Clinical Pharmacology : Advances and Applications最新文献

{"title":"A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of Iberdomide in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared with Healthy Subjects.","authors":"Yiming Cheng,&nbsp;Ying Ye,&nbsp;Allison Gaudy,&nbsp;Atalanta Ghosh,&nbsp;Yongjun Xue,&nbsp;Alice Wang,&nbsp;Simon Zhou,&nbsp;Yan Li","doi":"10.2147/CPAA.S397826","DOIUrl":"https://doi.org/10.2147/CPAA.S397826","url":null,"abstract":"<p><strong>Introduction: </strong>Iberdomide, a novel cereblon modulator (CELMoD^®), is currently under clinical investigation for hematology indications. To evaluate the influence of hepatic impairment on the pharmacokinetics (PK) of iberdomide and its major active metabolite M12, a phase 1, multicenter, open-label study was conducted in healthy subjects and subjects with mild, moderate, and severe hepatic impairment.</p><p><strong>Methods: </strong>Forty subjects were enrolled in the study and divided into five groups based on hepatic function. 1 mg iberdomide was administered and plasma samples were collected to evaluate the pharmacokinetics of iberdomide and M12.</p><p><strong>Results: </strong>After a single dose of iberdomide (1 mg), mean iberdomide Cmax (maximum observed concentration) and AUC (area under the concentration-time curve) exposure were generally comparable between hepatic impairment (HI) subjects (severe, moderate and mild) and their respective matched normal controls. Mean Cmax and AUC exposure of the metabolite M12 were generally comparable between mild HI and matched normal subjects. However, mean Cmax of the M12 was 30% and 65% lower and AUC was 57% and 63% lower in moderate and severe HI subjects as compared to their respective matched normal controls. However, given the relatively low M12 exposure as compared to its parent drug, the observed differences were not considered clinically meaningful.</p><p><strong>Conclusion: </strong>In summary, 1 mg single oral dose of iberdomide was generally well-tolerated. HI (mild, moderate or severe) had no clinically relevant impact on iberdomide PK and therefore, no dose adjustment is warranted.</p>","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"15 ","pages":"9-19"},"PeriodicalIF":2.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/10/f4/cpaa-15-9.PMC9985425.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10861161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Efficacy and Safety of a Novel Low-Dose Turmeric Extract Formulation in Healthy Adults with Chronic Knee Pain [Corrigendum].","authors":"","doi":"10.2147/CPAA.S427333","DOIUrl":"https://doi.org/10.2147/CPAA.S427333","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2147/CPAA.S307464.].</p>","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"15 ","pages":"63-65"},"PeriodicalIF":2.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/69/da/cpaa-15-63.PMC10314745.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10122336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recent Advances in Messenger Ribonucleic Acid (mRNA) Vaccines and Their Delivery Systems: A Review.","authors":"Wubetu Yihunie,&nbsp;Getinet Nibret,&nbsp;Yibeltal Aschale","doi":"10.2147/CPAA.S418314","DOIUrl":"https://doi.org/10.2147/CPAA.S418314","url":null,"abstract":"<p><p>Messenger ribonucleic acid (mRNA) was found as the intermediary that transfers genetic information from DNA to ribosomes for protein synthesis in 1961. The emergency use authorization of the two covid-19 mRNA vaccines, BNT162b2 and mRNA-1273, is a significant achievement in the history of vaccine development. Because they are generated in a cell-free environment using the in vitro transcription (IVT) process, mRNA vaccines are risk-free. Moreover, chemical modifications to the mRNA molecule, such as cap structures and changed nucleosides, have proved critical in overcoming immunogenicity concerns, achieving sustained stability, and achieving effective, accurate protein production in vivo. Several vaccine delivery strategies (including protamine, lipid nanoparticles (LNPs), polymers, nanoemulsions, and cell-based administration) were also optimized to load and transport RNA into the cytosol. LNPs, which are composed of a cationic or a pH-dependent ionizable lipid layer, a polyethylene glycol (PEG) component, phospholipids, and cholesterol, are the most advanced systems for delivering mRNA vaccines. Moreover, modifications of the four components that make up the LNPs showed to increase vaccine effectiveness and reduce side effects. Furthermore, the introduction of biodegradable lipids improved LNP biocompatibility. Furthermore, mRNA-based therapies are expected to be effective treatments for a variety of refractory conditions, including infectious diseases, metabolic genetic diseases, cancer, cardiovascular and cerebrovascular diseases. Therefore, the present review aims to provide the scientific community with up-to-date information on mRNA vaccines and their delivery systems.</p>","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"15 ","pages":"77-98"},"PeriodicalIF":2.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a1/97/cpaa-15-77.PMC10405914.