J Clin Pharm Ther [JOURNAL]
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200 papers
Voriconazole-induced severe skin allergy and neurological adverse event in a liver failure patient: A case report.
Lu Y, Li WJ, Gao SY … +6 more , Wang XX, Yang K, Hu W, Wu DF, Jiang QL, Cheng H
J Clin Pharm Ther · 2022 Oct · PMID 36097367 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Triazole antifungal-associated severe skin allergy has received little attention. Here we report a case of an acute-on-chronic liver failure (ACLF) patient with diffused skin allergy pervadin...
WHAT IS KNOWN AND OBJECTIVE: Triazole antifungal-associated severe skin allergy has received little attention. Here we report a case of an acute-on-chronic liver failure (ACLF) patient with diffused skin allergy pervading from the chest, abdomen, back, knees to perineum, with red colour and partially desquamation as well as a neurological adverse (insomnia) event after voriconazole treatment. CASE SUMMARY: A 40-year-old man with liver failure in our hospital had received voriconazole for invasive fungal infection therapy, and while waiting for liver transplantation exhibited a severe diffuse rash and a neurological adverse event. WHAT IS NEW AND CONCLUSION: To the best of our knowledge, this is the first report of a liver failure patient who suffered a severe allergy accompanied with a neurological adverse event after voriconazole administration.
The association between empiric antimicrobial therapy and the risk of clinical failure in critically ill patients with aspiration pneumonia.
Brumit JC, Cluck DB, Brown TP … +1 more , Tharp JL
J Clin Pharm Ther · 2022 Nov · PMID 36096493 · Publisher ↗
WHAT IS KNOWN AND OBJECT: Aspiration pneumonia is a clinically important infectious process that can result in increased morbidity and mortality. Empiric antimicrobial therapy with activity against anaerobes has been a s...
WHAT IS KNOWN AND OBJECT: Aspiration pneumonia is a clinically important infectious process that can result in increased morbidity and mortality. Empiric antimicrobial therapy with activity against anaerobes has been a standard practice based on previous studies, which isolated anaerobes from respiratory cultures. Recent studies have failed to identify anaerobes as causative pathogens, however, these studies did not assess patient outcomes based on the presence or absence of anaerobic coverage. METHODS: This retrospective cohort study evaluated patients at least 18 years of age requiring mechanical ventilation diagnosed with aspiration pneumonia between 1 October 2020 and 31 July 2021. The primary outcome was the incidence of clinical failure. Secondary outcomes included the time to clinical failure, the incidence of Clostridioides difficile infections and development of multidrug-resistant infections, as well as time on mechanical ventilation and intensive care unit length of stay. RESULTS: A total of 141 patients were included with 83 patients initially receiving anaerobic coverage and 58 patients treated without anaerobic coverage. There was no difference in the incidence of clinical failure between cohorts (18.1% vs. 22.4%; p = 0.41). There was a statistically significant difference in anaerobic escalations with more escalations in the cohort without anaerobic coverage (0% vs. 20.7%; p < 0.0001). Patients initially treated with drugs with anaerobic activity had a higher incidence of multidrug resistant infections on current admission (7.2% vs. 0%; p = 0.04) and a longer length of intensive care unit stay. WHAT IS NEW AND CONCLUSION: In critically ill adults with aspiration pneumonia, our study found no difference in clinical failure based on the presence or absence of empiric anaerobic coverage adding to evolving literature suggesting that anaerobic coverage is not routinely warranted in this patient population. Interpretation of the results needs to consider, however, that the retrospective design led to the inclusion of sicker patients in the anaerobic cohort. The frequency of empiric anaerobic coverage demonstrates the need for a prospective randomized control trial to confirm these findings.
Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System.
Chen C, Fu F, Ding L … +1 more , Xiao J
J Clin Pharm Ther · 2022 Nov · PMID 36089844 · Full text
WHAT IS KNOWN AND OBJECTIVE: Evidence on whether the coronavirus disease 2019 (COVID-19) vaccination could cause hearing-related adverse events is still conflicting. This study aims to access the association between COVI...
WHAT IS KNOWN AND OBJECTIVE: Evidence on whether the coronavirus disease 2019 (COVID-19) vaccination could cause hearing-related adverse events is still conflicting. This study aims to access the association between COVID-19 vaccine and hearing disorder. METHODS: The Vaccine Adverse Event Reporting System (VAERS) was queried between January 2020 to November 2021. The disproportionality pattern for hearing impairment of COVID-19 vaccine was accessed by calculating the reporting odds ratio (ROR) and proportional reporting ratio (PRR). A further subgroup analysis based on the type of COVID-19 vaccine and the doses administered was performed. In addition, the disproportionalities for hearing dysfunction between COVID-19 and influenza vaccines were compared. RESULTS AND DISCUSSION: A total of 14,956 reports of hearing-related adverse events were identified with COVID-19 vaccination and 151 with influenza vaccine during the analytic period in VAERS. The incidence of hearing disorder following COVID-19 vaccination was 6.66 per 100,000. The results of disproportionality analysis revealed that the adverse events of hearing impairment, after administration of COVID-19 vaccine, was significantly highly reported (ROR 2.38, 95% confidence interval [CI] 2.20-2.56; PRR: 2.35, χ 537.58), for both mRNA (ROR 2.37, 95% CI 2.20-2.55; PRR 2.34, χ 529.75) and virus vector vaccines (ROR 2.50, 95% CI 2.28-2.73; PRR 2.56, χ 418.57). While the disproportional level for hearing dysfunction was quite lower in influenza vaccine (ROR 0.36, 95% CI 0.30-0.42; PRR 0.36, χ 172.24). WHAT IS NEW AND CONCLUSION: This study identified increased risk for hearing disorder following administration of both mRNA and virus vector COVID-19 vaccines compared to influenza vaccination in real-world settings.
