Core Evidence最新文献

Riociguat in the Treatment of Chronic Thromboembolic Pulmonary Hypertension: An Evidence-Based Review of Its Place in Therapy. 瑞西奎特治疗慢性血栓栓塞性肺动脉高压:循证评价其治疗地位。

Core Evidence Pub Date : 2020-08-25 eCollection Date: 2020-01-01 DOI: 10.2147/CE.S172791

Sahai Donaldson, Richard Ogunti, Angesom Kibreab, Alem Mehari

{"title":"Riociguat in the Treatment of Chronic Thromboembolic Pulmonary Hypertension: An Evidence-Based Review of Its Place in Therapy.","authors":"Sahai Donaldson, Richard Ogunti, Angesom Kibreab, Alem Mehari","doi":"10.2147/CE.S172791","DOIUrl":"https://doi.org/10.2147/CE.S172791","url":null,"abstract":"Chronic thromboembolic pulmonary hypertension (CTEPH) is classified as group-4 pulmonary hypertension caused by organized thrombi in pulmonary arteries and vasculopathy in nonoccluded areas leading to right heart failure and death. In addition to chronic anticoagulation therapy, each patient with CTEPH should receive treatment assessment starting with evaluation for pulmonary endarterectomy (PEA), which is the guideline recommended treatment. There is increasing experience with balloon pulmonary angioplasty (BPA) for inoperable patients; this option, like PEA, is reserved for specialized centers with expertise in this treatment method. Inoperable patients are candidates for targeted drug therapy. Riociguat remains the only approved medical therapy for CTEPH patients deemed inoperable or with persistent pulmonary hypertension after PEA. The role of riociguat therapy preoperatively or in tandem with BPA is currently under investigation. The purpose of this review is to evaluate the safety and efficacy of riociguat in the treatment of CTEPH.","PeriodicalId":10764,"journal":{"name":"Core Evidence","volume":"15 ","pages":"31-40"},"PeriodicalIF":0.0,"publicationDate":"2020-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/CE.S172791","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38359250","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}

引用次数: 6

Management of Chemotherapy-Induced Nausea and Vomiting (CINV): A Short Review on the Role of Netupitant-Palonosetron (NEPA). 化疗引起的恶心和呕吐(CINV)的处理:奈妥吡坦-帕洛诺司琼(NEPA)作用的简要回顾。

Core Evidence Pub Date : 2020-07-27 eCollection Date: 2020-01-01 DOI: 10.2147/CE.S203634

Vito Lorusso, Anna Russo, Francesco Giotta, Paolo Codega

{"title":"Management of Chemotherapy-Induced Nausea and Vomiting (CINV): A Short Review on the Role of Netupitant-Palonosetron (NEPA).","authors":"Vito Lorusso, Anna Russo, Francesco Giotta, Paolo Codega","doi":"10.2147/CE.S203634","DOIUrl":"https://doi.org/10.2147/CE.S203634","url":null,"abstract":"Introduction: Antineoplastic drugs may induce several side effects, including chemotherapy-induced nausea and vomiting (CINV). Two neurotransmitters play a central role in mediating the emetic response: serotonin acting on the 5HT3 receptor and the substance P targeting the NK1 receptor. Indeed, a combination of a 5HT3 receptor antagonist (5HT3-RA) and a NK1 receptor antagonist (NK1-RA) together with dexamethasone has been shown to be very effective. In fact, this combination is actually widely used and recommended for CINV prophylaxis for highly emetogenic cisplatin-based adriamycin/cyclophosphamide (AC) and carboplatin-based regimens. NEPA (netupitant/palonosetron) is the only fixed combination antiemetic available and it is composed by the long-lasting second-generation 5HT3-RA palonosetron and the highly selective NK1-RA netupitant.Aim: The aims of this short review were to analyze the role of NEPA in CINV prophylaxis and management taking in account the risk factors related to the patient and to the antineoplastic treatment.Evidence review: CINV development is not only correlated to the emetogenic potential of the antineoplastic drugs but is also very influenced by the patient characteristics and history, such as gender, age, alcohol intake, nausea during pregnancy and motion sickness. In pivotal and post-registration studies, NEPA has demonstrated to be effective and safe in both highly and moderately emetogenic chemotherapy.Conclusion: A proper assessment of both chemotherapy- and patient-related risk factors is paramount to properly evaluate an appropriate prophylaxis of CINV and NEPA by simplifying the therapy, guarantees fully adherence to antiemetic guidelines, and consequently improves the control of CINV, especially in high risk patients.","PeriodicalId":10764,"journal":{"name":"Core Evidence","volume":"15 ","pages":"21-29"},"PeriodicalIF":0.0,"publicationDate":"2020-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/CE.S203634","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38278975","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}