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10019916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of Intramuscular Ephedrine Sulfate During Kidney Transplantation.","authors":"Gaurav P Patel,&nbsp;Susan A Smith,&nbsp;Michelle Romej,&nbsp;Billynda McAdoo,&nbsp;Elizabeth A Wilson","doi":"10.2147/CPAA.S418124","DOIUrl":"https://doi.org/10.2147/CPAA.S418124","url":null,"abstract":"<p><p>Hypotension during kidney transplantation can be common. Vasopressor use during these procedures is often avoided, with a fear of decreasing renal perfusion in the transplanted kidney. However, adequate perfusion for the rest of the body is also necessary, and given that these patients often have underlying hypertension or other comorbid conditions, an appropriate mean arterial pressure (MAP) has to be maintained. Intramuscular injections of ephedrine have been studied in the anesthesiology literature in a variety of case types, and it is seen as a safe and effective method to boost MAP. We present a case series of three patients who underwent renal transplantation and who received an intramuscular injection of ephedrine for hypotension control. The medication worked well for increasing blood pressures without apparent side effects. All three patients were followed for more than one year, and all patients had good graft function at the end of that time period. This series shows that while further research is necessary in this arena, intramuscular ephedrine may have a place in the management of persistent hypotension in the operating room during kidney transplantation.</p>","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"15 ","pages":"57-61"},"PeriodicalIF":2.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/18/0b/cpaa-15-57.PMC10305767.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10097480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Anti-VEGFs in Treating Diabetic Macular Edema in Alfaisal Eye Center, Khartoum, Sudan, 2019","authors":"Rayan Hamza Mohammed Ahmedalgabri, Tarig Omer, Fatima Zarroug, Abdullah Omer Elkhawad, M. Noma","doi":"10.2147/CPAA.S338926","DOIUrl":"https://doi.org/10.2147/CPAA.S338926","url":null,"abstract":"Background Anti-vascular endothelial growth factor (anti-VEGF) medicines have revolutionized DME and DR treatment. Despite the worldwide use of anti-VEGFs, their use remains limited in Sudan. This study aimed to assess the impact of anti-VEGF (ranibizumab and bevacizumab) injections in patients with diabetic macular oedema in Khartoum, Sudan. Methods An analytical comparative cross-sectional study was implemented in Alfaisal referral eye centre. A Standard questionnaire was used to collect the variables related to the research objectives. Thirty-four patients were recruited; 16 patients under ranibizumab (Lucentis) and 18 under bevacizumab (Avastin). Data were analyzed through SPSS 23, best-corrected visual acuity (BCVA) and central retinal thickness (CRT) measurements were considered as main outcomes to evaluate the treatment effectiveness. Results Among the 34 participants, 64.7% were males and 35.3% were females, with an average age of 62 years and 13 years of long standing diabetes. A total of 54 eyes received an average of 2.3 injections in an average of 7 months’ period. The mean BCVA before and after treatment for both drugs respectively 0.19 min and 0.21 min was statistically correlated (p = 0.000). For patients under Lucentis, the mean BCVA before and after medication was 0.20 min–0.24 min and 0.19–0.19 min for those who used Avastin. The mean central retinal thickness (CRT), before and after treatment for both drugs, was 492.22µm–422.89µm, respectively, with a significant correlation (p = 0.003). For patients under Lucentis, the mean CRT decreased from 536.30 µm to 425.19 µm; it dropped from 453.16µm to 421.18µm for patients under Avastin. About 79.4% (27/34) of the participants reported that injections were not affordable and 14.7% (5/34) complained from shortage of one dose, regardless of which type of treatment. Glycaemia control, duration of treatment, type and frequency of injections used were found to be the most contributing factors to the effectiveness of anti-VEGF medications. Conclusion Both anti-VEGF medications are effective in treating DME, Lucentis showed better improvements in BCVA and macular thickness than Avastin. Policymakers in Sudan require urgent alternative strategies to increase access to these medications.","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"14 1","pages":"37 - 47"},"PeriodicalIF":2.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45226773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating Pharmacists’ Pharmacological Knowledge and Views Regarding Pfizer-BioNTech COVID-19 Vaccine in Saudi Arabia","authors":"Nasser M Alorfi, A. Ashour","doi":"10.2147/CPAA.S356413","DOIUrl":"https://doi.org/10.2147/CPAA.S356413","url":null,"abstract":"Background The Pfizer-BioNTech COVID-19 vaccine has been widely used and approved for the prevention of 2019 coronavirus disease (COVID-19) for individuals aged 16 years and older in Saudi Arabia. The emergency use authorization of this vaccine is crucial to managing the pandemic in the Kingdom. This vaccination strategy requires proper usage, knowledge, and management by pharmacists and other health professionals. Methods This cross-sectional study was conducted using several previously validated questionnaires. Pharmacists working in different health sectors in Saudi Arabia in March–July 2021 participated via an online questionnaire. Comparative and descriptive analyses were used to analyze the data, and a P-value < 0.05 was considered significant. Results A total of 145 pharmacists with a mean age of 35.2 years (SD ± 5.59) were included. The study sample showed adequate general knowledge of COVID-19 and its causative virus signs. Overall, the results showed good knowledge of Pfizer-BioNTech COVID-19 vaccine and its pharmacological application among pharmacists in Saudi Arabia with significant chi square values (p< 0.0001). Conclusion Pharmacists have good knowledge and understanding of the Pfizer-BioNTech COVID-19 vaccine; interestingly, the majority expressed a high level of awareness and agreed that Pfizer-BioNTech COVID-19 vaccine is a valuable vaccine for COVID-19 management.","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"14 1","pages":"27 - 35"},"PeriodicalIF":2.