Overexpression of NIMA related kinase 2 in multiple myeloma and its relevance with disease features and prognosis to bortezomib treatment.
Gu X, Wang Z, Pan Q
J Clin Pharm Ther · 2022 Oct · PMID 36087032 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: NIMA related kinase 2 (NEK2) promotes the malignant transformation and enhances the chemoresistance to proteasome inhibitor in multiple myeloma (MM) cell lines. The current study aimed to fur...
WHAT IS KNOWN AND OBJECTIVE: NIMA related kinase 2 (NEK2) promotes the malignant transformation and enhances the chemoresistance to proteasome inhibitor in multiple myeloma (MM) cell lines. The current study aimed to further investigate its correlation with clinical features and responsiveness to bortezomib treatment in MM patients. METHODS: Totally, 76 MM patients and 30 health donors (HDs) were enrolled to collect bone marrow plasma cells for NEK2 detection using reverse transcription quantitative polymerase chain reaction (RT-qPCR). Meanwhile, NEK2 siRNA was transfected into the RPMI-8226 and KMS-11 cells, subsequently their cell viability was evaluated using Cell Counting Kit-8 reagent after treatment with different doses of bortezomib. RESULTS AND DISCUSSION: NEK2 expression was higher in MM patients compared with HDs (Z = -5.123, p < 0.001). Besides, elevated NEK2 expression was associated with the occurrence of the bone lesion (χ = 4.610, p = 0.032) and t (4; 14) (χ = 3.971, p = 0.046). Additionally, elevated NEK2 expression was correlated with declined objective response rate (ORR) (χ = 4.808, p = 0.028), but not with complete response (CR) (χ = 2.341, p = 0.126). More importantly, elevated NEK2 expression was correlated with shorter progression-free survival (PFS) (χ = 8.352, p = 0.039), but not with overall survival (OS) (χ = 5.624, p = 0.131), What is more, NEK2 silence decreased the cell viability under bortezomib treatment and the inhibitory concentration (IC ) value of bortezomib in RPMI-8226 and KMS-11 cell lines (all p < 0.05). WHAT IS NEW AND CONCLUSION: NEK2 overexpression links with occurrence of bone lesion, t (4; 14), and poor prognosis to bortezomib treatment in MM patients.
Impact of breakthrough trials on prescription trends of sodium-glucose cotransporter-2 inhibitors in Japan: An interrupted time-series analysis.
Iketani R, Imai S
J Clin Pharm Ther · 2022 Nov · PMID 36068684 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) have been increasingly prescribed for the treatment of type 2 diabetes mellitus (T2DM). We aimed to investigate the impact of clinical tri...
WHAT IS KNOWN AND OBJECTIVE: Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) have been increasingly prescribed for the treatment of type 2 diabetes mellitus (T2DM). We aimed to investigate the impact of clinical trials presenting remarkable results on the prescription of SGLT-2is and the relationship between the impact and generalisability of the breakthrough trials on SGLT-2is. METHODS: This retrospective cohort study involved 32,949 patients with T2DM who were prescribed at least one antidiabetic agent in the Japan Medical Data Center health insurance database. Prescription rates of SGLT-2is were calculated monthly from April 2014 to March 2020. We evaluated the impact of the EMPA-REG OUTCOME study for an Asian subgroup on the prescription rate of empagliflozin and the impact of the CANVAS/CANVAS-R study on the prescription rate of canagliflozin. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were estimated using the quasi-Poisson regression model in the overall population, subgroup with a history of cardiovascular disease (high-risk group), and subgroup without a history and risk factors of cardiovascular disease (low-risk group). RESULTS AND DISCUSSION: The EMPA-REG OUTCOME study for the Asian subgroup led to increased prescription rates of empagliflozin 3 months after its publication in the overall population and high-risk group but not in low-risk group (IRR [95% CI]: 1.40 [1.17-1.66], 1.39 [1.05-1.84], and 1.00 [0.79-1.27], respectively). The increase in high-risk group may be appropriate because this study included patients with a history of cardiovascular disease only. The CANVAS/CANVAS-R study led to increased prescription rates of canagliflozin 3 months after its publication in the overall population, high-risk group, and low-risk group (IRR [95% CI]: 1.52 [1.06-2.19], 1.39 [1.06-1.83], and 1.81 [1.20-2.75], respectively). The increase in low-risk group may not be appropriate because this study did not include patients without a history or risk factors of cardiovascular disease. WHAT IS NEW AND CONCLUSION: The breakthrough trials increased prescription rates not only for patients to whom the trial results could be extrapolated but also for those in whom trial benefits were not certain. Our findings suggest that information about breakthrough trials may need to be provided along with data on trial result generalisability.
