In a recent clinical trial led by researchers from the George Institute for Global Health — with branches in the United Kingdom, Australia, and India — they tested the effectiveness and safety of using an innovative drug for the treatment of high blood pressure, or hypertension.
This drug, nicknamed the “triple pill” by the investigators, combines low doses of three existing drugs for blood pressure.
Namely, these are: telmisartan (20 milligrams), amlodipine (2.5 milligrams), and chlorthalidone (12.5 milligrams).
According to World Health Organization (WHO) data from 2008, about 40 perecent of adults aged over 25 had raised blood pressure worldwide. The WHO also estimate that hypertension is responsible for 7.5 million of all deaths across the globe.
That is because this condition is a major risk factor for both heart disease and stroke, making it a priority to have effective treatments in place for the regulation of blood pressure.
The trial will also assess BPaMZ’s potential to treat MDR-TB in six months. Currently, treatment for drug-resistant TB is extremely complicated, expensive, and lengthy, involving a wide variety of medicines that have debilitating side-effects, can include injectable drugs, and are administered for nine months to two years or longer. Today, people with MDR-TB often go untreated, and of those who do receive treatment only about half are cured.
“As resistance to current TB treatments continues to grow, we need to introduce all-oral drug regimens that can treat every person with TB in six months or less, regardless of their resistance profile,” said Mel Spigelman, president and CEO of TB Alliance. “If proven successful in SimpliciTB, the BPaMZ regimen would represent a major step toward this goal.”
The BPaMZ regimen was previously studied in the Phase 2b study called NC-005, in which people with MDR-TB who were treated with the BPaMZ regimen cleared TB bacteria from their lungs up to three times faster than drug-sensitive TB patients treated with the standard (HRZE) treatment. NC-005 was an eight-week trial conducted at 10 sites across Uganda, South Africa and Tanzania. SimpliciTB builds on these results, testing BPaMZ over a longer duration, in more people and across more sites, and against both drug-sensitive and MDR-TB.
According to the World Health Organization’s most recent Global Tuberculosis Report, there is growing resistance to available drugs, which means the disease is becoming more deadly and difficult to treat. WHO estimates that in 2016 there were 600,000 new cases with resistance to rifampicin-the most effective first-line drug–of which 490,000 had MDR-TB.
Normally, people with hypertension start taking one blood pressure drug at low doses, only to have to return to their doctors time and again. They then get prescriptions for increasingly higher doses and more hypertension drugs.
According to study co-author Dr. Ruth Webster, “Patients are brought back [to the doctor’s office] at frequent intervals to see if they are meeting their targets with multiple visits required to tailor their treatments and dosage.”
“The problem with this approach,” she adds, is that it “is not only time inefficient, it’s costly. We also know that many doctors and patients find it too complicated and often don’t stick to the process.”
So, Dr. Webster and colleagues tested a method that, they hoped, would be more efficient, would not have additional side effects, and would remove some of the inconveniences related to a traditional treatment.
This is how they came up with the “triple pill,” which combines fixed low doses of three already existent drugs commonly used to treat hypertension.
‘Triple pill’ vs. traditional therapy
The clinical trial testing the efficacy and safety of the new combination pill took place in Sri Lanka. It involved 700 participants — aged 56, on average — whose average blood pressure amounted to 154/90 millimeters of mercury (mm Hg), which is a typical sign of hypertension.
Of all the participants, some took the combination pill, while others continued to follow their usual blood pressure-lowering therapy, as per their doctors’ advice.