European journal of clinical pharmacology · 2026
Clinical safety, tolerability, and efficacy of fospropofol disodium for sedation: a systematic review.
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Yan Caiyi, Jiao Bo, Xu Xiaolin, Chen Guo, Zhu Tao, Liu Jin, Chen Chan
Аннотация
PURPOSE: Fospropofol disodium (fospropofol) is a water-soluble prodrug of propofol with a distinct pharmacological and tolerability profile. However, evidence regarding the safety, tolerability, and efficacy of fospropofol across broader sedation contexts and different comparators remains insufficiently synthesized. This systematic review summarized current research findings on fospropofol to clarify its clinical role and guide future research.
METHODS: This systematic review was registered prior to initiation (PROSPERO CRD42023477740). Comprehensive searches were performed in PubMed, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, Embase via Ovid, ClinicalTrials.gov from inception to 26 August 2026. Randomized controlled trials (RCTs) evaluating fospropofol for sedation and reporting extractable efficacy or safety outcomes were eligible. Risk of bias was assessed using the Cochrane RoB 2 tool, and the certainty of evidence was evaluated according to the GRADE approach. Meta-analysis was performed for clinically comparable evidence groups, with other findings synthesized according to SWiM principles.
RESULTS: This systematic review included 10 original studies, comprising six procedural-sedation trials and four trials for ICU sedation. Quantitative synthesis was conducted for two comparable evidence groups, whereas the remaining outcomes were synthesized narratively. In three endoscopic procedural-sedation trials, fospropofol 6.5 mg/kg achieved a higher sedation success than 2 mg/kg (RR 3.27, 95% CI 2.62-4.08). In mechanically ventilated ICU patients, hypotension risk did not clearly differ between fospropofol and propofol (RR 0.93, 95% CI 0.67-1.28). Procedural studies showed a dose-dependent pattern in sedation efficacy, whereas ICU studies generally reported comparable target-sedation attainment between fospropofol and comparator sedatives. Paresthesia/pruritus was commonly reported, while rates of cardiorespiratory adverse events varied across settings and doses and showed no consistent comparative advantage for fospropofol. Evidence for injection pain and satisfaction was limited. Certainty of evidence ranged from high to very low, mainly because of risk of bias and imprecision.
CONCLUSIONS: Fospropofol can provide effective sedation across procedural and ICU settings, but its efficacy and safety profiles vary according to dose, comparator, and clinical setting. Higher doses may improve procedural-sedation efficacy but may also increase adverse effects in some settings. Current evidence does not establish a consistent cardiorespiratory safety advantage for fospropofol over other sedatives, and further adequately powered randomized trials are needed to clarify its comparative safety and optimal clinical role.
METHODS: This systematic review was registered prior to initiation (PROSPERO CRD42023477740). Comprehensive searches were performed in PubMed, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, Embase via Ovid, ClinicalTrials.gov from inception to 26 August 2026. Randomized controlled trials (RCTs) evaluating fospropofol for sedation and reporting extractable efficacy or safety outcomes were eligible. Risk of bias was assessed using the Cochrane RoB 2 tool, and the certainty of evidence was evaluated according to the GRADE approach. Meta-analysis was performed for clinically comparable evidence groups, with other findings synthesized according to SWiM principles.
RESULTS: This systematic review included 10 original studies, comprising six procedural-sedation trials and four trials for ICU sedation. Quantitative synthesis was conducted for two comparable evidence groups, whereas the remaining outcomes were synthesized narratively. In three endoscopic procedural-sedation trials, fospropofol 6.5 mg/kg achieved a higher sedation success than 2 mg/kg (RR 3.27, 95% CI 2.62-4.08). In mechanically ventilated ICU patients, hypotension risk did not clearly differ between fospropofol and propofol (RR 0.93, 95% CI 0.67-1.28). Procedural studies showed a dose-dependent pattern in sedation efficacy, whereas ICU studies generally reported comparable target-sedation attainment between fospropofol and comparator sedatives. Paresthesia/pruritus was commonly reported, while rates of cardiorespiratory adverse events varied across settings and doses and showed no consistent comparative advantage for fospropofol. Evidence for injection pain and satisfaction was limited. Certainty of evidence ranged from high to very low, mainly because of risk of bias and imprecision.
CONCLUSIONS: Fospropofol can provide effective sedation across procedural and ICU settings, but its efficacy and safety profiles vary according to dose, comparator, and clinical setting. Higher doses may improve procedural-sedation efficacy but may also increase adverse effects in some settings. Current evidence does not establish a consistent cardiorespiratory safety advantage for fospropofol over other sedatives, and further adequately powered randomized trials are needed to clarify its comparative safety and optimal clinical role.