Placebokontrollierte, doppelblinde Crossover-Studie zur Untersuchung der Wirkung einer parenteralen Gabe von Pantoprazol auf die Kontraktilität des Herzen

A double-blind, placebo-controlled cross-over trial of pantoprazole and it´s effects on myocardial contraction

by Nina Celine Hein
Doctoral thesis
Date of Examination:2015-03-25
Date of issue:2015-03-18
Advisor:Prof. Dr. Wolfgang Schillinger
Referee:Prof. Dr. Wolfgang Schillinger
Referee:Dr. Mladen Tzvetkov
Persistent Address: http://dx.doi.org/10.53846/goediss-4982

 

 

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Abstract

English

Purpose: Reports on cardiac problems with oral proton pump inhibitors have caused extensive safety reviews by the US Food and Drug Administration. We provide addi- tional data on acute cardiac effects of an intravenous application. Methods: Echocardiography was performed in 18 healthy volunteers after administration of a common high-dose regimen of pantoprazole (80 mg i.v. bolus followed by 8 mg/h for 1 h) or placebo. Design: The design included a randomized, double-blind, placebo-controlled cross-over trial. Results: Ejection fraction (%, mean ± SE) in the treat- ment group (placebo group) was 60.7 ± 1.1 (61.2 ± 1.7) at baseline, and 62.6 ± 1.1 (62.1 ± 1.9), 64.7 ± 1.6 (63.5 ± 1.3), 62.6 ± 1.6 (61.0 ± 1.6) and 63.0 ± 1.4 (61.8 ± 1.5) at 7.5, 15, 30 and 60 min after bolus appli- cation, respectively (p = n.s.). Similarly, no significant changes were found for cardiac output, cardiac index, blood pressure and heart rate. In contrast, gastric pH that was used as a treatment control was significantly increased 60 min after the application of pantoprazole as compared to baseline and to placebo. Conclusions: Pantoprazole as injection is safe in healthy subjects with respect to cardiac contractile function. However, in view of recent reports of negative inotropy of the drug, further studies in heart failure patients are required.
Keywords: Cardiac output; Heart failure; Cardiotonic agents; Pharmacology; Myocardial contraction
 
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