Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial
Results of trials of aspirin and dipyridamole combined versus aspirin alone for the secondary prevention of vascular events after ischaemic stroke of presumed arterial origin are inconsistent. Our aim was to resolve this uncertainty. We did a randomised controlled trial in which we assigned patients...
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| Veröffentlicht in: | The Lancet (British edition) 2006-05, Vol.367 (9523), p.1665-1673 |
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| description | Results of trials of aspirin and dipyridamole combined versus aspirin alone for the secondary prevention of vascular events after ischaemic stroke of presumed arterial origin are inconsistent. Our aim was to resolve this uncertainty.
We did a randomised controlled trial in which we assigned patients to aspirin (30–325 mg daily) with (n=1363) or without (n=1376) dipyridamole (200 mg twice daily) within 6 months of a transient ischaemic attack or minor stroke of presumed arterial origin. Our primary outcome event was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever happened first. Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with
ClinicalTrials.gov (NCT00161070).
Mean follow-up was 3·5 years (SD 2·0). Median aspirin dose was 75 mg in both treatment groups (range 30–325); extended-release dipyridamole was used by 83% (n=1131) of patients on the combination regimen. Primary outcome events arose in 173 (13%) patients on aspirin and dipyridamole and in 216 (16%) on aspirin alone (hazard ratio 0·80, 95% CI 0·66–0·98; absolute risk reduction 1·0% per year, 95% CI 0·1–1·8). Addition of the ESPRIT data to the meta-analysis of previous trials resulted in an overall risk ratio for the composite of vascular death, stroke, or myocardial infarction of 0·82 (95% CI 0·74–0·91). Patients on aspirin and dipyridamole discontinued trial medication more often than those on aspirin alone (470
vs 184), mainly because of headache.
The ESPRIT results, combined with the results of previous trials, provide sufficient evidence to prefer the combination regimen of aspirin plus dipyridamole over aspirin alone as antithrombotic therapy after cerebral ischaemia of arterial origin. |
| doi_str_mv | 10.1016/S0140-6736(06)68734-5 |
| format | Article |
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We did a randomised controlled trial in which we assigned patients to aspirin (30–325 mg daily) with (n=1363) or without (n=1376) dipyridamole (200 mg twice daily) within 6 months of a transient ischaemic attack or minor stroke of presumed arterial origin. Our primary outcome event was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever happened first. Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with
ClinicalTrials.gov (NCT00161070).
Mean follow-up was 3·5 years (SD 2·0). Median aspirin dose was 75 mg in both treatment groups (range 30–325); extended-release dipyridamole was used by 83% (n=1131) of patients on the combination regimen. Primary outcome events arose in 173 (13%) patients on aspirin and dipyridamole and in 216 (16%) on aspirin alone (hazard ratio 0·80, 95% CI 0·66–0·98; absolute risk reduction 1·0% per year, 95% CI 0·1–1·8). Addition of the ESPRIT data to the meta-analysis of previous trials resulted in an overall risk ratio for the composite of vascular death, stroke, or myocardial infarction of 0·82 (95% CI 0·74–0·91). Patients on aspirin and dipyridamole discontinued trial medication more often than those on aspirin alone (470
vs 184), mainly because of headache.
The ESPRIT results, combined with the results of previous trials, provide sufficient evidence to prefer the combination regimen of aspirin plus dipyridamole over aspirin alone as antithrombotic therapy after cerebral ischaemia of arterial origin.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(06)68734-5</identifier><identifier>PMID: 16714187</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Aged ; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage ; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use ; Aspirin ; Aspirin - administration & dosage ; Aspirin - therapeutic use ; Clinical trials ; Dipyridamole - administration & dosage ; Dipyridamole - adverse effects ; Dipyridamole - therapeutic use ; Drug therapy ; Drug Therapy, Combination ; Drug use ; Female ; Hospitals ; Humans ; International standards ; Ischemic Attack, Transient - complications ; Male ; Middle Aged ; Myocardial infarction ; Patients ; Platelet Aggregation Inhibitors - administration & dosage ; Platelet Aggregation Inhibitors - adverse effects ; Platelet Aggregation Inhibitors - therapeutic use ; Risk factors ; Risk reduction ; Stroke ; Stroke - etiology ; Stroke - prevention & control ; Systematic review</subject><ispartof>The Lancet (British edition), 2006-05, Vol.367 (9523), p.1665-1673</ispartof><rights>2006 Elsevier Ltd</rights><rights>Copyright Lancet Ltd. May 20-May 26, 2006</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-e8423a0fbd2319f77a8e9b26386a57ad58cfbc4b2dc813faa6a98729a95f4e483</citedby><cites>FETCH-LOGICAL-c415t-e8423a0fbd2319f77a8e9b26386a57ad58cfbc4b2dc813faa6a98729a95f4e483</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/199049979?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3538,27906,27907,45977,64365,64369,72219</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16714187$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Halkes, P H A</creatorcontrib><creatorcontrib>van Gijn, J</creatorcontrib><creatorcontrib>Kappelle, L J</creatorcontrib><creatorcontrib>Koudstaal, P J</creatorcontrib><creatorcontrib>Algra, A</creatorcontrib><creatorcontrib>The ESPRIT Study Group</creatorcontrib><creatorcontrib>ESPRIT Study Group</creatorcontrib><title>Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Results of trials of aspirin and dipyridamole combined versus aspirin alone for the secondary prevention of vascular events after ischaemic stroke of presumed arterial origin are inconsistent. Our aim was to resolve this uncertainty.
