The planned study design is a longitudinal retrospective observational cohort study based on a population with hypertension determined from the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) database in the United Kingdom. These databases will be utilized for baseline characteristics such as laboratory measures or comorbidities. CPRD database will be utilized to study treatment patterns and achieved systolic blood pressure (SBP) over time, and HES and Office for National Statistics (ONS) databases to follow up the study outcomes. Primary objective and first secondary objective will describe event rates over time for the primary and secondary cardiovascular (CV) outcomes, as well as for the other secondary outcomes (including end stage renal disease, dementia and all-cause death) via Kaplan-Meier analyses. Primary CV outcomes include nonfatal myocardial infarction, nonfatal stroke (ischemic or haemorrhagic), hospitalization for heart failure, and CV death. Secondary CV outcomes include the primary CV outcomes plus atrial fibrillation, carotid surgery, coronary revascularization (angioplasty or surgery), peripheral revascularization and abdominal aortic aneurysm repair. Possible risk factors for the primary and secondary outcomes will be assessed via a Cox proportional hazards model and will include patient demographics, clinical characteristics, laboratory measures, lifestyle, and medication characteristics. Summary statistics of these variables will be provided as part of the second secondary objective. To address the last secondary objective, treatment summary measures over time for anti-hypertensive therapies (including angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, calcium channel blocker, diuretic, beta-blockers, spironolactone, and alpha-blockers), as well as rates of all possible events informing treatment initiation, intensification, discontinuation, and re-start, and SBP levels will be described. Analyses will be provided for the whole study population and separately for each subgroup of interest (diabetes mellitus at baseline, atherosclerotic cardiovascular disease at baseline, and treatment with commonly prescribed anti-hypertensive agents (ramipril, irbesartan, or amlodipine) at baseline).
Primary outcome will be defined as composite of nonfatal myocardial infarction (MI), nonfatal stroke (ischemic or haemorrhagic), hospitalization for heart failure, and cardiovascular (CV) death.
Secondary outcomes will be defined as: composite of nonfatal MI, nonfatal stroke, hospitalization for heart failure, end stage renal disease (ESRD), and CV death; composite of nonfatal MI, nonfatal stroke, hospitalization for heart failure, ESRD, atrial fibrillation, carotid surgery, coronary revascularization (angioplasty or surgery), peripheral revascularization, dementia diagnosis, and CV death; nonfatal MI, nonfatal stroke, CV death, all-cause death, hospitalization for heart failure, ESRD, atrial fibrillation, carotid surgery, coronary revascularization (angioplasty or surgery), peripheral revascularization, abdominal aortic aneurysm repair, or dementia diagnosis, separately.
Descriptive variables during the follow-up will be anti-hypertensive therapies (including angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, calcium channel blocker, diuretic, beta-blockers, spironolactone, and alpha-blockers) and systolic blood pressure levels.
Pia Horvat - Chief Investigator - IQVIA Ltd
Nelly Ly - Corresponding Applicant - IQVIA Ltd
Alexandra Koumas - Collaborator - Axtria Inc. USA
Ankita Chauhan - Collaborator - Axtria Inc. USA
Anna Castelo Branco - Collaborator - IMS Health Sweden AB
Aurore Tricotel - Collaborator - IQVIA Operations France SAS
Christian Siegfried - Collaborator - Axtria Inc. USA
Christopher Lee - Collaborator - IQVIA Ltd
Emil Vatov - Collaborator - IQVIA Solution Bulgaria EOOD
Gianluca Lucrezi - Collaborator - IQVIA AG (Switzerland)
Jessica Lundbom - Collaborator - IQVIA Ltd
Louise Raiteri - Collaborator - IQVIA Ltd
Nelly Ly - Collaborator - IQVIA Ltd
Nicole Rutishauser - Collaborator - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Oriane BRETIN - Collaborator - IQVIA Operations France SAS
Quratul Ann - Collaborator - IQVIA Ltd
Sophia Rodopoulou - Collaborator - IQVIA Hellas Technology Solutions S.A.
Stavros Oikonomou - Collaborator - IQVIA Solution Bulgaria EOOD
Sushant Pal - Collaborator - Axtria India Pvt. Ltd.
Tarana Mehdikhanova - Collaborator - IQVIA Ltd
Vanessa Marzola - Collaborator - IMS Health Sweden AB
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation