J Clin Pharm Ther [JOURNAL]
Sun
200 papers
Real-world use of IBI305, a bevacizumab biosimilar, in a tertiary caner-specialized hospital in China.
Chen Z, Wang Y, Yang J … +2 more , Zhou H, Li G
J Clin Pharm Ther · 2022 Dec · PMID 36418209 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: To investigate and describe the real-world use of IBI305, a biosimilar of bevacizumab, across all approved indications in the first 12 months since its entry in National cancer center of Chin...
WHAT IS KNOWN AND OBJECTIVE: To investigate and describe the real-world use of IBI305, a biosimilar of bevacizumab, across all approved indications in the first 12 months since its entry in National cancer center of China. METHODS: A retrospective, observational study was carried out to describe the demographic and patient characteristics and treatment patterns of the adult patients who received IBI305 from December 2020 to December 2021. RESULTS AND DISCUSSION: Among 259 cases, 186 patients were non-small cell lung cancer (NSCLC), 86 patients were metastatic colorectal cancer (mCRC), five patients were hepatocellular carcinoma (HCC). More than half of the patients initiated IBI305 were bevacizumab-naive. In patients with NSCLC and mCRC, more than 40% of them received IBI305 as first-line therapy. Among pre-exposed patients, the majority of them were switched from reference product (RP) or other biosimilars to IBI305 within 28 days. WHAT IS NEW AND CONCLUSION: Early evidence from real world data suggests rapid clinical adoption of IBI305 in all approved tumour types.
Optimal exposure to docetaxel in adjuvant chemotherapy for early-stage breast cancer.
Guo J, Lin W, Weng Y … +8 more , Chen Y, Zeng S, Lin J, Zheng X, Li X, Lin M, Yu X, Chen Q
J Clin Pharm Ther · 2022 Dec · PMID 36418195 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Drug-induced neutropenia is the main reason for the dose limitation of docetaxel in patients with breast cancer. The area under the drug concentration-time curve (AUC) of docetaxel is associa...
WHAT IS KNOWN AND OBJECTIVE: Drug-induced neutropenia is the main reason for the dose limitation of docetaxel in patients with breast cancer. The area under the drug concentration-time curve (AUC) of docetaxel is associated with neutropenia. However, the optimal exposure to docetaxel for receiving postoperative adjuvant chemotherapy remains unclear. Therefore, we aimed to evaluate the relationship between the docetaxel AUC and neutropenia, identify potential influencing factors, and explore the best monitoring target for docetaxel when treating patients with early-stage breast cancer using a population pharmacokinetic (PopPK) model. METHODS: Docetaxel plasma concentration, demographics, clinical data, and related laboratory data were collected. PopPK analyses were performed using a nonlinear mixed-effect modelling program. The docetaxel AUC was determined using the maximum a posteriori Bayesian (MAPB) method. The docetaxel exposure-toxicity threshold measured from the AUC for neutropenia was determined using the receiver operating characteristic (ROC) curve. The correlation between docetaxel exposure and neutropenia was analysed using multivariable logistic regression. RESULTS: Among the 70 participants, 47 (67.1%) developed severe neutropenia. The PopPK analysis showed that the typical drug clearance (CL) rate was 37.4 L/h. Age was a significant covariate of CL rate, and aspartate aminotransferase and albumin levels were covariables of the volume of distribution. The multivariable regression analysis showed that AUC >3.0 mg.h/L (odds ratio [OR], 5.940; 95% confidence interval [CI], 1.693-20.843; P = 0.005), platinum use (OR, 0.156; 95% CI, 0.043-0.562; P = 0.005) and baseline haemoglobin level (OR, 0.938; 95% CI, 0.887-0.993; P = 0.027) were significant factors influencing the occurrence of grade 3/4 neutropenia. The AUC of first cycle may not predict the occurrence rates of grade 3/4 neutropenia in later cycles. WHAT IS NEW AND CONCLUSION: We developed a docetaxel PopPK model for patients with early-stage breast cancer. Age and AST and ALB levels were significant covariates. AUC estimated using the MAPB method can predict the toxicity of docetaxel in patients with breast cancer. Docetaxel AUC >3.0 mg.h/L, absence of platinum use and low baseline haemoglobin level were risk factors for docetaxel-induced grade 3/4 neutropenia. STUDY REGISTRATION: Chinese Clinical Trial Center Registry (ChiCTR2200056460).
Asparaginase-related diabetic ketoacidosis: Analysis of the FDA Adverse Event Reporting System (FAERS) data and literature review.
Li D, Gou J, Dong J … +5 more , Dong Y, Xi X, Chen C, Du Q, Liu S
J Clin Pharm Ther · 2022 Dec · PMID 36411584 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Diabetic ketoacidosis (DKA) may occur during asparaginase use. However, limited by the study population, the association between asparaginase and DKA has not been elucidated. The purpose of t...
