Pub Date : 2024-07-08DOI: 10.1007/s12325-024-02882-1
Patrick Connor Johnson, Abigail Bailey, Qiufei Ma, Neil Milloy, Emilia Biondi, Ruben G. W. Quek, Sarah Weatherby, Sophie Barlow
Introduction
Follicular lymphoma (FL) is an indolent subtype of non-Hodgkin's lymphoma (NHL), characterized by a long natural course of remissions/relapses. We aimed to evaluate real-world quality of life (QoL) in patients with FL, by line of therapy (LOT), and across countries.
Methods
Data were drawn from the Adelphi FL Disease Specific Programme™, a cross-sectional survey of physicians and their patients in Europe [France, Germany, Italy, Spain, the United Kingdom (UK)], and the United States (US) from June 2021 to January 2022. Patients provided demographics and patient-reported outcomes via the European Organisation for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Bivariate analysis assessed QoL versus NHL, across LOT [first line (1L), second line (2L), third line or later (3L+)] and country.
Results
Patients (n = 401) had a mean [standard deviation (SD)] age of 66.0 (9.24) years, 58.1% were male, and 41.9%/22.9% were Ann Arbor stage III/IV. Patients with FL mean EORTC global health status (GHS)/QoL, nausea/vomiting, pain, dyspnea, appetite loss, and diarrhea scores were statistically significantly worse (p < 0.05) versus the NHL reference values. Mean (SD) GHS/QoL worsened from 1L [56.5 (22.21)] to 3L+ [50.4 (20.11)]. Physical and role functioning, fatigue, pain, dyspnea, and diarrhea scores also significantly worsened across later LOTs (p < 0.05). Across all functional domains, mean scores were significantly lower (p < 0.05) and almost all symptom scores (excluding diarrhea) were significantly higher (p < 0.05) for European versus US patients.
Conclusions
Patients with FL at later LOTs had significantly worse scores in most QoL aspects than earlier LOTs. European patients had significantly lower functioning and higher symptom burden than in the US. These real-world findings highlight the need for novel FL therapies that alleviate patient burden, positively impacting QoL.
简介滤泡性淋巴瘤(FL)是非霍奇金淋巴瘤(NHL)的一种隐匿性亚型,其特点是缓解/复发的自然病程较长。我们的目的是评估FL患者在现实世界中的生活质量(QoL),按治疗方案(LOT)和国家进行评估:数据来自阿德尔菲 FL 特定疾病计划(Adelphi FL Disease Specific Programme™),这是一项于 2021 年 6 月至 2022 年 1 月对欧洲(法国、德国、意大利、西班牙、英国)和美国的医生及其患者进行的横断面调查。患者通过欧洲癌症研究和治疗组织 QoL 问卷(EORTC QLQ-C30)提供人口统计数据和患者报告结果。双变量分析评估了QoL与NHL、LOT[一线(1L)、二线(2L)、三线或三线以上(3L+)]和国家的关系:患者(n = 401)的平均[标准差(SD)]年龄为 66.0 (9.24)岁,58.1%为男性,41.9%/22.9%为Ann Arbor III/IV期。FL患者的平均EORTC总体健康状况(GHS)/生活质量(QoL)、恶心/呕吐、疼痛、呼吸困难、食欲不振和腹泻评分在统计学上明显降低(P晚期 LOT 的 FL 患者在大多数 QoL 方面的得分明显低于早期 LOT 患者。与美国相比,欧洲患者的功能明显较低,症状负担较重。这些真实世界的研究结果凸显了对新型 FL 疗法的需求,这种疗法可减轻患者的负担,并对 QoL 产生积极影响。
{"title":"Quality of Life Evaluation in Patients with Follicular Cell Lymphoma: A Real-World Study in Europe and the United States","authors":"Patrick Connor Johnson, Abigail Bailey, Qiufei Ma, Neil Milloy, Emilia Biondi, Ruben G. W. Quek, Sarah Weatherby, Sophie Barlow","doi":"10.1007/s12325-024-02882-1","DOIUrl":"10.1007/s12325-024-02882-1","url":null,"abstract":"<div><h3>Introduction</h3><p>Follicular lymphoma (FL) is an indolent subtype of non-Hodgkin's lymphoma (NHL), characterized by a long natural course of remissions/relapses. We aimed to evaluate real-world quality of life (QoL) in patients with FL, by line of therapy (LOT), and across countries.</p><h3>Methods</h3><p>Data were drawn from the Adelphi FL Disease Specific Programme™, a cross-sectional survey of physicians and their patients in Europe [France, Germany, Italy, Spain, the United Kingdom (UK)], and the United States (US) from June 2021 to January 2022. Patients provided demographics and patient-reported outcomes via the European Organisation for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Bivariate analysis assessed QoL versus NHL, across LOT [first line (1L), second line (2L), third line or later (3L+)] and country.</p><h3>Results</h3><p>Patients (<i>n</i> = 401) had a mean [standard deviation (SD)] age of 66.0 (9.24) years, 58.1% were male, and 41.9%/22.9% were Ann Arbor stage III/IV. Patients with FL mean EORTC global health status (GHS)/QoL, nausea/vomiting, pain, dyspnea, appetite loss, and diarrhea scores were statistically significantly worse (<i>p</i> < 0.05) versus the NHL reference values. Mean (SD) GHS/QoL worsened from 1L [56.5 (22.21)] to 3L+ [50.4 (20.11)]. Physical and role functioning, fatigue, pain, dyspnea, and diarrhea scores also significantly worsened across later LOTs (<i>p</i> < 0.05). Across all functional domains, mean scores were significantly lower (<i>p</i> < 0.05) and almost all symptom scores (excluding diarrhea) were significantly higher (<i>p</i> < 0.05) for European versus US patients.</p><h3>Conclusions</h3><p>Patients with FL at later LOTs had significantly worse scores in most QoL aspects than earlier LOTs. European patients had significantly lower functioning and higher symptom burden than in the US. These real-world findings highlight the need for novel FL therapies that alleviate patient burden, positively impacting QoL.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263223/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141553942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-08DOI: 10.1007/s12325-024-02937-3
Yujin Lee, Dominik Zalewski, Piotr Oleksy, Edward Wylęgała, Michał Orski, Jiwon Lee, Sunji Kim
Introduction
SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis®; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO).
