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| TITLE |
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Treatment of hypertension in patients 80 years of age or older.
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| AUTHORS |
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Nigel S Beckett, Ruth Peters, Astrid E. Fletcher, Jan A. Staessen, Lisheng Liu, Dan Dumitrascu, Vassil Stoyanovsky, Riitta Antikainen, Yuri Nikitin, Craig Anderson, Alli Belhani, Francoise Forette, Chakravarthi Rajkumar, Lutgarde Thijs, Winston Banya, Christopher J. Bulpitt, The HYVET Study Group
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| PUBLICATION INFORMATION |
Journal Name: The New England Journal of Medicine
Volume: 358(18)
Pages: 1887-98
Date Published: 05/01/2008
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| ABSTRACT/REVIEW |
What were the researchers trying to learn in this study? They wanted to know whether treating people 80 years old or older for high blood pressure is beneficial. It is clear that lowering blood pressure in younger people reduces heart attacks, strokes and death from these causes. While it is thought that reducing high blood pressure in people over 80 years also may reduce the risk of stroke, there has been some suggestion from studies that this benefit may be offset by possibly increasing the risk of death from other causes including side effects from treatment.
Indapamide (in DAP eh mide) is a diuretic, sometimes referred to as a "water pill," that lowers blood pressure by removing water from the body. It is marketed under the brand name Lozol®.
Perindopril (per IN doe pril) is a member of a family of drugs called angiotensin-converting enzyme (ACE) inhibitors. These drugs prevent the production of a certain natural chemical that causes blood vessels to constrict, which lowers blood pressure. It is marketed under the brand name Aceon®.
What did they find? The results of this trial indicate that high blood pressure treatment based on indapamide, with or without perindopril, significantly reduces the risks of death from stroke and death from any cause in very elderly patients.
With regard to the primary research objective, 51 fatal or non-fatal strokes occurred in the group treated with high blood pressure medications, compared to 69 fatal or non-fatal strokes in those treated with a nonactive placebo. This represents a 30% reduction in the rate of stroke for those treated compared to those given placebo. This is equivalent to 11 strokes being prevented for every 1,000 patients treated over 2 years.
The active-treatment group also had a 39% lower rate of death from stroke compared to the placebo group. The active-treatment group also saw a 21% reduction in the rate of death from any cause compared to the placebo group, a 23% reduction in the rate of death from cardiovascular causes, and a 64% reduction in the rate of heart failure, compared to the placebo group.
At the start of the study, the active-treatment group (1,933 patients) and the placebo group (1,912 patients) both had an average age of 83.6 years, with an average blood pressure while seated of 173.0/90.8 mm Hg. After 2 years in the study, the average blood pressure while seated was 15.0/6.1 mm Hg lower in the active-treatment group than in the placebo group. Also at 2 years, the target blood pressure was reached by 48.0% of patients in the active-treatment group compared to 19.9% of the placebo group.
The number of serious adverse side effects reported was 358 in the active-treatment group compared to 448 in the placebo group. Only five of these events (two in the active-treatment group and three in the placebo group) were classified as possibly having been due to the trial medication.
Who was studied? The researchers randomly assigned 3,845 patients from Europe, China, Australasia, and Tunisia who were 80 years of age or older and had a sustained systolic (top number) blood pressure of 160 mmHg or more. There were 86 patients from Western Europe, 2,144 patients from Eastern Europe, 1,526 patients from China, 19 from Australasia, and 70 from Tunisia. (Australasia is Australia, New Zealand, Papua New Guinea and neighboring islands.)
The age range at study entry was 80 to 105 years, with 73.0% of patients 80 to 84 years of age, 22.4% of patients 85 to 89 years of age, and 4.6% of patients 90 years of age or older
Patients were excluded if their conditions prevented them from taking the study medications, or if they had a severe form of high blood pressure called accelerated high blood pressure, high blood pressure caused by another condition (secondary high blood pressure), or a bleeding (hemorrhagic) stroke in the previous 6 months. Patients with heart failure taking high blood pressure medications were excluded, as were those with kidney problems or other problems with other organs, as well as those diagnosed with clinical dementia, or those requiring nursing care.
How was the study done? A total of 1,933 people were randomly assigned to the active-treatment group and received the diuretic indapamide, and 1,900 were assigned to receive a look-a-like placebo. The angiotensin-converting enzyme inhibitor perindopril was added to the active treatment group if necessary to achieve the target blood pressure of 150/80 mm Hg.
After participants were randomly assigned, patients were seen at least every 3 months during the first year and at least every 6 months thereafter.
The primary end-point (measure of success or failure) of the trial was any stroke (fatal or nonfatal). This end-point did not include transient ischemic attacks (TIAs), sometimes referred to as mini-strokes. Secondary end points included death from any cause, death from blood vessel or heart disease (cardiovascular and cardiac causes), and death from stroke.
What did researchers know before starting this study? While some previous studies have suggested treating patients 80 years of age or older is beneficial, others have not shown a benefit. Although the risk of stroke increases continuously with increasing blood pressures above approximately 115/75 mmHg, the association of blood pressure and stroke lessens with increasing age.
Randomized controlled clinical trials involving older adults either have excluded those 80 years of age or older, or have recruited too few elderly participants to show an advantage of treatment. A meta-analysis of results regarding the treatment of high blood pressure specifically in this age group suggested that the benefit of a 36% reduction in the risk of stroke might be offset by possible adverse effects, given a nearly significant 14% increase in the risk of death from any cause.
Why did they do it? They aimed to resolve persistent questions about benefits and risks of high blood pressure treatment in patients 80 years of age or older and to clear up clinical uncertainty about the relative benefits of treating high blood pressure in this age group.
What did the researchers say their study results mean? The researchers concluded that this study shows that high blood pressure treatment based on indapamide, with or without perindopril, in the very elderly, aimed to achieve a target blood pressure of 150/80 mmHg, is beneficial and is associated with reduced risks of death from stroke, death from any cause, and heart failure.
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