Effects of food on pharmacokinetics and safety of metformin hydrochloride tablets: A meta-analysis of pharmacokinetic, bioavailability, or bioequivalence studies
Abstract
Background The effects of food on the pharmacokinetics and safety of metformin hydrochloride (MH) are unclear. Objective To discover the effects of food on the pharmacokinetics and safety of MH, and its influence factors. Methods English and Chinese databases, and grey (unpublished) literature were searched for eligible studies (registration No. CRD 42022321067 in PROSPERO network). The summary weighted mean difference for continuous variables, and the risk ratio for dichotomous variables was calculated for the main pharmacokinetic parameters. Heterogeneity among the included studies was analyzed using the I2 test. Subgroup analyses, meta-regression, sensitivity analysis, and publication bias test were conducted. Results Fourteen clinical trials were included, comprising 408 participants. The pooled AUC0→t, AUC0→∞, and Cmax were decreased by about 30.21% (I2 = 16.7%, p = 0.276), 28.00% (I2 = 73.6%, p 0.05) confirmed that there is no publication bias. Conclusions Pharmacokinetics parameters of MH were affected by food. High-fat, high-calorie diet lowered the extent and rate of absorption while slowing the absorption of metformin. These findings suggest that it is necessary to increase the dosage of MH in order to maintain the same treatment effect when administration of MH after a high fat, high calorie diet.
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 408 participants or records.
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