Pharmacology Research & Perspectives最新文献

筛选
英文 中文
High prevalence of medication errors in a secondary-level Lithuanian hospital: A prospective cross-sectional observational study. 立陶宛一家二级医院的用药错误高发率:前瞻性横断面观察研究。
IF 2.9 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-08-01 DOI: 10.1002/prp2.1246
J Butauskaite, A Zumbakyte, L Aukstikalne, J Pancere, S Zukaitiene, E Karinauske
{"title":"High prevalence of medication errors in a secondary-level Lithuanian hospital: A prospective cross-sectional observational study.","authors":"J Butauskaite, A Zumbakyte, L Aukstikalne, J Pancere, S Zukaitiene, E Karinauske","doi":"10.1002/prp2.1246","DOIUrl":"10.1002/prp2.1246","url":null,"abstract":"<p><p>As the population continues to age, the occurrence of chronic illnesses and comorbidities that often necessitate the use of polypharmacy has been on the rise. Polypharmacy, among other factors that tend to coincide with chronic diseases, such as obesity, impaired kidney and liver function, and older age, can increase the risk of medication errors (MEs). Our study aims to evaluate the prevalence of MEs in the Internal medicine, Cardiology, and Neurology departments at the secondary-level university hospital. We conducted a prospective observational study of 145 patients' electronic or paper-based data of inpatient prescriptions and patients' pharmacokinetic risk factors, such as an impairment of renal and/or hepatic function, weight, and age. All included patients collectively received 1252 prescribed drugs. The median (Q1; Q3) number of drugs per patient was 8 (7;10). At least one ME was identified in 133 out of the 145 patients, indicating a significantly higher prevalence than hypothesized (91.7% vs. 50%; p < .001). There was moderate, positive correlation between the quantity of prescribed drugs and the number of MEs, meaning that the more drugs are prescribed, the higher the number of identified MEs (Spearman's ρ = 0.428; p < .001). These findings suggest that there is a need for continuous medication education activity for prescribing physicians, continuous evaluation of prescription appropriateness to objectively identify the MEs and to contribute to more rational patient treatment.</p>","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11291557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141860464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Predictors of gentamicin therapy failure in neonates with sepsis. 败血症新生儿庆大霉素治疗失败的预测因素。
IF 2.9 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-08-01 DOI: 10.1002/prp2.1250
Bonifasius Siyuka Singu, Clarissa Hildegard Pieper, Roger Karel Verbeeck, Ene I Ette
{"title":"Predictors of gentamicin therapy failure in neonates with sepsis.","authors":"Bonifasius Siyuka Singu, Clarissa Hildegard Pieper, Roger Karel Verbeeck, Ene I Ette","doi":"10.1002/prp2.1250","DOIUrl":"10.1002/prp2.1250","url":null,"abstract":"<p><p>Sepsis is a common disease with high morbidity and mortality among newborns in intensive care units world-wide. Gram-negative bacillary bacteria are the major source of infection in neonates. Gentamicin is the most widely used aminoglycoside antibiotic in empiric therapy against early-onset sepsis. However, therapy failure may result due to various factors. The purpose of this study was to identify predictors of gentamicin therapy failure in neonates with sepsis. This was a prospective cross-sectional study at the Neonatal Intensive Care Unit at Windhoek Central Hospital over a period of 5 months in 2019. Neonates received intravenous gentamicin 5 mg/kg/24 h in combination with either benzylpenicillin 100 000 IU/kg/12 h or ampicillin 50 mg/kg/8 h. Logistic regression modeling was performed to determine the predictors of treatment outcomes. 36% of the 50 neonates were classified as having gentamicin treatment failure. Increasing treatment duration by 1 day resulted in odds of treatment failure increasing from 1.0 to 2.41. Similarly, one unit increase in CRP increases odds of gentamicin treatment failure by 49%. The 1 kg increase in birthweight reduces the log odds of treatment failure by 6.848, resulting in 99.9% decrease in the odds of treatment failure. One unit increase in WBC reduces odds of gentamicin treatment failure by 27%. Estimates of significant predictors of treatment failure were precise, yielding odds ratios that were within 95% confidence interval. This study identified the following as predictors of gentamicin therapy failure in neonates: prolonged duration of treatment, elevated C-reactive protein, low birthweight, and low white blood cell count.</p>","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11301262/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141894063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
