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CARDIOVASCULAR

New ‘Triple Pill’ Lowers Blood Pressure More Than Usual Care

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A pill combining low doses of three blood pressure-lowering medications significantly increased the number of patients reaching blood pressure targets compared with usual care, researchers reported at the American College of Cardiology’s 67th Annual Scientific Session. There was also no significant increase in adverse effects with the “Triple Pill.”

“Most people—70 percent—reached blood pressure targets with the Triple Pill. The benefits were seen straight away and maintained until six months, whereas with usual care control rates were 55 percent at six months and even lower earlier in the trial,” said Ruth Webster, MBBS, of The George Institute for Global Health at the University of New South Wales in Sydney, Australia, and lead author of the study.

“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.”

Despite the availability of effective blood pressure-lowering drugs, high blood pressure remains a major problem around the world, Webster said. Effectively treating high blood pressure can help to prevent heart attacks, strokes and kidney problems. Globally, however, many people with high blood pressure receive no treatment, and only about a third of those who are treated achieve recommended reductions in blood pressure. Achieving desired reductions in blood pressure often requires treatment with more than one medication, which increases the complexity of treatment, and patients often have difficulty adhering to regimens that involve taking multiple pills every day.

This study 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 compared with usual care and that combining these drugs in a single pill would make it easier both for doctors to prescribe treatment and for patients to adhere to it, Webster said.

The TRIUMPH trial, which was conducted in Sri Lanka, enrolled 700 patients whose average age was 56 years, 58 percent of whom were women. Trial participants had an average blood pressure of 154/90 mm Hg. Over half (59 percent) were receiving no treatment for high blood pressure before they enrolled in the trial. In addition to high blood pressure, 32 percent of participants had diabetes or chronic kidney disease.

Patients were randomly assigned to receive either the combination pill or usual care. The combination pill, or Triple Pill, consisted of the blood pressure medications telmisartan (20 mg), amlodipine (2.5 mg) and chlorthalidone (12.5 mg). These medications use different mechanisms to reduce blood pressure by relaxing the blood vessels, so the heart does not need to pump as hard to send blood throughout the body. Usual care meant that patients received their doctor’s choice of blood pressure¬-lowering medication.

The trial’s primary endpoint was the proportion of patients who achieved a blood pressure target of 140/90 mm Hg or less (130/80 mm Hg or less in those with diabetes or chronic kidney disease) at six months.

Compared with patients receiving usual care, a significantly higher proportion of patients receiving the Triple Pill achieved their target blood pressure at six months. The average reduction in blood pressure was 8.7 mm Hg for participants receiving the Triple Pill and 4.5 mm Hg for those receiving usual care. At six months, 83 percent of participants in the Triple Pill group were still receiving the combination pill and one-third of those in the usual-care group were receiving at least two blood pressure-lowering drugs.

The maximum difference between the two groups of patients was observed at six weeks after starting treatment, when 68 percent of those receiving the Triple Pill had achieved a blood pressure within their target range, compared with 44 percent of those receiving usual care. This represented a 53 percent reduction in the risk for high blood pressure for patients receiving the Triple Pill, Webster said.

Rates of participants having to change treatment due to side effects were not significantly different in the two groups (6.6 percent for the Triple Pill, 6.8 percent for usual care). This should allay concerns that use of the three-drug combination pill could lead to an unacceptable increase in adverse medication side effects, Webster said. Each of the drugs used in the Triple Pill has been shown to be highly effective in reducing blood pressure and preventing deaths and illness due to heart disease and strokes, she said. Each drug represents a different class of blood pressure medication and previous studies have shown that combining such drugs results in synergistic effects.

“The most urgent need for innovative strategies to control blood pressure is in low- and middle-income countries,” Webster said.

“The Triple Pill approach is an opportunity to ‘leap frog’ over traditional approaches to care and adopt an innovative approach that has been shown to be effective.”

The study’s findings are also important for high-income countries, she said. “A control rate of 70 percent would be a considerable improvement even in high-income settings. Most hypertension guidelines in these countries do not recommend combination blood pressure-lowering therapy for initial treatment in all people,” she said.

“Our findings should prompt reconsideration of recommendations around the use of combination therapy.”

An inevitable consequence of a necessarily unblinded study (where both participants and their doctors know whether participants are assigned to the Triple Pill or usual care) is that doctors might manage patients differently depending on the assigned treatment. However, it is important to note this trial was designed to evaluate a new strategy of care in a real-world setting, Webster said.

To minimize the risk of bias in measuring the main outcomes, the number of patient visits was identical in both groups and all outcomes were standardized and objectively documented, she said.

