The Evening Versus Morning Polypill Utilization Study
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
Background and rationale:
In clinical practice, antihypertensives are generally prescribed for use in the morning,
whereas some statins are recommended for use in the evening. There is evidence that the
reduction in LDL cholesterol achieved with some statins is superior when taken in the night,
but it is unclear whether the additional reduction in LDL cholesterol(and the reported
improvement in BP control when aspirin is taken in the evening) is offset by a reduction in
adherence when taking medication in the evening. Current product labelling recommends night
use for simvastatin and does not state a timing preference for aspirin or blood pressure
lowering medicines. There is therefore uncertainty concerning the best timing of
administration of the polypill. This uncertainty will be addressed by this trial.
Trial design:
Randomised, open label cross over trial (n=75) of the polypill in the morning compared with
the evening administration compared with individual agent administration (acetylsalicylic
acid and blood pressure lowering agents in the morning, and statin in the evening) in
individuals at high risk of cardiovascular disease. Patients will be recruited to the RHP 2c
(acetylsalicylic acid 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorthiazide 12.5mg),
and will be randomly allocated to the sequence of time of administration.