Utilization of mechanistic modelling and simulation to analyse fenspiride proarrhythmic potency - Role of physiological and other non-drug related parameters.
Wiśniowska B, Holbrook M, Pollard C … +1 more , Polak S
J Clin Pharm Ther · 2022 Dec · PMID 36068182 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Fenspiride, a drug that had been used for decades for the treatment of respiratory diseases, was recently withdrawn from the market due to the potential risk of QT prolongation and proarrhyth...
WHAT IS KNOWN AND OBJECTIVE: Fenspiride, a drug that had been used for decades for the treatment of respiratory diseases, was recently withdrawn from the market due to the potential risk of QT prolongation and proarrhythmia. This is the first such withdrawal for many years and hence poses a question whether such risk could have been predicted and to what degree non-drug-specific parameters play a role in the reported QT prolongation and cases of TdP. The study aim was to test various 'what-if' scenarios to assess the influence of age, gender, heart rate, and plasma potassium concentration on QT interval prolongation due to various doses of fenspiride with the use of mechanistic mathematical modelling. METHODS: Concentration-time profiles were simulated with the use of a PBPK model developed based on published physico-chemical data, data from in vitro ADME experiments, and in vivo PK study results. Pharmacodynamic effect, that is, drug-triggered pseudoECG signal modification was simulated using a biophysically detailed model of human cardiac myocytes. Analysis of the qNet metric was also performed to classify proarrhythmic risk related to fenspiride. RESULTS: In the simulation study, arrhythmia was not observed even in the 'what-if' scenarios with extreme exposure, age, heart rate, and plasma potassium concentration. The qNet metric value positioned fenspiride in the intermediate risk class. WHAT IS NEW AND CONCLUSION: It can be hypothesized that the clinically observed arrhythmia cases were not directly caused by fenspiride alone but a combination of multiple factors, including comedications.
Antiretroviral drug-drug interactions: A comparison of online drug interaction databases.
Drwiega EN, Badowski ME, Michienzi S
J Clin Pharm Ther · 2022 Oct · PMID 36059105 · Full text
WHAT IS KNOWN AND OBJECTIVE: Antiretrovirals have a high drug interaction potential, which can lead to increased toxicity and/or decreased efficacy. Multiple databases are available to assess drug-drug interactions. The...
WHAT IS KNOWN AND OBJECTIVE: Antiretrovirals have a high drug interaction potential, which can lead to increased toxicity and/or decreased efficacy. Multiple databases are available to assess drug-drug interactions. The aim of our study was to compare interaction identification for commonly used ARVs and concomitant medications between six different online drug-drug interaction databases. COMMENT: This was a cross-sectional review using each of the following six databases: LexiComp®, Clinical Pharmacology®, Micromedex®, Epocrates®, University of Liverpool, and University of Toronto. Sixteen antiretroviral drugs and 100 of the DrugStats Database "Top 200 of 2019" list of medications were included. Each of the six databases identified a different number of actual or potential interactions. The number of interactions ranged from 211 to 283. WHAT IS NEW AND CONCLUSIONS: A variety of databases exist with inconsistent identification of actual or potential drug-drug interactions amongst them. It may be beneficial to cross-reference multiple databases prior to making decisions regarding patient care.
Level of therapeutic innovation from the registration studies of the new drugs for the prophylaxis of migraine.
Motola D, Santi Laurini G, Bonaldo G … +1 more , Montanaro N
J Clin Pharm Ther · 2022 Dec · PMID 36054749 · Full text
WHAT IS KNOWN AND OBJECTIVE: Migraine is one of the most prevalent and disabling medical illnesses. Preventive drugs are used to reduce the frequency, severity, and duration of attacks. Most patients were no longer on th...
WHAT IS KNOWN AND OBJECTIVE: Migraine is one of the most prevalent and disabling medical illnesses. Preventive drugs are used to reduce the frequency, severity, and duration of attacks. Most patients were no longer on their medication due to contraindications or poor clinical response. Therefore, there is need for novel prophylactic agents for migraine. New preventive treatments are those of the class of calcitonin gene related peptide (CGRP)-targeting therapies. We aimed to assess the real level of therapeutic innovation of these new drugs. METHODS: The information on the new drugs was collected from several documents, including the European public assessment reports. The level of therapeutic innovation was assessed with the algorithm published by some of us in 2006. RESULTS: All new approved drugs (eptinezumab, galcanezumab, fremanezumab, erenumab) are indicated for the prophylaxis of migraine in adults who have at least four migraine days for month. All these drugs have been tested only in comparison to placebo. Their level of therapeutic innovation was only modest, that is, the lowest value of our algorithm. DISCUSSION: The new monoclonal antibodies of the class of CGRP targeting therapies have been authorized with efficacy data only against placebo. They do not offer additional clinical benefits compared to available therapies for the prevention of migraine attacks, with the exception of a lower frequency of administration and a more rapid effect. All this assigns to these drugs only a modest role in therapy according to our algorithm for therapeutic innovation with a significantly higher cost than similar therapies.