Methods
This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product.
Results
A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study.
Conclusions
This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease.
Trial Registration
ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.
{"title":"Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases","authors":"Yujin Lee, Dominik Zalewski, Piotr Oleksy, Edward Wylęgała, Michał Orski, Jiwon Lee, Sunji Kim","doi":"10.1007/s12325-024-02937-3","DOIUrl":"10.1007/s12325-024-02937-3","url":null,"abstract":"<div><h3>Introduction</h3><p>SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis<sup>®</sup>; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO).</p><h3>Methods</h3><p>This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product.</p><h3>Results</h3><p>A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study.</p><h3>Conclusions</h3><p>This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141553944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-08DOI: 10.1007/s12325-024-02935-5
Katalin Pungor, Jennifer Lee, Tom Denee, Yerkebulan Kambarov, Riikka Nissinen, Kevin Ampeh, Marco Pellegrini, Francesco Parmeggiani
Introduction
X-linked retinitis pigmentosa (XLRP) is a rare, incurable, vision-threatening, genetic disease. In this study, we aimed to reveal the real-world burden of this disease from the viewpoint of retina specialists and geneticists involved directly in XLRP care and to identify unique insights that may not otherwise be available through typical clinical studies or health economic research.
Methods
In this exploratory, cross-sectional study (EXPLORE XLRP-1), retina specialists (n = 20) and geneticists (n = 5) in France, Germany, Italy, Spain, and the UK provided anonymized insights on their experiences managing patients with XLRP (n = 80) via an online survey and 60-min telephone interview.
Results
Survey respondents reported that patient independence decreased over time, where 37% of patients were considered “completely autonomous” at diagnosis versus 23% at the last consultation. At their last visit, 45% of patients were active in the workforce; 67% (12/18) of “completely autonomous” patients had active working status compared with 13% (1/8) of “completely dependent” patients. The average time from onset of symptoms to diagnosis was 4 years and varied among countries. In 78% of patients, XLRP was confirmed by genetic testing, the rate of which varied among countries (range, 50–94%), taking up to 6 months to receive results. Specialists identified unmet needs in XLRP management including more standardized assessments of quality of life (QoL) as well as easier and earlier access to specialists, genetic testing, patient support programs, and effective treatment options.
Conclusions
The diagnosis, genetic testing, and management pathways among patients with XLRP can vary considerably. There is a need for more standardized diagnosis and management pathways, and QoL assessments, due to the major impact that XLRP has on patients’ lives.
{"title":"Impacts of X-linked Retinitis Pigmentosa and Patient Pathways in European Countries: Results from the Cross-sectional EXPLORE XLRP-1 Physician Survey","authors":"Katalin Pungor, Jennifer Lee, Tom Denee, Yerkebulan Kambarov, Riikka Nissinen, Kevin Ampeh, Marco Pellegrini, Francesco Parmeggiani","doi":"10.1007/s12325-024-02935-5","DOIUrl":"10.1007/s12325-024-02935-5","url":null,"abstract":"<div><h3>Introduction</h3><p>X-linked retinitis pigmentosa (XLRP) is a rare, incurable, vision-threatening, genetic disease. In this study, we aimed to reveal the real-world burden of this disease from the viewpoint of retina specialists and geneticists involved directly in XLRP care and to identify unique insights that may not otherwise be available through typical clinical studies or health economic research.</p><h3>Methods</h3><p>In this exploratory, cross-sectional study (EXPLORE XLRP-1), retina specialists (<i>n</i> = 20) and geneticists (<i>n</i> = 5) in France, Germany, Italy, Spain, and the UK provided anonymized insights on their experiences managing patients with XLRP (<i>n</i> = 80) via an online survey and 60-min telephone interview.</p><h3>Results</h3><p>Survey respondents reported that patient independence decreased over time, where 37% of patients were considered “completely autonomous” at diagnosis versus 23% at the last consultation. At their last visit, 45% of patients were active in the workforce; 67% (12/18) of “completely autonomous” patients had active working status compared with 13% (1/8) of “completely dependent” patients. The average time from onset of symptoms to diagnosis was 4 years and varied among countries. In 78% of patients, XLRP was confirmed by genetic testing, the rate of which varied among countries (range, 50–94%), taking up to 6 months to receive results. Specialists identified unmet needs in XLRP management including more standardized assessments of quality of life (QoL) as well as easier and earlier access to specialists, genetic testing, patient support programs, and effective treatment options.</p><h3>Conclusions</h3><p>The diagnosis, genetic testing, and management pathways among patients with XLRP can vary considerably. There is a need for more standardized diagnosis and management pathways, and QoL assessments, due to the major impact that XLRP has on patients’ lives.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141553983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-04DOI: 10.1007/s12325-024-02926-6
Mona Darwish, Obinna N. Obianom, James M. Youakim, Inger Darling, Viera Lukacova, Heather Bradley
Introduction
Trofinetide is the first drug to be approved for the treatment of Rett syndrome. Hepatic impairment is not expected to affect the pharmacokinetic (PK) profile of trofinetide because of predominant renal excretion. This study was conducted to help understand the potential impact of any hepatic impairment on trofinetide PK.
