ABSTRACT
OBJECTIVE： To systematically review the efficacy and safety of colesevelam hydrochloride combined with other hypoglycemic drugs in the treatment of T2DM， and to provide evidence-based reference for clinical treatment of T2DM. METHODS： Retrieved from PubMed， Embase， Medline， Cochrane Library， CJFD， VIP and Wanfang database during database establishement-Jul. 2019， randomized controlled trials （RCT） about the efficacy and safety of colesevelam hydrochloride combined with other hypoglycemic drugs （trial group） vs. placebo or other hypoglycemic drugs （control group） in the treatment of T2DM were collected. After extracting data from clinical studies that met the inclusion criteria， the quality of the studies was evaluated by Cochrane System Evaluator Manual 5.1.0. Meta-analysis was conducted by using Rev Man 5.3 statistical software in respects of the levels HbA1c， FPG， LDL-C， the incidence of total ADR， incidence of hypoglycemia and incidence of gastrointestinal ADR. RESULTS： A total of 11 RCTs were included， involving 2 625 patients. Results of Meta-analysis showed that HbA1c levels [MD＝－0.37， 95％CI（－0.51， －0.22），P＜0.001]， FPG level [MD＝－0.47， 95％CI（－0.88， －0.07）， P＝0.02] and LDL-C level [MD＝－0.38， 95％CI（－0.49， －0.28）， P＜0.001] in trial group were significantly lower than control group， with statistical significance. In terms of safety， the incidence of total ADR [OR＝1.24， 95％CI（1.06， 1.45）， P＝0.007] and gastrointestinal ADR [OR＝1.78，95％CI（1.05， 3.02），P＝0.03] in trial group were significantly higher than control group， with statistical significance. There was no significant difference in the incidence of hypoglycemia [OR＝1.03， 95％CI（0.62，1.72），P＝0.90]. CONCLUSIONS： Colesevelam hydrochloride combined with other hypoglycemic drugs can effectively reduce the levels of HbA1c， FPG and LDL-C in T2DM patients， but attention should be paid to the occurrence of gastrointestinal ADR.