OBJECTIVE: To examine the feasibility and efficacy of a multifactorial intervention programme directed towards hypercholesterolaemia, smoking, and diabetes mellitus in treated hypertensive patients after more than 3 years' follow-up and to describe the incidence of cardiovascular complications. DESIGN: Open, randomized, parallel-group study with allocation either to a comprehensive multiple risk factor modification programme or to usual care. SETTING:Outpatient clinic in a city hospital. PATIENTS: A total of 508 male patients with treated hypertension, aged 50-72 years, with at least one of the following: serum cholesterol > or = 6.5 mmol L-1, smoking or diabetes mellitus. INTERVENTION: Individually given advice and group meetings based on nutritional advice and behavioral treatment principles. Drug therapy could be instituted to achieve the treatment goals in the intervention group: serum total cholesterol below 6.0 mmol L-1, no smoking, and HbA1c below 6.0%. Diastolic blood pressure below 90 mmHg was the treatment goal in both groups. MAIN OUTCOME MEASUREMENTS: Serum cholesterol, HbA1c, diastolic blood pressure, smoking. Cardiovascular end-points were recorded. RESULTS: The net changes were (change intervention--change usual care): serum cholesterol -5.0% (95% confidence interval, -7.6 to -2.3%), 17.6% more stopped smoking (P = 0.04); diastolic blood pressure and HbA1c remained unchanged. The incidence of stroke was lower in the intervention group compared with the usual-care group: 2.0 and 6.7%, respectively (P = 0.017). CONCLUSION: The intervention programme was comparatively successful with regards to the effects on hypercholesterolaemia and smoking habits. An unexpected decrease in the stroke incidence was observed in the intervention group compared with the usual-care group.
RCT Entities:
OBJECTIVE: To examine the feasibility and efficacy of a multifactorial intervention programme directed towards hypercholesterolaemia, smoking, and diabetes mellitus in treated hypertensivepatients after more than 3 years' follow-up and to describe the incidence of cardiovascular complications. DESIGN: Open, randomized, parallel-group study with allocation either to a comprehensive multiple risk factor modification programme or to usual care. SETTING:Outpatient clinic in a city hospital. PATIENTS: A total of 508 male patients with treated hypertension, aged 50-72 years, with at least one of the following: serum cholesterol > or = 6.5 mmol L-1, smoking or diabetes mellitus. INTERVENTION: Individually given advice and group meetings based on nutritional advice and behavioral treatment principles. Drug therapy could be instituted to achieve the treatment goals in the intervention group: serum total cholesterol below 6.0 mmol L-1, no smoking, and HbA1c below 6.0%. Diastolic blood pressure below 90 mmHg was the treatment goal in both groups. MAIN OUTCOME MEASUREMENTS: Serum cholesterol, HbA1c, diastolic blood pressure, smoking. Cardiovascular end-points were recorded. RESULTS: The net changes were (change intervention--change usual care): serum cholesterol -5.0% (95% confidence interval, -7.6 to -2.3%), 17.6% more stopped smoking (P = 0.04); diastolic blood pressure and HbA1c remained unchanged. The incidence of stroke was lower in the intervention group compared with the usual-care group: 2.0 and 6.7%, respectively (P = 0.017). CONCLUSION: The intervention programme was comparatively successful with regards to the effects on hypercholesterolaemia and smoking habits. An unexpected decrease in the stroke incidence was observed in the intervention group compared with the usual-care group.
Authors: Gastón Perman; Emiliano Rossi; Gabriel D Waisman; Cristina Agüero; Claudio D González; Carlos L Pallordet; Silvana Figar; Fernán González Bernaldo de Quirós; Joann Canning; Enrique R Soriano Journal: Cost Eff Resour Alloc Date: 2011-04-05