WHAT IS KNOWN AND OBJECTIVE: Diabetic ketoacidosis (DKA) may occur during asparaginase use. However, limited by the study population, the association between asparaginase and DKA has not been elucidated. The purpose of this study was to determine the potential association between asparaginase and DKA and analyse related clinical characteristics and possible risk factor. METHODS: Disproportionality analysis with the reporting odd ratio (ROR) was used to detect the adverse reaction signals of asparaginase-associated DKA in Food and Drug Administration Adverse Event Reporting System (FAERS). A literature review was conducted to further analyse clinical characteristics, possible risk factor and something noteworthy in asparaginase-associated DKA. RESULTS AND DISCUSSION: A total of 12 reports of DKA associated with l-asparaginase (l-asp) and 6 reports associated with pegaspargase (PEG-asp) were extracted in FAERS, more than 50% of the cases were classified as serious adverse events. DKA was a positive signal of l-asp (ROR = 2.397, 95% CI 1.360-4.226), while not closely related to the use of PEG-asp (ROR = 1.602, 95% CI 0.719-3.570). Searched in PubMed, Embase and Web of Science, a total of eight patients were collected. The patients were mainly adolescent patients, aged between 11 and 25 years old with a median age of 16 years. Drug dosage form distribution is unbalanced, 7 patients received l-asp and only 1 received PEG-asp. WHAT IS NEW AND CONCLUSIONS: The ROR of KDA caused by l-asp was statistically significant, but there was not a statistical association for DKA caused by PEG-asp. Asparaginase dosage form may affect the occurrence of DKA, but further research is needed.
Apatinib plus paclitaxel versus paclitaxel monotherapy for platinum-resistant recurrent ovarian cancer treatment: A retrospective cohort study.
Geng A, Yang H, Wang Z … +1 more , Wu C
J Clin Pharm Ther · 2022 Dec · PMID 36404135 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Apatinib, an oral antiangiogenic drug, exerts potential anti-tumour effects on platinum-resistant recurrent ovarian cancer (PROC). This study intended to evaluate the efficacy and safety of a...
WHAT IS KNOWN AND OBJECTIVE: Apatinib, an oral antiangiogenic drug, exerts potential anti-tumour effects on platinum-resistant recurrent ovarian cancer (PROC). This study intended to evaluate the efficacy and safety of apatinib plus paclitaxel compared to paclitaxel monotherapy in PROC patients. METHODS: This retrospective cohort study reviewed 70 PROC patients who received apatinib plus paclitaxel (apatinib plus paclitaxel group) (N = 32) or paclitaxel monotherapy (paclitaxel monotherapy group) (N = 38). The recommended regimens were as follows: paclitaxel (60 mg/m ) administrated once a week with a maximum of 18 weeks; apatinib (250-375 mg/day) administrated until disease progression or patient intolerance. RESULTS AND DISCUSSION: Disease control rate was elevated (84.4% vs. 60.5%, P = 0.028), whereas objective response rate only disclosed an increasing trend (lacked statistical significance) (37.5% vs. 18.4%, P = 0.074) in apatinib plus paclitaxel group compared with paclitaxel monotherapy group. Progression-free survival (median [95% confidence interval (CI)]: 5.0 [2.5-7.5] months vs. 3.8 [2.4-5.2] months, P = 0.033) and overall survival (median [95% CI]: 21.1 [13.2-29.0] months vs. 14.8 [11.4-18.2] months, P = 0.032) were both prolonged in apatinib plus paclitaxel group compared to paclitaxel monotherapy group, which were further verified in the multivariate Cox's proportional hazard regression analyses (both P < 0.050). Additionally, the incidence of each adverse event was not different between the two groups (all P > 0.050). WHAT IS NEW AND CONCLUSION: Apatinib plus paclitaxel exhibits better efficacy and acceptable toxicity compared with paclitaxel monotherapy in PROC patients.
Low-dose febuxostat exhibits a superior renal-protective effect and non-inferior safety profile compared to allopurinol in chronic kidney disease patients complicated with hyperuricemia: A double-centre, randomized, controlled study.
Yang N, Cao B
J Clin Pharm Ther · 2022 Dec · PMID 36403976 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The present study compared the efficacy and safety of low-dose febuxostat versus allopurinol in chronic kidney disease (CKD) patients complicated with hyperuricemia (HUA). METHODS: In this do...
WHAT IS KNOWN AND OBJECTIVE: The present study compared the efficacy and safety of low-dose febuxostat versus allopurinol in chronic kidney disease (CKD) patients complicated with hyperuricemia (HUA). METHODS: In this double-centre, randomized, controlled study, 120 CKD patients complicated with HUA were recruited and randomly assigned to low-dose febuxostat group (20 mg/day) or allopurinol group (200 mg/day) at 1:1 ratio. The serum creatinine (Scr), serum uric acid (SUA), and estimated glomerular filtration rate (eGFR) were measured at baseline (M0), month (M) 1, M3, and M6. Besides, the drug-related adverse events (AEs) were recorded. The primary outcome was the proportion of patients showing a > 10% decline in eGFR from M0 to M6. RESULTS: The eGFR level was increased at M6, but similar at M0, M1 and M3 in febuxostat group compared with allopurinol group. Notably, the proportion of patients with >10% decline in eGFR from M0 to M6 was decreased in febuxostat group compared with allopurinol group. However, there was no difference of Scr, SUA at M0, M1, M3 and M6 between febuxostat group and allopurinol group. Moreover, there was no difference of drug-related AEs between febuxostat group and allopurinol group. Further subgroup analysis exhibited that low-dose febuxostat presented superior effect on attenuating eGFR decline and lowering SUA level compared with allopurinol in CKD stage 3 subgroup, but not in CKD stage 2 subgroup. CONCLUSION: Low-dose febuxostat may exhibit a superior renal-protective effect, non-inferior SUA lowering ability and safety profile compared with allopurinol in CKD patients complicated with HUA.
