1.Mechanical Circulatory Support in the Cardiac Catheterization Laboratory for Cardiogenic Shock
Matt RYAN ; Natalia BRICENO ; Divaka PERERA
Korean Circulation Journal 2019;49(3):197-213
Despite the development of acute revascularisation, the mortality rate for cardiogenic shock remains around 50%. Mechanical circulatory support devices have long held promise in improving outcomes in shock, but high-quality evidence of benefit has not been forthcoming. In this article we review the currently available devices for treating shock, their physiological effects and the evidence base for their use in practice. We subsequently look ahead within this developing field, including new devices and novel indications for established technology.
Cardiac Catheterization
;
Cardiac Catheters
;
Extracorporeal Membrane Oxygenation
;
Mortality
;
Myocardial Infarction
;
Shock
;
Shock, Cardiogenic
2.Mechanical Circulatory Support in the Cardiac Catheterization Laboratory for Cardiogenic Shock
Matt RYAN ; Natalia BRICENO ; Divaka PERERA
Korean Circulation Journal 2019;49(3):197-213
Despite the development of acute revascularisation, the mortality rate for cardiogenic shock remains around 50%. Mechanical circulatory support devices have long held promise in improving outcomes in shock, but high-quality evidence of benefit has not been forthcoming. In this article we review the currently available devices for treating shock, their physiological effects and the evidence base for their use in practice. We subsequently look ahead within this developing field, including new devices and novel indications for established technology.
3.Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Abiraterone Clinical Trials
Matthew RASHID ; Eli OLDHAM ; Griffin K. HUGHES ; Andriana M. PEÑA ; Chase LADD ; Brooke GARDNER ; Ryan MCINTIRE ; Bradley JOHNSON ; Jordan TUIA ; Alyson HASLAM ; Vinay PRASAD ; Matt VASSAR
Journal of Urologic Oncology 2024;22(3):211-223
Purpose:
Our study aimed to evaluate the risk and benefit profiles of clinical trials using abiraterone in cancer treatment.
Materials and Methods:
A comprehensive search was conducted on May 24, 2023, using databases such as PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. We extracted data on adverse events, progression-free survival, overall survival, objective response rate (ORR), and prostate-specific antigen response rate (PSA-RR). The Common Terminology Criteria for Adverse Events were used to assess risks, while ORR and PSA-RR were used to assess benefits. Trials were categorized as positive, negative, or indeterminate based on their safety profiles and efficacy outcomes.
Results:
Nearly all clinical trials testing abiraterone in prostate cancer showed promising outcomes with 89% of studies meeting their endpoint. Our study supports abiraterone’s use in prostate cancer, its only U.S. Food and Drug Administration-approved indication to treat, with a median ORR of 20.0% and a median PSA-RR of 42.0%. However, when looking at the 3 novel indications tested, the risk-to-benefit profile was similar to that of its original approval. Even though most novel indications failed to meet their primary endpoint, the overall toxicity profile was similar to that found in prostate cancer.
Conclusion
Abiraterone showed an overall risk-to-benefit portfolio that supports the use of its treatment in prostate cancer. Although the primary endpoints in ovarian and breast cancer trials were not met, the use was appropriate when assessing how the mechanism of action for abiraterone could be beneficial in patients with these types of cancers.
4.Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Abiraterone Clinical Trials
Matthew RASHID ; Eli OLDHAM ; Griffin K. HUGHES ; Andriana M. PEÑA ; Chase LADD ; Brooke GARDNER ; Ryan MCINTIRE ; Bradley JOHNSON ; Jordan TUIA ; Alyson HASLAM ; Vinay PRASAD ; Matt VASSAR
Journal of Urologic Oncology 2024;22(3):211-223
Purpose:
Our study aimed to evaluate the risk and benefit profiles of clinical trials using abiraterone in cancer treatment.
Materials and Methods:
A comprehensive search was conducted on May 24, 2023, using databases such as PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. We extracted data on adverse events, progression-free survival, overall survival, objective response rate (ORR), and prostate-specific antigen response rate (PSA-RR). The Common Terminology Criteria for Adverse Events were used to assess risks, while ORR and PSA-RR were used to assess benefits. Trials were categorized as positive, negative, or indeterminate based on their safety profiles and efficacy outcomes.
Results:
Nearly all clinical trials testing abiraterone in prostate cancer showed promising outcomes with 89% of studies meeting their endpoint. Our study supports abiraterone’s use in prostate cancer, its only U.S. Food and Drug Administration-approved indication to treat, with a median ORR of 20.0% and a median PSA-RR of 42.0%. However, when looking at the 3 novel indications tested, the risk-to-benefit profile was similar to that of its original approval. Even though most novel indications failed to meet their primary endpoint, the overall toxicity profile was similar to that found in prostate cancer.
Conclusion
Abiraterone showed an overall risk-to-benefit portfolio that supports the use of its treatment in prostate cancer. Although the primary endpoints in ovarian and breast cancer trials were not met, the use was appropriate when assessing how the mechanism of action for abiraterone could be beneficial in patients with these types of cancers.
5.Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Abiraterone Clinical Trials
Matthew RASHID ; Eli OLDHAM ; Griffin K. HUGHES ; Andriana M. PEÑA ; Chase LADD ; Brooke GARDNER ; Ryan MCINTIRE ; Bradley JOHNSON ; Jordan TUIA ; Alyson HASLAM ; Vinay PRASAD ; Matt VASSAR
Journal of Urologic Oncology 2024;22(3):211-223
Purpose:
Our study aimed to evaluate the risk and benefit profiles of clinical trials using abiraterone in cancer treatment.
Materials and Methods:
A comprehensive search was conducted on May 24, 2023, using databases such as PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. We extracted data on adverse events, progression-free survival, overall survival, objective response rate (ORR), and prostate-specific antigen response rate (PSA-RR). The Common Terminology Criteria for Adverse Events were used to assess risks, while ORR and PSA-RR were used to assess benefits. Trials were categorized as positive, negative, or indeterminate based on their safety profiles and efficacy outcomes.
Results:
Nearly all clinical trials testing abiraterone in prostate cancer showed promising outcomes with 89% of studies meeting their endpoint. Our study supports abiraterone’s use in prostate cancer, its only U.S. Food and Drug Administration-approved indication to treat, with a median ORR of 20.0% and a median PSA-RR of 42.0%. However, when looking at the 3 novel indications tested, the risk-to-benefit profile was similar to that of its original approval. Even though most novel indications failed to meet their primary endpoint, the overall toxicity profile was similar to that found in prostate cancer.
Conclusion
Abiraterone showed an overall risk-to-benefit portfolio that supports the use of its treatment in prostate cancer. Although the primary endpoints in ovarian and breast cancer trials were not met, the use was appropriate when assessing how the mechanism of action for abiraterone could be beneficial in patients with these types of cancers.