In the United Kingdom (UK) 13 out of 100 patients suffer from high blood pressure. It is an important risk factor for diseases involving the heart or the blood vessels, for diseases involving the blood vessels of the brain and the cerebral blood circulation, and for early death. High blood pressure can be treated with one or more drugs from these groups: Beta-blocker, angiotensin-converting enzyme inhibitor, angiotensin II receptor blockers, calcium channel blockers, and diuretic. Each group have different working mechanisms, and because of this they have different benefits and side effects.
Our study will compare the benefit on heart and brain diseases, and on mortality of the Beta-blocker group against each of the four other groups, in patient recently diagnosed and starting for the first time a treatment for high blood pressure.
Moreover, our study will give information about patients treated during several years, which is of importance as high blood pressure is a chronic disease. In addition, using data from the primary health care system in the UK will help understand the benefits of these drugs in day to day clinical practice.
Primary objective is to compare the all-cause mortality in newly hypertensive patients initiating a Beta-blocker in monotherapy, compared to angiotensin-converting enzyme inhibitor (ACE-I) monotherapy, compared to angiotensin II receptor blockers monotherapy, compared to calcium channel blockers (CCB) monotherapy, compared to diuretic monotherapy. Secondary outcomes are cardiovascular mortality, cardiovascular events (myocardial infarction, angina, arrhythmia), cerebrovascular events (stroke) and discontinuation of index treatment.
Newly hypertensive patients initiating a monotherapy with an antihypertensive drug between 2000 and 2017 will be allocated to one of the cohort: Beta-blocker, ACE-I, ARB, CCB, or diuretic. Only patients with a diagnosis of hypertension for the first time ever within the 6 months before the first antihypertensive prescription date (index date) will be included. Patients will be followed until: addition of another antihypertensive drug, discontinuation of the index antihypertensive class, occurrence of an outcome of interest (depending on the analysis: death, cardiovascular or cerebrovascular events, treatment discontinuation), patient death, last data collection date in the CRPD, or end of study period, which ever came first.
Differences in all-cause mortality between cohorts will be assessed using Cox proportional hazards models, and differences in the secondary outcomes using Cox proportional hazards models and Fine and Gray's proportional subdistribution hazards models.
All-cause mortality (Primary outcome)
Cardiovascular mortality
Cardiovascular event
- Myocardial infarction
- Arrhythmia
- Angina episode
Cerebrovascular event
- Stroke
- Haemorrhagic stroke
- Ischaemic stroke
Discontinuation of index treatment
Caroline Foch - Chief Investigator - Merck Healthcare KGaA (Merck Group)
Caroline Foch - Corresponding Applicant - Merck Healthcare KGaA (Merck Group)
Arthur Allignol - Collaborator - Merck Healthcare KGaA (Merck Group)
Emmanuelle Boutmy - Collaborator - Merck Healthcare KGaA (Merck Group)
Patrice Verpillat - Collaborator - Merck Healthcare KGaA (Merck Group)
Thilo Hohenberger - Collaborator - Merck Healthcare KGaA (Merck Group)
Meritxell Sabido - Chief Investigator - Merck Healthcare KGaA (Merck Group)
ONS Death Registration Data