FDA regulatory considerations for oncology drug development. 美国食品及药物管理局对肿瘤药物开发的监管考虑。
IF 2.9 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-08-01 DOI: 10.1002/prp2.1254
Hanlim Moon, Dae Young Zang, Min-Hee Ryu, YeonSook Seo, Bitna Oh, Sunjin Hwang, Lee Farrand
{"title":"FDA regulatory considerations for oncology drug development.","authors":"Hanlim Moon, Dae Young Zang, Min-Hee Ryu, YeonSook Seo, Bitna Oh, Sunjin Hwang, Lee Farrand","doi":"10.1002/prp2.1254","DOIUrl":"10.1002/prp2.1254","url":null,"abstract":"","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11286537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141793044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Involvement of Piezo 1 mechanoceptors in vascular stiffness in isolated small resistance arteries of male and female Dahl salt‐sensitive hypertensive rats Piezo 1 机械感受器参与了雌雄达尔盐敏感高血压大鼠离体小阻力动脉血管僵化的研究
IF 2.6 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-06-22 DOI: 10.1002/prp2.1227
Eric A. Mensah, Noriko Daneshtalab, Reza Tabrizchi
{"title":"Involvement of Piezo 1 mechanoceptors in vascular stiffness in isolated small resistance arteries of male and female Dahl salt‐sensitive hypertensive rats","authors":"Eric A. Mensah, Noriko Daneshtalab, Reza Tabrizchi","doi":"10.1002/prp2.1227","DOIUrl":"https://doi.org/10.1002/prp2.1227","url":null,"abstract":"Piezo are mechanosensitive non‐selective cation channels that are suggested to be involved in vascular development and function. The aim of our study was to determine any sex‐specific contributions of the mechanosensitive Piezo 1 channels on blood vessel wall stiffness. Composite Young modulus (CYM) was determined using pressure myograph experimental approach using third‐order mesenteric arteries (intact and denuded) from Dahl salt‐sensitive male and female normotensive and hypertensive rats (<jats:italic>n</jats:italic> = 6–8). The effects of Piezo 1 agonist (Yoda 1; 10 μM), and antagonist (GsMTx‐4; 2 μM) were studied in intact and denuded vessels. The distribution of Piezo 1 was identified using immunohistochemistry. In intact blood vessels, there were no differences in CYM between the experimental groups, however, removal of the endothelium unmasked significant increases in CYM in normotensive males and female groups compared to hypertensive males. The presence of Yoda 1 did not affect CYM in any groups. In the intact tissues, GsMTx‐4 led to significant increases in CYM in hypertensive females, and normotensive males and females, but not in hypertensive males. In the denuded vessels, GsMTx‐4, produced a significant increase in CYM but only in the female normotensives. Differential expression of Piezo 1 were found in male versus female blood vessels. Our findings support a greater contribution of Piezo 1 mechanoceptors to vascular biomechanics of male hypertensive compared to male normotensive or female groups. The evidence also points to a possible differential vasoregulatory role for Piezo 1 in endothelial versus vascular smooth cells, with a greater contribution in males than females.","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141523334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Asciminib, a novel allosteric inhibitor of BCR‐ABL1, shows synergistic effects when used in combination with imatinib with or without drug resistance 阿西米尼是一种新型 BCR-ABL1 异源抑制剂,与伊马替尼联合使用时,无论有无耐药性,都能产生协同效应
IF 2.6 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-06-21 DOI: 10.1002/prp2.1214
Naoki Okamoto, Kenta Yagi, Sayaka Imawaka, Mayu Takaoka, Fuka Aizawa, Takahiro Niimura, Mitsuhiro Goda, Koji Miyata, Kei Kawada, Yuki Izawa‐Ishizawa, Satoshi Sakaguchi, Keisuke Ishizawa
{"title":"Asciminib, a novel allosteric inhibitor of BCR‐ABL1, shows synergistic effects when used in combination with imatinib with or without drug resistance","authors":"Naoki Okamoto, Kenta Yagi, Sayaka Imawaka, Mayu Takaoka, Fuka Aizawa, Takahiro Niimura, Mitsuhiro Goda, Koji Miyata, Kei Kawada, Yuki Izawa‐Ishizawa, Satoshi Sakaguchi, Keisuke Ishizawa","doi":"10.1002/prp2.1214","DOIUrl":"https://doi.org/10.1002/prp2.1214","url":null,"abstract":"In the treatment of chronic myeloid leukemia (CML), resistance to BCR‐ABL inhibitors makes it difficult to continue treatment and is directly related to life expectancy. Therefore, asciminib was introduced to the market as a useful drug for overcoming drug resistance. While combining molecular targeted drugs is useful to avoid drug resistance, the new BCR‐ABL inhibitor asciminib and conventional BCR‐ABL inhibitors should be used as monotherapy in principle. Therefore, we investigated the synergistic effect