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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?

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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