Efficacy and tolerability of lurasidone in schizophrenia: A systematic review and meta-analysis of short-term, randomized, placebo controlled trials

INTRODUCTION: Lurasidone is an atypical antipsychotic approved for the treatment of patients with schizophrenia. We report on a meta-analysis focusing on both the efficacy and safety/tolerability of lurasidone in the treatment of patients with schizophrenia. OBJECTIVES: To obtain pooled estimates from placebo-controlled clinical trials on the efficacy and safety/tolerability of lurasidone in schizophrenia. METHODS: We selected acute, randomized placebo-controlled trials of lurasidone for schizophrenia. Primary outcome for efficacy was the Positive and Negative Syndrome Scale (PANSS) change and for “acceptability” was all-cause discontinuation. Secondary outcomes included specific adverse events, body weight change, ≥7% weight gain, and glucose and lipid parameter change. RESULTS: Across 10 RCTs (n=3,963, age=40.5±2.3 years, males=64.7 %, trial duration=6.0 weeks), lurasidone outperformed placebo regarding the PANSS total score (N=10, n=3,354, SMD=-0.34, 95% CI: -0.47−-0.21, p<0.001). Stratifying the analysis by dose, lurasidone significantly outperformed placebo at doses 40-160 mg/day. Lurasidone was associated with significantly lower all-cause discontinuation than placebo (N=10, n=3,410, RR=0.87, 95% CI: 0.78−0.97, p=0.014). Lurasidone had significantly higher body weight change compared with placebo (N=10, n=3,359, SMD=0.17, 95% CI: 0.09−0.24, p<0.001), but without significant differences regarding ≥7% body weight gain (N=9, n=3,186, p=0.112). Lurasidone did not differ from placebo in total cholesterol (N=10, n=3,140, p=0.439), LDL-cholesterol (N=7, n=2,414, p=0.849), triglycerides (N=10, n=3,140, p=0.238), and fasting glucose change (N=10, n=3,112, p=0.633). CONCLUSIONS: In short-term trials, lurasidone was efficacious, acceptable and safe, having minimal effect on body weight gain and glucose and lipid metabolism. DISCLOSURE: K. Hagi is a full time employee of Sumitomo Dainippon Phrma Co., Ltd.