The impact of enteric coating of aspirin on aspirin responsiveness in patients with suspected or newly diagnosed ischemic stroke: prospective cohort study: results from the (ECASIS) study

Background and purpose Uncertainty remains regarding the impact of enteric-coated aspirin (EC-ASA) on secondary prevention of ischemic stroke compared to plain aspirin (P-ASA). Hence, this study was designed to investigate the effect of EC formulation on ASA response via evaluating thromboxane B2 (T...

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Veröffentlicht in:European journal of clinical pharmacology 2022-11, Vol.78 (11), p.1801-1811
Hauptverfasser: Elshafei, Mohamed Nabil, Imam, Yahia, Alsaud, Arwa Ebrahim, Chandra, Prem, Parray, Aijaz, Abdelmoneim, Mohamed S., Obeidat, Khaldun, Saeid, Razan, Ali, Mohammad, Ayadathil, Raheem, Mohamed, Mouhand F. H., Abdallah, Ibtihal M., Mohammed, Shaban, Akhtar, Naveed, Danjuma, Mohammed Ibn-Masoud
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container_end_page 1811
container_issue 11
container_start_page 1801
container_title European journal of clinical pharmacology
container_volume 78
creator Elshafei, Mohamed Nabil
Imam, Yahia
Alsaud, Arwa Ebrahim
Chandra, Prem
Parray, Aijaz
Abdelmoneim, Mohamed S.
Obeidat, Khaldun
Saeid, Razan
Ali, Mohammad
Ayadathil, Raheem
Mohamed, Mouhand F. H.
Abdallah, Ibtihal M.
Mohammed, Shaban
Akhtar, Naveed
Danjuma, Mohammed Ibn-Masoud
description Background and purpose Uncertainty remains regarding the impact of enteric-coated aspirin (EC-ASA) on secondary prevention of ischemic stroke compared to plain aspirin (P-ASA). Hence, this study was designed to investigate the effect of EC formulation on ASA response via evaluating thromboxane B2 (TXB2) levels in patients with suspected or newly diagnosed stroke. Methods A prospective cohort study on suspected or newly diagnosed ischemic stroke patients who are aspirin-naive was conducted. Patients were received either EC aspirin or plain aspirin for at least 3 days. The primary outcome was the proportion of aspirin non-responsiveness between two groups (level of residual serum TXB2 associated with elevated thrombotic risk ( 3.1 ng/ml) within 72 h after three daily aspirin doses, while secondary outcomes were the incidence of early gastrointestinal tract (GIT) bleeding with the various aspirin preparations. (Trial registration: Clinicaltrials.gov NCT04330872 registered on 02 April 2020). Results Of 42 patients, ischemic strokes were confirmed in both P-ASA (81%) and EC-ASA (67%) arms. ASA non-responsiveness showed no significant difference between the two formulations (P-ASA vs. EC-ASA; 28.6% vs 23.8%; P  = 0.726). Univariate and multivariate logistic regression analysis showed that patients treated with EC-ASA were more likely to have a lower rate of non-responders compared to P-ASA (unadjusted OR 0.78; 95% CI 0.20, 3.11); with the risk highest in type 2 diabetic patients with HBA1c > 6.5% (adjusted OR 6; 95% CI 1.02, 35.27; P  = 0.047). No incidence of GIT bleeding observed throughout the study. Conclusion A significant proportion of ASA non-responsiveness was recorded regardless of ASA formulation administered. The increased risk of ASA non-responsiveness in diabetic patients needs further exploration by larger prospective studies.