Methods
This study used physiologically based PK modeling to estimate trofinetide exposure (maximum drug concentration and area under the concentration-time curve from time zero to infinity) in virtual patients with mild, moderate, and severe hepatic impairment (per Child-Pugh classification) compared with virtual healthy subjects following a 12 g oral trofinetide dose.
Results
In individual deterministic simulations for matched individuals and stochastic simulations at the population level (100 virtual individuals simulated per population), as anticipated, predicted plasma exposures were similar for healthy subjects and for patients with mild, moderate, and severe hepatic impairment. However, predicted blood concentration exposures slightly increased with increasing severity of hepatic impairment because of change in hematocrit levels.
Conclusion
This study indicates that hepatic impairment is not expected to have a clinically relevant effect on exposure to trofinetide.
{"title":"Effect of Hepatic Impairment on Trofinetide Exposures Using an In Silico Physiologically Based Pharmacokinetic Model","authors":"Mona Darwish, Obinna N. Obianom, James M. Youakim, Inger Darling, Viera Lukacova, Heather Bradley","doi":"10.1007/s12325-024-02926-6","DOIUrl":"10.1007/s12325-024-02926-6","url":null,"abstract":"<div><h3>Introduction</h3><p>Trofinetide is the first drug to be approved for the treatment of Rett syndrome. Hepatic impairment is not expected to affect the pharmacokinetic (PK) profile of trofinetide because of predominant renal excretion. This study was conducted to help understand the potential impact of any hepatic impairment on trofinetide PK.</p><h3>Methods</h3><p>This study used physiologically based PK modeling to estimate trofinetide exposure (maximum drug concentration and area under the concentration-time curve from time zero to infinity) in virtual patients with mild, moderate, and severe hepatic impairment (per Child-Pugh classification) compared with virtual healthy subjects following a 12 g oral trofinetide dose.</p><h3>Results</h3><p>In individual deterministic simulations for matched individuals and stochastic simulations at the population level (100 virtual individuals simulated per population), as anticipated, predicted plasma exposures were similar for healthy subjects and for patients with mild, moderate, and severe hepatic impairment. However, predicted blood concentration exposures slightly increased with increasing severity of hepatic impairment because of change in hematocrit levels.</p><h3>Conclusion</h3><p>This study indicates that hepatic impairment is not expected to have a clinically relevant effect on exposure to trofinetide.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263405/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141496766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-04DOI: 10.1007/s12325-024-02916-8
Leopoldo Perez de Isla, Evangelos Liberopoulos, Melania Dovizio, Chiara Veronesi, Luca Degli Esposti, Alberto Zambon
Introduction
Adherence to cardiovascular drug treatment can significantly benefit from a reduced pill burden, but data on this matter derived from real-life settings are currently scanty. This analysis assessed the possible changes in adherence in patients treated with rosuvastatin and ezetimibe (ROS/EZE) as free multi-pill combination who switched to ROS/EZE as single-pill combination in the setting of real clinical practice in Italy.
Methods
A retrospective analysis was conducted on the administrative databases for a catchment area of about seven million health-assisted residents. Adults receiving ROS/EZE as a single-pill combination from January 2010 to June 2020 (followed up to 2021) were identified. The date of the first prescription of single-pill combination of ROS/EZE was considered as the index date. The analysis included the users of ROS/EZE as a free combination during the year before the index date. Baseline demographic and clinical characteristics were collected during the period of data availability prior to the index date. Adherence to therapy was evaluated as proportion of days covered (PDC), namely the percentage of days during which a patient had access to medication, in the 12-month interval preceding or following the index date (PDC < 25% non-adherence; PDC = 25–75% partial adherence; PDC > 75% adherence).