引用次数: 9

Vedolizumab in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Safety, Efficacy, and Place of Therapy. 韦多利珠单抗治疗溃疡性结肠炎：基于证据的安全性、疗效和治疗地点综述。

Core Evidence Pub Date : 2020-04-01 eCollection Date: 2020-01-01 DOI: 10.2147/CE.S179053

Noritaka Takatsu, Takashi Hisabe, Daijiro Higashi, Toshiharu Ueki, Toshiyuki Matsui

{"title":"Vedolizumab in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Safety, Efficacy, and Place of Therapy.","authors":"Noritaka Takatsu, Takashi Hisabe, Daijiro Higashi, Toshiharu Ueki, Toshiyuki Matsui","doi":"10.2147/CE.S179053","DOIUrl":"10.2147/CE.S179053","url":null,"abstract":"Introduction: Selective blockade of the integrins and mucosal adhesion molecules is a promising therapeutic strategy for ulcerative colitis (UC). Vedolizumab (VDZ), a humanized IgG1 monoclonal antibody against α4β7 integrin, selectively blocks the trafficking of the leukocytes into the gastrointestinal tract through its binding with the α4β7 integrin.Aim: In this review, we provide an overview of the unique mechanism of VDZ, along with its efficacy, safety, and pharmacokinetic and pharmacodynamic data obtained from clinical trials, observational studies, and meta-analyses.Evidence review: A positive exposure-efficacy relationship with regard to clinical remission and clinical response was apparent in VDZ induction therapy. No drug-specific safety signals are currently available.Place in therapy: VDZ has been shown to be effective as first- or second-line induction and maintenance therapy in UC.Conclusion: VDZ is a safe and effective treatment option for patients with UC. Prolonged VDZ induction therapy may contribute to improved outcomes in patients with UC, particularly those previously treated with tumor necrosis factor-α. Prospective head-to-head study of VDZ and other biologics would alter the positioning of VDZ much more clearly.","PeriodicalId":10764,"journal":{"name":"Core Evidence","volume":"15 ","pages":"7-20"},"PeriodicalIF":0.0,"publicationDate":"2020-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/CE.S179053","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37826554","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}

引用次数: 10

Apixaban: An Update of the Evidence for Its Place in the Prevention of Stroke in Patients with Atrial Fibrillation. 阿哌沙班:其在房颤患者卒中预防中的最新证据。

Core Evidence Pub Date : 2020-01-21 eCollection Date: 2020-01-01 DOI: 10.2147/CE.S172935

Julia Seeger, Jochen Wöhrle

引用次数: 4

Pertuzumab in the treatment of HER2-positive breast cancer: an evidence-based review of its safety, efficacy, and place in therapy 帕妥珠单抗治疗her2阳性乳腺癌:其安全性、有效性和治疗地位的循证评价

Core Evidence Pub Date : 2019-10-01 DOI: 10.2147/CE.S217848

K. Ishii, Nao Morii, H. Yamashiro

{"title":"Pertuzumab in the treatment of HER2-positive breast cancer: an evidence-based review of its safety, efficacy, and place in therapy","authors":"K. Ishii, Nao Morii, H. Yamashiro","doi":"10.2147/CE.S217848","DOIUrl":"https://doi.org/10.2147/CE.S217848","url":null,"abstract":"Abstract Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is a distinct subset of breast cancer that results from overexpression of HER2 protein. Pertuzumab—a recombinant humanized monoclonal antibody that binds to the extracellular dimerization domain II of HER2—was recently approved for adjuvant therapy and neoadjuvant therapy of HER2-positive early breast cancer. As pertuzumab and trastuzumab bind to different domains of the extracellular dimerization domain of HER2, a combination therapy of pertuzumab and trastuzumab is beneficial for the treatment of metastatic cancer, advanced local cancer, or early cancer by dual HER2 blockage. Many clinical trials have been performed using pertuzumab for breast cancer patients; these include the CLEOPATRA trial for palliative therapy, the APHINITY trial for adjuvant therapy, and the NeoSphere and the TRYPHAENA trials for neoadjuvant therapy. These trials revealed pertuzumab to be a safe and effective drug regardless of the patient age and hormone receptor status. Notably, pertuzumab use was associated with severe cardiac toxicity in some cases; however, the risk of pertuzumab-induced cardiac dysfunction was low. The most common adverse effect associated with pertuzumab-use was diarrhea, but most cases were not severe. Several different chemotherapeutic agents have been investigated to determine optimal chemotherapeutic combinations for dual HER2 blockage. Some exploratory analyses indicate that pertuzumab treatment offered little benefit to patients with node-negative and small primary tumors; pertuzumab treatment was also found not be cost-effective. Further research will reveal the appropriate usage of pertuzumab for treating a subset of eligible patients.","PeriodicalId":10764,"journal":{"name":"Core Evidence","volume":"14 1","pages":"51 - 70"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/CE.S217848","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48578131","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}

