1.Literature analysis of adverse drug reactions induced by dronedarone
Keke SHANGGUAN ; Manqing CAO ; Ronghuan WANG
China Pharmacy 2023;34(7):854-858
OBJECTIVE To analyze the clinical manifestations and characteristics of adverse drug reactions (ADR) induced by dronedarone,and to provide reference for clinically safe drug use. METHODS Retrieved from PubMed database, Wanfang database,CNKI and VIP (up to August 31st, 2022),ADR cases of dronedarone were analyzed retrospectively in respect of patient’s age,gender,nationality,usage and dosage of dronedarone,and occurrence time,clinical manifestations,treatment measures and outcome of ADR,etc. RESULTS A total of 26 case reports were included,with a total of 27 patients. The age of the patients was 41-86 years old,with an average age of 68.8 years. The proportion of patients aged 60-79 was the largest (20 cases,74.1%). There was no significant difference in the number of males (14 cases) and females (13 cases). The patients came from 6 countries, of which the United States was the largest (16 cases,59.3%). The dosage of 14 patients was 400 mg bid;one patient was 200 mg bid;the dosage for 12 patients was not specified. The most ADR cases (16 cases,59.3%) occurred within 1 month,of which 11 cases(40.7%) occurred within 1 week,and there were no ADR reports with medication more than 12 months. Organs/systems involved in ADRs were mainly liver and biliary diseases (7 case times,23.3%),skin and subcutaneous tissue diseases (6 case times, 20.0%),respiratory tract,thoracic and mediastinal diseases (5 case times,16.7%). In addition,ADR also occurred in heart diseases, kidney and urinary system diseases,vascular diseases,medical examinations and eye diseases. Among 27 patients,there were 3 cases of death,the ADR were bronchiolitis obliterans with organizing pneumonia,toxic epidermal necrolysis and hepatic failure, respectively. One patient underwent liver transplantation. CONCLUSIONS Dronedarone can cause multiple organ system ADR. Before use,it is necessary to improve the examination including ECG,liver function,lung function,etc. and strengthen drug use monitoring within one month after the start of use,especially the ADR of hepatobiliary,skin and respiratory system. The occurrence of severe ADR has no obvious relationship with the duration of medication; even if it is taken safely for a long time,it still needs continuous pharmaceutical monitoring and follow-up to ensure the clinical medication safety of patients.
2.Apixaban for the prevention and treatment of cancer-associated venous thromboembolism:a rapid health technology assessment
Huayu WANG ; Keke SHANGGUAN ; Ying WANG ; Yankui LI
China Pharmacy 2025;36(10):1260-1265
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of apixaban in the prevention and treatment of cancer-associated venous thromboembolism (CA-VTE), and provide evidence-based reference for clinical treatment. METHODS Retrieved from PubMed, the Cochrane Library, CNKI, Wanfang, VIP database and other websites of health technology assessment (HTA), systematic review/meta-analysis, pharmacoeconomic studies and HTA reports of apixaban in the prevention and treatment of CA-VTE were collected. After data extraction and quality evaluation, the results of the included study were analyzed descriptively. RESULTS A total of 23 literatures were included, involving 16 systematic review/meta-analysis and 7 pharmacoeconomic studies. In terms of efficacy, compared with placebo, prophylactic use of apixaban could significantly reduce the incidence of venous thromboembolism (VTE) in outpatient adult cancer patients receiving chemotherapy (P<0.05). Compared with low-molecular weight heparin (LMWH), rivaroxaban and warfarin, there were no statistically significant differences in the incidence of VTE for apixaban (P>0.05); nevertheless, apixaban was ranked as the most preferable choice. For the treatment of patients with CA-VTE, compared with warfarin, apixaban could significantly reduce the recurrence rate of VTE (P<0.05). While compared with patients treated with LMWH, rivaroxaban, edoxaban and dabigatran, there were no statistically significant differences in the recurrence rates of VTE, deep venous thrombosis and pulmonary embolism among patients using apixaban (P>0.05). In terms of safety, compared with placebo, prophylactic use of apixaban showed a higher occurrence of major bleeding in outpatient adult cancer patients receiving chemotherapy (P<0.05), while compared withpatients treated with LMWH, rivaroxaban, and warfarin, there were no statistically significant differences in the incidence of major bleeding among patients using apixaban (P>0.05); despite this, apixaban was ranked as the most favorable option. For the treatment of patients with CA-VTE, compared with dalteparin, the incidence of major bleeding and all-cause mortality of apixaban were similar (P>0.05), while the incidence of clinically relevant non-major bleeding (CRNMB) was higher (P<0.05). Compared with edoxaban, the incidence of major bleeding of apixaban was reduced significantly (P<0.05), while there was no significant difference in the incidence of CRNMB, the incidence of clinically relevant bleeding and all-cause mortality (P>0.05). Compared with rivaroxaban, warfarin and dabigatran, there were no significant differences in the incidence of major bleeding, the incidence of CRNMB, the incidence of clinically relevant bleeding and all-cause mortality (P>0.05). In terms of cost-effectiveness, the researches in China showed that apixaban was cost-effective in preventing CA-VTE; foreign studies showed that apixaban was cost-effective in preventing and treating CA-VTE. CONCLUSIONS Apixaban is effective, safe and cost- effective in the prevention and treatment of CA-VTE.