Results
A total of 1219 patients (61.1% male, aged 66.2 ± 10.4 years) were included. Cardiovascular comorbidities were found in 83.3% of them, diabetes in 26.4%, and a combination of both in 16.2%. Single-pill combination of ROS/EZE was associated with a higher proportion of adherent patients compared to free-pill combination (75.2% vs 51.8%, p < 0.001).
Conclusions
This real-world analysis suggested that switching from a regimen based on separate pills to one based on a single-pill combination resulted in improved adherence to ROS/EZE therapy.
{"title":"Differential Adherence to Free and Single-Pill Combination of Rosuvastatin/Ezetimibe: Findings from a Real-World Analysis in Italy","authors":"Leopoldo Perez de Isla, Evangelos Liberopoulos, Melania Dovizio, Chiara Veronesi, Luca Degli Esposti, Alberto Zambon","doi":"10.1007/s12325-024-02916-8","DOIUrl":"10.1007/s12325-024-02916-8","url":null,"abstract":"<div><h3>Introduction</h3><p>Adherence to cardiovascular drug treatment can significantly benefit from a reduced pill burden, but data on this matter derived from real-life settings are currently scanty. This analysis assessed the possible changes in adherence in patients treated with rosuvastatin and ezetimibe (ROS/EZE) as free multi-pill combination who switched to ROS/EZE as single-pill combination in the setting of real clinical practice in Italy.</p><h3>Methods</h3><p>A retrospective analysis was conducted on the administrative databases for a catchment area of about seven million health-assisted residents. Adults receiving ROS/EZE as a single-pill combination from January 2010 to June 2020 (followed up to 2021) were identified. The date of the first prescription of single-pill combination of ROS/EZE was considered as the index date. The analysis included the users of ROS/EZE as a free combination during the year before the index date. Baseline demographic and clinical characteristics were collected during the period of data availability prior to the index date. Adherence to therapy was evaluated as proportion of days covered (PDC), namely the percentage of days during which a patient had access to medication, in the 12-month interval preceding or following the index date (PDC < 25% non-adherence; PDC = 25–75% partial adherence; PDC > 75% adherence).</p><h3>Results</h3><p>A total of 1219 patients (61.1% male, aged 66.2 ± 10.4 years) were included. Cardiovascular comorbidities were found in 83.3% of them, diabetes in 26.4%, and a combination of both in 16.2%. Single-pill combination of ROS/EZE was associated with a higher proportion of adherent patients compared to free-pill combination (75.2% vs 51.8%, <i>p</i> < 0.001).</p><h3>Conclusions</h3><p>This real-world analysis suggested that switching from a regimen based on separate pills to one based on a single-pill combination resulted in improved adherence to ROS/EZE therapy.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263226/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141496765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-03DOI: 10.1007/s12325-024-02913-x
Hiddo Heerspink, Stephen Nolan, Juan-Jesus Carrero, Matthew Arnold, Roberto Pecoits-Filho, Juan José García Sánchez, Eric Wittbrodt, Claudia Cabrera, Carolyn S. P. Lam, Hungta Chen, Eiichiro Kanda, Mitja Lainscak, Carol Pollock, David C. Wheeler
Introduction
This analysis examined the baseline characteristics and clinical outcomes of patients with chronic kidney disease (CKD) and rapid or non-rapid estimated glomerular filtration rate (eGFR) decline, using retrospective data from DISCOVER CKD (ClinicalTrials.gov, NCT04034992).
Methods
Data (2008–2020) were extracted from UK Clinical Practice Research Datalink, US TriNetX, US Limited Claims and Electronic Health Record Dataset, and Japan Medical Data Vision. Patients with CKD (two consecutive eGFR measures < 75 mL/min/1.73 m2 recorded 90–730 days apart) were included. Rapid eGFR decline was defined as an annual decline of > 4 mL/min/1.73 m2 at 2 years post-index; non-rapid eGFR decline was defined as an annual decline of ≤ 4 mL/min/1.73 m2. Clinical outcomes assessed included all-cause mortality, kidney outcomes (composite risk of kidney failure [progression to CKD stage 5] or > 50% eGFR decline, and kidney failure alone), cardiovascular events—including major adverse cardiovascular events (MACE; non-fatal myocardial infarction/stroke and cardiovascular death)—and all-cause hospitalization.
Results
Across databases, rapid eGFR decline occurred in 13.7% of 804,237 eligible patients. Mean annual eGFR decline ranged between − 6.21 and − 6.86 mL/min/1.73 m2 in patients with rapid eGFR decline versus between − 0.11 and − 0.77 mL/min/1.73 m2 in patients with non-rapid eGFR decline. Rapid eGFR decline was associated with increased comorbidity burden and medication prescriptions. Across databases, the composite risk of kidney failure or > 50% decline in eGFR was significantly greater in patients with rapid versus non-rapid eGFR decline (P < 0.01); all-cause mortality, kidney failure alone, MACE, and all-cause hospitalization each significantly increased in two databases (P < 0.01–0.05).
Conclusion
Understanding patient factors associated with rapid eGFR decline in patients with CKD may help identify individuals who would benefit from proactive management to minimize the risk of adverse outcomes.
Trial Registration
ClinicalTrials.gov identifier, NCT04034992.