doi_str_mv 10.1007/s00228-022-03391-2
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H. ; Abdallah, Ibtihal M. ; Mohammed, Shaban ; Akhtar, Naveed ; Danjuma, Mohammed Ibn-Masoud</creator><creatorcontrib>Elshafei, Mohamed Nabil ; Imam, Yahia ; Alsaud, Arwa Ebrahim ; Chandra, Prem ; Parray, Aijaz ; Abdelmoneim, Mohamed S. ; Obeidat, Khaldun ; Saeid, Razan ; Ali, Mohammad ; Ayadathil, Raheem ; Mohamed, Mouhand F. H. ; Abdallah, Ibtihal M. ; Mohammed, Shaban ; Akhtar, Naveed ; Danjuma, Mohammed Ibn-Masoud</creatorcontrib><description>Background and purpose Uncertainty remains regarding the impact of enteric-coated aspirin (EC-ASA) on secondary prevention of ischemic stroke compared to plain aspirin (P-ASA). Hence, this study was designed to investigate the effect of EC formulation on ASA response via evaluating thromboxane B2 (TXB2) levels in patients with suspected or newly diagnosed stroke. Methods A prospective cohort study on suspected or newly diagnosed ischemic stroke patients who are aspirin-naive was conducted. Patients were received either EC aspirin or plain aspirin for at least 3 days. The primary outcome was the proportion of aspirin non-responsiveness between two groups (level of residual serum TXB2 associated with elevated thrombotic risk (&lt; 99.0% inhibition or TXB2 &gt; 3.1 ng/ml) within 72 h after three daily aspirin doses, while secondary outcomes were the incidence of early gastrointestinal tract (GIT) bleeding with the various aspirin preparations. (Trial registration: Clinicaltrials.gov NCT04330872 registered on 02 April 2020). Results Of 42 patients, ischemic strokes were confirmed in both P-ASA (81%) and EC-ASA (67%) arms. ASA non-responsiveness showed no significant difference between the two formulations (P-ASA vs. EC-ASA; 28.6% vs 23.8%; P  = 0.726). Univariate and multivariate logistic regression analysis showed that patients treated with EC-ASA were more likely to have a lower rate of non-responders compared to P-ASA (unadjusted OR 0.78; 95% CI 0.20, 3.11); with the risk highest in type 2 diabetic patients with HBA1c &gt; 6.5% (adjusted OR 6; 95% CI 1.02, 35.27; P  = 0.047). No incidence of GIT bleeding observed throughout the study. Conclusion A significant proportion of ASA non-responsiveness was recorded regardless of ASA formulation administered. The increased risk of ASA non-responsiveness in diabetic patients needs further exploration by larger prospective studies.</description><identifier>ISSN: 0031-6970</identifier><identifier>EISSN: 1432-1041</identifier><identifier>DOI: 10.1007/s00228-022-03391-2</identifier><identifier>PMID: 36121499</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Aspirin ; Biomedical and Life Sciences ; Biomedicine ; Bleeding ; Clinical Trial ; Cohort analysis ; Diabetes ; Diabetes mellitus ; Gastrointestinal tract ; Ischemia ; Pharmacology/Toxicology ; Stroke</subject><ispartof>European journal of clinical pharmacology, 2022-11, Vol.78 (11), p.1801-1811</ispartof><rights>The Author(s) 2022</rights><rights>The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). 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H.</creatorcontrib><creatorcontrib>Abdallah, Ibtihal M.</creatorcontrib><creatorcontrib>Mohammed, Shaban</creatorcontrib><creatorcontrib>Akhtar, Naveed</creatorcontrib><creatorcontrib>Danjuma, Mohammed Ibn-Masoud</creatorcontrib><title>The impact of enteric coating of aspirin on aspirin responsiveness in patients with suspected or newly diagnosed ischemic stroke: prospective cohort study: results from the (ECASIS) study</title><title>European journal of clinical pharmacology</title><addtitle>Eur J Clin Pharmacol</addtitle><description>Background and purpose Uncertainty remains regarding the impact of enteric-coated aspirin (EC-ASA) on secondary prevention of ischemic stroke compared to plain aspirin (P-ASA). Hence, this study was designed to investigate the effect of EC formulation on ASA response via evaluating thromboxane B2 (TXB2) levels in patients with suspected or newly diagnosed stroke. Methods A prospective cohort study on suspected or newly diagnosed ischemic stroke patients who are aspirin-naive was conducted. Patients were received either EC aspirin or plain aspirin