Comparative tolerability of targeted therapies in pulmonary hypertension
Introduction The objective of this study was to estimate the safety profile of pulmonary hypertension-specific therapies using placebo-controlled and active comparator trials. Material and methods The search corpus comprised Medline, Scopus, Embase and Clinical Trials databases. A systematic review...
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| Format: | Article |
| Language: | English |
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Termedia Publishing House
2020-06-01
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| Series: | Archives of Medical Science |
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| Online Access: | https://www.archivesofmedicalscience.com/Comparative-tolerability-of-targeted-therapies-in-pulmonary-hypertension,114130,0,2.html |
| _version_ | 1827287702676963328 |
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| author | Magdalena Jasińska-Stroschein Karolina Stawarczyk Anna Stępień Daria Orszulak-Michalak |
| author_facet | Magdalena Jasińska-Stroschein Karolina Stawarczyk Anna Stępień Daria Orszulak-Michalak |
| author_sort | Magdalena Jasińska-Stroschein |
| collection | DOAJ |
| description | Introduction
The objective of this study was to estimate the safety profile of pulmonary hypertension-specific therapies using placebo-controlled and active comparator trials.
Material and methods
The search corpus comprised Medline, Scopus, Embase and Clinical Trials databases. A systematic review and meta-analysis was performed to assess the relative risk of severe events and discontinuations as well as of adverse drug reactions (ADRs) classified into 26 categories and 21 subcategories defined by the Medical Dictionary for Regulatory Activities (MedRA).
Results
Pulmonary hypertension-specific therapies had the greatest effect on such events as flushing and headache as well as jaw pain, limb pain and myalgia or gastrointestinal disorders. The relative risk for ADRs in patients receiving monotherapy (vs. placebo/supportive therapies) and combined regimens (vs. monotherapy) was significantly increased. The risk of cessation for the combined regimen was slightly higher (Q inter-group , p = 0.0778). Such ADRs as blood and lymphatic system disorders with the anemia subgroup, gastrointestinal disorders with diarrhea and nausea subgroups, respiratory and thoracic diseases or nervous system disorders with headache tended to occur more often in combination regimens as compared to monotherapy.
Conclusions
About half of the main categories and subcategories of adverse reactions according to MedRA were associated with a relatively high frequency and hazard ratio. Their risk can be increased when combination regimens are used, especially. |
| first_indexed | 2024-04-24T11:16:27Z |
| format | Article |
| id | doaj.art-c5e5d8ebaaac4f408cfeb7949f3fd91e |
| institution | Directory Open Access Journal |
| issn | 1734-1922 1896-9151 |
| language | English |
| last_indexed | 2024-04-24T11:16:27Z |
| publishDate | 2020-06-01 |
| publisher | Termedia Publishing House |
| record_format | Article |
| series | Archives of Medical Science |
| spelling | doaj.art-c5e5d8ebaaac4f408cfeb7949f3fd91e2024-04-11T08:11:15ZengTermedia Publishing HouseArchives of Medical Science1734-19221896-91512020-06-0120116718810.5114/aoms.2020.96143114130Comparative tolerability of targeted therapies in pulmonary hypertensionMagdalena Jasińska-Stroschein0Karolina Stawarczyk1Anna Stępień2Daria Orszulak-Michalak3Department of Biopharmacy, Medical University of Lodz, Lodz, PolandDepartment of Biopharmacy, Medical University of Lodz, Lodz, PolandDepartment of Biopharmacy, Medical University of Lodz, Lodz, PolandDepartment of Biopharmacy, Medical University of Lodz, Lodz, PolandIntroduction The objective of this study was to estimate the safety profile of pulmonary hypertension-specific therapies using placebo-controlled and active comparator trials. Material and methods The search corpus comprised Medline, Scopus, Embase and Clinical Trials databases. A systematic review and meta-analysis was performed to assess the relative risk of severe events and discontinuations as well as of adverse drug reactions (ADRs) classified into 26 categories and 21 subcategories defined by the Medical Dictionary for Regulatory Activities (MedRA). Results Pulmonary hypertension-specific therapies had the greatest effect on such events as flushing and headache as well as jaw pain, limb pain and myalgia or gastrointestinal disorders. The relative risk for ADRs in patients receiving monotherapy (vs. placebo/supportive therapies) and combined regimens (vs. monotherapy) was significantly increased. The risk of cessation for the combined regimen was slightly higher (Q inter-group , p = 0.0778). Such ADRs as blood and lymphatic system disorders with the anemia subgroup, gastrointestinal disorders with diarrhea and nausea subgroups, respiratory and thoracic diseases or nervous system disorders with headache tended to occur more often in combination regimens as compared to monotherapy. Conclusions About half of the main categories and subcategories of adverse reactions according to MedRA were associated with a relatively high frequency and hazard ratio. Their risk can be increased when combination regimens are used, especially.https://www.archivesofmedicalscience.com/Comparative-tolerability-of-targeted-therapies-in-pulmonary-hypertension,114130,0,2.htmlpulmonary arterial hypertensiontargeted drugsadverse drug reactionsmeta-analysis |
| spellingShingle | Magdalena Jasińska-Stroschein Karolina Stawarczyk Anna Stępień Daria Orszulak-Michalak Comparative tolerability of targeted therapies in pulmonary hypertension Archives of Medical Science pulmonary arterial hypertension targeted drugs adverse drug reactions meta-analysis |
| title | Comparative tolerability of targeted therapies in pulmonary hypertension |
| title_full | Comparative tolerability of targeted therapies in pulmonary hypertension |
| title_fullStr | Comparative tolerability of targeted therapies in pulmonary hypertension |
| title_full_unstemmed | Comparative tolerability of targeted therapies in pulmonary hypertension |
| title_short | Comparative tolerability of targeted therapies in pulmonary hypertension |
| title_sort | comparative tolerability of targeted therapies in pulmonary hypertension |
| topic | pulmonary arterial hypertension targeted drugs adverse drug reactions meta-analysis |
| url | https://www.archivesofmedicalscience.com/Comparative-tolerability-of-targeted-therapies-in-pulmonary-hypertension,114130,0,2.html |
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