Hypertension (high blood pressure) affects approximately one third of the population and is associated with a range of serious conditions including heart attacks, strokes and kidney disease. It is therefore important to keep blood pressure within normal levels. Usually, patients with hypertension will be asked to make lifestyle changes but if their blood pressure remains high, they may be prescribed a blood pressure lowering drug. If this drug alone fails to reduce blood pressure to a target level, an additional, different type of blood pressure lowering drug may be prescribed. However, taking multiple tablets can be burdensome for patients and there is evidence that if they can be combined in a single tablet, they will be more effective as it is easier for patients to remember to take them. We want to examine the efficacy and safety of taking candesartan (a type of drug known as an angiotensin receptor blocker) and indapamide (a type of drug known as a diuretic) in combination. Patients with a diagnosis of hypertension prescribed either drug who have the other added to their prescription will be selected in the Clinical Practice Research Datalink. Their blood pressure at the time they begin taking the two drugs together will be extracted, evaluated and compared to subsequent measurements recorded at 30–150 days and 90–270 days. Side effects recorded in the first year after starting the combined treatment will also be extracted and evaluated. This will provide important data which will inform drug development and hence improve patient outcomes
Hypertension affects approximately 30% of the UK population and features in the aetiology of a range of conditions. This study aims to evaluate the efficacy and safety of concomitant treatment with two anti-hypertensives, candesartan and indapamide.. A retrospective cohort study will be conducted in the Clinical Practice Research Datalink Aurum and GOLD databases. Patients with essential arterial hypertension prescribed candesartan or indapamide at a stable dose followed by augmentation of the other monocomponent will be selected. The combination of candesartan in two different strengths and indapamide will be presented separately. The index date will be defined as the date that candesartan and indapamide are prescribed in combination. 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. Blood pressure measurements at baseline and checkpoints 1 and 2 will be compared using the dependent t test or paired sample Wilcoxon signed ranks test depending on the distribution. Between groups comparisons will use the independent t-tests (or Mann-Whitney U test) for two groups or ANOVA (or Kruskal-Wallis tests) if there are more than two The proportion of patients reaching targets will be reported. The incidence of safety events will be reported in the year post index and compared to a reference group whose antihypertensive therapy (candesartan or indapamide) is augmented with a different antihypertensive agent. This study will provide valuable data that will assist in the potential development of a fixed dosed combination therapy. There is evidence that combined therapy improves patient compliance and hence both short term and long term outcomes with ultimate efficiencies for health services.
Systolic blood pressure change, diastolic blood pressure change, adverse events.
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Irena Orel - Collaborator - Krka - Slovenia
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Redenšek Trampuž - Collaborator - Krka - Slovenia
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data Sciences