Efficacy and safety of preoperative versus postoperative NSAIDs on pain relief in patients undergoing hip arthroscopy surgery: A multicentre, randomized, controlled trial.
Zhang W, Zhao Q, Yang G … +3 more , Han N, Peng C, Chen H
J Clin Pharm Ther · 2022 Dec · PMID 36054477 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Postoperative pain relief is a critical issue for hip arthroscopy surgery (HAS). This study aimed to investigate the effect of preemptive non-steroidal anti-inflammatory drugs (NSAIDs) for po...
WHAT IS KNOWN AND OBJECTIVE: Postoperative pain relief is a critical issue for hip arthroscopy surgery (HAS). This study aimed to investigate the effect of preemptive non-steroidal anti-inflammatory drugs (NSAIDs) for postoperative analgesia in femoroacetabular impingement (FAI) patients receiving HAS. METHODS: This multicenter, randomized, controlled study enrolled 204 FAI patients receiving HAS, then assigned them to preoperative (PRE, N = 103) or postoperative (POS, N = 101) group as a 1:1 ratio; the PRE group administrated NSAIDs from 24 h pre-surgery to day 7 (D7) post-surgery, while the POS group administrated NSAIDs from 12 h post-surgery to D7 post-surgery. RESULTS AND DISCUSSION: Pain at rest was reduced at D1 (p = 0.016) and D2 (p = 0.023); pain at movement was decreased at D1 (p = 0.002), D2 (p = 0.020), and D3 (p = 0.030) in the PRE group compared with POS group, but not at other time points (all p > 0.05). Patient's satisfaction was increased at D1 (p = 0.013) and D3 (p = 0.029) in the PRE group compared to the POS group, but not at D7 (p = 0.145). Pethidine was less consumed at D3 (p = 0.038) and D7 (p = 0.017) in the PRE group in contrast with the POS group. Harris hip scores were similar at D7 (p = 0.124), month 1 (M1) (p = 0.273), and M3 (p = 0.360) between groups. Adverse events incidence was similar between groups (all p > 0.05). Besides, subgroup analysis discovered that pain was not influenced by the types of NSAID in both groups (all p > 0.05). WHAT IS NEW AND CONCLUSION: Starting NSAIDs before HAS provides better short-term pain relief and improves patient's satisfaction compared with its postoperative utilization, while does not induce additional adverse events in FAI patients.
Antibiotic use during the first 6 months of COVID-19 pandemic in Iran: A large-scale multi-centre study.
Salehi M, Khalili H, Seifi A … +25 more , Davoudi H, Darazam IA, Jahangard-Rafsanjani Z, Mohammadnejad E, Heydari B, Siahkaly SJM, Tabarsi P, Kalantari S, Menshadi SAD, Babamahmoodi F, Khorvash F, Davarpanah MA, Soltani R, Yaghoobi MH, Anari SAM, Khodadadi J, Aliramezani A, Hantooshzadeh S, Naderi HR, Hajiabdolbaghi M, Elyasi S, Firouzabadi D, Kasgari HA, Roshanzamiri S, Ebrahimpour S
J Clin Pharm Ther · 2022 Dec · PMID 36054303 · Full text
WHAT IS KNOWN AND OBJECTIVE: Although antibiotics are ineffective against viral infections, epidemiological studies have revealed that the COVID-19 pandemic resulted in the overuse of antibiotics and disruption of antimi...
WHAT IS KNOWN AND OBJECTIVE: Although antibiotics are ineffective against viral infections, epidemiological studies have revealed that the COVID-19 pandemic resulted in the overuse of antibiotics and disruption of antimicrobial stewardship programmes. We investigated the pattern of antibiotic use during the first 6 months of the COVID-19 pandemic in Iran. METHODS: A multi-centre retrospective study was designed to investigate the use of 16 broad-spectrum antibiotics in 12 medical centres. The rate of antibiotic use was calculated and reported based on the Defined Daily Dose (DDD) per 100 hospital bed-days. The bacterial co-infection rate was also reported. RESULTS AND DISCUSSION: Totally, 43,791 hospitalized COVID-19 patients were recruited in this study. It was found that 121.6 DDD of antibiotics were used per 100 hospital bed-days, which estimated that each patient received approximately 1.21 DDDs of antibiotics every day. However, the bacterial co-infections were detected only in 14.4% of the cases. A direct correlation was observed between the rate of antibiotic use and mortality (r[142] = 0.237, p = 0.004). The rate of antibiotic consumption was not significantly different between the ICU and non-ICU settings (p = 0.15). WHAT IS NEW AND CONCLUSION: In this study, widespread antibiotic use was detected in the absence of the confirmed bacterial coinfection in COVID-19 patients. This over-consumption of broad-spectrum antibiotics may be associated with increased mortality in hospitalized COVID-19 patients, which can be an alarming finding.