简介这项分析利用DISCOVER CKD(ClinicalTrials.gov,NCT04034992)的回顾性数据,研究了慢性肾脏病(CKD)患者的基线特征和临床结局,以及快速或非快速估计肾小球滤过率(eGFR)下降的情况:从英国临床实践研究数据链(UK Clinical Practice Research Datalink)、美国 TriNetX、美国有限索赔和电子健康记录数据集(US Limited Claims and Electronic Health Record Dataset)以及日本医疗数据视野(Japan Medical Data Vision)中提取数据(2008-2020 年)。纳入的患者均为慢性肾脏病患者(两次连续的 eGFR 测量结果相隔 90-730 天)。eGFR快速下降的定义是指数发布后2年的年下降率> 4 mL/min/1.73 m2;eGFR非快速下降的定义是年下降率≤ 4 mL/min/1.73 m2。评估的临床结果包括全因死亡率、肾脏结果(肾衰竭[进展到CKD 5期]或eGFR下降>50%和单纯肾衰竭的复合风险)、心血管事件(包括主要不良心血管事件(MACE;非致死性心肌梗死/脑卒中和心血管死亡))和全因住院:在所有数据库中,804 237 名符合条件的患者中有 13.7% 出现了 eGFR 快速下降。eGFR快速下降患者的年平均eGFR下降幅度在-6.21至-6.86 mL/min/1.73 m2之间,而eGFR非快速下降患者的年平均eGFR下降幅度在-0.11至-0.77 mL/min/1.73 m2之间。eGFR 快速下降与合并症负担和药物处方增加有关。在所有数据库中,eGFR 快速下降的患者发生肾衰竭或 eGFR 下降>50% 的复合风险明显高于 eGFR 非快速下降的患者(P 结论:eGFR 快速下降的患者发生肾衰竭或 eGFR 下降>50% 的复合风险明显高于 eGFR 非快速下降的患者:了解与慢性肾功能衰竭患者 eGFR 快速下降相关的患者因素,有助于确定哪些患者可从积极的管理中获益,从而将不良后果的风险降至最低:试验注册:ClinicalTrials.gov标识符,NCT04034992。
{"title":"Clinical Outcomes in Patients with CKD and Rapid or Non-rapid eGFR Decline: A Report from the DISCOVER CKD Retrospective Cohort","authors":"Hiddo Heerspink, Stephen Nolan, Juan-Jesus Carrero, Matthew Arnold, Roberto Pecoits-Filho, Juan José García Sánchez, Eric Wittbrodt, Claudia Cabrera, Carolyn S. P. Lam, Hungta Chen, Eiichiro Kanda, Mitja Lainscak, Carol Pollock, David C. Wheeler","doi":"10.1007/s12325-024-02913-x","DOIUrl":"10.1007/s12325-024-02913-x","url":null,"abstract":"<div><h3>Introduction</h3><p>This analysis examined the baseline characteristics and clinical outcomes of patients with chronic kidney disease (CKD) and rapid or non-rapid estimated glomerular filtration rate (eGFR) decline, using retrospective data from DISCOVER CKD (ClinicalTrials.gov, NCT04034992).</p><h3>Methods</h3><p>Data (2008–2020) were extracted from UK Clinical Practice Research Datalink, US TriNetX, US Limited Claims and Electronic Health Record Dataset, and Japan Medical Data Vision. Patients with CKD (two consecutive eGFR measures < 75 mL/min/1.73 m<sup>2</sup> recorded 90–730 days apart) were included. Rapid eGFR decline was defined as an annual decline of > 4 mL/min/1.73 m<sup>2</sup> at 2 years post-index; non-rapid eGFR decline was defined as an annual decline of ≤ 4 mL/min/1.73 m<sup>2</sup>. Clinical outcomes assessed included all-cause mortality, kidney outcomes (composite risk of kidney failure [progression to CKD stage 5] or > 50% eGFR decline, and kidney failure alone), cardiovascular events—including major adverse cardiovascular events (MACE; non-fatal myocardial infarction/stroke and cardiovascular death)—and all-cause hospitalization.</p><h3>Results</h3><p>Across databases, rapid eGFR decline occurred in 13.7% of 804,237 eligible patients. Mean annual eGFR decline ranged between − 6.21 and − 6.86 mL/min/1.73 m<sup>2</sup> in patients with rapid eGFR decline versus between − 0.11 and − 0.77 mL/min/1.73 m<sup>2</sup> in patients with non-rapid eGFR decline. Rapid eGFR decline was associated with increased comorbidity burden and medication prescriptions. Across databases, the composite risk of kidney failure or > 50% decline in eGFR was significantly greater in patients with rapid versus non-rapid eGFR decline (<i>P</i> < 0.01); all-cause mortality, kidney failure alone, MACE, and all-cause hospitalization each significantly increased in two databases (<i>P</i> < 0.01–0.05).</p><h3>Conclusion</h3><p>Understanding patient factors associated with rapid eGFR decline in patients with CKD may help identify individuals who would benefit from proactive management to minimize the risk of adverse outcomes.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov identifier, NCT04034992.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263227/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141490524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-03DOI: 10.1007/s12325-024-02919-5
Raymond C. Chang, Ryan L. Miller, Katherine W. Kwon, Joanna C. Huang
Introduction
Cardiovascular-kidney-metabolic (CKM) syndrome is highly prevalent in the US Medicare population and is projected to increase further. Sodium-glucose co-transporter 2 inhibitors have indications in chronic kidney disease (CKD), heart failure (HF), and type 2 diabetes (T2D), providing protective efficacy across conditions within CKM syndrome. The objective of this study was to develop a model to extrapolate key outcomes observed in pivotal clinical trials to the US Medicare population, and to assess the potential direct cost offsets associated with dapagliflozin therapy.