Effects of the international economic sanctions on access to medicine of the Iranian people: A systematic review.
Asadi-Pooya AA, Nazari M, Damabi NM
J Clin Pharm Ther · 2022 Dec · PMID 36401156 · Publisher ↗
OBJECTIVE: We hypothesized that the international economic sanctions have affected various groups of Iranian people and have compromised their right to access medicines. METHODS: Scopus and MEDLINE from their inception t...
OBJECTIVE: We hypothesized that the international economic sanctions have affected various groups of Iranian people and have compromised their right to access medicines. METHODS: Scopus and MEDLINE from their inception to 15 May 2022 were systematically searched for related published original manuscripts. The following keywords were used (title/abstract): "sanction(s)" AND "Iran". The inclusion criteria were all human studies and articles written in English. RESULTS: We could identify 24 articles. Sanctions have severely restricted patients with thalassemia, haemophilia, epilepsy, and multiple sclerosis from receiving their medical needs. Surveys and interviews of patients, healthcare professionals, and policy-makers have repeatedly shown that sanctions have greatly affected the health system in Iran. CONCLUSION: International economic sanctions have limited access of the Iranian people to medicines and are associated with the suffering of Iranians. This situation should provide a lesson for policymakers in other similar instances worldwide.
Test performance of self-report adherence tools in patients with hypertension: A systematic review and a meta-analysis.
Al-Alaili MK, Abdi AM, Basgut B
J Clin Pharm Ther · 2022 Dec · PMID 36401121 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: Adherence has proved to have a positive influence on achieving plausible treatment outcomes. Self-report questionnaires are widely used in evaluating adherence, creating thus a high-powered...
WHAT IS KNOWN AND OBJECTIVES: Adherence has proved to have a positive influence on achieving plausible treatment outcomes. Self-report questionnaires are widely used in evaluating adherence, creating thus a high-powered research field. This review aims to provide an update of scales used in hypertension, which are compared and analysed against reliability and validity. METHODS: PubMed, Web of Science and Cochrane Library were searched in May 2022 to identify studies. We extracted the study characteristics and evaluated their quality. A random-effects model with subgroup analysis was used to calculate estimates and heterogeneity parameters as well as regressions, funnel and forest plots. A bivariate model was selected to conduct validity analyses and draw receiver operating characteristic (ROC) curves. RESULTS AND DISCUSSION: Fifty-five articles were identified and classified into 22 different reliable and validated tools. Pooled analyses predicted an overall good Cronbach's alpha of 0.76 (95%CI:0.67-0.83), a good ICC of 0.8 (95%CI:0.72-0.86) and an excellent correlation coefficient of 0.91 (95%CI:0.86-0.95), which all showed high heterogeneity and slight detection of asymmetry. Regression analyses showed that only time and the number of items/scale type influenced significantly retest and alpha, respectively. Overall validity showed acceptable sensitivity of 0.65 (95%CI:0.53-0.75) and specificity of 0.57 (95%CI:0.47-0.67) with a good Area Under Curve (AUC) of 0.637. Upon comparison, four tools showed superiority over Morisky's scale. WHAT IS NEW AND CONCLUSION: Adherence is a multi-dimensional phenomenon, which deems scales to be highly variable or complex; thus, complicating the selection process. Adherence to Refills and Medications Scale (ARMS) is the most promising free non-inferior alternative to Morisky, the most used scale.
The role of the clinical pharmacist in the prevention of drug-induced acute kidney injury in the intensive care unit.
Polat EC, Koc A, Demirkan K
J Clin Pharm Ther · 2022 Dec · PMID 36394173 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Acute kidney injury (AKI) is a disorder that is commonly seen in patients in the intensive care unit (ICU) and has a detrimental impact on the patients' clinical prognosis. Although a variety...
