Descriptive efficiency and safety of a combination of ramipril and bisoprolol in patients with primary hypertension: A Database Study

Date of Approval: 
2020-10-08 00:00:00
Lay Summary: 
High blood pressure affects approximately 31% of men and 26% of women in the UK. Ramipril and bisoprolol are two medications commonly used to treat high blood pressure. Combining both treatments may improve the effectiveness (how well the medication works) and safety with less side effects and better quality of life for patients. This study aims to look at how well these separate medications work when prescribed together by describing the changes in blood pressure at 3 months and 6 months from when patients first started both treatments at dose strengths greater than 5 mg. The main side effects that are recorded within the first year after being prescribed both medications will also be investigated. The results of this study will provide better understanding of the effects of these two medications when taken together.
Technical Summary: 
The aim of this cohort study is to describe the effectiveness of the free combination of ramipril and bisoprolol on change of blood pressure (BP) in individuals with uncontrolled primary hypertension who start at dosage ≥5mg on both treatments Ramipril and Bisoprolol. The treatment with the free combination of ramipril and bisoprolol will be categorised as either a concomitant prescription or a sequential add-on prescription according to how the treatment was modified at index date. Concomitant initiation is defined when an individual is first prescribed with dosages ≥5mg for both drugs, ramipril and bisoprolol (or in a time window < 15 days). Sequential add-on prescription is defined when a dosage ≥5mg for the second monocomponent is added more than 15 days after of an existing stable treatment at a dosage ≥5mg of the first component. Individuals will be excluded if they have a record of the second monocomponent at a dosage ≥5mg in the 6-months prior to its initiation. Individuals will be followed-up for a maximum of 12-months, or until the dosage of any of the monocomponents is decreased to <5 mg, one of the drugs or both are stopped, a change in another hypertensive medication, loss to follow up or death. Changes in systolic and diastolic BP and the proportion of individuals who achieve BP control will be assessed at 3 months and 6 months compared to the baseline BP measurement at ID. The patient profile of demographic characteristics, existing comorbidities, prior cardiovascular disease history and concomitant medications use will also be described. The incidence of safety events of interest reported during treatment period + 30 days with a maximum follow-up of 12 months after ID will be reported.
Health Outcomes to be Measured: 
Effectiveness: Blood pressure change and blood pressure control; Safety (Adverse Events): Hepatic impairment; Obstructive pulmonary disorders; Anaphylactic shock; Hypotension; Renal impairment/renal dysfunction; Bradycardia; Arrhythmia; Peripheral artery disease; Severe skin reaction; Bone marrow depression; Pancreatitis; Death.
Application Number: 

Emmanuelle Jacquot - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
Kirsty Andresen - Corresponding Applicant - OXON Epidemiology - UK
Bélène Podmore - Collaborator - OXON Epidemiology - Spain
Ignacio Mendez - Collaborator - OXON Epidemiology - Spain
Lorena Baquero Portela - Collaborator - OXON Epidemiology - Spain
MIGUEL DESCALZO - Collaborator - OXON Epidemiology - Spain
Nawab Qizilbash - Collaborator - OXON Epidemiology - Spain
Raúl Sánchez - Collaborator - OXON Epidemiology - Spain
Rosie Barnett - Collaborator - OXON Epidemiology - Spain

HES Admitted Patient Care;ONS Death Registration Data