◽  
Leah P. McMann ◽  
Andrew C. Peterson
Keyword(s):  
Penile Erection ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

Effects of Mixed Dietary Supplements on Total Plasma Homocysteine Concentrations (tHcy): A Randomized, Double-Blind, Placebo-Controlled Trial

2012 ◽  
Vol 82 (4) ◽  
pp. 260-266 ◽  
Author(s):  
Salah E. Gariballa ◽  
Sarah J. Forster ◽  
Hilary J. Powers
Keyword(s):  
Older Patients ◽  
Controlled Trial ◽  
Plasma Homocysteine ◽  
Acute Illness ◽  
Vitamin B ◽  
Total Plasma ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nutrient Supplement ◽  
Plasma Thcy

Background: Although a number of studies have reported raised total plasma homocysteine (tHcy) concentrations in free-living older people, there are no data on homocysteine response to a mixed nutrient supplement in older patients. A raised plasma homocysteine concentration in older patients is partly a reflection of their co-morbidity, including impaired renal function, and there is uncertainty about the extent to which dietary interventions can improve plasma tHcy. Aim: To determine the plasma tHcy response to dietary supplements during acute illness. Methods: Two-hundred and thirty-six hospitalized, acutely ill older patients, who were part of a randomized double-blind placebo-controlled trial, were assigned to receive a daily oral nutritional supplement drink containing 1.3 mg of vitamin B2, 1.4 mg of vitamin B6, 1.5 μg of B12, 200 μg of folic acid, or a placebo, for 6 weeks. Outcome measures were plasma tHcy concentration at baseline, 6 weeks, and 6 months. Results: The mean plasma tHcy concentration fell among patients given the supplements (mean difference 4.1 µmol/L [95 % C.I, 0.14 to 8.03), p = 0.043], but tHcy concentration increased between 6 weeks and 6 months, after patients stopped taking the supplements [mean difference -2.0 µmol/L (95 % C.I, -03.9 to -0.18), p = 0.033]. About 46 % of patients in the placebo group and 55 % of patients in the supplement group had hyperhomocysteinemia (>14 µmol/L) at baseline compared with 45 % and 29 % at the end of the treatment period. Conclusions: A mixed nutrient supplement containing physiological amounts of B vitamins significantly reduced plasma tHcy concentrations in older patients recovering from acute illness.

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