Efficacy and safety of novel thiazolidinedione lobeglitazone for managing type-2 diabetes a meta-analysis.

BACKGROUND AND AIMS: No meta-analysis has analysed the safety and efficacy of lobeglitazone in type-2 diabetes (T2DM). We undertook this meta-analysis to address this knowledge-gap.

METHODS

Electronic databases were searched for RCTs involving type-2 diabetes patients receiving lobeglitazone in intervention arm, and placebo/active comparator in control arm. Primary outcome was to evaluate changes in HbA1c. Secondary outcomes were to evaluate alterations in glucose, lipids and adverse events.

RESULTS

From initially screened 65 articles, data from 4 RCTs (828 patients) which fulfilled all criteria was analysed. Over 24 weeks, when compared to sitagliptin 100 mg/d and half maximal pioglitazone dose (15 mg/d), lobeglitazone 0.5 mg/day had comparable impact on HbA1c [MD 0.03% (95%CI: 0.11-0.17); P = 0.65; I2 = 0%], fasting glucose [MD 1.47 mg/dl (95%CI: 4.66-7.60); P = 0.64; I2 = 0%], triglycerides [MD-9.96 mg/dl (95%CI: 43.55-23.62); P = 0.56; I2 = 81%], LDL-cholesterol [MD0.74 mg/dl (95%CI: 4.60-6.09); P = 0.79; I2 = 0%] and HDL-cholesterol [MD1.55 mg/dl (95%CI: 3.72-6.82); P = 0.56]. Occurrence of treatment-emergent adverse events (AEs) [RR 1.07 (95% CI:0.78-1.47); P = 0.67; I2 = 0%] and severe AEs [RR 1.05(95%CI: 0.42-2.65); P = 0.91; I2 = 0%] were similar. Edema and weight gain were significantly higher with lobeglitazone compared to controls [RR 2.58 (95%CI: 1.08-6.17); P = 0.03; I2 = 0%]. Lobeglitazone 0.5 mg/d compared to half-maximal pioglitazone (15 mg/d), had similar edema and weight gain [RR 1.65 95% CI: 0.78-1.47)]. BMD percent changes at neck of femur was comparable in both groups [MD 0.07% (95%CI: 0.19-0.33); P = 0.60; I2 = 91%]. Low dose lobeglitazone (0.25 mg/d) was inferior to high dose lobeglitazone (0.5 mg/d) with regards to glycaemic efficacy with advantage of lower weight gain and edema.

CONCLUSION

The current evidence makes lobeglitazone unlikely to replace pioglitazone as the preferred thiazolidinedione in T2DM.