WHAT IS KNOWN AND OBJECTIVE: Acute kidney injury (AKI) is a disorder that is commonly seen in patients in the intensive care unit (ICU) and has a detrimental impact on the patients' clinical prognosis. Although a variety of factors contribute to the development of AKI in patients, drug-induced AKI is a common occurrence in the ICU. With the widespread availability of clinical pharmacy services, the clinical pharmacist's consultation service to the healthcare team aids in the resolution of drug-related issues and the enhancement of therapeutic outcomes. The involvement of a clinical pharmacist in the ICU team is expected to minimize the incidence of drug-induced AKI and enhance therapeutic results. Therefore, the goal of our study was to demonstrate the impact of having a clinical pharmacist on the occurrence, stages, and treatment of AKI. METHODS: The study included two patient groups: intervention (n = 75) (IG) and control (n = 75) (CG) groups. The clinical pharmacist has made recommendations to the ICU team regarding the treatment of IG patients on drug selection, drug administration routes, drug dose adjustment, drug-drug interactions, drug-food or nutritional solution interactions, drug side effect management, and drug incompatibility. No interventions were provided by the clinical pharmacist in the CG patients. The clinical pharmacist visited patients regularly and noted the laboratory findings and pharmacological treatments of patients in the study groups on the patient follow-up forms. The obtained data of IG and CG were compared and statistical methods were used to assess them. RESULTS AND DISCUSSION: According to our findings, AKI was found to be more common in CG than in IG (p < 0.05). Stage 1 was shown to be the most common AKI stage in the patients (p > 0.05). The gap between the patients' highest Cr and basal sCr values was less in IG (p < 0.05). When the association between reasons for ICU admission and AKI was investigated, pulmonary edema and acute respiratory failure were found to have a significant and positive relationship with AKI (p < 0.05). Furthermore, it was shown that patients with diabetes and cancer comorbidities were the most vulnerable to developing AKI (p < 0.05). Antibiotics, anaesthetics, and cardiovascular system medication categories were found to have a significant and positive correlation with AKI in patients (p < 0.05). Also, it was revealed that the usage of vancomycin, colistin, ampicillin-sulbactam, clarithromycin, ceftriaxone, midazolam, and dexketoprofen caused AKI (p < 0.05). WHAT IS NEW AND CONCLUSION: Our findings demonstrate that if a clinical pharmacist is included in the ICU team and provides consultation services to the ICU team regarding patient treatment by performing regular patient follow-up, the incidence of AKI in patients can be minimized and therapeutic outcomes can be improved.
Bilateral toxic epithelial keratopathy following instillation of expired topical eye drops.
AlGhadeer H, AlHumaidan A
J Clin Pharm Ther · 2022 Dec · PMID 36394117 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Toxic corneal epitheliopathies are common, but the majority are probably so mild that they are subclinical. Clinically significant epithelial keratopathy can occur following a single drop of...
WHAT IS KNOWN AND OBJECTIVE: Toxic corneal epitheliopathies are common, but the majority are probably so mild that they are subclinical. Clinically significant epithelial keratopathy can occur following a single drop of topical expired carboxymethylcellulose sodium eye drops. CASE SUMMARY: This case presents A 34-year-old female who presented to the emergency department with a history of severe ocular pain and reduced vision after bilateral instillation of expired eye drops. Both eyes were diagnosed with toxic epithelial keratopathy. The presenting best corrected visual acuity (BCVA) was 20/100 in the right eye and 20/300 in the left eye. The BCVA at last follow-up was 20/20 in both eyes. WHAT IS NEW AND CONCLUSION: The safe use and storage of ophthalmic drugs, including their use before the expiration date, should be reinforced to patients by all healthcare practitioners to avoid complications such as toxic keratopathy.
Influence of CYP3A4*22 and CYP3A5*3 combined genotypes on tacrolimus dose requirements in Egyptian renal transplant patients.
Ebid AIM, Ismail DA, Lotfy NM … +2 more , Mahmoud MA, ELSharkawy M
J Clin Pharm Ther · 2022 Dec · PMID 36379901 · Publisher ↗
BACKGROUND: Tacrolimus is a widely prescribed immunosuppressant agent for kidney transplantation. However, optimal dosing is challenging due to its narrow therapeutic index, potentially serious adverse effects, and wide...
BACKGROUND: Tacrolimus is a widely prescribed immunosuppressant agent for kidney transplantation. However, optimal dosing is challenging due to its narrow therapeutic index, potentially serious adverse effects, and wide inter-individual variability in pharmacokinetics. Cytochrome P450 3A (CPY3A) enzymes metabolize tacrolimus, so allelic variants such as CYP3A4*22 and CYP3A5*3 may contribute to individual differences in pharmacokinetics and therapeutic efficacy of tacrolimus. This study assessed the frequency and influences of CYP3A4*22 and CYP3A5*3 genotypes, alone and combined, on tacrolimus pharmacokinetics and dose requirements in Egyptian kidney transplant patients. METHODS: This is a prospective multicenter observational cohort study. Patients were genotyped for the CYP3A4*22 (rs35599367), and CYP3A5*3 (rs776746). Tacrolimus dose (mg), through blood level (ng/ml), and dose-adjusted trough concentration (C0/D) (ng/ml per mg/kg) were recorded during the first and third months post-transplantation and compared among genotype groups. RESULTS: The CYP3A4*22 allele was rare (3.2% of subjects) while the CYP3A5*3 allele was widespread (90.38%) in this cohort. At the third month post-transplantation, median C0/D was significantly higher among CYP3A4*22 carriers than CYP3A4*1/*1 (146.25 [100-380] versus 85.57 [27-370] ng/ml per mg/kg, p = 0.028). Patients harbouring the one copy of the CYP3A4*22 allele and the CYP3A5*3/*3 genotype (n = 5) were classified as poor tacrolimus metabolizers, the CYP3A5*3/*3 plus CYP3A4*1/*1 genotype as intermediate metabolizers (n = 60), and the CYP3A4*1/*1 plus CYP3A5*1/*1 genotype as normal metabolizers (n = 13). During the first month post-transplantation, C0/D was significantly greater in poor metabolizers (113.07 ng/ml per mg/kg) than intermediate and normal metabolizers (90.380 and 49.09 ng/ml per mg/kg) (p < 0.0005). This rank order was also observed during the third month. Acute rejection rate and renal function at discharge did not differ among genotypes. CONCLUSION: Pharmacogenetics testing for CYP3A4*22 and CYP3A5*3 before renal transplantation may help in the adjustment of tacrolimus starting dose and identify patients at risk of tacrolimus overexposure or underexposure.