and mechanism of the combination of asciminib and imatinib. We generated imatinib‐resistant cells using the human CML cell line K562, examined the effects of imatinib and asciminib exposure on cell survival using the WST‐8 assay, and comprehensively analyzed genetic variation related to drug resistance using RNA‐seq and real‐time PCR. A synergistic effect was observed when imatinib and asciminib were combined with or without imatinib resistance. Three genes, GRRP1, ESPN, and NOXA1, were extracted as the sites of action of asciminib. Asciminib in combination with BCR‐ABL inhibitors may improve the therapeutic efficacy of conventional BCR‐ABL inhibitors and prevent the development of resistance. Its dosage may be effective even at minimal doses that do not cause side effects. Further verification of this mechanism of action is needed. Additionally, cross‐resistance between BCR‐ABL inhibitors and asciminib may occur, which needs to be clarified through further validation as soon as possible.","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141523379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A novel and selective fluorescent ligand for the study of adenosine A2B receptors 用于研究腺苷 A2B 受体的新型选择性荧光配体
IF 2.6 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-06-21 DOI: 10.1002/prp2.1223
Foteini Patera, Sarah J. Mistry, Nicholas D. Kindon, Eleonora Comeo, Joelle Goulding, Barrie Kellam, Laura E. Kilpatrick, Hester Franks, Stephen J. Hill
{"title":"A novel and selective fluorescent ligand for the study of adenosine A2B receptors","authors":"Foteini Patera, Sarah J. Mistry, Nicholas D. Kindon, Eleonora Comeo, Joelle Goulding, Barrie Kellam, Laura E. Kilpatrick, Hester Franks, Stephen J. Hill","doi":"10.1002/prp2.1223","DOIUrl":"https://doi.org/10.1002/prp2.1223","url":null,"abstract":"Fluorescent ligands have proved to be powerful tools in the study of G protein‐coupled receptors in living cells. Here we have characterized a new fluorescent ligand PSB603‐BY630 that has high selectivity for the human adenosine A<jats:sub>2B</jats:sub> receptor (A<jats:sub>2B</jats:sub>R). The A<jats:sub>2B</jats:sub>R appears to play an important role in regulating immune responses in the tumor microenvironment. Here we have used PSB603‐BY630 to monitor specific binding to A<jats:sub>2B</jats:sub>Rs in M1‐ and M2‐like macrophages derived from CD14+ human monocytes. PSB603‐BY630 bound with high affinity (18.3 nM) to nanoluciferase‐tagged A<jats:sub>2B</jats:sub>Rs stably expressed in HEK293G cells. The ligand exhibited very high selectivity for the A<jats:sub>2B</jats:sub>R with negligible specific‐binding detected at NLuc‐A<jats:sub>2A</jats:sub>R, NLuc‐A<jats:sub>1</jats:sub>R, or NLuc‐A<jats:sub>3</jats:sub>R receptors at concentrations up to 500 nM. Competition binding studies showed the expected pharmacology at A<jats:sub>2B</jats:sub>R with the A<jats:sub>2B</jats:sub>R‐selective ligands PSB603 and MRS‐1706 demonstrating potent inhibition of the specific binding of 50 nM PSB603‐BY630 to A<jats:sub>2B</jats:sub>R. Functional studies in HEK293G cells using Glosensor to monitor G<jats:sub>s</jats:sub>‐coupled cyclic AMP responses indicated that PSB603‐BY630 acted as a negative allosteric regular of the agonist responses to BAY 60–6583. Furthermore, flow cytometry analysis confirmed that PSB603‐BY630 could be used to selectively label endogenous A<jats:sub>2B</jats:sub>Rs expressed on human macrophages. This ligand should be an important addition to the library of fluorescent ligands which are selective for the different adenosine receptor subtypes, and will enable study of the role of A<jats:sub>2B</jats:sub>Rs on immune cells in the tumor microenvironment.","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141531765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Not first-line antihypertensive agents, but still effective-The efficacy and safety of imidazoline receptor agonists: A network meta-analysis. 不是一线降压药,但仍然有效-咪唑啉受体激动剂的疗效和安全性:网络荟萃分析。
IF 2.6 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-06-01 DOI: 10.1002/prp2.1215
András Érszegi, Réka Viola, Muh Akbar Bahar, Barbara Tóth, Imola Fejes, Anna Vágvölgyi, Dezső Csupor
