Monalisa Jena1, Archana Mishra2, Biswa Ranjan Mishra3, Santanu Nath3, Rituparna Maiti4. 1. Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India. 2. Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi, India. 3. Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India. 4. Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India. pharm_rituparna@aiimsbhubaneswar.edu.in.
Abstract
OBJECTIVE:Patients with schizophrenia are at higher risk of cardiovascular morbidity and mortality than healthy individuals. This study was conducted to compare the effect of lurasidone and olanzapine on cardiometabolic parameters in unmedicated patients with schizophrenia. METHODS: The present study was a randomized open-label, parallel design, active-controlled clinical trial. After recruitment and randomization of 101 patients, a baseline assessment was done by PANSS, SOFAS, lipid profile, fasting blood glucose, HbA1c, serum insulin and serum hs-CRP. HOMA-IR, atherogenic index, coronary risk index and cardiovascular risk indices were calculated as derived parameters. Patients received either lurasidone 80 mg or olanzapine 10 mg as monotherapy and followed up after 6 weeks. RESULTS: There was a significant increase in fasting blood glucose (p < 0.001), HbA1c (p < 0.001) and serum insulin (p < 0.001) after 6 weeks of therapy in both the treatment groups but the difference between the groups was not significant (FBS, p = 0.209; HbA1c, p = 0.209; serum insulin, p = 0.720). Olanzapine showed worsening of lipid profile (p < 0.001) while the same improved with lurasidone (p < 0.001) and the difference between the groups was found to be significant (p < 0.001). Serum HDL level decreased in both the treatment groups (olanzapine, p < 0.001; lurasidone, p < 0.001) but the difference between the groups was not significant (p = 0.333). There was an increase in hs-CRP levels in both the treatment groups (olanzapine, p < 0.001; lurasidone, p < 0.001) with no significant difference between them (p = 0.467). Atherogenic index, coronary risk index and cardiovascular risk index increased significantly in the olanzapine group as compared with the lurasidone group (p < 0.001). CONCLUSION:Lurasidone showed a favourable effect on lipid profile and cardiovascular risk indices over olanzapine. However, long-term studies are needed to establish and generalize the findings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03304457.
RCT Entities:
OBJECTIVE:Patients with schizophrenia are at higher risk of cardiovascular morbidity and mortality than healthy individuals. This study was conducted to compare the effect of lurasidone and olanzapine on cardiometabolic parameters in unmedicated patients with schizophrenia. METHODS: The present study was a randomized open-label, parallel design, active-controlled clinical trial. After recruitment and randomization of 101 patients, a baseline assessment was done by PANSS, SOFAS, lipid profile, fasting blood glucose, HbA1c, serum insulin and serum hs-CRP. HOMA-IR, atherogenic index, coronary risk index and cardiovascular risk indices were calculated as derived parameters. Patients received either lurasidone 80 mg or olanzapine 10 mg as monotherapy and followed up after 6 weeks. RESULTS: There was a significant increase in fasting blood glucose (p < 0.001), HbA1c (p < 0.001) and serum insulin (p < 0.001) after 6 weeks of therapy in both the treatment groups but the difference between the groups was not significant (FBS, p = 0.209; HbA1c, p = 0.209; serum insulin, p = 0.720). Olanzapine showed worsening of lipid profile (p < 0.001) while the same improved with lurasidone (p < 0.001) and the difference between the groups was found to be significant (p < 0.001). Serum HDL level decreased in both the treatment groups (olanzapine, p < 0.001; lurasidone, p < 0.001) but the difference between the groups was not significant (p = 0.333). There was an increase in hs-CRP levels in both the treatment groups (olanzapine, p < 0.001; lurasidone, p < 0.001) with no significant difference between them (p = 0.467). Atherogenic index, coronary risk index and cardiovascular risk index increased significantly in the olanzapine group as compared with the lurasidone group (p < 0.001). CONCLUSION:Lurasidone showed a favourable effect on lipid profile and cardiovascular risk indices over olanzapine. However, long-term studies are needed to establish and generalize the findings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03304457.