2012CirculationRequires access

Abstract 17185: Comparison of Clinical efficacy and Safety of Clopidogrel Resinate (Pregrel®) With Clopidogrel Bisulfate (Plavix®) in Patients Undergoing Percutaneous Coronary Intervention

Mahn Won Park, Kiyuk Chang, Sung‐Ho Her, Jung Sun Cho, Jong Min Lee, Yoon Seok Koh, Yoon Seok Choi, Hun‐Jun Park, Dong‐Bin Kim, Pum Joon Kim, Chul-Su Park, Chan Jun Kim, Wook Sung Jung, Ki Bae Seoung

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Abstract

Introduction While clopidogrel bisulfate (Plavix®) is very susceptible to degradation or chiral inversion by moisture including acidic or alkaline conditions as well as dry heat, clopidogrel resinate (Pregrel®), a new salt form of clopidogrel, is very stable in the physicochemical stability and the gastrointestinal stability tests as well as was highly safe in toxicity studies compared to conventional clopidogrel bisulfate. In 2007, clopidogrel resinate was approved for marketing by the Korean Food and Drug Administration based on a Phase I bioequivalence study. However, no data are available on the comparison of impact of the two drugs on adverse clinical outcomes. Methods Plavix was used exclusively from January 2004 through April 2010 and then Pregrel was used exclusively from May 2010 through September 2011. We dichotomized the overall population into two groups according to prescribed type of clopidogrel: Plavix (n= 9,127) and Pregrel (n= 1,360) group. We compared adverse outcomes with the use of pro...

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Introduction While clopidogrel bisulfate (Plavix®) is very susceptible to degradation or chiral inversion by moisture including acidic or alkaline conditions as well as dry heat, clopidogrel resinate (Pregrel®), a new salt form of clopidogrel, is very stable in the physicochemical stability and the gastrointestinal stability tests as well as was highly safe in toxicity studies compared to conventional clopidogrel bisulfate. In 2007, clopidogrel resinate was approved for marketing by the Korean Food and Drug Administration based on a Phase I bioequivalence study. However, no data are available on the comparison of impact of the two drugs on adverse clinical outcomes. Methods Plavix was used exclusively from January 2004 through April 2010 and then Pregrel was used exclusively from May 2010 through September 2011. We dichotomized the overall population into two groups according to prescribed type of clopidogrel: Plavix (n= 9,127) and Pregrel (n= 1,360) group. We compared adverse outcomes with the use of pro...

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Available abstract

Introduction While clopidogrel bisulfate (Plavix®) is very susceptible to degradation or chiral inversion by moisture including acidic or alkaline conditions as well as dry heat, clopidogrel resinate (Pregrel®), a new salt form of clopidogrel, is very stable in the physicochemical stability and the gastrointestinal stability tests as well as was highly safe in toxicity studies compared to conventional clopidogrel bisulfate. In 2007, clopidogrel resinate was approved for marketing by the Korean Food and Drug Administration based on a Phase I bioequivalence study. However, no data are available on the comparison of impact of the two drugs on adverse clinical outcomes. Methods Plavix was used exclusively from January 2004 through April 2010 and then Pregrel was used exclusively from May 2010 through September 2011. We dichotomized the overall population into two groups according to prescribed type of clopidogrel: Plavix (n= 9,127) and Pregrel (n= 1,360) group. We compared adverse outcomes with the use of pro...

Key concepts: Clopidogrel, Medicine, Percutaneous coronary intervention, Adverse effect, Internal medicine, Anesthesia, Pharmacology, Aspirin

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Abstract 17185: Comparison of Clinical efficacy and Safety of Clopidogrel Resinate (Pregrel®) With Clopidogrel Bisulfate (Plavix®) in Patients Undergoing Percutaneous Coronary Intervention — Research Paper | ScholarLens