Clinical effectiveness of combining two drugs versus monotherapy as initial treatment strategy in hypertension - a matched cohort study in CPRD

Date of Approval
Application Number
16_166
Technical Summary

The main objective of this study is to assess the effectiveness of initiating therapy with two drugs in combination versus monotherapy as the initial drug treatment strategy in hypertension.
Adults with hypertension and initiating antihypertensive drugs, including angiotensin-converting enzyme inhibitors, angiotensin-II receptor blockers, calcium-channel blockers, thiazide and thiazide-like diuretics and beta-blockers, between 2006 and 2014 will be identified and followed until 2015. Patients initiating two drugs in combination (given as fixed or free combination) will be matched (1:4) to those initiated on a single drug using a propensity score built on key baseline characteristics to control for channelling bias.
The primary outcome will be time to blood pressure control while secondary outcomes will include a composite endpoint (acute non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) and time to treatment response. Incidence rates will be estimated in each cohort. Cox proportional hazards models will be used to estimate hazard ratios and assess the potential association between initial therapy strategy and these outcomes.
Analyses will be replicated for patients with grade 1 hypertension and for patients initiating angiotensin-converting enzyme inhibitors and/or calcium-channel blockers. This large population-based study should identify any potential benefits associated with an initially more intensive hypertension treatment strategy.

Health Outcomes to be Measured

Primary outcome. Time to Blood Pressure control Secondary outcomes. Risk of a serious cardiovascular (composite endpoint of acute non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) Time to treatment response

Collaborators

Karine Marinier - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
Karine Marinier - Corresponding Applicant - IRIS - Institut de Recherches Internationales Servier
Giuseppe Mancia - Collaborator - University Milano-Bicocca
Martine De CHAMPVALLINS - Collaborator - Servier Laboratories - UK
Neil Poulter - Collaborator - Imperial College London
Pauline Macouillard - Collaborator - IT&M Stats

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation