EFFECT OF A NEW TRIPLE SINGLE-PILL COMBINATION ON ORTHOSTATIC HYPOTENSION AND SYMPTOMATIC HYPOTENSION

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Objective: We evaluated the effect of GMRx2 (US tradename WIDAPLIKTM), a single pill triple combination (SPC) of telmisartan (T), amlodipine (A) and indapamide (I) on orthostatic and symptomatic hypotension, compared with placebo and dual blood pressure (BP) therapies, in patients with hypertension. Design and method: Individual patient data from two randomised controlled trials were analyzed: (1) a placebo-controlled trial (PCT, n=295) investigated the efficacy of GMRx2 Dose 1 (T 10 mg/A 1.25 mg/I 0.625 mg), or Dose 2 (T 20 mg/A 2.5 mg/I 1.25 mg), versus placebo over 4 weeks; and (2) an active-controlled trial (ACT, n=1385) comparing GMRx2 Dose 2 over 6 weeks followed by escalation to Dose 3 (T 40 mg/A 5 mg/I 2.5 mg) over weeks 6-12 versus dual therapies at comparable doses. Orthostatic hypotension was defined as a decrease in clinic SBP of >=20 mmHg or DBP of >=10 mmHg from sitting to standing. Occurrence of symptomatic hypotension was collected as an adverse event of special interest. Results: 1584 participants (mean age: 58 years; 52% female) were included. In PCT, the incidence of orthostatic hypotension at week 4 was similar across treatment groups (GMRx2 Dose 1: 6.2%, Dose 2: 3.4%, placebo 4.8%). Symptomatic hypotension was more common in the GMRx2 groups (3.5% to 5.1%) than in the placebo group (0.0%). In ACT, orthostatic hypotension was comparable at both week 6 (GMRx2 Dose 2: 5.0% vs dual therapies 5.0–7.0%) and week 12 (GMRx2 Dose 3: 5.0% vs dual therapies 5.0–8.0%), with no significant differences between groups. At week 6, symptomatic hypotension was low across all treatment groups (0.4–1.0%). At week 12, symptomatic hypotension was numerically higher in the GMRx2 Dose 3 (5.9%), compared to dual therapies (1.4–4.0%). Conclusions: GMRx2 was not associated with an increased risk of orthostatic hypotension compared with dual therapies or placebo. Low levels of symptomatic hypotension were evident in all active treatment groups. These data provide further evidence that low dose SPCs have acceptable tolerability, even when used as initial therapy.

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