Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei Province
ObjectiveThere is a lack of studies investigating the safety of combination regimens specifically for cardiovascular and cerebrovascular diseases. This study aimed to evaluate the safety of combination drugs for cardiovascular and cerebrovascular diseases using real-world data.MethodsWe analyzed adv...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2024.1451713/full |
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| author | Jia Wang Yuhang Zhao Zherui Chen Rui Huang |
| author_facet | Jia Wang Yuhang Zhao Zherui Chen Rui Huang |
| author_sort | Jia Wang |
| collection | DOAJ |
| description | ObjectiveThere is a lack of studies investigating the safety of combination regimens specifically for cardiovascular and cerebrovascular diseases. This study aimed to evaluate the safety of combination drugs for cardiovascular and cerebrovascular diseases using real-world data.MethodsWe analyzed adverse drug reaction data received by the Hubei Adverse Drug Reaction Center from the first quarter of 2014 to the fourth quarter of 2022. The safety of combined drugs for cardiovascular and cerebrovascular diseases in different people was assessed using the association rule method and Ω shrinkage measurement.ResultsA total of 53,038 reports were included in this study, revealing 9 signals of adverse reactions caused by combination drugs. The strongest signal found in this study was jaundice caused by the combination of amlodipine and atorvastatin (Ω 0.025:3.08, lift: 1116.69, conviction: 1.75). Additionally, the combination of aspirin with other drugs was associated with hemorrhaging in various organs. Female patients showed a cold signal when taking vitamin C and vitamin B6 together compared to male patients (Ω 0.025:0.89, lift: 7.15, conviction: 1.12). Patients under 60 years old had a palpitations signal when combining eritrea bei sha Tanzania and felodipine (Ω 0.025:0.41, lift: 14.65, conviction: 3.8), and an erythema signal when combining nifedipine (Ω 0.025:0.23, lift: 8.17, conviction: 1.077).ConclusionAmong the 9 signals identified in this study, 4 were off-label adverse drug reactions that require further clinical research for exploration and confirmation, in order to provide more scientifically informed drug labeling. Five adverse events associated with aspirin-induced bleeding were identified. Notably, different adverse drug reactions were observed in different populations, suggesting the need for future studies to expedite the development of personalized medicine. |
| format | Article |
| id | doaj-art-bcebc43dcaef4d48986ffc79c1b3481c |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj-art-bcebc43dcaef4d48986ffc79c1b3481c2025-01-08T06:11:57ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-01-011510.3389/fphar.2024.14517131451713Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei ProvinceJia Wang0Yuhang Zhao1Zherui Chen2Rui Huang3Personnel section, Traditional Chinese and Western Medicine Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaSchool of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaSchool of Statistics and Mathematics, Zhongnan University of Economics and Law, Wuhan, ChinaSchool of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaObjectiveThere is a lack of studies investigating the safety of combination regimens specifically for cardiovascular and cerebrovascular diseases. This study aimed to evaluate the safety of combination drugs for cardiovascular and cerebrovascular diseases using real-world data.MethodsWe analyzed adverse drug reaction data received by the Hubei Adverse Drug Reaction Center from the first quarter of 2014 to the fourth quarter of 2022. The safety of combined drugs for cardiovascular and cerebrovascular diseases in different people was assessed using the association rule method and Ω shrinkage measurement.ResultsA total of 53,038 reports were included in this study, revealing 9 signals of adverse reactions caused by combination drugs. The strongest signal found in this study was jaundice caused by the combination of amlodipine and atorvastatin (Ω 0.025:3.08, lift: 1116.69, conviction: 1.75). Additionally, the combination of aspirin with other drugs was associated with hemorrhaging in various organs. Female patients showed a cold signal when taking vitamin C and vitamin B6 together compared to male patients (Ω 0.025:0.89, lift: 7.15, conviction: 1.12). Patients under 60 years old had a palpitations signal when combining eritrea bei sha Tanzania and felodipine (Ω 0.025:0.41, lift: 14.65, conviction: 3.8), and an erythema signal when combining nifedipine (Ω 0.025:0.23, lift: 8.17, conviction: 1.077).ConclusionAmong the 9 signals identified in this study, 4 were off-label adverse drug reactions that require further clinical research for exploration and confirmation, in order to provide more scientifically informed drug labeling. Five adverse events associated with aspirin-induced bleeding were identified. Notably, different adverse drug reactions were observed in different populations, suggesting the need for future studies to expedite the development of personalized medicine.https://www.frontiersin.org/articles/10.3389/fphar.2024.1451713/fullcardiovascular diseasescerebrovascular diseasesadverse drug reactionassociation ruleΩ shrinkage measurement |
| spellingShingle | Jia Wang Yuhang Zhao Zherui Chen Rui Huang Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei Province Frontiers in Pharmacology cardiovascular diseases cerebrovascular diseases adverse drug reaction association rule Ω shrinkage measurement |
| title | Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei Province |
| title_full | Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei Province |
| title_fullStr | Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei Province |
| title_full_unstemmed | Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei Province |
| title_short | Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei Province |
| title_sort | safety of combined drug use in patients with cardiovascular and cerebrovascular diseases an analysis based on the spontaneous reporting database of adverse drug reactions in hubei province |
| topic | cardiovascular diseases cerebrovascular diseases adverse drug reaction association rule Ω shrinkage measurement |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2024.1451713/full |
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