Delay in desmopressin therapy: Disaster in waiting.
Kroll C, Zandvakili A
J Clin Pharm Ther · 2022 Dec · PMID 36376238 · Full text
WHAT IS KNOWN AND OBJECTIVE: Central diabetes insipidus (DI) is a complex disease that requires firm adherence to desmopressin therapy. There is little information on the onset of hypernatremia after withdrawal of desmop...
WHAT IS KNOWN AND OBJECTIVE: Central diabetes insipidus (DI) is a complex disease that requires firm adherence to desmopressin therapy. There is little information on the onset of hypernatremia after withdrawal of desmopressin. CASE SUMMARY: We present a case of an elderly woman with central DI whose serum sodium jumped from 141 to 171 mEq/L after 48-72 h of holding oral desmopressin. Her DI crisis resolved with intravenous desmopressin and free water administration. WHAT IS NEW AND CONCLUSION: Based on this precipitous onset of DI crisis, we recommend not withholding desmopressin for more than 24 h.
Central nervous system adverse events of ceftazidime/avibactam: A retrospective study using Food and Drug Administration Adverse Event Reporting System.
Guo X, Guo M, Li J … +1 more , Cui X
J Clin Pharm Ther · 2022 Dec · PMID 36369970 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Many antibiotics are well known for being associated with adverse events (AEs) of central nervous system, ceftazidime/avibactam (CAZ/AVI) is a novel β-lactam/β-lactamase inhibitor combination...
WHAT IS KNOWN AND OBJECTIVE: Many antibiotics are well known for being associated with adverse events (AEs) of central nervous system, ceftazidime/avibactam (CAZ/AVI) is a novel β-lactam/β-lactamase inhibitor combinations. In this commentary, we analyzed reports of nervous system disorders associated with CAZ/AVI, meropenem, imipenem, ceftazidime, ceftriaxone, and cefepime in the Food and Drug Administration (FDA) Adverse Event Reporting System database from January 2015 to March 2022. COMMENT: The reporting odds ratios (RORs) method was used to detect the safety signals. Up to 15.62% of CAZ/AVI AEs exhibit nervous system disorders associated with CAZ/AVI. A nervous system disorder signal was detected for CAZ/AVI compared with meropenem, ceftazidime, and ceftriaxone. Compared with meropenem, imipenem, ceftazidime, and ceftriaxone, encephalopathy, myoclonus, reported with CAZ/AVI exhibited significant RORs. WHAT IS NEW AND CONCLUSION: This study found that CAZ/AVI showed a relatively stronger sign nervous system disorder than meropenem, ceftazidime, and ceftriaxone in the real world. The poor clinical outcome of these events should attract clinical attention, especially for patients with older than 65 years old and long treatment courses.
Comparison of vancomycin area under the concentration-time curve (AUC) using two-point pharmacokinetics versus two open-access online single-concentration vancomycin calculators.
Ondrush NM, Ademovic R, Seabury RW … +3 more , Darko W, Miller CD, Mogle BT
J Clin Pharm Ther · 2022 Dec · PMID 36351763 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Current vancomycin monitoring guidelines recommend the use of area under the concentration-time curve (AUC ) monitoring in patients with serious Methicillin-Resistant Staphylococcus aureus (M...
WHAT IS KNOWN AND OBJECTIVE: Current vancomycin monitoring guidelines recommend the use of area under the concentration-time curve (AUC ) monitoring in patients with serious Methicillin-Resistant Staphylococcus aureus (MRSA) infections by utilizing either a Bayesian approach or first-order analytic equations. Several open-access websites exist that allow estimation of vancomycin AUC with the use of a single steady-state concentration. It is uncertain how these open-access calculators perform against guideline-recommended methods. The objective was to compare AUC estimates from two online, open-access, single-concentration vancomycin calculators compared with the two-point pharmacokinetic (2PK) method. METHODS: AUC estimates were made using the 2PK reference method and the single-concentration vancomycin calculators, ClinCalc and VancoPK. The AUC estimates from the 2PK reference method were compared to the online calculators by assessing bias (median AUC difference) and precision (AUC difference ± 100 mg*h/L). Clinical precision was also assessed by characterizing the frequency that the 2PK reference method and the online calculators showed clinical disagreement based on the following AUC categories: (1) AUC < 400 mg*h/L; (2) AUC 400-600 mg*h/L and (3) AUC > 600 mg*h/L. RESULTS AND DISCUSSION: A total of 253 patients were included in the study. The AUC estimates from the ClinCalc and VancoPK single-concentration vancomycin calculators showed some bias and imprecision, though VancoPK appeared to have less. Clinical disagreement versus the 2PK reference method occurred in 31.2% and 19.4% of AUC estimates from the ClinCalc and VancoPK single-concentration vancomycin calculators, suggesting clinical imprecision. WHAT IS NEW AND CONCLUSION: The AUC estimates from single-concentration, online vancomycin calculators showed some bias and imprecision in comparison to the 2PK method. Institutions should validate these online, trough-only calculators relative to a 2PK method in their patient populations prior to adoption as standard-of-care.
