High
blood pressure is the leading cause of mortality and cardiovascular disease
globally, and most of the disease burden occurs in low- and middle-income
countries. Recent guidelines recommend lower blood pressure targets
among high-risk patients, increasing the need for more effective treatment
strategies.
Treatment with a pill combining low
doses of three antihypertensive drugs results in an increased proportion of
patients with mild-to-moderate hypertension achieving their target blood
pressure (BP), according to a study published in the Journal of the American
Medical Association. This outcome of the randomized TRIple pill vs
Usual care Management for Patients with mild-to moderate Hypertension (TRIUMPH)
trial was also reported at the American
College of Cardiology’s 67th Annual Scientific Session.
The combination capsule consisted of telmisartan (20 mg), amlodipine (2.5 mg), and chlorthalidone (12.5 mg). Usual care was the physician’s choice of blood pressure-lowering medication.
Key Points
Question: Does
the use of a pill containing low doses of 3 antihypertensive medications
provide improved blood pressure control compared with usual care among patients
with mild or moderate hypertension?
Findings: In
this randomized clinical trial of 700 patients with hypertension who were
untreated or receiving monotherapy, 70% of patients in the triple combination
pill therapy group achieved a systolic/diastolic blood pressure of less than
140/90 mm Hg (or <130/80 mm Hg in patients with diabetes or chronic kidney
disease) at 6 months compared with 55% of patients in the usual care group (a
significant difference).
Meaning: Use
of a low-dose triple combination blood pressure–lowering pill for initiation of
treatment or escalation from monotherapy increased the proportion of patients
with hypertension reaching their blood pressure targets.
Benefits: A fixed low-dose combination therapy with inexpensive
blood pressure–lowering drugs has the potential to address several barriers to
improve blood pressure control. Low-dose combinations improve efficacy, adverse
events are minimized at half-standard doses, and the benefits are additive
across blood pressure–lowering medication classes.
Furthermore, fixed-dose
combinations can improve medication adherence due to regimen simplification,
thereby reducing patient, physician, and health system barriers related to
multiple visits and prolonged titration schedules.
Importance Poorly
controlled hypertension is a leading global public health problem requiring new
treatment strategies.
Objective To
assess whether a low-dose triple combination antihypertensive medication would
achieve better blood pressure (BP) control vs usual care.
Design, Setting, and Participants Randomized,
open-label trial of a low-dose triple BP therapy vs usual care for adults with
hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg; or in
patients with diabetes or chronic kidney disease: >130 mm Hg and/or >80
mm Hg) requiring initiation (untreated patients) or escalation (patients
receiving monotherapy) of antihypertensive therapy. Patients were enrolled from
11 urban hospital clinics in Sri Lanka from February 2016 to May 2017;
follow-up ended in October 2017.
Interventions A
once-daily fixed-dose triple combination pill (20 mg of telmisartan, 2.5 mg of
amlodipine, and 12.5 mg of chlorthalidone) therapy or usual care.
Main Outcomes and Measures The
primary outcome was the proportion achieving target systolic/diastolic BP
(<140/90 mm Hg or <130/80 mm Hg in patients with diabetes or chronic
kidney disease) at 6 months. Secondary outcomes included mean
systolic/diastolic BP difference during follow-up and withdrawal of BP
medications due to an adverse event.
Results Among
700 randomized patients (mean age, 56 years; 58% women; 29% had diabetes; mean
baseline systolic/diastolic BP, 154/90 mm Hg), 675 (96%) completed the trial.
The triple combination pill increased the proportion achieving target BP vs
usual care at 6 months. Mean systolic/diastolic BP at 6 months was 125/76 mm Hg
for the triple combination pill vs 134/81 mm Hg for usual care. Overall, 419
adverse events were reported in 255 patients (38.1% for triple combination pill
vs 34.8% for usual care) with the most common being musculoskeletal pain and
dizziness, presyncope, or syncope. There were no significant between-group
differences in the proportion of patient withdrawal from BP-lowering therapy
due to adverse events.
Conclusions and Relevance Among
patients with mild to moderate hypertension, treatment with a pill containing
low doses of 3 antihypertensive drugs led to an increased proportion of
patients achieving their target BP goal vs usual care. Use of such medication
as initial therapy or to replace monotherapy may be an effective way to improve
BP control.
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