Methods
All US 2022 Medicare beneficiaries (≥ 65 years of age) eligible to receive dapagliflozin were estimated according to drug label indication and Medicare enrollment and claims data. Incidence of key outcomes from the dapagliflozin clinical program were modelled over a 4-year time horizon based on patient-level data with CKD, HF, and T2D. Published cost data of relevant clinical outcomes were used to calculate direct medical care cost-offset associated with treatment with dapagliflozin.
Results
In a population of 13.1 million patients with CKM syndrome, treatment with dapagliflozin in addition to historical standard of care (hSoC) versus hSoC alone led to fewer incidents of HF-related events (hospitalization for HF, 613,545; urgent HF visit, 98,896), renal events (kidney failure, 285,041; ≥ 50% sustained decline in kidney function, 375,137), and 450,355 fewer deaths (of which 225,346 and 13,206 incidences of cardiovascular and renal death were avoided). In total this led to medical care cost offsets of $99.3 billion versus treatment with hSoC only (dapagliflozin plus hSoC, $310.3 billion; hSoC, $211.0 billion).
Conclusion
By extrapolating data from trials across multiple indications within CKM syndrome, this broader perspective shows that considerable medical care cost offsets may result through attenuated incidence of clinical events in CKD, T2D, and HF populations if treated with dapagliflozin in addition to hSoC over a 4-year time horizon.
{"title":"Cost Offset of Dapagliflozin in the US Medicare Population with Cardio-Kidney Metabolic Syndrome","authors":"Raymond C. Chang, Ryan L. Miller, Katherine W. Kwon, Joanna C. Huang","doi":"10.1007/s12325-024-02919-5","DOIUrl":"10.1007/s12325-024-02919-5","url":null,"abstract":"<div><h3>Introduction</h3><p>Cardiovascular-kidney-metabolic (CKM) syndrome is highly prevalent in the US Medicare population and is projected to increase further. Sodium-glucose co-transporter 2 inhibitors have indications in chronic kidney disease (CKD), heart failure (HF), and type 2 diabetes (T2D), providing protective efficacy across conditions within CKM syndrome. The objective of this study was to develop a model to extrapolate key outcomes observed in pivotal clinical trials to the US Medicare population, and to assess the potential direct cost offsets associated with dapagliflozin therapy.</p><h3>Methods</h3><p>All US 2022 Medicare beneficiaries (≥ 65 years of age) eligible to receive dapagliflozin were estimated according to drug label indication and Medicare enrollment and claims data. Incidence of key outcomes from the dapagliflozin clinical program were modelled over a 4-year time horizon based on patient-level data with CKD, HF, and T2D. Published cost data of relevant clinical outcomes were used to calculate direct medical care cost-offset associated with treatment with dapagliflozin.</p><h3>Results</h3><p>In a population of 13.1 million patients with CKM syndrome, treatment with dapagliflozin in addition to historical standard of care (hSoC) versus hSoC alone led to fewer incidents of HF-related events (hospitalization for HF, 613,545; urgent HF visit, 98,896), renal events (kidney failure, 285,041; ≥ 50% sustained decline in kidney function, 375,137), and 450,355 fewer deaths (of which 225,346 and 13,206 incidences of cardiovascular and renal death were avoided). In total this led to medical care cost offsets of $99.3 billion versus treatment with hSoC only (dapagliflozin plus hSoC, $310.3 billion; hSoC, $211.0 billion).</p><h3>Conclusion</h3><p>By extrapolating data from trials across multiple indications within CKM syndrome, this broader perspective shows that considerable medical care cost offsets may result through attenuated incidence of clinical events in CKD, T2D, and HF populations if treated with dapagliflozin in addition to hSoC over a 4-year time horizon.</p><p>Graphical abstract available for this article.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263419/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141490525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-03DOI: 10.1007/s12325-024-02936-4
Jyoti Patel, Jie Meng, Hoa Le, Yoko Tanaka, Sudarshan Phani, Maribel Salas, Chuntao Wu, David Sternberg, Stephen Esker, Jeffrey P. Anderson, Aaron Crowley, Summera Q. Zhou, Camryn Lieb, Haiyan Sun, Quan V. Doan, Anu Santhanagopal, Karen L. Reckamp
Introduction
For patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced/metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after osimertinib and platinum-based chemotherapy (PBC), no uniformly accepted standard of care exists. Moreover, limited efficacy of standard treatments indicates an unmet medical need, which is being addressed by ongoing clinical investigations, including the HERTHENA-Lung01 (NCT04619004) study of patritumab deruxtecan (HER3‑DXd). However, because limited information is available on real-world clinical outcomes in such patients, early-phase trials of investigational therapies lack sufficient context for comparison. This study describes the real-world clinical characteristics, treatments, and outcomes for patients with EGFRm mNSCLC who initiated a new line of therapy following previous osimertinib and PBC, including a subset matched to the HERTHENA-Lung01 population.
