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Efficacy of multiple risk factor intervention in treated hypertensive men - RIS
Description:
RIS was an open-label, parallel group study, which tested the feasibility and efficacy of a multifactorial outpatient program directed towards smoking cessation, control of hyperglycemia and hyperlipidemia among treated hypertensive men.
Hypothesis:
The comprehensive intervention program as compared to usual care, will be associated with a lower prevalence of smoking, lower serum cholesterol and glycosylated hemoglobin (HbA1c).
Study Design
Study Design:
Patients Enrolled: 508
Mean Follow Up: 3.3 years
Mean Patient Age: 50-72 years
Female: 0%
Patient Populations:
Age 50-72
Hypertension
One or more of the following: diabetes mellitus, current smoking, hypercholesterolemia.
Primary Endpoints:
Serum total cholesterol, smoking cessation rate, percentage of subjects with HbA1c < 6.0%, cardiovascular morbidity and mortality.
Drug/Procedures Used:
Specific goals of the intervention were to help current smokers to stop, to reduce HbA1c in diabetic subjects to <6.0%, to obtain a serum cholesterol level <6.0 mmol/L. This was achieved with a) repeated group information of nonpharmacological methods directed towards hypercholesterolemia and diabetes mellitus, b) motivation of the patient by the participating physician to participate in the program, c) free smoking cessation program which included weekly meetings and an offer of nicotine gum. In the usual care group, participating physicians treated diabetes, hypertension and hypercholesterolema according to standard clinical practice.
Concomitant Medications:
thiazide diuretics (46-49%)
At baseline:
beta blockers (70-81%)
calcium channel blockers (14%)
ACE inhibitors (4%)
Other antihypertensive drugs (25-26%)
insulin (2-5%)
oral hypoglycemic drugs (8-13%)
lipid-lowering drugs (0-2%)
Principal Findings:
A total of 508 male patients were enrolled (253 intervention, 255 usual care). At baseline, only 4 patients were on lipid-lowering therapy, and antihypertensive regimen was based on beta-blockers and/or diuretics.
After 3.3 years of follow-up, compliance with nonpharmacological treatment program was 87% in the intervention group. Calcium antagonists and ACE inhibitors were used more frequently in both groups compared with baseline. In the intervention group, 43% of patients were on lipid-lowering therapy, compared with 3% in the usual care group.
In the intervention group, net reductions were achieved in body weight (-2.0 kg vs. -0.8 kg in usual treatment group, p = 0.006), body mass index (-0.6 vs. -0.2, p = 0.007), total cholesterol (-0.78 mmol/L vs. -0.39 mmol/L, p = 0.0001), low-density lipoprotein (-0.72 vs. -0.34, p = 0.0001), and smoking cessation rate (32.8% vs. 15.2%, p = 0.038). The goal of HbA1c < 6.0% among diabetic patients was achieved in 20% of patients in the intervention group, compared with 4% of patients in the usual care group (p = 0.06).
There were no significant differences between the groups in mortality or coronary morbidity. The incidence of stroke was significantly lower in the intervention group (2.0% vs. 6.7% in the usual care group, p = 0.017).
Interpretation:
In a population of middle-aged hypertensive men, an aggressive multiple risk factor intervention program was associated with moderate reduction in serum cholesterol and in a greater rate of smoking cessation. Among patients with diabetes mellitus, there was a trend towards an overall better glucose control with the intervention program. There was also a statistically significant, unexpected decrease in the incidence of stroke among patients enrolled in the intensive program.
References:
Agewall S, Wikstrand J, Samuelsson O, et al. The efficacy of multiple risk factor intervention in treated hypertensive men during long-term follow up. Risk Factor Intervention Study Group. J Intern Med. 1994;236:651-9
Keywords: Motivation, Stroke, Hyperglycemia, Nicotine, Behavior Therapy, Follow-Up Studies, Diuretics, Body Weight, Risk Factors, Hypercholesterolemia, Tobacco Use Cessation Devices, Lipoproteins, LDL, Glycated Hemoglobin A, Cholesterol, Body Mass Index, Middle Aged, Hypertension, Diabetes Mellitus
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