We did a randomised controlled trial in which we assigned patients to aspirin (30–325 mg daily) with (n=1363) or without (n=1376) dipyridamole (200 mg twice daily) within 6 months of a transient ischaemic attack or minor stroke of presumed arterial origin. Our primary outcome event was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever happened first. Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with
ClinicalTrials.gov (NCT00161070).
Mean follow-up was 3·5 years (SD 2·0). Median aspirin dose was 75 mg in both treatment groups (range 30–325); extended-release dipyridamole was used by 83% (n=1131) of patients on the combination regimen. Primary outcome events arose in 173 (13%) patients on aspirin and dipyridamole and in 216 (16%) on aspirin alone (hazard ratio 0·80, 95% CI 0·66–0·98; absolute risk reduction 1·0% per year, 95% CI 0·1–1·8). Addition of the ESPRIT data to the meta-analysis of previous trials resulted in an overall risk ratio for the composite of vascular death, stroke, or myocardial infarction of 0·82 (95% CI 0·74–0·91). Patients on aspirin and dipyridamole discontinued trial medication more often than those on aspirin alone (470
vs 184), mainly because of headache.
The ESPRIT results, combined with the results of previous trials, provide sufficient evidence to prefer the combination regimen of aspirin plus dipyridamole over aspirin alone as antithrombotic therapy after cerebral ischaemia of arterial origin.</description><subject>Aged</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - therapeutic use</subject><subject>Aspirin</subject><subject>Aspirin - administration & dosage</subject><subject>Aspirin - therapeutic use</subject><subject>Clinical trials</subject><subject>Dipyridamole - administration & dosage</subject><subject>Dipyridamole - adverse effects</subject><subject>Dipyridamole - therapeutic use</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Drug use</subject><subject>Female</subject><subject>Hospitals</subject><subject>Humans</subject><subject>International standards</subject><subject>Ischemic Attack, Transient - complications</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial infarction</subject><subject>Patients</subject><subject>Platelet Aggregation Inhibitors - administration & dosage</subject><subject>Platelet Aggregation Inhibitors - adverse effects</subject><subject>Platelet Aggregation Inhibitors - therapeutic use</subject><subject>Risk factors</subject><subject>Risk reduction</subject><subject>Stroke</subject><subject>Stroke - etiology</subject><subject>Stroke - prevention & control</subject><subject>Systematic 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edition)</jtitle><addtitle>Lancet</addtitle><date>2006-05-20</date><risdate>2006</risdate><volume>367</volume><issue>9523</issue><spage>1665</spage><epage>1673</epage><pages>1665-1673</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Results of trials of aspirin and dipyridamole combined versus aspirin alone for the secondary prevention of vascular events after ischaemic stroke of presumed arterial origin are inconsistent. Our aim was to resolve this uncertainty.
We did a randomised controlled trial in which we assigned patients to aspirin (30–325 mg daily) with (n=1363) or without (n=1376) dipyridamole (200 mg twice daily) within 6 months of a transient ischaemic attack or minor stroke of presumed arterial origin. Our primary outcome event was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever happened first. Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with
ClinicalTrials.gov (NCT00161070).
Mean follow-up was 3·5 years (SD 2·0). Median aspirin dose was 75 mg in both treatment groups (range 30–325); extended-release dipyridamole was used by 83% (n=1131) of patients on the combination regimen. Primary outcome events arose in 173 (13%) patients on aspirin and dipyridamole and in 216 (16%) on aspirin alone (hazard ratio 0·80, 95% CI 0·66–0·98; absolute risk reduction 1·0% per year, 95% CI 0·1–1·8). Addition of the ESPRIT data to the meta-analysis of previous trials resulted in an overall risk ratio for the composite of vascular death, stroke, or myocardial infarction of 0·82 (95% CI 0·74–0·91). Patients on aspirin and dipyridamole discontinued trial medication more often than those on aspirin alone (470
vs 184), mainly because of headache.
The ESPRIT results, combined with the results of previous trials, provide sufficient evidence to prefer the combination regimen of aspirin plus dipyridamole over aspirin alone as antithrombotic therapy after cerebral ischaemia of arterial origin.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>16714187</pmid><doi>10.1016/S0140-6736(06)68734-5</doi><tpages>9</tpages></addata></record> |
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| subjects | Aged Anti-Inflammatory Agents, Non-Steroidal - administration & dosage Anti-Inflammatory Agents, Non-Steroidal - therapeutic use Aspirin Aspirin - administration & dosage Aspirin - therapeutic use Clinical trials Dipyridamole - administration & dosage Dipyridamole - adverse effects Dipyridamole - therapeutic use Drug therapy Drug Therapy, Combination Drug use Female Hospitals Humans International standards Ischemic Attack, Transient - complications Male Middle Aged Myocardial infarction Patients Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - adverse effects Platelet Aggregation Inhibitors - therapeutic use Risk factors Risk reduction Stroke Stroke - etiology Stroke - prevention & control Systematic review |
| title | Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial |
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