引用次数: 34

Anabolics in the management of glucocorticoid-induced osteoporosis: an evidence-based review of long-term safety, efficacy and place in therapy 糖皮质激素所致骨质疏松症的合成代谢管理:长期安全性，有效性和治疗的循证回顾

Core Evidence Pub Date : 2019-08-23 DOI: 10.2147/CE.S172820

A. Taylor, K. Saag

{"title":"Anabolics in the management of glucocorticoid-induced osteoporosis: an evidence-based review of long-term safety, efficacy and place in therapy","authors":"A. Taylor, K. Saag","doi":"10.2147/CE.S172820","DOIUrl":"https://doi.org/10.2147/CE.S172820","url":null,"abstract":"Introduction Glucocorticoid-induced osteoporosis is an underrecognized complication of chronic glucocorticoid therapy characterized by a decrease in new bone formation. Anabolic therapies, such as teriparatide, a recombinant human parathyroid hormone, combat the disease by promoting new bone growth. Aims This article outlines the pathophysiology of glucocorticoid-induced osteoporosis and details the evidence of efficacy, safety, and patterns of use of teriparatide and other future anabolic therapies. Evidence review In multiple clinical trials, teriparatide has been shown to significantly increase lumbar spine bone mineral density (BMD) in patients with glucocorticoid-induced osteoporosis when compared with placebo, alendronate, and risedronate. When compared with alendronate, significantly fewer vertebral fractures were noted in the teriparatide group. Adverse effects noted in clinical trials include nausea, insomnia, flushing, myalgias, and mild hypercalcemia/hyperuricemia. Early studies in rats noted an increased incidence of osteosarcoma; however, an increased rate beyond levels seen in general populations has not been noted in human studies or with long-term pharmacovigilance. Abaloparatide and romosozumab are newer anabolic therapies that have shown some benefit in postmenopausal osteoporosis but have not yet been studied in the chronic glucocorticoid population. Place in therapy Major specialty organizations continue to recommend bisphosphonates as first-line therapy in glucocorticoid-induced osteoporosis due to the proven benefit and relative affordability. However, the use of anabolics shows promise to improve outcomes by increasing BMD and reducing fracture-associated morbidity and mortality and has a role for selected populations at high fracture risk.","PeriodicalId":10764,"journal":{"name":"Core Evidence","volume":"14 1","pages":"41 - 50"},"PeriodicalIF":0.0,"publicationDate":"2019-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/CE.S172820","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45945026","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}

引用次数: 14

Tedizolid phosphate for the treatment of acute bacterial skin and skin-structure infections: an evidence-based review of its place in therapy 磷酸二唑脂治疗急性细菌性皮肤和皮肤结构感染:对其治疗地位的循证回顾