Methods
This retrospective analysis used a US database derived from deidentified electronic health records. The reference cohort included patients with EGFRm mNSCLC who had initiated a new line of therapy between November 13, 2015 and June 30, 2021, following prior osimertinib and PBC. A subset of patients resembling the HERTHENA-Lung01 population was then extracted from the reference cohort; this matched subset was optimized using propensity score (PS) weighting. Endpoints were real-world overall survival (rwOS) and real-world progression-free survival (rwPFS). Confirmed real-world objective response rate (rwORR; partial/complete response confirmed ≥ 28 days later) was calculated for the response-evaluable subgroups of patients (with ≥ 2 response assessments spaced ≥ 28 days apart).
Results
In the reference cohort (N = 273), multiple treatment regimens were used, and none was predominant. Median rwPFS and rwOS were 3.3 and 8.6 months, respectively; confirmed rwORR (response evaluable, n = 123) was 13.0%. In the matched subset (n = 126), after PS weighting, median rwPFS and rwOS were 4.2 and 9.1 months, respectively; confirmed rwORR (response evaluable, n = 57) was 14.1%.
Conclusion
The treatment landscape for this heavily pretreated population of patients with EGFRm mNSCLC is fragmented, with no uniformly accepted standard of care. A high unmet need exists for therapeutic options that provide meaningful improvements in clinical benefit.
{"title":"Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic or Unresectable EGFR-Mutated Non-Small Cell Lung Cancer Previously Treated with Osimertinib and Platinum-Based Chemotherapy","authors":"Jyoti Patel, Jie Meng, Hoa Le, Yoko Tanaka, Sudarshan Phani, Maribel Salas, Chuntao Wu, David Sternberg, Stephen Esker, Jeffrey P. Anderson, Aaron Crowley, Summera Q. Zhou, Camryn Lieb, Haiyan Sun, Quan V. Doan, Anu Santhanagopal, Karen L. Reckamp","doi":"10.1007/s12325-024-02936-4","DOIUrl":"10.1007/s12325-024-02936-4","url":null,"abstract":"<div><h3>Introduction</h3><p>For patients with epidermal growth factor receptor-mutated (<i>EGFR</i>m) locally advanced/metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after osimertinib and platinum-based chemotherapy (PBC), no uniformly accepted standard of care exists. Moreover, limited efficacy of standard treatments indicates an unmet medical need, which is being addressed by ongoing clinical investigations, including the HERTHENA-Lung01 (NCT04619004) study of patritumab deruxtecan (HER3‑DXd). However, because limited information is available on real-world clinical outcomes in such patients, early-phase trials of investigational therapies lack sufficient context for comparison. This study describes the real-world clinical characteristics, treatments, and outcomes for patients with <i>EGFR</i>m mNSCLC who initiated a new line of therapy following previous osimertinib and PBC, including a subset matched to the HERTHENA-Lung01 population.</p><h3>Methods</h3><p>This retrospective analysis used a US database derived from deidentified electronic health records. The reference cohort included patients with <i>EGFR</i>m mNSCLC who had initiated a new line of therapy between November 13, 2015 and June 30, 2021, following prior osimertinib and PBC. A subset of patients resembling the HERTHENA-Lung01 population was then extracted from the reference cohort; this matched subset was optimized using propensity score (PS) weighting. Endpoints were real-world overall survival (rwOS) and real-world progression-free survival (rwPFS). Confirmed real-world objective response rate (rwORR; partial/complete response confirmed ≥ 28 days later) was calculated for the response-evaluable subgroups of patients (with ≥ 2 response assessments spaced ≥ 28 days apart).</p><h3>Results</h3><p>In the reference cohort (<i>N</i> = 273), multiple treatment regimens were used, and none was predominant. Median rwPFS and rwOS were 3.3 and 8.6 months, respectively; confirmed rwORR (response evaluable,<i> n</i> = 123) was 13.0%. In the matched subset (<i>n</i> = 126), after PS weighting, median rwPFS and rwOS were 4.2 and 9.1 months, respectively; confirmed rwORR (response evaluable, <i>n</i> = 57) was 14.1%.</p><h3>Conclusion</h3><p>The treatment landscape for this heavily pretreated population of patients with <i>EGFR</i>m mNSCLC is fragmented, with no uniformly accepted standard of care. A high unmet need exists for therapeutic options that provide meaningful improvements in clinical benefit.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263477/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141490529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-03DOI: 10.1007/s12325-024-02915-9
Joel Iff, Chloe Carmichael, Stephanie McKee, Ihor Sehinovych, Carolyn McNeill, Carolina Tesi-Rocha, Erik Henricson, Francesco Muntoni, Helen Kitchen
Introduction
Duchenne muscular dystrophy (DMD) is characterized by rapid functional decline. Current available treatment options aim to delay disease progression or stabilize physical function. To aid in healthcare providers’ understanding of the symptoms of disease that impact patients’ experience, this study explored children’s physical functioning, activities of daily living (ADLs), and health-related quality of life (HRQoL) after receiving eteplirsen, a weekly infusion indicated for individuals with DMD with exon 51 skip-amenable mutations.
