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PACE
Prevention by low dose Aspirin of Cardiovascular disease in the Elderly
Ongoing trial
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Author(s) |
(a) Silagy CA, McNeil JJ, Bulpitt CJ, Donnan GA, Tonkin AM, Worsam B
(b) Silagy CA, McNeil JJ, Donnan GA, Tonkin AM, Worsam B, Campion K
(c) Silagy CA, McNeil JJ, Donnan GA, Tonkin AM, Worsam B, Campion K
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Title(s) |
(a) Rationale for a primary prevention study using low-dose aspirin to prevent coronary and cerebrovascular disease in the elderly
(b) Adverse effects of low-dose aspirin in a healthy elderly population
(c) The Pace pilot study: 12-month results and implications for future primary prevention trials in the elderly
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Reference(s) |
(a) J Am Geriatr Soc 1991;39:484-91
(b) Clin Pharmacol Ther 1993;54:84-9
(c) J Am Geriatr Soc 1994;42:643-7
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Disease |
Cardiovascular and cerebrovascular disease
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Purpose |
To test the effect of low-dose aspirin in the primary prevention of cardiovascular and cerebrovascular disease in the elderly
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Study design |
Randomised, double-blind, placebo-controlled
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Follow-up |
4 years
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Patients |
Aim 15,000 healthy subjects, aged ≥ 70 years, with no evidence of pre-existing cardiovascular or cerebrovascular disease
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Treatment regimen |
Aspirin, 100 mg/day, or placebo
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Results |
Results from a pilot phase with 400 subjects (aspirin 200, placebo 200) followed for 1 year show that gastrointestinal symptoms occurred in 18% of subjects receiving aspirin vs 13% receiving placebo. Aspirin-treated subjects had a significant decrease in mean haemoglobin levels. Two fatal cardiovascular events, 3 nonfatal cardiovascular events and 8 nonfatal cerebrovascular events occurred during 1 year, which were 15%, 15% and 40%, respectively, of the incidences in age- and sex-matched general population. Compliance with medication was 87%
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Comments |
Secondary ‘soft’ endpoints (eg transient ischaemic attack and unstable angina) required withdrawal from the study and possibly contributed to the small number of primary ‘hard’ endpoints
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