PATHWAY-1: Monotherapy vs. dual therapy for initial treatment for hypertension
There is evidence from other clinical trials that patients who have their hypertension more aggressively treated early on, maintain better blood pressure control in the longer term. Patients treated less aggressively do not appear to "catch-up" in terms of BP control.
PATHWAY-1 is designed to determine if initial combination therapy for hypertension results in better BP control than initial monotherapy. The study also aims to determine if the "never catch-up" phenomenon persists for at least one year, to understand the mechanism underlying this phenomenon and better understand predictors of BP control, to validate the NICE/BHS "ACD" algorithm, and to determine the safety/tolerability of initial combination therapy.
The protocol for PATHWAY-1 is shown above. Patients will be recruited if their BP is above target, and they are either untreated or on monotherapy. Patients will be randomised to either initial dual therapy (with an angiotensin receptor blocker, losartan, and a diuretic, hydrochlorothiazide) or monotherapy (with either of losartan or hydrochlorothiazide). The monotherapy group will be stepped up to dual therapy, before both arms of the trial are switched to open-label treatment with a combination-tablet containing both therapeutic agents.