HypertensionRandomised controlled trial
Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial
- Randomised controlled trial
- double-blind
- active-controlled
- international
- 4-week active run-in
- 2:1:1:1 allocation
- Conducted between July 9, 2021 and Sept 1, 2023
Authors' conclusion
A novel low-dose SPC product of telmisartan, amlodipine, and indapamide provided clinically meaningful improvements in blood pressure reduction compared with dual combinations and was well tolerated.
Study context
- Population
- Adults with hypertension on 0–3 antihypertensive drugs, screening systolic blood pressure (SBP) 140–179 mm Hg (no drugs) to 110–150 mm Hg (three drugs); Australia, Czech Republic, New Zealand, Poland, Sri Lanka, UK, USA
- Participants
- 1,385 adults
- Comparison
- Low-dose triple SPC GMRx2 vs dual combinations of its components
- GMRx2n = 551
- Telmisartan-indapamiden = 276reference
- Telmisartan-amlodipinen = 282reference
- Amlodipine-indapamiden = 276reference
- Primary endpoint
- Mean change in home SBP from baseline
- Follow-up
- Week 12
Primary result
As reported in the abstract
Home SBP
GMRx2
126
mean · mm Hg
Difference (95% CI)P value
GMRx2 vs Telmisartan-indapamide
−2.5(−3.7 to −1.3)
P < 0.0001GMRx2 vs Telmisartan-amlodipine
−5.4(−6.8 to −4.1)
P < 0.0001GMRx2 vs Amlodipine-indapamide
−4.4(−5.8 to −3.1)
P < 0.0001Secondary outcomes
| Outcome | GMRx2 | Telmisartan-indapamide | Telmisartan-amlodipine | Amlodipine-indapamide |
|---|---|---|---|---|
| Clinic BP control rate <140/90 mm Hg · week 12 | 74% | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract |
- Clinic BP control rate <140/90 mm Hg — Superior with GMRx2 to each dual combination (range for dual combinations)
- 53-61%
Clinic BP difference, GMRx2 vs each dual combination · week 12
- Differences in clinic BP for the same comparisons (vs telmisartan-indapamide, telmisartan-amlodipine, amlodipine-indapamide)
- 4.3/3.5 mm Hg, 5.6/3.7 mm Hg, and 6.3/4.5 mm Hg
- all p<0.001
Safety
Withdrawal of treatment due to AE (primary safety outcome) · baseline to week 12
Withdrawal of treatment due to AE (primary safety outcome) · baseline to week 12
- None of the differences statistically significant
Original publication
Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial. Lancet. Published 19 October 2024. doi:10.1016/s0140-6736(24)01744-6
Summarised from the published abstract; every number is checked against it