The researchers are now conducting a follow-up qualitative study to find out what participants and their doctors thought about using the Triple Pill. And they are conducting a cost-effectiveness evaluation to determine whether the Triple Pill is a cost-effective solution for blood pressure control.

Recommended targets for blood pressure control vary by country. In the U.S., guidance released in 2017 by the ACC and the American Heart Association recommends initiating treatment if blood pressure exceeds 130/80 mm Hg. European guidelines recommend that treatment should aim to achieve a blood pressure level of 140/90 mm Hg or less. The study was funded by the National Health and Medical Research Council of Australia as part of the Global Alliance for Chronic Disease.

CARDIOVASCULAR

Heart Disease Common Among Firefighters Who Die Of Cardiac Arrest

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Firefighters who died from cardiac arrest were much more likely than those who died of other causes to show signs of both atherosclerotic and hypertensive heart disease at autopsy, according to new research in Journal of the American Heart Association, the Open Access Journal of the American Heart Association/American Stroke Association.

Among firefighters, more job-related deaths stem from cardiac arrest than from any other cause. To understand which heart diseases affect firefighters who die of cardiac arrest, this study looked at autopsy reports for firefighters who had died in the line of duty. Results showed that the most common diseases were narrowed arteries, or coronary artery disease, and structural abnormalities. These abnormalities included an enlarged heart (cardiomegaly) and increased wall thickness (hypertrophy) of the heart’s primary chamber for pumping blood, or left ventricle.

“Firefighters face many dangers, but the greatest risk is from underlying cardiovascular disease in combination with the physiological strain that the work places on the firefighter,” said study lead author Denise L. Smith, Ph.D., Tisch Distinguished Professor and director of the First Responder Health and Safety Laboratory at Skidmore College in Saratoga Springs, New York.

“Medical screening is necessary to establish that a firefighter is healthy enough to do this strenuous work.”

In terms of specific risks, narrowing of the arteries, enlarged heart and prior heart attack all were all independently associated with a greatly increased likelihood of death from cardiac arrest than firefighters who died of other causes. Similarly, firefighters who had a prior heart attack were 6 times more likely to have a duty-related death. an enlarged heart or a prior heart attack.

The researchers looked at autopsy records for U.S. male firefighters who died on duty between 1999 and 2014. Of 627 total deaths, 276 resulted from cardiac arrest and 351 from trauma. At the time of death, the firefighters were between 18 and 65 years old.

In the United States, approximately 1 in 7 people will die of sudden cardiac arrest. The life-threatening condition occurs when the heart’s electrical system stops working properly. Symptoms include unresponsiveness and gasping for air or not breathing. Immediate medical treatment is critical, including CPR and calling 9-1-1.

Cardiac arrest differs from a heart attack, which occurs when a blockage prevents blood flow to the heart, although heart attack and other heart conditions can cause cardiac arrest. Since cardiac arrest often is the first sign of underlying heart disease, screening and treatment for common heart diseases are critical.

“Historically, screening has focused more on risk factors for coronary artery disease,” Smith said.

“While this screening remains essential, it is important that clinicians also consider testing to identify an enlarged heart and increased wall thickness.”

Several limitations could have affected the study’s results. Among these limitations were differences in autopsy descriptions of heart disease, the use of a cut-off weight for an enlarged heart, and lack of information about other risk factors such as smoking and high blood pressure.

To control risk factors, the American Heart Association recommends lifestyle changes known as Life’s Simple 7®: manage blood pressure, control cholesterol, reduce blood sugar, get active, eat better, lose weight and stop smoking.

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CARDIOVASCULAR

Targeted And Population-Based Strategies Both Necessary For Blood Pressure Control

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Hypertension, or high blood pressure, is the leading risk factor for heart disease, and improvements in both targeted and population-based strategies for blood pressure control can lead to better prevention and control of hypertension, according to a review paper published today in the Journal of the American College of Cardiology. This paper is part of an eight-part health promotion series where each paper will focus on a different risk factor for cardiovascular disease.

The prevalence of hypertension globally is high and continues to increase. High blood pressure is associated with an increased risk of stroke, ischemic heart disease, heart failure and noncardiac vascular disease, as well as other conditions.

“Hypertension is caused by a combination of genetic, environmental and social determinants,” said Robert M. Carey, MD, professor of medicine at the University of Virginia School of Medicine and lead author of the paper.

“While genetic predisposition is nonmodifiable and conveys lifelong cardiovascular risk, the risk for hypertension is modifiable and largely preventable due to a strong influence by key environmental and lifestyle factors.”

Modifiable lifestyle factors, which are gradually introduced in childhood and early adult life, include being overweight/obesity, unhealthy diet, high sodium and low potassium intake, insufficient physical activity and consumption of alcohol. Many adults do not change their lifestyle after being diagnosed with hypertension and sustaining any changes that are made can be difficult.

