Study identification

PURI

https://redirect.ema.europa.eu/resource/34126

EU PAS number

EUPAS25523

Study ID

34126

Official title and acronym

Bendroflumethiazide versus Indapamide for Primary Hypertension: Observational (BISON) study within CPRD

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This 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.

Study status

Ongoing
Research institution and networks

Institutions

University of Dundee
United Kingdom
First published:
01/02/2024
Institution
Educational Institution

Contact details

Thomas MacDonald

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

FARR Institute research grant and, MEMO departmental funds
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable