The efficacy and safety of concomitant treatment with telmisartan, candesartan or bisoprolol in combination with amlodipine in patients with essential arterial hypertension: outcomes in real world practice

Date of ISAC Approval: 
Lay Summary: 
Amlodipine, bisoprolol and telmisartan are well-established medicines used to manage high blood pressure. A single tablet containing amlodipine and telmisartan and another containing amlodipine and bisoprolol are proposed as substitute therapies for high blood pressure in patients already treated with either pair of medicines as individual tablets at the same dose. Combined tablets reduce the number of tablets taken daily and the effort involved for the patient in managing their tablets. The aim of this study is to examine the safety and effectiveness of telmisartan/amlodipine and bisoprolol/amlodipine when taken together. Patients with high blood pressure prescribed telmisartan, bisoprolol or amlodipine at a stable dose, who are then prescribed one of the other medicines (amlodipine followed by telmisartan or bisoprolol; telmisartan or bisoprolol followed by amlodipine) will be identified from CPRD. Change in blood pressure will be investigated at 30-150 days and 90-270 days after the addition of the second medicine. Any side effects recorded in the first year after starting the combined treatment will be investigated. Because patients usually receive only one blood pressure medication initially, we will be able to determine how the addition of the other medicine affects blood pressure and side effects.
Technical Summary: 
The aim of this study is to evaluate the effectiveness and safety of concomitant treatment with telmisartan and amlodipine or bisoprolol and amlodipine for the treatment of hypertension to support the marketing authorisation application of fixed-dose combinations. A retrospective cohort study will be conducted using data from the Clinical Practice Research Datalink (CPRD). Patients with essential arterial hypertension prescribed telmisartan, bisoprolol or amlodipine at a stable dose followed by augmentation of antihypertensive therapy using the other monocomponent will be identified from CPRD. The index date will be defined as the date that telmisartan or bisoprolol are prescribed in combination with amlodipine. Other antihypertensive agents can be prescribed concomitantly provided they are not initiated or modified less than one month prior to the index date. Patients with secondary hypertension will be excluded. Study subjects will be matched to a reference group whose antihypertensive therapy (telmisartan, bisoprolol or amlodipine) is augmented with an additional antihypertensive agent other than telmisartan, bisoprolol or amlodipine. Change in systolic and diastolic blood pressure between baseline and 30-150 days and 90-270 days post index will be investigated. The incidence of safety events of interest reported in the first year post index will be calculated.
Health Outcomes to be Measured: 
Changes in blood pressure

Professor Craig Currie - Chief Investigator - Pharmatelligence
Dr Christopher Morgan - Researcher - Pharmatelligence
Dr Sara Jenkins-Jones - Researcher - Pharmatelligence
Sarah Holden - Corresponding Applicant - Pharmatelligence