| Compliance and adverse event withdrawal: their impact on the West of Scotland Coronary Prevention Study. | |
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MedLine Citation:
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PMID: 9402445 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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AIMS: To assess the additional benefit gained from high compliance in the West of Scotland Coronary Prevention Study and to examine cases where withdrawal from trial medication was due to an adverse event. METHODS: The incidence of definite coronary heart disease or non-fatal myocardial infarction, cardiovascular mortality, definite or suspect coronary heart disease death or non-fatal myocardial infarction, the need for coronary revascularization procedures, all-cause mortality and incident cancers were measured in the entire cohort and compared with the high compliance group. The adverse events associated with withdrawal were coded by body system. RESULTS: In subjects with compliance > or = 75%, treatment with pravastatin resulted in a 38% risk reduction for definite coronary heart disease death or non-fatal myocardial infarction and for cardiovascular mortality, a 46% reduction in risk or coronary revascularization and a 32% risk reduction (P = 0.015) for all-cause mortality. CONCLUSIONS: The analysis of the effect of pravastatin in the subgroup of high compliers to randomized medication demonstrated a substantial increase in the estimated risk reductions in comparison with that achieved in the intention-to-treat analysis. This result has significant implications for the motivation of high compliance among patients and for the assessment of the cost-effectiveness of treatment. |
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Authors:
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: European heart journal Volume: 18 ISSN: 0195-668X ISO Abbreviation: Eur. Heart J. Publication Date: 1997 Nov |
Date Detail:
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Created Date: 1998-01-28 Completed Date: 1998-01-28 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8006263 Medline TA: Eur Heart J Country: ENGLAND |
Other Details:
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Languages: eng Pagination: 1718-24 Citation Subset: IM |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Anticholesteremic Agents
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therapeutic use* Coronary Disease / prevention & control* Double-Blind Method Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use* Male Middle Aged Myocardial Infarction / prevention & control Patient Compliance* Patient Dropouts Pravastatin / therapeutic use* |
| Chemical | |
Reg. No./Substance:
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0/Anticholesteremic Agents; 0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 81093-37-0/Pravastatin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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