Methods
Fifteen caregivers of male individuals with DMD participated in a 60-min, semi-structured interview. Open-ended questioning explored changes in the children’s condition or maintenance in abilities since eteplirsen initiation.
Results
Children with DMD (age 7–15 years [mean 10.9]; steroid treatment at interview, n = 8; time since eteplirsen initiation 3–24 months [mean 14.9]) were described by caregivers as ambulatory (n = 9) and non-ambulatory (n = 6). Caregivers of ambulatory children reported improvements or maintenance of walking ability (n = 7/9), running (n = 6/9), and using stairs (n = 4/9). Continued decline in using stairs was reported by two caregivers. In upper-limb functioning, improvements or maintenances in fine-motor movements were reported by nearly half of all caregivers (n = 7/15), with one caregiver noting a continued decline. Subsequent improvements or maintenances in ADLs were described. Improvements or maintenances in fatigue (n = 9/15), muscle weakness (n = 7/15), and pain (n = 6/15) were reported, although some caregivers described a continued decline (n = 3/15 fatigue, n = 1/15 muscle weakness, n = 2/15 pain). Importantly, most caregivers who reported maintenances in ability perceived this as a positive outcome (n = 6/9).
Conclusion
This exploratory study indicated that most caregivers perceived improvements or maintenances in aspects of their child’s physical functioning, ADLs, and HRQoL since eteplirsen initiation, which they perceived to be a positive outcome.
{"title":"Eteplirsen Treatment for Duchenne Muscular Dystrophy: A Qualitative Patient Experience Study","authors":"Joel Iff, Chloe Carmichael, Stephanie McKee, Ihor Sehinovych, Carolyn McNeill, Carolina Tesi-Rocha, Erik Henricson, Francesco Muntoni, Helen Kitchen","doi":"10.1007/s12325-024-02915-9","DOIUrl":"10.1007/s12325-024-02915-9","url":null,"abstract":"<div><h3>Introduction</h3><p>Duchenne muscular dystrophy (DMD) is characterized by rapid functional decline. Current available treatment options aim to delay disease progression or stabilize physical function. To aid in healthcare providers’ understanding of the symptoms of disease that impact patients’ experience, this study explored children’s physical functioning, activities of daily living (ADLs), and health-related quality of life (HRQoL) after receiving eteplirsen, a weekly infusion indicated for individuals with DMD with exon 51 skip-amenable mutations.</p><h3>Methods</h3><p>Fifteen caregivers of male individuals with DMD participated in a 60-min, semi-structured interview. Open-ended questioning explored changes in the children’s condition or maintenance in abilities since eteplirsen initiation.</p><h3>Results</h3><p>Children with DMD (age 7–15 years [mean 10.9]; steroid treatment at interview, <i>n</i> = 8; time since eteplirsen initiation 3–24 months [mean 14.9]) were described by caregivers as ambulatory (<i>n</i> = 9) and non-ambulatory (<i>n</i> = 6). Caregivers of ambulatory children reported improvements or maintenance of walking ability (<i>n</i> = 7/9), running (<i>n</i> = 6/9), and using stairs (<i>n</i> = 4/9). Continued decline in using stairs was reported by two caregivers. In upper-limb functioning, improvements or maintenances in fine-motor movements were reported by nearly half of all caregivers (<i>n</i> = 7/15), with one caregiver noting a continued decline. Subsequent improvements or maintenances in ADLs were described. Improvements or maintenances in fatigue (<i>n</i> = 9/15), muscle weakness (<i>n</i> = 7/15), and pain (<i>n</i> = 6/15) were reported, although some caregivers described a continued decline (<i>n</i> = 3/15 fatigue, <i>n</i> = 1/15 muscle weakness, <i>n</i> = 2/15 pain). Importantly, most caregivers who reported maintenances in ability perceived this as a positive outcome (<i>n</i> = 6/9).</p><h3>Conclusion</h3><p>This exploratory study indicated that most caregivers perceived improvements or maintenances in aspects of their child’s physical functioning, ADLs, and HRQoL since eteplirsen initiation, which they perceived to be a positive outcome.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263411/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141490526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-03DOI: 10.1007/s12325-024-02934-6
Sergio Gianesini
{"title":"A Response to: Letter to the Editor Regarding “Cardiovascular Insights for the Appropriate Management of Chronic Venous Disease: A Narrative Review of Implications for the Use of Venoactive Drugs”","authors":"Sergio Gianesini","doi":"10.1007/s12325-024-02934-6","DOIUrl":"10.1007/s12325-024-02934-6","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263230/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141490523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}