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46283202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exenatide Once Weekly for Management of Type 2 Diabetes: A Review","authors":"Jun Inaishi, Y. Saisho","doi":"10.2147/CPAA.S288846","DOIUrl":"https://doi.org/10.2147/CPAA.S288846","url":null,"abstract":"Abstract Exenatide is one of the exendin-based glucagon-like peptide 1 receptor agonists (GLP-1RAs) and is currently available in two formulations, ie, exenatide twice daily (BID), a short-acting GLP-1RA, and exenatide once weekly (QW), a long-acting GLP-1RA. Clinical efficacy and safety of exenatide 2 mg QW in patients with type 2 diabetes (T2DM) has been demonstrated in the DURATION study program. Exenatide QW has been shown to achieve greater HbA1c reduction compared with exenatide BID, with less injection frequency and greater treatment satisfaction. However, exenatide QW failed to show a significant cardiovascular risk reduction in a cardiovascular outcome trial (CVOT), the EXSCEL trial, while other GLP-1RAs have shown positive CV outcomes. Furthermore, exenatide QW has been shown to be inferior to liraglutide and semaglutide with respect to HbA1c or body weight reduction in the head-to-head trials. Thus, although the long-term efficacy and safety of exenatide QW have been demonstrated, exenatide QW might be selected with lower priority within the class of GLP1-RAs for the management of T2DM, especially for patients at high CV risk. On the other hand, exenatide QW is now expected to be a treatment option for children with T2DM or patients with Parkinson’s disease. This review provides an overview of the current evidence regarding the clinical efficacy and safety of exenatide QW and discusses the current perspectives on exenatide QW for treatment of T2DM.","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"14 1","pages":"19 - 26"},"PeriodicalIF":2.0,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41643553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antileishmanial Activity of Tamoxifen by Targeting Sphingolipid Metabolism: A Review","authors":"Kaleab Alemayehu Zewdie, Haftom Gebregergs Hailu, M. A. Ayza, B. Tesfaye","doi":"10.2147/CPAA.S344268","DOIUrl":"https://doi.org/10.2147/CPAA.S344268","url":null,"abstract":"Abstract Leishmaniasis is a widespread group of neglected parasitic diseases caused by protozoa of the genus Leishmania. Around 2 million new cases are reported each year and around 12 million people are at risk of being infected. Although various therapies have been used to treat leishmaniasis, they have been associated with increased cytotoxicity and drug resistance problems. Hence, the present review was intended to show the potential of tamoxifen as an alternative option for the treatment of leishmaniasis. Tamoxifen is a known selective estrogen receptor modulator and has been widely used for the treatment of early-stage breast cancer. Various experimental and clinical studies revealed that it has an antileishmanial effect by decreasing parasitic burden, with low cost and few side effects. The antileishmanial action of tamoxifen has been related to its potential effect on sphingolipid metabolism. Besides, it affects mitochondrial function by inducing alterations in the plasma membrane potential. However, further detailed studies are required to show the ultimate effects on health outcomes.","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"14 1","pages":"11 - 17"},"PeriodicalIF":2.0,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41979156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Response to Article \"Anti-Diarrheal Activity of Hydromethanolic Crude Extract and Solvent Fractions of Acacia Seyal (Fabaceae) Roots in Mice\" [Letter].","authors":"Novaria Sari Dewi Panjaitan,&nbsp;Fitriana Fitriana,&nbsp;Sarwo Handayani","doi":"10.2147/CPAA.S398217","DOIUrl":"https://doi.org/10.2147/CPAA.S398217","url":null,"abstract":"of anti-diarrheal","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"14 ","pages":"111-112"},"PeriodicalIF":2.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/30/93/cpaa-14-111.PMC9719282.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10344845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anti-Diarrheal Activities of Hydromethanolic Crude Extract and Solvent Fractions of <i>Acacia seyal</i> (Fabaceae) Roots in Mice [Response to Letter].","authors":"Assefa Kebad Mengesha,&nbsp;Eshetie Melese Birru,&nbsp;Meaza Adugna","doi":"10.2147/CPAA.S400000","DOIUrl":"https://doi.org/10.2147/CPAA.S400000","url":null,"abstract":"","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"14 ","pages":"113-114"},"PeriodicalIF":2.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c4/55/cpaa-14-113.PMC9744855.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10731619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}