Dynamic changes in the levels of sCD62L and SPARC in chronic myeloid leukaemia patients during imatinib treatment.
Elkholy MM, Fahmi MW, El-Haggar SM
J Clin Pharm Ther · 2022 Dec · PMID 36053969 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Chronic myeloid leukaemia (CML) microenvironment is responsible for resistance of leukaemic cells to tyrosine kinase inhibitor, altered adhesion, increased proliferation and leukaemic cells g...
WHAT IS KNOWN AND OBJECTIVE: Chronic myeloid leukaemia (CML) microenvironment is responsible for resistance of leukaemic cells to tyrosine kinase inhibitor, altered adhesion, increased proliferation and leukaemic cells growth and survival through the secretion of many soluble molecules. We aimed at monitoring soluble L-selectin (sCD62L) and secreted protein acidic and rich in cysteine (SPARC) levels in chronic phase chronic myeloid leukaemia (CP-CML) patients and assessing the impact of imatinib on these parameters. METHODS: This prospective controlled clinical trial enrolled 35 subjects classified into two groups: control group included 10 healthy volunteers and CP-CML patients group included 25 newly diagnosed CP-CML patients received imatinib 400 mg once daily. sCD62L plasma levels, SPARC serum levels, breakpoint cluster region-Abelson1 (BCR-ABL1) %, complete blood count with differential, liver and kidney functions parameters were assessed at baseline and after 3 and 6 months of treatment. RESULTS AND DISCUSSION: At baseline, sCD62L and SPARC were significantly elevated in CP-CML patients (p < 0.05) compared to control group. After 3 months of treatment, sCD62L was non-significantly decreased (p > 0.05), while surprisingly SPARC was significantly increased (p < 0.05) compared to baseline. Moreover, after 6 months of treatment, sCD62L was significantly decreased (p < 0.05) and SPARC was non-significantly decreased (p > 0.05) compared to baseline. In addition, sCD62L was significantly correlated with WBCs and neutrophils counts, while SPARC was significantly correlated with lymphocytes count at baseline and after 3 and 6 months of imatinib treatment. WHAT IS NEW AND CONCLUSION: The elevated levels of sCD62L and SPARC at diagnosis in CP-CML patients could reflect their roles in CML pathogenesis and the dynamic changes in their levels during imatinib therapy might suppose additional mechanisms of action of imatinib beside inhibition of BCR-ABL. Furthermore, imatinib showed a significant impact on sCD62L and SPARC levels during treatment period.
Evaluating linezolid dose regimens against methicillin-resistant Staphylococcus aureus based on renal function in populations with different body weight.
Zuo M, Sun Y, Zhao X … +6 more , Xu G, Wang N, Chen J, Zhu L, Yang W, Zhao M
J Clin Pharm Ther · 2022 Dec · PMID 36053892 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Linezolid is an alternative first-line agent for MRSA pneumonia. This study assessed whether dose adjustments of linezolid against methicillin-resistant Staphylococcus aureus (MRSA) infection...
WHAT IS KNOWN AND OBJECTIVE: Linezolid is an alternative first-line agent for MRSA pneumonia. This study assessed whether dose adjustments of linezolid against methicillin-resistant Staphylococcus aureus (MRSA) infections were needed based on renal function in populations with different body weight. METHODS: Monte Carlo simulations were conducted to evaluate renal function in relation to the probability of target attainment (PTA) in three population groups with different body weight. Area under the concentration time curve (AUC)/ minimum inhibitory concentration (MIC) ratio and percentage of time above the MIC (%T > MIC) were regarded as pharmacokinetic/pharmacodynamic targets. The PTA and cumulative fractions of response (CFR) were calculated to assess the efficacy. Regarding safety, trough plasma concentration (C ) > 8 mg/L was used as target for toxicity. RESULTS AND DISCUSSION: Using AUC/MIC >100 as the target pharmacodynamic (PD) index, the CFR of linezolid at the standard dose (600 mg every 12 h [q12h]) were 57.01%, 93.22%, and 99.93% in patients with normal renal function, patients with renal dysfunction and low body weight patients with renal dysfunction, respectively. Using 100%T > MIC as the target PD index, all the CFR of three population groups were more than 90% at the standard dose. The percentages of C > 8 mg/L at the standard dose of linezolid were 24.16%, 53.24%, and 90.10% in three population groups on day 7. WHAT IS NEW AND CONCLUSION: The risk of thrombocytopenia of linezolid was extremely higher in low body weight patients with renal impairment when receiving standard linezolid dose compared with patients with normal renal function. 450 mg q12h and 300 mg q12h might be effective and safe against MRSA infection in patients with renal dysfunction and low body weight patients with renal dysfunction, respectively.