CytoSorb haemoadsorption for removal of apixaban-A proof-of-concept pilot case for a randomized controlled trial.
Buonocore M, Rex S, Degezelle K … +1 more , Meyns B
J Clin Pharm Ther · 2022 Dec · PMID 36351749 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Emergent cardiac surgery in patients under anticoagulant therapy is still a major point of concern. Recently approved reversal agents are often not available or not suitable in the cardiac su...
WHAT IS KNOWN AND OBJECTIVE: Emergent cardiac surgery in patients under anticoagulant therapy is still a major point of concern. Recently approved reversal agents are often not available or not suitable in the cardiac surgery setting, and timely discontinuation of the drug is not always feasible. CytoSorb® haemoadsorption therapy has been approved in Europe for intraoperative ticagrelor and rivaroxaban removal during cardiopulmonary bypass (CPB), but thus far the efficacy of CytoSorb® haemoadsorber on other anticoagulants (apixaban, dabigatran, edoxaban) has only been tested in vitro, and some signals of clinical benefits have reported in a few case reports. CASE SUMMARY: We describe a case of CPB implementation with CytoSorb® in a haemodynamic unstable patient with prosthetic aortic valve endocarditis on apixaban therapy. WHAT IS NEW AND CONCLUSION: CytoSorb® proved to be effective for removal of apixaban in emergency surgery setting by direct measurements of drug levels before and during CPB circulation.
Efficacy and safety of rituximab biosimilars or reference product as first-line treatment in patients with low-tumour-burden follicular lymphoma: A systematic review and meta-analysis.
Yang L, Zheng Z, Li N … +3 more , Zheng B, Liu M, Cai H
J Clin Pharm Ther · 2022 Dec · PMID 36345167 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The role of rituximab in the first-line treatment of low-tumour-burden follicular lymphoma (LTB-FL) has been supported by a large number of data. However, whether rituximab biosimilars have t...
WHAT IS KNOWN AND OBJECTIVE: The role of rituximab in the first-line treatment of low-tumour-burden follicular lymphoma (LTB-FL) has been supported by a large number of data. However, whether rituximab biosimilars have the same efficacy and safety as the reference drug (MabThera) is still controversial. METHODS: Electronic databases and the ClinicalTrail.gov website were extensively searched using relevant search criteria. The risk of bias of the included studies was assessed using the RoB 2 assessment scale, and the RevMan 5.4 statistical software was used for meta-analysis. RESULTS AND DISCUSSION: A total of 1223 patients were included in four clinical randomized controlled trials. There was no statistical difference in efficacy between biosimilars and MabThera groups (the objective response rate: RR = 1.00, 95% CI: 0.93-1.08, p = 0.92; the progression-free survival: RR = 1.04, 95% CI: 0.96-1.12, p = 0.30; the overall survival: RR = 1.00, 95% CI: 0.98-1.03, p = 0.76; the serious adverse events: RR = 1.15, 95% CI: 0.69-1.89, p = 0.59; the infusion-related reaction: RR = 0.91, 95% CI: 0.77-1.09, p = 0.32). In terms of safety, there was also no significant difference between two groups. WHAT IS NEW AND CONCLUSION: Our study concluded that the efficacy and safety of rituximab biosimilars in the treatment of LTB-FL are highly similar to those of the original drug.
Dosage optimization of voriconazole in children with haematological malignancies based on population pharmacokinetics.
Wu Y, Lv C, Wu D … +6 more , Qi J, Cai R, Zhou S, Li C, Wei Y, Liu T
J Clin Pharm Ther · 2022 Dec · PMID 36345158 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: Voriconazole has a complex pharmacokinetic profile and exhibits different pharmacokinetic characteristics in adults and children. Nevertheless, few studies have been conducted on the populat...
WHAT IS KNOWN AND OBJECTIVES: Voriconazole has a complex pharmacokinetic profile and exhibits different pharmacokinetic characteristics in adults and children. Nevertheless, few studies have been conducted on the population pharmacokinetics (PPK) of voriconazole in children with haematological malignancies. This study aims to build a PPK model and propose a suitable voriconazole treatment scheme for children with haematological malignancies. METHODS: We retrospectively collected 146 samples from 67 children aged from 1.08 to 17.92 years. The PPK model was established using nonlinear mixed effects modelling (NONMEM). Dosage simulations were conducted on the basis of the final model's covariates. RESULTS AND DISCUSSION: Data were fully characterized by a one-compartment model with first-order absorption and elimination. The weight (WT), CYP2C19 phenotype, and Albumin (ALB) were notable covariates for clearance (CL). The typical values of CL, the volume of distribution (V), and oral bioavailability (F) were 2.29 L/h, 76 L, and 0.902, respectively. The proposed doses for different CYP2C19 genotypes were presented in this ranking: EM (extensive metabolizer) > IM (intermediate metabolizer) > PM (poor metabolizer). Furthermore, higher dosages for light WT patients were recommended while lower ALB levels required lower doses. The probability of achieving the target (PTA) for the recommended doses ranged from 72.2% to 99%. WHAT IS NEW AND CONCLUSION: We successfully built a voriconazole PPK model for children with hematologic malignancies. Dosing regimens were developed for different patients based on the final model, which could enhance the rational use of voriconazole in children with haematological malignancies.
