ACC 2018: A Low-Dose Triple Combination Capsule Lowers Blood Pressure More Than Usual Care With No Increase in Adverse Effects
March 12, 2018—Orlando, Florida—A capsule that combines low doses of three antihypertensive medications increased the number of patients who reached blood pressure targets significantly vs usual care. No significant increase in adverse effects was observed with the combination capsule.
This outcome of the randomized TRIple pill vs Usual care Management for Patients with mild-to moderate Hypertension (TRIUMPH) trial was reported at the American College of Cardiology’s 67th Annual Scientific Session, from March 10 – 12.
Ruth Webster, MBBS, of the George Institute for Global Health at the University of New South Wales, Sydney, Australia, explained that, despite the availability of effective blood pressure-lowering drugs, hypertension remains a major global problem. Treating high blood pressure effectively can help prevent heart attacks, strokes, and kidney problems.
Many of those with high blood pressure receive no treatment, however, and only about a third of those who are treated achieve recommended blood pressure reductions. Achieving desired reductions in blood pressure often requires more than one medication, which increases treatment complexity. Patients often find it difficult to adhere to regimens that involve multiple pills daily.
Recommended targets for blood pressure control vary by country. In the US, 2017 guidance of the American College of Cardiology and American Heart Association recommended antihypertensive treatment if blood pressure exceeds 130/80 mmHg. European guidelines recommend a level of ≤140/90 mmHg.
TRIUMPH was the first large trial designed to test the theory that starting treatment with low doses of three drugs could achieve better blood pressure control than usual care and that combining these drugs in a single capsule would facilitate both prescription and adherence.
The TRIUMPH trial was conducted in Sri Lanka. It enrolled 700 patients whose average age was 56 years, 58% of whom were women. Participants had an average blood pressure of 154/90 mm Hg. Over half (59%) were receiving no treatment for high blood pressure before they enrollment. In addition to high blood pressure, 32% had diabetes or chronic kidney disease.
Patients were randomized to either the combination capsule or usual care. 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.
The primary endpoint was the proportion of patients who achieved a target of ≤140/90 mm Hg (≤130/80 mm Hg in those with diabetes or chronic kidney disease) at 6 months.
Compared with patients receiving usual care, a significantly higher proportion of patients receiving the combination capsule achieved target blood pressure at 6 months. Average blood pressure reduction was 8.7 mm Hg for the combination and 4.5 mm Hg for those receiving usual care.
After 6 months, 83% of patients who received the combination capsule were still receiving it and one-third of those in the usual-care group were receiving at least 2 antihypertensive drugs.
The maximum difference between the 2 groups of patients was observed 6 weeks after starting treatment, when 68% of those receiving the triple combination had achieved blood pressure within their target range vs 44% of those receiving usual care. This represented a 53% reduction in the risk of hypertension for patients receiving the combination.
Rates of participants having to change treatment due to side effects did not differ significantly between in the two groups (6.6% for the triple combination, 6.8% for usual care). This comparable rate should allay concerns that use of the combination capsule could lead to an unacceptable increase in side effects.
Each of the drugs used in the triple capsule has been shown to be highly effective in reducing blood pressure and preventing deaths and illness due to heart disease and strokes. Each drug represents a different class of medication and combining such drugs has been shown to lead to synergistic effects.
According to Dr. Webster, low- and middle-income countries have the most urgent need for new strategies for controlling blood pressure. The triple capsule approach provides an innovative opportunity for clinicians to provide effective care for patients.
The study’s findings are also important for high-income countries.
Dr. Webster noted that high-income settings that could achieve a control rate of 70% would be a considerable improvement. For initial treatment, most guidelines do not recommend using combination blood pressure-lowering therapy; however, the current findings suggest that these recommendations related to combination therapy should be reconsidered.
Dr. Webster’s team is conducting a cost-effectiveness study as well as a follow-up qualitative study to learn what participants and physicians thought about using the combination capsule.
According to Dr. Webster, of the patients who received the combination capsule, 70% reached their blood pressure target. Importantly, benefits were seen immediately and maintained through 6 months. Comparatively, 55% of patients receiving usual care achieved blood pressure control at 6 months, with even lower rates earlier in the trial. Dr. Webster noted that their results demonstrate that the new delivery of antihypertensive drugs was as safe as current therapies and was more effective.
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