Clinical pharmacokinetics of nadolol: A systematic review.
Kalsoom S, Zamir A, Rehman AU … +6 more , Ashraf W, Imran I, Saeed H, Majeed A, Alqahtani F, Rasool MF
J Clin Pharm Ther · 2022 Oct · PMID 36040016 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Nadolol is a non-selective beta-adrenergic antagonist that is used for the treatment of hypertension and angina. The primary route for its administration is oral. It is given once daily as it...
WHAT IS KNOWN AND OBJECTIVE: Nadolol is a non-selective beta-adrenergic antagonist that is used for the treatment of hypertension and angina. The primary route for its administration is oral. It is given once daily as it has a longer half-life (t½). The purpose of conducting this systematic review is to provide a comprehensive view of all the available pharmacokinetic (PK) data on nadolol in humans. This review aimed to systematically collate and analyze publish data on the clinical PK of nadolol in humans and this can be beneficial for the clinicians in dosage adjustments. METHODS: Two electronic databases PubMed and Google Scholar were used for conducting a systematic literature search. All the relevant articles containing PK data of nadolol in humans were retrieved. A total of 1275 articles were searched from both databases and after applying eligibility criteria finally, 22 articles were included for conducting the systematic review. RESULTS AND DISCUSSION: The area under the plasma concentration curve (AUC) and maximum plasma concentration (C ) of nadolol increased in a dose-dependent manner. The t½ of nadolol was increased to double (18.2-68.6 h) in the patients with chronic kidney disease while the serum t½ became shorter (3.2-4.3 h) when administered to the children. The bioavailability of nadolol was greatly reduced by the coadministration of green tea. Nadolol can be effectively removed by hemodialysis. It undergoes enterohepatic circulation thus activated charcoal decreased its bioavailability. WHAT IS NEW AND CONCLUSION: Since, there is no previous report of a systematic review on the PK of nadolol, the current review encompasses all the relevant published articles on nadolol in humans. The analysis and understanding of PK parameters (AUC, C , and t½) of nadolol may be helpful in the development and evaluation of PK models.
Comparison of different sedatives in children before general anaesthesia for selective surgery: A network meta-analysis.
Yang CQ, Yu KH, Huang RR … +3 more , Qu SS, Zhang JM, Li YL
J Clin Pharm Ther · 2022 Oct · PMID 36029118 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: It is estimated that 60% of children undergoing anaesthesia develop severe preoperative anxiety. The anxiety is associated with adverse reactions. Sedatives such as dexmedetomidine, midazolam...
WHAT IS KNOWN AND OBJECTIVE: It is estimated that 60% of children undergoing anaesthesia develop severe preoperative anxiety. The anxiety is associated with adverse reactions. Sedatives such as dexmedetomidine, midazolam, clonidine, ketamine, and melatonin can be used as premedication against preoperative anxiety. However, no consensus has been reached on the choice of pre-anaesthetic sedatives in children before selective surgery. Therefore, the current network meta-analysis (NMA) was carried out to evaluate different sedatives in children aged between 1 and 7 before general anaesthesia for selective surgery. METHODS: Randomized clinical trials (RCTs) were retrieved from Pubmed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases from inception to October 22, 2021. Primary outcomes showed satisfactory sedation at parent separation and also at induction or mask acceptance. Secondary outcomes were those related to added benefits and side effects. The present NMA was conducted using the R software. Results of the study were reported as Relative Risk (RR) or Mean Difference (MD) at a 95% credible intervals (CrIs). RESULTS AND DISCUSSION: A total of 48 trials were included in the present study. It was found that the effectiveness of dexmedetomidine, midazolam, clonidine, and ketamine were superior to that of placebo in satisfactory sedation at parent separation and induction or mask acceptance. There was no significant difference between melatonin and placebo in satisfactory sedation at induction or mask acceptance. Dexmedetomidine, ketamine, clonidine, and melatonin were superior to placebo in reducing emergence delirium (ED). In addition, midazolam prolonged the length of stay in the post anaesthesia care unit (PACU) as compared with placebo. Dexmedetomidine caused a significant reduction in systolic blood pressure (SBP) and heart rate (HR). Nevertheless, it was noted that the hemodynamic changes were roughly within safety limits. WHAT IS NEW AND CONCLUSION: It was evident that the studied drugs can provide effective sedation with exception of melatonin and placebo. However, it was found that midazolam, ketamine, and clonidine lead to several side effects. The findings of the present study supported that dexmedetomidine, especially intranasal administration, has potential in the optimal selection of the sedatives for premedication in children. This is because the drug has effective sedation, reduced incidence of ED, side effects, and onset time.
Clinical features, treatment outcomes and prognostic factors of allopurinol-induced DRESS in 52 patients.
Liu Q, Zhao S, Chen W
J Clin Pharm Ther · 2022 Sep · PMID 35971667 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Allopurinol-induced drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare but serious and potentially life-threatening drug hypersensitivity syndrome. In this study, we aime...