Remimazolam versus propofol for deep sedation/anaesthesia in upper gastrointestinal endoscopy in elderly patients: A multicenter, randomized controlled trial.
Lu K, Wei S, Ling W … +14 more , Wei Y, Ran X, Huang H, Wang M, Wei N, Liao Y, Qin Z, Pan M, Wei Q, Fu L, Xiong B, Ma C, Jiang J, Huang Y
J Clin Pharm Ther · 2022 Dec · PMID 36334013 · Full text
BACKGROUND AND OBJECTIVE: Propofol is the most commonly used sedative in gastrointestinal endoscopic procedures, but is associated with cardiorespiratory suppression, particularly in elderly patients. Remimazolam is a ne...
BACKGROUND AND OBJECTIVE: Propofol is the most commonly used sedative in gastrointestinal endoscopic procedures, but is associated with cardiorespiratory suppression, particularly in elderly patients. Remimazolam is a new short-acting GABA(A) receptor agonist with minimal impact on cardiorespiratory suppression, and may be a viable alternative in elderly patients undergoing endoscopic procedures. METHODS: This multicenter, randomized controlled trial was conducted between September 2020 and September 2021. Elderly patients (65-85 years of age) scheduled to undergo upper gastrointestinal endoscopy were randomized in 1:1 ratio to receive remimazolam tosilate (300 mg/h) or propofol (3 g/h) in addition to 50-μg fentanyl, until the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) reached ≤1. MOAA/S was maintained at 0 or 1 throughout the procedure using 2.5 mg remimazolam or 0.5 mg/kg propofol boluses in the two groups, respectively. The primary outcome was the rate of hypotension (defined as systolic blood pressure at ≤90 mmHg or > 30% decline vs. the baseline). Bradycardia was defined as heart rate ≤50 per minute; respiratory depression was defined as respiratory rate <8 per minute and/or SpO < 90%. RESULTS: A total of 400 patients (161 men and 239 women; 70.4 ± 4.6 years of age) were enrolled (200 patients per group). Average body mass index was 22.2 ± 2.4 kg/m . The rate of hypotension was 36.5% in the remimazolam group and 69.6% in the propofol group (p < 0.001). The remimazolam group also had a lower rate of bradycardia (1.5% vs. 8.5%, p < 0.001), respiratory depression (4.5% vs. 10.0%, p < 0.05) and pain at the injection site (0% vs. 12.0%, p < 0.001). CONCLUSION: Remimazolam was associated with a lower rate of hypotension in elderly patients undergoing upper gastrointestinal endoscopy under deep sedation/anaesthesia than propofol.
The correlation between paclitaxel chemotoxicity and the plasma albumin level in cancer patients.
Fan W, Yin W, Zhou F … +4 more , Wang Y, Fan J, Zang F, Lin B
J Clin Pharm Ther · 2022 Dec · PMID 36325658 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The aim of this study was to evaluate the pharmacokinetics of paclitaxel in cancer patients with hypoalbuminemia following paclitaxel-containing chemotherapy and to provide a reference for th...
WHAT IS KNOWN AND OBJECTIVE: The aim of this study was to evaluate the pharmacokinetics of paclitaxel in cancer patients with hypoalbuminemia following paclitaxel-containing chemotherapy and to provide a reference for the prevention of adverse events (AEs) after paclitaxel administration. METHODS: Peripheral blood was collected from cancer patients treated with paclitaxel. The plasma concentration of paclitaxel was determined by ultra-high performance liquid chromatography after 24 ± 8 h of chemotherapy, and individual paclitaxel time above a threshold concentration of 0.05 μmol/L (T ) was calculated using the population pharmacokinetic model. Haematological and non-haematological toxicities were monitored after chemotherapy, and the correlation between different chemotherapy toxicities and T was evaluated using the Prism software. RESULTS AND DISCUSSION: The enrolled patients were divided into the hypoalbuminemia group and normal albumin level group. The mean T values in the normal albumin level and hypoalbuminemia groups were 36.89 and 24.93 h, respectively (P < 0.001). The risk of myelosuppression was positively correlated with T . Due to the lower T , the incidences of immediate AEs such as gastrointestinal reactions and rashes were higher in the hypoalbuminemia group than in the normal albumin level group, and the incidences of delayed AEs such as myelosuppression and neurotoxicity were lower in the hypoalbuminemia group. WHAT IS NEW AND CONCLUSIONS: Plasma albumin level has a conclusive effect on T , which can predict the potential clinical toxicity of paclitaxel. The study provides a theoretical basis for administration of paclitaxel.
