If 103 million Americans have high blood pressure (hypertension), it's safe to say that's one very big problem indeed. Those latest numbers from the American Heart Association support worldwide statistics that hypertension affects nearly a third of the U.S. adult population. Revised guidelines in 2017 defined hypertension as 130/80, lowering numbers from 140/90.
A potentially game-changing report of a new clinical trial published in the Journal of the American Medical Association in August 2018 may be able to make more than a dent in the numbers of those with high blood pressure. It determined that using a low-dose, triple combination pill to start therapy, or changing from taking just one pill, increased the number of patients with mild to moderate high blood pressure who safely reached their blood pressure targets — which were set at that 140/90 level for this research.
The triple combo, low-dose medication — researchers called it the "Triple Pill" — is comprised of:
- 20mg of telmisartan, an angiotensin receptor blocker that enlarges or dilates blood vessels
- 2.5mg of amlodipine, a calcium channel blocker that relaxes blood vessels
- and 12.5mg of chlorthalidone, a diuretic that helps the body rid itself of extra salt or sodium, and water
Researchers looked at 700 patients in Sri Lanka, South Asia who were assigned either the combo pill or who were receiving "standard care." At 6 months, almost 70 percent of the triple-combo group had reached their target, compared with 55 percent in the usual care group. The average blood pressure reading for the former was 125/76 and for the latter, 134/81.
A worldwide problem
In an email interview, HealthCentral talked to the principal investigator of the trial, professor and cardiologist Anushka Patel, M.B.B.S., S.M., Ph.D., chief scientist of The George Institute for Global Health in its Newton, New South Wales, Australia branch.
The study has gotten significant attention worldwide, and she explained why. She thinks it reflects "an understanding that uncontrolled hypertension is a problem affecting all countries, and that an innovative yet potentially quite simple approach might have substantial impact. Clinical guidelines are slow to change, however, so it might take some time before the results of the trial influence recommendations to doctors. And of course, even when guidelines change, it takes time for doctors to change their practice."
Getting us to take our pills remains a challenge for the medical community. Research shows half of us don't take our meds as prescribed, and nearly 125,000 of us die annually because of it.
With hypertension treatment, patients traditionally start with a low-dose drug, then get an increased dose, then may have another drug added, and must keep returning to the physician for adjustments. That's often a prescription for failure, most blood pressure experts agree.
Managing therapeutic inertia
Dr. Patel think it's hard for us to adjust to taking preventive pills "forever," especially when we feel pretty good while we're still at increased risk of a heart attack or stroke. Then increase the number of pills and prospects for adherence worsen.
"But I think it is worth emphasizing that the problem of under-treatment is not just about people taking the pills that they have been prescribed, but also doctors not prescribing a sufficient type or quantity of preventive medications," she said. "This is a concept often described as 'therapeutic inertia,' something we seem to have successfully bypassed with the Triple Pill approach."
One of the trial's most important findings, she said, was that side effects of the three pills were not additive, meaning there was no increase in side effects. That helps diminish the "heavy-hitting" potential aspect of a three-in-one medication.
None of these triple combos exists yet, each at half-dose, in a single pill. Of course, she notes, the three drugs can be prescribed separately. The researchers packaged them in a single pill which made things easier for doctors to prescribe and for patients to take.
Tackle this from all angles
Cost is always a factor, and Dr. Patel says that pricing and reimbursement will differ in different countries. "The drugs used are all generic, so they can be manufactured at low cost," she says. "The final cost to the consumer depends on local circumstances."
Finally, we wanted to ask her about why blood pressure is, well, such a "bear" to control. "There have been problems at many levels: 1) under-diagnosis 2) even if diagnosed, under-treatment 3) even if treated, reluctance to prescribe and/or take sufficient medications. And, remember, this is usually lifelong treatment and long-term medication adherence is not easy."
What's being done isn't enough, she agrees. "Ultimately, we need to do a lot more in treating people adequately, but we also need to do more to lower blood pressure levels in everyone through more exercise, weight loss and reducing the levels of salt in our food supply. These are all big challenges but can be addressed if we tackle the problem from all angles."
This study, and the entire idea behind it, makes really good sense, said Mark Huffman, M.D., M.P.H., associate professor of preventive medicine and cardiology at Northwestern University's Feinberg School of Medicine. He spoke to HealthCentral in a telephone interview.
"When we think about trying to help lower blood pressure, it's best to try to get it down simply with as few side effects and as few pills as possible," he said. "Most people do need three drugs. This may be something patients will like better because of its simplicity."
There is one triple-combo medication on the United States market, but it's comprised of higher doses for consumers with treatment-resistant hypertension. Dr. Huffman shared that he's currently engaged in research around a quadruple pill with quarter doses.
"Tolerability is a really important aspect," he said. "Discontinuation rates are pretty high, usually due to side effects. Using medications of lower doses usually leads to fewer side effects, and that simplifies things."
As everyone knows, simpler is usually better especially with blood pressure medication.