TREATMENT IN MORNING VS EVENING DR AMY ROGERS MRCGP CLINICAL RESEARCH FELLOW MEDICINES MONITORING...
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Transcript of TREATMENT IN MORNING VS EVENING DR AMY ROGERS MRCGP CLINICAL RESEARCH FELLOW MEDICINES MONITORING...
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TREATMENT IN MORNING VS EVENING
DR AMY ROGERS MRCGP
CLINICAL RESEARCH FELLOW
MEDICINES MONITORING UNITUNIVERSITY OF DUNDEE
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ETHOSChallenge assumptions – Why do we prescribe tablets in the morning?
Use IT and data technology – web-based study
record linkage
Can we improve outcomes without increasing drug exposure?
"Social Network Analysis Visualization" by MartinGrandjean - Own work : http://www.martingrandjean.ch/wp-content/uploads/2013/10/Graphe3.png. Licensed under CC BY-SA 3.0 via Wikimedia Commons - https://commons.wikimedia.org/wiki/File:Social_Network_Analysis_Visualization.png#/media/File:Social_Network_Analysis_Visualization.png
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CIRCADIAN VARIABILITY
http://sleepless-days.blogspot.co.uk/2011/07/around-clock-doc.html
White coat hypertension
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PREVIOUS RESEARCH
3 Spanish studies by Hermida et al.
Patients taking >1 blood pressure medication at night had a reduction in cardiovascular outcomes of almost 65%.
Chronobiol Int 2010;27:1629-51
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CONT.
MAPEC trial results
(Hermida et al) Chronobiol Int 2010;27:1629-51
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POSSIBLE EXPLANATIONS
Correction of non-dipping pattern
Delayed onset of action
Duration of action less then 24 hours
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PROBLEMS WITH MAPEC
Randomisation was unclear
Very high event rate – unrepresentative population?
poor validation of outcomes?
Too good to be true?
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AIM
to compare evening versus morning dosing of antihypertensive drugs
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METHOD
Participants sign up online
Randomised
Email follow-up
Record linkage
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OUTCOMES
Primary APTC events: vascular death
hospitalized MI hospitalized stroke
Secondary Adherence
Patient reported outcomes eg falls, fractures
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SUB-STUDIES
Home Blood Pressure Monitoring
Cognitive Function
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WHY THIS STUDY?
Outcomes matter
But, money does too: large study
no pharma funding
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NUMBERS
Pilot study: 308 patients
0.84%/yr cardiovascular risk
Need to randomise 10,269 people
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RECRUITMENT
Secondary care hypertension clinics
BHS research network
Primary care letter sent by GP advertising study
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TIMELINE
Pilot recruitment started 2011
Full study recruitment started Dec
2014
English R+D approvals
Spring 2015
Follow-up period ~3.5
years
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CURRENT STATUS
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QUESTIONS?
www.timestudy.co.uk