Core Evidence Pub Date : 2019-07-01 DOI: 10.2147/CE.S187499

M. Bassetti, Nadia Castaldo, A. Carnelutti, M. Peghin, D. Giacobbe

{"title":"Tedizolid phosphate for the treatment of acute bacterial skin and skin-structure infections: an evidence-based review of its place in therapy","authors":"M. Bassetti, Nadia Castaldo, A. Carnelutti, M. Peghin, D. Giacobbe","doi":"10.2147/CE.S187499","DOIUrl":"https://doi.org/10.2147/CE.S187499","url":null,"abstract":"Introduction Tedizolid phosphate is an oxazolidinone approved for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) and active against methicillin-resistant Staphylococcus aureus. Aims The objective of this article was to review the evidence for the efficacy and safety of tedizolid phosphate for the treatment of ABSSSI. Evidence review Approval of tedizolid phosphate for the treatment of ABSSSI was based on the results of two phase III randomized controlled trials, ESTABLISH-1 (NCT01170221) and ESTABLISH-2 (NCT01421511), comparing 6-day once-daily tedizolid vs 10-day twice-daily linezolid. In ESTABLISH-1, noninferiority was met with early clinical response rates of 79.5% and 79.4% in tedizolid and linezolid groups, respectively (difference 0.1%, 95% CI –6.1% to 6.2%, with a 10% noninferiority margin). In ESTABLISH-2, noninferiority was met with 85% and 83% rates of early clinical response in tedizolid and linezolid groups, respectively (difference 2.6%, 95% CI –3.0% to 8.2%). Pooled data from ESTABLISH-1 and ESTABLISH-2 indicated a lower frequency of thrombocytopenia in tedizolid-treated than in linezolid-treated patients. Conclusion Tedizolid offers the option of an intravenous to oral switch, allows once-daily administration, and presents lower risk of myelotoxicity when a 6-day course is used for the treatment of ABSSSI. Greater economic cost associated with this antibiotic could be offset by its shorter treatment duration and possibility of oral administration in routine clinical practice, although either sponsored or nonsponsored postmarketing observational experience remains essential for ultimately confirming the effectiveness and tolerability of tedizolid outside clinical trials.","PeriodicalId":10764,"journal":{"name":"Core Evidence","volume":"14 1","pages":"31 - 40"},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/CE.S187499","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46326244","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}

引用次数: 16

Lomitapide: a review of its clinical use, efficacy, and tolerability 洛米他吡的临床应用、疗效和耐受性综述

Core Evidence Pub Date : 2019-07-01 DOI: 10.2147/CE.S174169

R. Alonso, A. Cuevas, P. Mata

引用次数: 32

Enasidenib in the treatment of relapsed/refractory acute myeloid leukemia: an evidence-based review of its place in therapy. Enasidenib治疗复发/难治性急性髓性白血病:基于证据的治疗回顾

Core Evidence Pub Date : 2019-04-26 eCollection Date: 2019-01-01 DOI: 10.2147/CE.S172912

Maria Galkin, Brian A Jonas

{"title":"Enasidenib in the treatment of relapsed/refractory acute myeloid leukemia: an evidence-based review of its place in therapy.","authors":"Maria Galkin, Brian A Jonas","doi":"10.2147/CE.S172912","DOIUrl":"https://doi.org/10.2147/CE.S172912","url":null,"abstract":"Introduction: Acute myeloid leukemia (AML) remains a disease with high mortality, especially for older patients and those with relapsed/refractory (R/R) disease. With recent advances in molecular testing, targeting particular leukemogenic mutations such as those occurring in isocitrate dehydrogenase (IDH) became possible. Enasidenib is a new small-molecule inhibitor of mutant isocitrate dehydrogenase-2 (IDH2). Aim: The objective of this article is to review the evidence for the use of enasidenib in R/R AML, as well as to outline future directions of enasidenib therapy. Evidence Review: Enasidenib was approved in August 2017, after a successful Phase I/II trial showing an overall response rate (ORR) of 40.3% in R/R disease, with 19.3% of patients achieving complete remission (CR). Enrollees in the trial were mostly older adults. The most prominent toxicities were hyperbilirubinemia and IDH-differentiation syndrome (IDH-DS), though the drug was generally well tolerated and the maximum tolerated dose was not reached. A Phase III trial is currently ongoing. Conclusion: Enasidenib provides a new therapeutic option for patients with R/R AML. Further studies are ongoing to ascertain its role in combination with other agents and newly diagnosed disease.","PeriodicalId":10764,"journal":{"name":"Core Evidence","volume":"14 ","pages":"3-17"},"PeriodicalIF":0.0,"publicationDate":"2019-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/CE.S172912","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37264171","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}

引用次数: 18

Erratum: Clinical utility of patiromer, sodium zirconium cyclosilicate, and sodium polystyrene sulfonate for the treatment of hyperkalemia: an evidence-based review [Erratum]. 勘误:帕特罗默、环硅酸锆钠和聚苯乙烯磺酸钠治疗高钾血症的临床应用:一项基于证据的综述[勘误]。

Core Evidence Pub Date : 2019-02-27 eCollection Date: 2019-01-01 DOI: 10.2147/CE.S205026

引用次数: 0