{"title":"Not first-line antihypertensive agents, but still effective-The efficacy and safety of imidazoline receptor agonists: A network meta-analysis.","authors":"András Érszegi, Réka Viola, Muh Akbar Bahar, Barbara Tóth, Imola Fejes, Anna Vágvölgyi, Dezső Csupor","doi":"10.1002/prp2.1215","DOIUrl":"10.1002/prp2.1215","url":null,"abstract":"<p><p>Cardiovascular disorders are the leading cause of death in the world. Many organ diseases (kidney, heart, and brain) are substantially more prone to develop in people with hypertension. In the treatment of hypertension, first-line medications are recommended, while imidazoline receptor agonists are not first-line antihypertensives. Our goal was to conduct a network meta-analysis to assess the efficacy and safety of imidazoline receptor agonists. The meta-analysis was performed following the PRISMA guidelines using the PICOS format, considering the CONSORT recommendations. Studies were collected from four databases: PubMed, Cochrane Library, Web of Science, and Embase. A total of 5960 articles were found. After filtering, 27 studies remained eligible for network meta-analysis. Moxonidine reduced blood pressure in sitting position statistically significantly after 8 weeks of treatment (SBP MD: 23.80; 95% CI: 17.45-30.15; DBP MD: 10.90; 95% CI: 8.45-13.35) compared to placebo. Moreover, moxonidine reduced blood pressure more effectively than enalapril; however, this difference was not significant (SBP MD: 3.10; 95% CI: -2.60-8.80; DBP MD: 1.30; 95% CI: -1.25-3.85). Dry mouth was experienced as a side effect in the case of all imidazoline receptor agonists. After 8 weeks of treatment, the appearance of dry mouth was highest with clonidine (OR: 9.27 95% CI: 4.70-18.29) and lowest with rilmenidine (OR: 6.46 95% CI: 0.85-49.13) compared to placebo. Somnolence was less frequent with moxonidine compared to rilmenidine (OR: 0.63 95% CI: 0.17-2.31). Imidazoline receptor agonists were nearly as effective as the first-line drugs in the examined studies. However, their utility as antihypertensives is limited due to their side effects. As a result, they are not first-line antihypertensives and should not be used in monotherapy. However, in the case of resistant hypertension, they are a viable option. According to our findings, from the point of view of safety and efficacy, moxonidine appears to be the best choice among imidazoline receptor agonists.</p>","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11133783/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141162225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exogenous melatonin's effect on salivary cortisol and amylase: A randomized controlled trial. 外源性褪黑素对唾液皮质醇和淀粉酶的影响:随机对照试验
IF 2.9 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-06-01 DOI: 10.1002/prp2.1205
Praewpat Pachimsawat, Piyanee Ratanachamnong, Nattinee Jantaratnotai
{"title":"Exogenous melatonin's effect on salivary cortisol and amylase: A randomized controlled trial.","authors":"Praewpat Pachimsawat, Piyanee Ratanachamnong, Nattinee Jantaratnotai","doi":"10.1002/prp2.1205","DOIUrl":"10.1002/prp2.1205","url":null,"abstract":"<p><p>This study aimed to examine the effect of acute exogenous melatonin administration on salivary cortisol and alpha-amylase (sCort and sAA) as representatives of the HPA axis and the sympathetic nervous system, respectively. A single-dose prolonged-release melatonin (2 mg) or a placebo tablet was given to healthy volunteers (n = 64) at 20:00 h in a crossover design. The saliva was collected at six time points (20:00, 21:00, awakening, 30 min after awakening, 10:00, and 12:00 h) and was measured for sCort, sAA, and salivary melatonin (sMT) levels. Pulse rates and sleep parameters were also collected. Melatonin was effective in improving sleep onset latency by 7:04 min (p = .037) and increasing total sleep time by 24 min (p = .006). Participants with poor baseline sleep quality responded more strongly to melatonin than participants with normal baseline sleep quality as they reported more satisfaction in having adequate sleep (p = .017). Melatonin administration resulted in higher sCort levels at awakening time point (p = .023) and a tendency of lower sAA levels but these were not significant. Melatonin ingestion at 20:00 h resulted in a marked increase in sMT levels at 21:00 h and remained higher than baseline up to at least 10:00 h (p < .001). Melatonin increases sCort levels at certain time point with a tendency to lower sAA levels. These opposing effects of melatonin suggested a complex interplay between melatonin and these biomarkers. Also, the results confirmed the positive acute effect of a single-dose melatonin on sleep quality.</p>","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11103136/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141065830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bioequivalence and the food effect of macitentan/tadalafil 10/20 fixed-dose combination tablets versus the use of single-component tablets in healthy subjects. 健康受试者服用马西替坦/他达拉非 10/20 固定剂量复方片剂与服用单组分片剂的生物等效性和食物效应。
IF 2.9 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-06-01 DOI: 10.1002/prp2.1202
