At 6 weeks 68% of those receiving the Triple Pill achieved a blood pressure within their target range, versus 44% of those receiving usual care.
Ruth Webster, MBBS
A new study, presented today at the 67th American College of Cardiology Annual Scientific Session, concluded that initial use of low-dose triple combination therapy is a safe and highly effective strategy to rapidly achieve blood pressure control compared with usual care.
The Triple Pill, which combines low doses of 3 blood pressure-lowering medications, was found to significantly increase the number of patients reaching blood pressure targets when compared with usual care. Researchers found no significant increase in adverse effects with the combination therapy.
“Most people — 70% — reached blood pressure targets with the Triple Pill,” lead study author Ruth Webster, MBBS, The George Institute for Global Health at the University of New South Wales, said in a statement. “The benefits were seen straight away and maintained until 6 months, whereas with usual care control rates were 55% at 6 months and even lower earlier in the trial.”
Findings demonstrated that early use of a low-dose 3 in 1 combination blood pressure lowering pill is safe and provides faster and better control of blood pressure as opposed to usual care.
This study, known as TRIUMPH, was the first large trial designed to test the theory that starting treatment with low doses of 3 drugs could better achieve blood pressure control versus usual care.
Webster said that combining the 3 drugs in a single pill would make it easier for clinicians to not only prescribe treatment but for patients to adhere to it.
“Based on our findings, we conclude that this new method of using blood pressure-lowering drugs was more effective and just as safe as current approaches,” Webster added.
TRIUMPH was conducted in Sri Lanka and enrolled 700 patients with an average age of 56 years, of which a majority of participants (58%) were women.
Participants had an average blood pressure of 154/90 mmHg, and more than half (59%) were receiving no treatment to maintain levels before enrolling in the trial. In addition to high blood pressure, 32% of patients suffered from diabetes or chronic kidney disease.
Study patients were randomly assigned to receive either the combination pill which consisted of blood pressure medications telmisartan (20 mg), amlodipine (2.5 mg) and chlorthalidone (12.5 mg), or usual care — which meant that patients received doctor’s choice of blood pressure-lowering medication.
The primary outcome of the study was achieving a blood pressure target at 6 months of <140/90 mmHG or less (<130/80 mmHg in those with diabetes and/or chronic kidney disease).
Secondary outcomes included blood pressure control at 6 and 12 weeks, a mean change in systolic blood pressure and diastolic blood pressure at 6 months, tolerance to treatment at 6 months, and self-reported blood pressure lowering medication use.
Findings concluded that when comparing the 2 patient arms, a significantly higher proportion of patients receiving the Triple Pill achieved their target blood pressure at 6 months. Average reduction in blood pressure was 8.7 mmHG for those receiving the triple-combination therapy and 4.5 mmHg for those receiving usual care.
At the 6-month mark, 83% of participants in the Triple Pill arm were still receiving the combination pill and one-third of those in the usual-care group were receiving at least 2 blood pressure-lowering drugs.
The largest difference between the 2 arms was observed at 6 weeks when 68% of those receiving the Triple Pill achieved a blood pressure within their target range, versus 44% of those receiving usual care. Researchers said that this represented a 53% reduction in the risk for high blood pressure in those receiving the Triple Pill.
The rate of patients having to change treatment due to side effects was not significantly different in the groups (6.6% for the Triple Pill and 6.8% for usual care).
Each of the drugs that make up the Triple Pill represent a different class of blood pressure medication and previous studies suggest that combining them results in synergistic effects. The 3 medications also have proven highly effective in reducing blood pressure and preventing deaths and illness due to heart disease and strokes.
Researchers strongly support the strategy of early use of the Triple Pill therapy in all settings, especially in areas with an urgent need like low and middle-income countries that have great disease burden.
These findings are also important for high-income countries too.
“A control rate of 70% would be a considerable improvement even in high-income settings,” Webster said. “Most hypertension guidelines in these countries do not recommend combination blood pressure-lowering therapy for initial treatment in all people. Our findings should prompt reconsideration of recommendations around the use of combination therapy.”
A follow-up qualitative study is being conducted to collect thoughts from patients and doctors about the Triple Pill. Researchers are also conducting a cost-effectiveness evaluation to determine whether the Triple Pill is a cost-effective solution for blood pressure management.
In the US guidance released in 2017 by the American College of Cardiology and the American Heart Association, it’s recommended to initiate treatment if blood pressure exceeds 130/80 mmHG, while European guidelines recommend that treatment should aim to achieve a blood pressure level of 140/90 mmHg or less.
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