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Aims: To analyse the clinical characteristics and risk factors for tigecycline‐induced pancreatitis (TIP) and evaluate the safety and efficiency of tigecycline use in non‐TIP. Methods: A retrospective case‐control study was conducted on adult and juvenile patients administered tigecycline for >3 days. The adults were classified as TIP, non‐TIP (pancreatitis with other causes) and non‐pancreatitis. Univariate analyses were performed to compare TIP and non‐pancreatitis, and multivariate analysis was used to identify risk factors for TIP. The clinical characteristics of TIP, and the safety and efficiency of tigecycline use in non‐TIP were evaluated. Results: A total of 3910 patients (3823 adults and 87 juveniles) were enrolled. The adult patients comprised 21 TIP, 82 non‐TIP and 3720 non‐pancreatitis. The TIP prevalence was 0.56% in adults and 1.15% in juveniles. The mean time from tigecycline use to symptom onset was 7.2 days, and all cases were mild pancreatitis. The mean time from tigecycline withdrawal to symptom relief was 3.6 days. The multivariate analysis identified comorbid renal insufficiency as an independent risk factor for TIP (odds ratio = 3.032). Among the 82 non‐TIP patients, 81.7% had severe pancreatitis and 47.6% had necrotizing pancreatitis. The modified computed tomography severity score after tigecycline use was similar to that before tigecycline use, but the pancreatic enzymes and infection indices were significantly decreased. Conclusions: The prevalence of TIP was low. Comorbid renal insufficiency was as an independent risk factor for TIP. Tigecycline is safe and efficient for treatment of pancreatitis, especially necrotizing pancreatitis, with intra‐abdominal infection. [ABSTRACT FROM AUTHOR]

Background: Tigecycline has been widely used to treat hospital‐acquired pneumonia (HAP) off‐label since it is effective against a wide range of multidrug‐resistant bacteria. However, no recommended dosage for this indication has been evaluated, resulting in possible inadequate treatment. Aims: The aims of this study are to establish the population pharmacokinetic (PPK) model of tigecycline in Chinese patients with HAP, as well as to evaluate the exposure‐response relationship for the treatment of HAP with multidrug‐resistant gram‐negative bacteria. Methods: A PPK analysis of tigecycline was conducted on pooled data from 328 blood samples obtained from 89 patients with HAP. Tigecycline plasma concentrations were measured by a two‐dimensional liquid chromatographic system and the data were analysed using Phoenix NLMETM software. Exposure‐response analyses for efficacy were performed based on the data from 79 HAP patients with multidrug‐resistant gram‐negative infections. Classification and regression tree and logistic regression analyses were employed to identify which pharmacokinetic‐pharmacodynamic (PK‐PD) indices and magnitudes were the significant predictors of tigecycline efficacy. Results: A two‐compartment model with zero‐order absorption and first‐order elimination adequately described the data. A larger body weight was associated with increased central volume of distribution and clearance (P <.005), and increased age, baseline creatinine concentration and aspertate aminotransferase were associated with decreased clearance (P <.005). The AUC0‐12h × V/MIC ratio, APACHEII score and combined Pseudomonas aeruginosa infection are the strong predictors for tigecycline clinical response. Classification and regression tree analyses indicated that the combination of APACHEII score < 24 and AUC0‐12h × V/MIC ratio ≥ 100 was associated with clinical success. Conclusions: The proposed PPK model may serve as the basis for estimating tigecycline exposure for PK‐PD analyses, and the PK‐PD index and magnitude found in this study could be used for designing proper dosage regimens of tigecycline. [ABSTRACT FROM AUTHOR]