opportunities for research in primary care jen dumbleton clinical trial manager university of...
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OPPORTUNITIES FOR RESEARCH IN PRIMARY
CAREJen Dumbleton
Clinical Trial ManagerUniversity of Nottingham
[email protected] 823 1053
Essex, Herts Valley & Luton Primary Care Forum Meeting, 3 July 2015
Update on Existing Research…
An ultra simple randomised study to investigate whether a one week
course of H. pylori eradication reduces hospitalisation for ulcer bleeding in patients using aspirin
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Mil
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s
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35Aspirin vs NSAIDs
Aspirin
NSAIDs
HEAT Hypothesis
Ulcer
NSAIDs
Some bleed
Ulcer
H. pylori
Some bleed
Aspirin
+
HEAT Entry CriteriaINCLUSION≥ 60 years of ageSubjects taking aspirin ≤325mg daily who have had
4 or more 28-day prescriptions in the last year.Subjects concurrently using other anti-platelet
agents are allowed to enter the study.
EXCLUSIONSubjects currently prescribed anti-ulcer therapy
such as H2-receptor antagonists and proton-pump inhibitors.
Subjects currently prescribed oral non-steroidal anti-inflammatory drugs (NSAIDs).
Trial Design
GP Practices search systems (MIQUEST) for eligible patients
Aspirin ≤325mg daily60+ yoNot prescribed NSAIDs / PPIs
Screening Visit with Breath test
+ve -ve
RANDOMISE (double-blind)
Placebo H. pylori eradication treatmentClarithromycin 500mgMetronidazole 400mg
Lansoprazole 30mg
2 years’ follow-up (no visits) until 87 endpoints occur
>700 GP practices
17,628 consented patients
Largest UK CTIMP!
Benefits of taking partSimple study (low workload, ideal for
practices new to research).Large team on hand to help with any queries.Assuming all participating patients ultimately
undergo eradication, the trial should prevent around 585 hospitalisations and 59 deaths, at a saving of approximately £5.85 million.
This potentially makes the trial itself a cost effective therapeutic intervention.
We’re excited!Aspirin
World’s most famous drugHelps the 2 biggest killers (Western world)Most important issue in prophylaxis of ulcer
bleedingImportant trial
Big questionBrings outcomes studies to non-pharma arenaEasy to do
1 week treatment No FU
Establishes paradigms for future
Allopurinol in Ischaemic Heart Disease
A new study coming soon…
Ischaemic heart disease (IHD)IHD is common with prevalence
4.6% Scotland3.5% England
4% of men and 0.5% of women have had MI14% of men and 8% of women age 65-74yrs
have had anginaIHD is the commonest cause of death in UK1 in 5 men and 1 in 7 women die of IHD
Why might allopurinol help in IHD?Reduces left ventricular hypertrophy
diabetes angina
Reduces blood pressureImproves arterial stiffnessImproves endothelial function*Reduces oxidative stress*Improves exercise time and chest pain in
angina
* 600mg daily more effective than 300mg daily
ALL-HEART studyDoes allopurinol improve cardiovascular outcomes in
patients with IHD?5,215 patients with IHDRandomised to
Allopurinol 600mg daily added to usual carevs
Usual careFollowed up for average of 4 years
Electronic record-linkage Hospitalisations and deaths
Annual questionnaire Quality of life Health resource usage Compliance, adverse events, gout flares and skin rashes
ALL HEART Allopurinol Study
GP search for eligible patients 60+ years Ischaemic heart disease (IHD) – angina or myocardial infarction Not taking ULT (no history of gout)
CONSENT VISIT Inclusion / exclusion criteria checked Blood samples taken ( FBC, urea & electrolytes, creatinine, eGFR & urate) Questionnaires Randomisation (50:50 allopurinol / no medication)
500 patients to take:
100mg allopurinol daily for 2 weeks
500 patients to have no addition to their medication
Increased to 300mg daily for 2 weeks
Increased to 600mg daily if tolerated
6 WEEK VISIT
Bloods are re-taken (FBC, urea & electrolytes, creatinine, eGFR & urate)
Annually (for 4-5 years)
Contact by phone / post / email (questionnaires)
Record linkage for endpoint identification
KEY POINTS- Low workload (search
for eligible patients)- Patient visits (1 or 2)
performed by CRN or practice nurse
- No manual follow-up by practice
GP participation300 GP practices
150 in Scotland, 150 in EnglandHope to randomise around 15 patients per
practiceWe will make it as easy as possible for
practices to participateStudy supported by the CRN (service support
costs paid for time)
