In persistent hypertension, low-dose triple-pill therapy increased the likelihood of achieving target BP at 6 mo
- Donato, Anthony MD, MHPE
Question
In patients with persistent hypertension, what is the effectiveness of fixed, low-dose, triple-combination pill therapy compared with usual care?
Methods
Design
Randomized controlled trial (Triple Pill vs Usual Care Management for Patients With Mild-to-Moderate Hypertension [TRIUMPH] trial). ACTRN12612001120864; slctr.lk Identifier SLCTR/2015/020.
Allocation
Concealed.
Blinding
Unblinded.
Follow-up period
6 months.
Setting
11 hospital outpatient centers in Sri Lanka.
Patients
700 adults ≥ 18 years of age (mean age 56 y, 58% women) who had persistent hypertension requiring initiation of treatment (currently not receiving treatment) or titration of pharmacologic therapy (currently treated with a single drug). Exclusion criteria included use of ≥ 2 blood pressure–lowering drugs; systolic blood pressure (SBP) > 180 mm Hg and/or diastolic blood pressure (DBP) > 110 mm Hg; accelerated hypertension or need for slower titration of treatment; contraindication to study treatment; abnormal laboratory values that made participation unsuitable; another condition expected to alter the medication regimen; or pregnancy, breastfeeding, or childbearing potential without contraceptive use.
Intervention
Triple-pill therapy (n = 349) or usual care (n = 351). The triple-pill group stopped monotherapy and started the low-dose triple pill of telmisartan, 20 mg, amlodipine, 2.5 mg, and chlorthalidone, 12.5 mg, once daily. Treatment could be stopped, maintained, or increased at the discretion of the treating physician.
Outcomes
Primary outcome was the proportion of patients who achieved a target BP (SBP < 140 mm Hg and DBP < 90 mm Hg) at 6 months. In patients with diabetes mellitus or chronic kidney disease, the target BP was SBP < 130 mm Hg and DBP < 80 mm Hg. Secondary outcomes included the primary outcome at 6 and 12 weeks, reduction in SBP and DBP at 6 months, and adverse events.
Patient follow-up
92% for the primary outcome.
Main results
The proportions of patients who achieved the target BP at the 3 time points are in the Table. 3.4% of patients in the triple-pill group increased to the higher dose. At 6 months, reductions in mean SBP (−29.1 vs −20.3 mm Hg, mean difference −8.8, 95% CI −11.2 to −6.4) and mean DBP (−13.9 vs −9.3, mean difference −4.6, CI −6.0 to −3.1) were greater in the triple-pill group than in the usual care group. Groups did not differ for the proportion of patients with adverse events (38% vs 35%).
Conclusion
In patients with persistent hypertension, fixed, low-dose, triple-combination pill therapy increased the likelihood of achieving target blood pressure compared with usual care.