Social determinants such as race and socioeconomic status are also risk factors for hypertension. High blood pressure is more prevalent in black and Hispanic populations as well as poorer areas and certain geographical areas such as the southeastern U.S.

According to the authors, prevention and control of hypertension can be achieved through targeted and population-based strategies. The targeted approach is the traditional strategy used in health care practice and seeks to achieve a clinically important reduction in blood pressure for individual patients. The population-based strategy aims to achieve small reductions that are applied to the entire population, resulting in a small downward shift in the entire blood pressure distribution. Studies have shown that the population-based approach may be better at preventing cardiovascular disease compared with the targeted strategy.

Factors preventing successful hypertension control include inaccurate blood pressure measurement and diagnosis of hypertension, lack of hypertension awareness and access to health care, and proper hypertension treatment and control. Low rates of medication adherence is also a common problem.

“Challenges to the prevention, detection, awareness and management of hypertension will require a multipronged approach directed not only to high-risk populations, but also to communities, schools, worksites and the food industry,” Carey said.

In the review, the authors discuss the Chronic Care Model, a framework for redesigning health care and addressing deficiencies in the care of chronic conditions such as hypertension, which may offer strategies for overcoming barriers at the health system, physician, patient and community levels. It is a collaborative partnership among the patient, provider and health system that incorporates a multilevel approach for control of hypertension. The model includes six domains — decision support, self-management support, delivery design, information systems, community resources and health care systems — which have been shown to lead to activated patients, responsive health care teams, improved health services and treatment outcomes, and cost-effectiveness. It also recognizes a collaborative partnership between the patient, provider and the care team. Community groups and organizations also play a significant role in providing health care information and support to various populations. Connected health, such as telemedicine and telephone and mobile health interventions can also help deliver improved care to a of greater number of patients with hypertension.

“Remarkable progress has been made in the understanding of blood pressure as a risk factor for heart disease and improving approaches to the prevention and treatment of hypertension,” said Carey.

“However, further research is still necessary to optimize care for these patients.”

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CARDIOVASCULAR

Clock Drawing Cognitive Test Should Be Done Routinely In Patients With High Blood Pressure

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A clock drawing test for detecting cognitive dysfunction should be conducted routinely in patients with high blood pressure, according to research presented today at ESC Congress 2018.

Patients with high blood pressure who have impaired cognitive function are at increased risk of developing dementia within five years. Despite this known link, cognitive function is not routinely measured in patients with high blood pressure.

“The ability to draw the numbers of a clock and a particular time is an easy way to find out if a patient with high blood pressure has cognitive impairment,” said study author Dr Augusto Vicario of the Heart and Brain Unit, Cardiovascular Institute of Buenos Aires, Argentina.

“Identifying these patients provides the opportunity to intervene before dementia develops.”

The Heart-Brain Study in Argentina evaluated the usefulness of the clock drawing test compared to the Mini-Mental State Examination (MMSE) to detect cognitive impairment in 1,414 adults with high blood pressure recruited from 18 cardiology centres in Argentina. The average blood pressure was 144/84 mmHg, average age was 60 years, and 62% were women.

For the clock drawing test, patients were given a piece of paper with a 10 cm diameter circle on it. They were asked to write the numbers of the clock in the correct position inside the circle and then draw hands on the clock indicating the time “twenty to four.” Patients were scored as having normal, moderate, or severe cognitive impairment. The MMSE has 11 questions and produces a score out of 30 indicating no (24-30), mild (18-23), or severe (0-17) cognitive impairment.

The researchers found a higher prevalence of cognitive impairment with the clock drawing test (36%) compared to the MMSE (21%). Three out ten patients who had a normal MMSE score had an abnormal clock drawing result. The disparity in results between the two tests was greatest in middle aged patients.

Dr Vicario said:

“Untreated high blood pressure silently and progressively damages the arteries in the subcortex of the brain and stops communication between the subcortex and frontal lobe. This disconnect leads to impaired ‘executive functions’ such as planning, visuospatial abilities, remembering details, and decision-making. The clock drawing test is known to evaluate executive functions. The MMSE evaluates several other cognitive abilities but is weakly correlated with executive functions.”

He continued:

“Our study suggests that the clock drawing test should be preferred over the MMSE for early detection of executive dysfunction in patients with high blood pressure, particularly in middle age. We think the score on the clock drawing test can be considered a surrogate measure of silent vascular damage in the brain and identifies patients at greater risk of developing dementia. In our study more than one-third of patients were at risk.”

Dr Vicario concluded:

“The clock drawing test should be adopted as a routine screening tool for cognitive decline in patients with high blood pressure. Further studies are needed to determine whether lowering blood pressure can prevent progression to dementia.”

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