Key result
The combination of amlodipine and atorvastatin generated the strongest adverse drug reaction signal for jaundice (Ω0.025: 3.08, lift: 1116.69), while aspirin combined with other drugs was associated with bleeding events.
Why the study?
There is a lack of studies investigating the safety of combination drug regimens specifically for cardiovascular and cerebrovascular diseases.
Does combination drug therapy cause specific adverse drug reactions in patients with cardiovascular and cerebrovascular diseases?
Observational (n=53,038)
Does combination drug therapy cause specific adverse drug reactions in patients with cardiovascular and cerebrovascular diseases?
Real-world pharmacovigilance data identified 9 adverse drug reaction signals from combination therapies in cardiovascular patients, notably highlighting a strong signal for jaundice with amlodipine and atorvastatin.
Answers are grounded in this paper and cite their sources.
May warrant monitoring for jaundice with amlodipine-atorvastatin; leaves open causal confirmation in cardiovascular cohorts.
Objective: There 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. Methods: We 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. Results: A 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). Conclusion: Among 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.
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Wang et al. (2025) conducted an observational in Cardiovascular and cerebrovascular diseases (n=53,038). Combined drug use (e.g., amlodipine and atorvastatin) vs. Single drug use or other combinations was evaluated on Adverse drug reaction signals (e.g., jaundice from amlodipine and atorvastatin) (Ω0.025: 3.08). The combination of amlodipine and atorvastatin generated the strongest adverse drug reaction signal for jaundice (Ω0.025: 3.08, lift: 1116.69), while aspirin combined with other drugs was associated with bleeding events.
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