for at least 3 days. The primary outcome was the proportion of aspirin non-responsiveness between two groups (level of residual serum TXB2 associated with elevated thrombotic risk (&lt; 99.0% inhibition or TXB2 &gt; 3.1 ng/ml) within 72 h after three daily aspirin doses, while secondary outcomes were the incidence of early gastrointestinal tract (GIT) bleeding with the various aspirin preparations. (Trial registration: Clinicaltrials.gov NCT04330872 registered on 02 April 2020). Results Of 42 patients, ischemic strokes were confirmed in both P-ASA (81%) and EC-ASA (67%) arms. ASA non-responsiveness showed no significant difference between the two formulations (P-ASA vs. EC-ASA; 28.6% vs 23.8%; P  = 0.726). Univariate and multivariate logistic regression analysis showed that patients treated with EC-ASA were more likely to have a lower rate of non-responders compared to P-ASA (unadjusted OR 0.78; 95% CI 0.20, 3.11); with the risk highest in type 2 diabetic patients with HBA1c &gt; 6.5% (adjusted OR 6; 95% CI 1.02, 35.27; P  = 0.047). No incidence of GIT bleeding observed throughout the study. Conclusion A significant proportion of ASA non-responsiveness was recorded regardless of ASA formulation administered. The increased risk of ASA non-responsiveness in diabetic patients needs further exploration by larger prospective studies.</description><subject>Aspirin</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Bleeding</subject><subject>Clinical Trial</subject><subject>Cohort analysis</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Gastrointestinal tract</subject><subject>Ischemia</subject><subject>Pharmacology/Toxicology</subject><subject>Stroke</subject><issn>0031-6970</issn><issn>1432-1041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>BENPR</sourceid><recordid>eNp9ks1u1DAQxyMEokvhBThZ4lIOKf5I4rgHpGpVaKVKHFrOluNMNi6JHeyk1T4bL8dsUxXBgYttzfzmPx-eLHvP6CmjVH5KlHJe53jkVAjFcv4i27BC8JzRgr3MNpQKlldK0qPsTUp3lLJSUfE6OxIV46xQapP9uu2BuHEydiahI-BniM4SG8zs_O5gMmly0XkS_PMzQpqCT-4ePKRE0DIhjrGJPLi5J2lJE9gZWhIi8fAw7EnrzM6HhCaXbA8j5khzDD_gjEwxPOIoh3n7EGd0Le3-7JBnGVC0i2EkMxZ6crE9v7m6-bgCb7NXnRkSvHu6j7PvXy5ut5f59bevV9vz69wWJZvzTthOKNmUqsAx1ZUUpoHGiLqk0ArJawaGm7Zousq0Td1ZBp1slaw5yBKoFcfZ51V3WpoRWouNRjPoKbrRxL0Oxum_Pd71ehfutSqLShUSBU6eBGL4uUCa9YhTgGEwHsKSNJeslIoWokL0wz_oXViix_aQ4ryi-IMHiq-UxdmlCN1zMYzqw27odTc0HvpxNzTHILEGJYT9DuIf6f9E_Qb4H8B9</recordid><startdate>20221101</startdate><enddate>20221101</enddate><creator>Elshafei, Mohamed Nabil</creator><creator>Imam, Yahia</creator><creator>Alsaud, Arwa Ebrahim</creator><creator>Chandra, Prem</creator><creator>Parray, Aijaz</creator><creator>Abdelmoneim, Mohamed S.</creator><creator>Obeidat, Khaldun</creator><creator>Saeid, Razan</creator><creator>Ali, Mohammad</creator><creator>Ayadathil, Raheem</creator><creator>Mohamed, Mouhand F. H.</creator><creator>Abdallah, Ibtihal M.</creator><creator>Mohammed, Shaban</creator><creator>Akhtar, Naveed</creator><creator>Danjuma, Mohammed Ibn-Masoud</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-3229-6825</orcidid></search><sort><creationdate>20221101</creationdate><title>The impact of enteric coating of aspirin on aspirin responsiveness in patients with suspected or newly diagnosed ischemic stroke: prospective cohort study: results from the (ECASIS) study</title><author>Elshafei, Mohamed Nabil ; Imam, Yahia ; Alsaud, Arwa Ebrahim ; Chandra, Prem ; Parray, Aijaz ; Abdelmoneim, Mohamed S. ; Obeidat, Khaldun ; Saeid, Razan ; Ali, Mohammad ; Ayadathil, Raheem ; Mohamed, Mouhand F. H. ; Abdallah, Ibtihal M. ; Mohammed, Shaban ; Akhtar, Naveed ; Danjuma, Mohammed Ibn-Masoud</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c451t-f3cf397b5940338673abeba3850ed37281ea2ad4bf6adb8fc1ef7d9782e75e0c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Aspirin</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Bleeding</topic><topic>Clinical Trial</topic><topic>Cohort analysis</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Gastrointestinal tract</topic><topic>Ischemia</topic><topic>Pharmacology/Toxicology</topic><topic>Stroke</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Elshafei, Mohamed Nabil</creatorcontrib><creatorcontrib>Imam, Yahia</creatorcontrib><creatorcontrib>Alsaud, Arwa Ebrahim</creatorcontrib><creatorcontrib>Chandra, Prem</creatorcontrib><creatorcontrib>Parray, Aijaz</creatorcontrib><creatorcontrib>Abdelmoneim, Mohamed S.