Jennifer Lynn Ford, Ahad Sabet, Jaya Natarajan, Hans Stieltjes, Daniel L Chao, Navin Goyal, Denes Csonka
{"title":"Bioequivalence and the food effect of macitentan/tadalafil 10/20 fixed-dose combination tablets versus the use of single-component tablets in healthy subjects.","authors":"Jennifer Lynn Ford, Ahad Sabet, Jaya Natarajan, Hans Stieltjes, Daniel L Chao, Navin Goyal, Denes Csonka","doi":"10.1002/prp2.1202","DOIUrl":"10.1002/prp2.1202","url":null,"abstract":"<p><p>The primary aim was to demonstrate bioequivalence between the 10/20 mg fixed-dose combination (FDC) of macitentan/tadalafil in a single tablet and the free combination of both drugs, and to evaluate the food effect on the 10/20 mg FDC in healthy participants. In this single-center, randomized, open-label, 3-way crossover, single-dose Phase 1 study in healthy adult participants, macitentan/tadalafil was administered as a 10/20 mg FDC formulation and compared with the free combination of macitentan and tadalafil. The food effect on the FDC was also evaluated. Pharmacokinetic sampling (216 h) was conducted. The 90% confidence intervals (CIs) for the geometric mean ratios of maximum observed plasma analyte concentration (C<sub>max</sub>) and area under the plasma analyte concentration-time curves (AUCs) for Treatment A (FDC, fasted) versus C (free combination, fasted) were within bioequivalence limits demonstrating that the FDC formulation can be considered bioequivalent to the free combination. The 90% CIs for the geometric mean ratios of C<sub>max</sub> and AUC for Treatment B (FDC, fed) versus A (FDC, fasted) were contained within bioequivalence limits demonstrating that there was no food effect. The administration of the 10/20 mg FDC was generally safe and well tolerated in healthy participants. This study demonstrated bioequivalence between the FDC of macitentan/tadalafil (10/20 mg) in a single tablet and the free combination of both drugs in healthy participants, and that the FDC can be taken without regard to food, similarly to the individual components. The FDC was generally safe and well tolerated.</p>","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11103125/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141065827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Incidence and management of the main serious adverse events reported after COVID-19 vaccination. 接种 COVID-19 疫苗后报告的主要严重不良事件的发生率和处理情况。
IF 2.6 4区 医学
Pharmacology Research & Perspectives Pub Date : 2024-06-01 DOI: 10.1002/prp2.1224
Teresa Padilla-Flores, Alicia Sampieri, Luis Vaca
{"title":"Incidence and management of the main serious adverse events reported after COVID-19 vaccination.","authors":"Teresa Padilla-Flores, Alicia Sampieri, Luis Vaca","doi":"10.1002/prp2.1224","DOIUrl":"10.1002/prp2.1224","url":null,"abstract":"<p><p>Coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2n first appeared in Wuhan, China in 2019. Soon after, it was declared a pandemic by the World Health Organization. The health crisis imposed by a new virus and its rapid spread worldwide prompted the fast development of vaccines. For the first time in human history, two vaccines based on recombinant genetic material technology were approved for human use. These mRNA vaccines were applied in massive immunization programs around the world, followed by other vaccines based on more traditional approaches. Even though all vaccines were tested in clinical trials prior to their general administration, serious adverse events, usually of very low incidence, were mostly identified after application of millions of doses. Establishing a direct correlation (the cause-effect paradigm) between vaccination and the appearance of adverse effects has proven challenging. This review focuses on the main adverse effects observed after vaccination, including anaphylaxis, myocarditis, vaccine-induced thrombotic thrombocytopenia, Guillain-Barré syndrome, and transverse myelitis reported in the context of COVID-19 vaccination. We highlight the symptoms, laboratory tests required for an adequate diagnosis, and briefly outline the recommended treatments for these adverse effects. The aim of this work is to increase awareness among healthcare personnel about the serious adverse events that may arise post-vaccination. Regardless of the ongoing discussion about the safety of COVID-19 vaccination, these adverse effects must be identified promptly and treated effectively to reduce the risk of complications.</p>","PeriodicalId":19948,"journal":{"name":"Pharmacology Research & Perspectives","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11167235/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141306465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信