Diagnostic value of bronchoalveolar lavage fluid galactomannan assay for invasive pulmonary aspergillosis in adults: A meta-analysis.
Li C, Sun L, Liu Y … +4 more , Zhou H, Chen J, She M, Wang Y
J Clin Pharm Ther · 2022 Dec · PMID 36324286 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: To analyse the diagnostic accuracy of bronchoalveolar lavage fluid galactomannan (BALF-GM) assay for invasive pulmonary aspergillosis (IPA) in adults to determine the optimal diagnostic cut-o...
WHAT IS KNOWN AND OBJECTIVE: To analyse the diagnostic accuracy of bronchoalveolar lavage fluid galactomannan (BALF-GM) assay for invasive pulmonary aspergillosis (IPA) in adults to determine the optimal diagnostic cut-off by meta-analysis. METHODS: PubMed, Embase, Web of Science, Cochrane Library, China national knowledge infrastructure (CNKI), and China Wanfang databases were searched to collect relevant studies on the diagnostic value of BALF-GM for IPA from inception to March 2022. The summary receiver operating characteristic (SROC) curve was drawn to determine the optimal diagnostic cut-off. RESULTS AND DISCUSSION: Nineteen articles (56 data sets) were included. The pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR) were 0.79 (95% CI: 0.72-0.84), 0.92 (95% CI: 0.88-0.94), 9.25 (95% CI: 6.84-12.52), 0.23 (95% CI: 0.18-0.30), 39.44 (95% CI: 29.55-52.65), and 0.92 (95% CI: 0.90-0.94), respectively. The area under the curves (AUCs) were 0.92, 0.86, 0.93, 0.89, 0.88, and 0.94 when the cut-off values were 0.5, 0.8, 1.0, 1.5, 2.0, and 3.0, respectively. Sixteen studies were included in the combined analysis when the cut-off value was 0.5. The results showed that the pooled sensitivity, specificity, PLR, NLR and DOR of BALF-GM (cut-off 0.5) for the diagnosis of IPA were 0.89 (95% CI: 0.83-0.93), 0.79 (95% CI: 0.71-0.86), 4.33 (95% CI: 3.04-6.16), 0.14 (95% CI: 0.09-0.22), and 31.51 (95% CI: 17.43-56.98). The AUC was 0.92 (95% CI: 0.89-0.94). WHAT IS NEW AND CONCLUSIONS: BALF-GM has excellent diagnostic accuracy for adult IPA, which can be diagnosed early and treated early to reduce the mortality rate. Considering the sensitivity, specificity, PLR and NLR, the recommended diagnostic cut-off of BALF-GM for adult IPA is 0.5.
The effect of changing to Bictegravir on lipids using real world data: A brief report.
Heseltine T, Hughes E, Mathew J … +2 more , Murray S, Khoo S
J Clin Pharm Ther · 2022 Dec · PMID 36324275 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Cardiovascular disease is of increasing concern in patients living with HIV. The significant advancement in antiretroviral treatment has ensured that patients are now succumbing to traditiona...
WHAT IS KNOWN AND OBJECTIVE: Cardiovascular disease is of increasing concern in patients living with HIV. The significant advancement in antiretroviral treatment has ensured that patients are now succumbing to traditional diseases of ageing. First generation antiretroviral therapy caused multiple side effects including significant dyslipidaemia. Despite the advancement and improving safety profile of treatment concerns remain about antiretroviral induced dyslipidaemia. We sought to investigate the real-world effect on lipids in patients switching to a Bictegravir based regime. METHODS: We conducted a retrospective analysis in patients switching therapy to Biktarvy at the Royal Liverpool University Hospital. Data was collected from the HIV database that is established for clinical use, as an electronic patient record, and audit purposes. Lipid data was cross checked with the Trust electronic reporting system. Participants were included if they were HIV-positive, >18 years and had switched to Biktarvy Patients were also required to have a lipid profile available 52 weeks prior to switching and 100 weeks post switching. Summary statistic were calculated and multiple regressions models were constructed to assess the independent predictors of lipid change. We also performed one way analysis of covariance (ANCOVA) to assess the impact of switching therapy on each quartile of the baseline lipid panel. RESULTS AND DISCUSSION: There were 135 patients included in the analysis with a mean age of 47. The majority of the population were male (80%). At a mean follow up of 42 weeks post switch there was no significant difference in total cholesterol (p = 0.64), triglyceride (p = 0.64) or high density lipoprotein (HDL) cholesterol (p = 0.08). In the regression analysis the highest quartile of baseline total cholesterol and triglyceride were independently associated with improvement in lipid markers. Switching from protease inhibitor therapy was also significantly associated with improvement in triglyceride. In addition, the ANCVOA demonstrated that the highest quartiles of total cholesterol, triglyceride and the lowest quartile of HDL were associated with significant improvement in lipid markers after switching to Bictegravir. WHAT IS NEW AND CONCLUSION: We demonstrated that patients with the most adverse lipid profiles at baseline had significant improvements in lipid profiles. In addition, patient switching away from protease inhibitor therapy also had significant improvements in triglyceride.
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