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The hypertensive patient with multiple risk factors: is treatment really so difficult?
1Centro di Fisiologia Clinica e Ipertensione and Istituto di Clinica Medica, University of Milan and Ospedale Maggiore and Istituto Auxologico Italiano, Italy.
Insights
This study investigates if treating high blood pressure and high cholesterol together benefits patients more than treating just one. It explores the additive benefits of lowering cardiovascular disease risk factors.
Area of Science:
- Cardiology
- Hypertension Research
- Atherosclerosis Studies
Background:
- Hypertension and hypercholesterolemia are common cardiovascular disease risk factors.
- Current guidelines emphasize evaluating global cardiovascular risk and treating modifiable factors.
- The additive benefits of treating multiple risk factors remained unproven in intervention trials.
Purpose of the Study:
- To investigate the benefits of simultaneously lowering blood pressure and plasma cholesterol on carotid plaque progression.
- To determine if combined treatment offers additive antiatherosclerotic effects in hypertensive patients.
- To compare the efficacy of an ACE inhibitor versus a diuretic and statin versus placebo.
Main Methods:
- The Plaque Hypertension Lipid-Lowering Italian Study (PHYLLIS) is a 3-year, multicenter, double-blind, randomized trial.
- Factorial design comparing fosinopril (ACE inhibitor) + hydrochlorothiazide, and diet + placebo vs. diet + pravastatin.
- Carotid plaque progression assessed via B-mode ultrasound with central reading.
Main Results:
- The study is currently underway and expected to provide evidence on combined risk factor treatment.
- Animal studies suggest ACE inhibitors benefit experimental atherosclerosis.
- The trial will compare antihypertensive and lipid-lowering regimens.
Conclusions:
- The PHYLLIS study aims to provide crucial evidence on the benefits of managing multiple cardiovascular risk factors concurrently.
- Findings will inform treatment strategies for hypertensive patients with elevated cholesterol.
- This research addresses a gap in understanding additive treatment benefits for cardiovascular disease prevention.
Abstract:
Multiple risk factors for cardiovascular disease, particularly hypercholesterolemia, are often present in the hypertensive patient. Recent guidelines, ranging from those prepared by the World Health Organization/International Society of Hypertension to those of the three European Societies of Cardiology, Atherosclerosis, and Hypertension, stress the importance of evaluating global risk, based on the presence of all cardiovascular risk factors in an individual or in a group of subjects. It has also been suggested that treatment should aim to correct all modifiable risk factors. This is a reasonable recommendation, but although observational epidemiologic studies have shown that the effects of concomitant risk factors are additive, if not multiplicative, it is surprising that no intervention trial has been undertaken to determine whether the benefits of treating more than one risk factor are also additive. The Plaque Hypertension Lipid-Lowering Italian Study (PHYLLIS) is the first such study. Its aim is to investigate the potential benefit of lowering blood pressure and plasma cholesterol on the progression of carotid plaque in hypertensive patients with elevated plasma cholesterol. Using a factorial design, the antiatherosclerotic effect of two different antihypertensive drugs, the angiotensin-converting enzyme (ACE) inhibitor fosinopril and the diuretic hydrochlorothiazide will be compared. The study aims to confirm animal experiments demonstrating the benefit of ACE inhibitors on experimental atherosclerosis. PHYLLIS will also compare the effects of two lipid-lowering regimens, diet plus placebo and diet plus pravastatin, in the study population. This 3-year, multicenter, double-blind, randomized Italian study, using B-mode ultrasound evaluation of the carotid walls with central reading of the ultrasound scans (Bowman Gray University, Winston-Salem, NC) is now underway and should provide useful evidence about the benefits of multiple risk factor treatment in the hypertensive patient.