WHAT IS KNOWN AND OBJECTIVE: Allopurinol-induced drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare but serious and potentially life-threatening drug hypersensitivity syndrome. In this study, we aimed to investigate the clinical features, treatment outcomes, and prognostic factors of allopurinol-induced DRESS. METHODS: Case reports of allopurinol-induced DRESS published by China from January 2000 to August 2021 were retrieved from CNKI, Wan Fang, VIP, and PubMed databases for analysis. RESULTS AND DISCUSSION: This study included 52 patients, consisting of 41 (78.8%) males and 11 (21.2%) females (M:F = 3.7:1). The mean of age was 56.1 ± 17.1 years (range: 18-86 years). The mean of latency periods was 24.6 ± 15.0 days (range:1-63 days). Most patients presented with fever, cutaneous eruption, eosinophilia, lymphadenopathy, and facial edema. 36/52 (69.2%) patients showed two or more internal organs involved. Liver and kidney injuries were the most common visceral manifestation. Pulmonary involvement (34.6%), cardiac involvement (25.0%) and gastrointestinal involvement (21.2%) were relatively less known but severe complications. 2/52 (3.8%) patients showed nervous system involved, presenting as leukoencephalopathy or peripheral neuropathy. 2/52 (3.8%) patients presented with secondary hemophagocytic lymphohistiocytosis.1/52 (1.9%) patient developed pure red cell aplasia and 1/52 (1.9%) patient developed painless thyroiditis. HLA*B 58:01 allele was tested in 18/52 (34.6%) patients. 16/18 (88.9%) cases were positive. 48/52 (92.3%) patients were treated with systemic corticosteroids. 16/52 (30.8%) patients were cured, 23/52 (44.2%) patients received partial recovery, and 13/52 (25.0%) patients were died. Septic shock, gastrointestinal bleeding and multiple organ failure were the leading causes of death. Advanced age, underlying cardiovascular disease, chronic kidney disease and high dose of allopurinol, infection and internal organ involvement (including kidney, heart, lung and gastrointestinal tract) were risk factors for death. WHAT IS NEW AND CONCLUSION: We explored clinical features, treatment outcomes and prognostic factors of 52 allopurinol-induced DRESS cases in China. Ethnicity, especially Han Chinese, and positive HLA-B*58:01 allele are the clearest risk factors so far. Advanced age, underlying cardiovascular disease, chronic kidney disease and high dose of allopurinol, infection and internal organ involvement (including kidney, heart, lung and gastrointestinal tract) were associated with poorer outcomes. Early identification and discontinuation of the causative drug are crucial to the management of DRESS. For patients with severe disease, corticosteroids are recommended as the first-line therapy. However, further studies are needed to address diagnostic criteria of DRESS for early diagnosis, as well as to develop standardized corticosteroid treatment regimens.
Suspected opioid-induced hyperalgesia in an infant following surgery: A case report.
Efune PN, Rebstock SE
J Clin Pharm Ther · 2022 Sep · PMID 35968556 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Opioids are commonly administered to infants having surgery. Opioid induced hyperalgesia (OIH) is a known adverse effect of opioids in adults but can be difficult to identify in infants. CASE...
WHAT IS KNOWN AND OBJECTIVE: Opioids are commonly administered to infants having surgery. Opioid induced hyperalgesia (OIH) is a known adverse effect of opioids in adults but can be difficult to identify in infants. CASE SUMMARY: A 3-month-old received high-dose fentanyl during anorectoplasty for imperforate anus. He had signs and symptoms of OIH immediately after surgery. His pain and agitation were difficult to manage but improved after he received ketamine. WHAT IS NEW AND CONCLUSION: OIH should be considered in infants postoperatively when pain worsens despite administration of escalating doses of opioids. Ketamine can be an effective therapeutic for OIH.
Sodium-glucose cotransporter-2 inhibitor-induced euglycemic diabetic ketoacidosis: A case report.
Han J, Xie S, Jiao H
J Clin Pharm Ther · 2022 Sep · PMID 35949163 · Publisher ↗
Abstract loading — click title to view on PubMed.
Pharmacokinetic principles of dose adjustment of mTOR inhibitors in solid organ transplanted patients.
Hartinger JM, Ryšánek P, Slanař O … +1 more , Šíma M
J Clin Pharm Ther · 2022 Sep · PMID 35934622 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: mTOR inhibitors possess narrow therapeutic range and substantial pharmacokinetic variability and the consequences from suboptimal dosing are serious. The aim of this review is to summarize t...
