A Cardiovascular Risk Optimization Program in People With Schizophrenia: A Pilot Randomized Controlled Clinical Trial

Abstract

Background: Cardiovascular disease is one of the leading causes of premature death in people with schizophrenia. Some modifiable factors that have been implicated include unhealthy lifestyle, medication side effects, and physical comorbidities. The goal of this study was to assess the efficacy of a 6-month, multifactorial cardiovascular risk intervention to reduce cardiovascular risk (CVR) in people with schizophrenia.

Methods: We conducted a 2-arm, parallel, randomized clinical trial in a regional mental health center. Participants with at least 1 poorly controlled cardiovascular risk factor (CVRF) (hypertension, diabetes mellitus, hypercholesterolemia, or tobacco smoking) were randomly assigned to the intervention group or to a control group. The subjects in the intervention group received a patient-centered approach that included promoting a healthy lifestyle, pharmacological management of CVRFs, psychotropic drug optimization, and motivational follow-up [Programa d'optimització del RISc CArdiovascular (PRISCA)]. The main outcome was change in CVR as assessed using the Framingham-REGICOR function, after 6 months compared with the baseline in both groups.

Results: Forty-six participants were randomly assigned to the PRISCA group (n=23) or the control group (n=23). The most prevalent CVRFs at baseline were hypercholesterolemia (84.8%) and tobacco smoking (39.1%). The PRISCA group showed a significant reduction in the REGICOR score (-0.96%; 95% CI: -1.60 to -0.32, P=0.011) after 6 months (relative risk reduction of 20.9%), with no significant changes in the control group (0.21%; 95% CI: -0.47 to 0.89, P=0.706). In the PRISCA group, low-density lipoprotein cholesterol also decreased significantly (-27.14 mg/dL; 95% CI: -46.28 to -8.00, P=0.008).

Conclusion: A patient-centered, multifactorial cardiovascular risk intervention improved CVR in people with schizophrenia after 6 months, which was achieved mainly by improving the lipid profile.

Trial registration: ClinicalTrials.gov NCT04276012.