</creatorcontrib><creatorcontrib>Obeidat, Khaldun</creatorcontrib><creatorcontrib>Saeid, Razan</creatorcontrib><creatorcontrib>Ali, Mohammad</creatorcontrib><creatorcontrib>Ayadathil, Raheem</creatorcontrib><creatorcontrib>Mohamed, Mouhand F. H.</creatorcontrib><creatorcontrib>Abdallah, Ibtihal M.</creatorcontrib><creatorcontrib>Mohammed, Shaban</creatorcontrib><creatorcontrib>Akhtar, Naveed</creatorcontrib><creatorcontrib>Danjuma, Mohammed Ibn-Masoud</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Elshafei, Mohamed Nabil</au><au>Imam, Yahia</au><au>Alsaud, Arwa Ebrahim</au><au>Chandra, Prem</au><au>Parray, Aijaz</au><au>Abdelmoneim, Mohamed S.</au><au>Obeidat, Khaldun</au><au>Saeid, Razan</au><au>Ali, Mohammad</au><au>Ayadathil, Raheem</au><au>Mohamed, Mouhand F. H.</au><au>Abdallah, Ibtihal M.</au><au>Mohammed, Shaban</au><au>Akhtar, Naveed</au><au>Danjuma, Mohammed Ibn-Masoud</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The impact of enteric coating of aspirin on aspirin responsiveness in patients with suspected or newly diagnosed ischemic stroke: prospective cohort study: results from the (ECASIS) study</atitle><jtitle>European journal of clinical pharmacology</jtitle><stitle>Eur J Clin Pharmacol</stitle><date>2022-11-01</date><risdate>2022</risdate><volume>78</volume><issue>11</issue><spage>1801</spage><epage>1811</epage><pages>1801-1811</pages><issn>0031-6970</issn><eissn>1432-1041</eissn><abstract>Background and purpose Uncertainty remains regarding the impact of enteric-coated aspirin (EC-ASA) on secondary prevention of ischemic stroke compared to plain aspirin (P-ASA). Hence, this study was designed to investigate the effect of EC formulation on ASA response via evaluating thromboxane B2 (TXB2) levels in patients with suspected or newly diagnosed stroke. Methods A prospective cohort study on suspected or newly diagnosed ischemic stroke patients who are aspirin-naive was conducted. Patients were received either EC aspirin or plain aspirin for at least 3 days. The primary outcome was the proportion of aspirin non-responsiveness between two groups (level of residual serum TXB2 associated with elevated thrombotic risk (&lt; 99.0% inhibition or TXB2 &gt; 3.1 ng/ml) within 72 h after three daily aspirin doses, while secondary outcomes were the incidence of early gastrointestinal tract (GIT) bleeding with the various aspirin preparations. (Trial registration: Clinicaltrials.gov NCT04330872 registered on 02 April 2020). Results Of 42 patients, ischemic strokes were confirmed in both P-ASA (81%) and EC-ASA (67%) arms. ASA non-responsiveness showed no significant difference between the two formulations (P-ASA vs. EC-ASA; 28.6% vs 23.8%; P  = 0.726). Univariate and multivariate logistic regression analysis showed that patients treated with EC-ASA were more likely to have a lower rate of non-responders compared to P-ASA (unadjusted OR 0.78; 95% CI 0.20, 3.11); with the risk highest in type 2 diabetic patients with HBA1c &gt; 6.5% (adjusted OR 6; 95% CI 1.02, 35.27; P  = 0.047). No incidence of GIT bleeding observed throughout the study. Conclusion A significant proportion of ASA non-responsiveness was recorded regardless of ASA formulation administered. The increased risk of ASA non-responsiveness in diabetic patients needs further exploration by larger prospective studies.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>36121499</pmid><doi>10.1007/s00228-022-03391-2</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-3229-6825</orcidid><oa>free_for_read</oa></addata></record>
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subjects Aspirin
Biomedical and Life Sciences
Biomedicine
Bleeding
Clinical Trial
Cohort analysis
Diabetes
Diabetes mellitus
Gastrointestinal tract
Ischemia
Pharmacology/Toxicology
Stroke
title The impact of enteric coating of aspirin on aspirin responsiveness in patients with suspected or newly diagnosed ischemic stroke: prospective cohort study: results from the (ECASIS) study
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