Aim:To evaluate the long-term efficacy, tolerability, and safety profile of iloperidone.
Materials and methods:A 12 month, prospective, interventional, open label, flexible dose study was conducted on 50 drug naïve, first-episode patients aged 18 to 65 years, fulfilling the International Classification of Diseases-10 criteria for psychosis, for assessing long-term efficacy and adverse events, including biochemical parameters of iloperidone. Detailed clinical examination was carried out. Sociodemographic data and baseline parameters were recorded.Results: Two patients dropped out during the course of therapy. M/F ratio was 1.77:1. Mean age of patients was 28.76 ± 10.28 [mean ± standard deviation (SD)] years. Rural/urban ratio was 2.84:1.25. Patients were illiterate, 18 belonged to low socioeconomic class. It was observed that iloperidone was fairly efficacious not only in preventing relapse or aggravation of symptoms but also well restored the patient to almost near-normal till the end point. After 3 months, 20/48 (41.66%) patients showed significant weight gain that was evident. Mean total weight gain from baseline to end point was 2.89 kg and was statistically significant. There was significant rise in body mass index (BMI) but no patient crossed the upper normal limit. Iloperidone did not cause significant rise (p < 0.6955) in fasting blood sugar (FBS), and no significant alterations in total cholesterol (TC), triglyceride, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol were recorded. Dizziness was one of the earliest adverse events appearing within 2 to 3 days; others were insomnia, weight gain, increased appetite, anxiety, headache, sedation, etc.
Conclusion:On long-term basis, iloperidone is fairly efficacious and has favorable tolerability profile with modest weight gain and practically no alteration in FBS, and lipid profile as well as absence of extrapyramidal side effects.