Status: Ongoing First registered on: 13/09/2018
Last updated on: 13/03/2020
1. Study identification
EU PAS Register NumberEUPAS25523
Official titleBendroflumethiazide versus Indapamide for Primary Hypertension: Observational (BISON) study within CPRD
Study title acronymBISON
Study typeObservational study
Brief description of the studyThis study aims to compare the effects of prescribing indapamide, a thiazide-like diuretic, with bendroflumethiazide, a thiazide diuretic, as the first-line choice of diuretic in the treatment of hypertension. The outcome measure will be a composite of non-fatal myocardial infarction, acute coronary syndrome, stroke, acute decompensated heart failure or death from cardiovascular causes. We will identify in CPRD all patients aged 18 years and over with first diagnosis of hypertension after 1987. Among them, we will form two groups with first ever prescription of indapamide or bendroflumethiazide. We will follow the groups either to the date of last prescription, date of medication switch, date of additional medication for hypertension (such as beta-blockers, calcium channel blockers, ACE inhibitors, alpha-blockers, ARBs or other antihypertensive medication), date of outcome, date of de-registration with the medical practice or the date of last practice data collection. We will also extract information on patient age, sex, medical practice, co-morbidities, co-prescribed medication, smoking, weight and alcohol consumption. Incidence of event rates will be calculated in each group. Descriptive analysis, and univariate and multivariate Cox regression survival models will be used as appropriate. Subgroup analyses will be implemented for known risk factors. This large population-based study may provide new evidence on the potential benefit of treating hypertensive patients with indapamide or bendroflumethiazide and may inform future clinical trials.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableISAC protocol 17_232 https://www.cprd.com/isac/
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsMEMO
Department/Research groupMedicines Monitoring Unit
Organisation/affiliationUniversity of Dundee
Website/Homepage
Details of (Primary) lead investigator
Title Professor
Last name MacDonald
First name Thomas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/2018
Start date of data collection13/09/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report30/06/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councilsFARR Institute research grant and50
EU funding scheme
OtherMEMO departmental funds50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name MacDonald
First name Thomas
Address line 1Medicines Monitoring Unit/Hypertension Research Centre
Address line 2Ninewells Hospital & Medical School 
Address line 3Level 7 
CityDundee 
PostcodeDD1 9 SY 
CountryUnited Kingdom
Phone number (incl. country code)441382383119 
Alternative phone number441382383232 
Fax number (incl. country code)441382643204 
Email address t.m.macdonald@dundee.ac.uk
Public Enquiries
Title Professor 
Last name MacDonald 
First name Thomas 
Address line 1Medicines Monitoring Unit/Hypertension Research Centre 
Address line 2Ninewells Hospital & Medical School 
Address line 3Level 7 
CityDundee 
PostcodeDD1 9 SY 
CountryUnited Kingdom 
Phone number (incl. country code)441382383119 
Alternative phone number441382383232 
Fax number (incl. country code)441382643204 
Email address t.m.macdonald@dundee.ac.uk 
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