WHAT IS KNOWN AND OBJECTIVES: mTOR inhibitors possess narrow therapeutic range and substantial pharmacokinetic variability and the consequences from suboptimal dosing are serious. The aim of this review is to summarize the current knowledge about the factors influencing mTOR inhibitors pharmacokinetics and the possibility of using these relationships in order to improve its therapy individualization in solid organ transplanted patients. METHODS: Literature search from Pubmed and Web of Science databases were performed using Boolean search operators in order to identify relevant studies. RESULTS AND DISCUSSION: A total of 701 reports were identified from the initial literature search. Out of which 40 studies dealt with relationships between various factors and pharmacokinetics of mTOR inhibitors and with relevance of these associations for dosage optimization. WHAT IS NEW AND CONCLUSION: The overview of the current covariates for pharmacokinetic variability of mTOR inhibitors has been provided on the level of absorption, distribution and elimination, and consequences of these relationships for dosing optimization has been summarized.
Leucovorin (folinic acid) rescue for high-dose methotrexate: A review.
Jiang R, Mei S, Zhao Z
J Clin Pharm Ther · 2022 Sep · PMID 35929573 · Publisher ↗
High-dose methotrexate (HDMTX) is active against various malignancies; it possesses serious toxicities and is associated with patient characteristics, dosage regimens, comedications, and physiological status. There are m...
High-dose methotrexate (HDMTX) is active against various malignancies; it possesses serious toxicities and is associated with patient characteristics, dosage regimens, comedications, and physiological status. There are many strategies to overcome HDMTX-induced toxicities, such as hydration, alkalization, leucovorin rescue, and haemodialysis. Leucovorin rescue is a cornerstone for toxicity prevention in HDMTX treatment. However, the leucovorin dose adjustment and the existence of leucovorin overrescue are still controversial. At present, various methods for calculating leucovorin doses in different tumour types have been proposed, including empirical calculations based on MTX plasma concentration, the Bleyer nomogram, and other methods. Nonetheless, leucovorin rescue protocols differ greatly across tumour types and medical institutions. Further studies are needed to investigate the optimal dosage regimen for leucovorin rescue in various tumours using HDMTX.
Evaluation of the hospital care quality perceived by patients with immune-mediated inflammatory diseases from the pharmacy service. SACVINFA study.
Ramírez E, Romero-Jiménez R, Hernández-Muniesa B … +12 more , Fernández-Pacheco M, Calvo A, Chamorro-de-Vega E, Herrero N, Úbeda B, Morell A, Ais-Larisgoitia A, Lobato-Matilla E, Muñoz Á, Casado A, Casado MÁ, Escudero-Vilaplana V
J Clin Pharm Ther · 2022 Dec · PMID 35929568 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Immune-mediated inflammatory diseases (IMIDs) are a group of chronic and highly disabling diseases. The objective is to evaluate the satisfaction with the health care received by patients wit...
WHAT IS KNOWN AND OBJECTIVE: Immune-mediated inflammatory diseases (IMIDs) are a group of chronic and highly disabling diseases. The objective is to evaluate the satisfaction with the health care received by patients with the most prevalent IMIDs in Spain: inflammatory bowel disease (IBD), psoriasis (Ps) psoriatic arthritis (PsA), rheumatoid arthritis (RA) and spondyloarthropathies (SpAs), and to determine the factors that influence patient satisfaction. METHODS: This was an observational, cross-sectional, multicentre study in a real-world evidence context conducted in the Pharmacy Service in four hospital centres of the Community of Madrid that belong to the National Health System. The study included adult patients diagnosed with an IMID who had attended the Pharmacy Service at least three times. The patients were grouped according to the main IMID. Health care satisfaction was evaluated using the chronic patient experience assessment (IEXPAC) questionnaire. The responses to IEXPAC are grouped into three factors: productive interactions, new relational model and patient self-management, with a total score from 0 (worst) to 10 (best experience). Health-related quality of life (HRQoL) was also evaluated using the EQ-5D-5L questionnaire, and pharmacological adherence was evaluated through the Morisky-Green test. RESULTS AND DISCUSSION: A total of 578 patients were analysed (IBD = 25.3%; Ps = 19.7%; SpAs = 18.7%; RA = 18.5%; PsA = 17.8%). The mean age (SD) was 49.8 (12.3) years and 50.7% were male. The average score (SD) for the total IEXPAC sample was 6.6 (1.9). RA was the IMID with the lowest score, at 5.83 (2.0), significantly lower than the scores of Ps (SD) [7.01 (1.7); p = 0.003], IBD [6.83 (1, 9); p = 0.012] and SpAs [6.80 (1.6); p = 0.001]. Productive interactions (SD) [8.5 (1.8)] and patient self-management (SD) [7.3 (2.3)] were the factors with the highest scores, and the new relational model had the lowest score (SD) [3.2 (2.7)]. Male gender, a longer time interval between medication administrations and a higher HRQoL were correlated with better patient satisfaction. Current biological therapy (according to the Anatomical Chemical classification system) also had a significant influence; patients treated with tumour necrosis factor inhibitors and interleukin inhibitors showed greater satisfaction than those treated with selective immunosuppressants. WHAT IS NEW AND CONCLUSION: The IEXPAC results show high general satisfaction with care quality reported by patients with IMIDs treated in the Pharmacy Service. However, there are areas of improvement in care quality specially health professional-patient communication, such as increasing access to information, and promoting and facilitating relationships with patients in similar conditions.
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