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  • Frontiers Media SA  (5)
  • Zhang, Qilin  (5)
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  • Frontiers Media SA  (5)
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  • 1
    Online Resource
    Online Resource
    Cost-Effectiveness Analysis of Camrelizumab vs. Placebo Added to Chemotherapy as First-Line Therapy for Advanced or Metastatic Esophageal Squamous Cell Carcinoma in China
    Frontiers Media SA ; 2021
    In:  Frontiers in Oncology Vol. 11 ( 2021-12-1)
    Details
    In: Frontiers in Oncology, Frontiers Media SA, Vol. 11 ( 2021-12-1)
    Abstract: The purpose of this cost-effectiveness analysis was to estimate the effects of adding camrelizumab to standard chemotherapy as the first-line treatment in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) on health and economic outcomes in China. Methods A Markov model was developed to simulate the clinical course of typical patients with advanced or metastatic ESCC in the ESCORT-1st trial. Weibull survival model was employed to fit the Kaplan-Meier progression-free survival and overall survival probabilities of the camrelizumab-chemotherapy and placebo-chemotherapy strategy, respectively. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICER) were estimated over a 5-year lifetime horizon. Meanwhile, one-way and probabilistic sensitivity analyses were conducted to test the uncertainty in the model. Results On baseline analysis, the incremental effectiveness and cost of camrelizumab-chemotherapy versus placebo-chemotherapy were 0.15 QALYs and $7,110.56, resulting in an ICER of $46,671.10/QALY, higher than the willingness-to-pay (WTP) threshold of China ($31,498.70/QALY). The results were sensitive to the utility of PFS and cost of camrelizumab. Conclusion The findings from the present analysis suggest that the addition of camrelizumab to chemotherapy might not be cost-effective in patients with advanced or metastatic ESCC in China.
    Type of Medium: Online Resource
    ISSN: 2234-943X
    URL: Article
    DOI: 10.3389/fonc.2021.790373
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2021
    detail.hit.zdb_id: 2649216-7
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Table4.DOCX
    Frontiers Media SA ; 2022
    In:  Frontiers in Pharmacology Vol. 13 ( 2022-9-6)
    Details
    In: Frontiers in Pharmacology, Frontiers Media SA, Vol. 13 ( 2022-9-6)
    Abstract: Objective: The objective of this study was to scientifically and systematically explore the association between fluoroquinolones (ciprofloxacin, levofloxacin, and moxifloxacin) and tendonitis and tendon rupture through the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: Disproportionality analysis was used to quantify the signals of fluoroquinolone-associated suspected tendonitis and tendon rupture based on the FAERS data from January 2016 to March 2021. Clinical characteristics, the onset time, oral and intravenous administrations, and the serious outcomes of fluoroquinolone-associated tendonitis and tendon rupture were further analyzed. Results: Out of 35,667 fluoroquinolone-associated adverse events recorded in the FAERS database during the study period, 1,771 tendonitis and 1,018 tendon ruptures induced by fluoroquinolones as the suspected drug were analyzed, with a median age of 49.88–63.87 years. All three fluoroquinolones detected positive signals of tendonitis and tendon rupture in the four methods. Ciprofloxacin had the strongest statistical association with tendonitis with the highest positive signal values (ROR 98.50, PRR 93.25, IC 6.15, and EBGM 76.80), while levofloxacin showed the strongest statistical association with tendon rupture (ROR 76.38, PRR 73.75, IC 5.84, and EBGM 63.89). Compared with ciprofloxacin and levofloxacin, moxifloxacin was relatively weakly associated with tendonitis and tendon rupture. Oral fluoroquinolone-induced tendonitis and tendon rupture had a stronger signal strength than intravenous administration. The majority of fluroquinolone-related suspected tendonitis and tendon rupture tended to occur within a few days or one month. As for the disability rate of tendonitis, ciprofloxacin counted the highest ( n = 461, 50.94%), with moxifloxacin the lowest ( n = 20, 29.41%). Conclusion: Fluoroquinolone-induced tendonitis and tendon rupture tended to occur early and might result in serious outcomes. Our study provided valuable references for early identification of the risk of fluoroquinolone-induced tendonitis and tendon rupture.
    Type of Medium: Online Resource
    ISSN: 1663-9812
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.3389/fphar.2022.990241
    DOI: 10.3389/fphar.2022.990241.s001
    DOI: 10.3389/fphar.2022.990241.s002
    DOI: 10.3389/fphar.2022.990241.s003
    DOI: 10.3389/fphar.2022.990241.s004
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2587355-6
    SSG: 15,3
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    Online Resource
  • 3
    Online Resource
    Online Resource
    Cost-effectiveness of osimertinib versus standard EGFR-TKI as first-line treatment for EGFR-mutated advanced non-small-cell lung cancer in China
    Frontiers Media SA ; 2022
    In:  Frontiers in Pharmacology Vol. 13 ( 2022-9-20)
    Details
    In: Frontiers in Pharmacology, Frontiers Media SA, Vol. 13 ( 2022-9-20)
    Abstract: Objective: The purpose of this study was to estimate the cost-effectiveness of osimertinib for the first-line treatment of patients with EGFR-mutated advanced non-small-cell lung cancer (NSCLC) from the perspective of the Chinese healthcare system. Methods: A Markov model was developed to simulate the outcomes and direct medical costs of osimertinib or standard EGFR-TKI in the first-line treatment of patients with previously untreated EGFR-mutated advanced NSCLC. Individual patient survival data were extracted from the FLAURA randomized clinical trial. Clinical costs and utilities’ input estimates were collected from the local hospital and available literature reports. The quality-adjusted life-year (QALY), incremental cost-effectiveness ratio (ICER), incremental net monetary benefit (INMB), and incremental net health benefit (INHB) were calculated for the two treatment strategies over a 10-year lifetime horizon. In addition, one-way sensitivity analysis, probabilistic sensitivity analysis, and subgroup analysis were performed to test the robustness of the model. Results: On baseline analysis, osimertinib achieved additional 0.39 QALYs and $15,443.78 incremental costs compared with standard EGFR-TKI (gefitinib or erlotinib), which resulted in the ICER of $39,369.53/QALY. The INMB was -$755.11, and the INHB was -0.02 QALYs at a WTP threshold of $37,663.26/QALY in China. The one-way sensitivity analysis showed that the utility of PFS had the strongest association with the ICER. Osimertinib had approximately 46.4% probability of being cost-effective at the WTP threshold of $37,663.26/QALY. Conclusion: First-line osimertinib therapy might not be cost-effective in China for patients with EGFR-mutated advanced NSCLC compared with standard EGFR-TKI based on its current marketed price. A significantly more favorable cost-effectiveness could be achieved when the price of osimertinib was reduced by 5%.
    Type of Medium: Online Resource
    ISSN: 1663-9812
    URL: Article
    DOI: 10.3389/fphar.2022.920479
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2587355-6
    SSG: 15,3
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  • 4
    Online Resource
    Online Resource
    DataSheet1.docx
    Frontiers Media SA ; 2022
    In:  Frontiers in Pharmacology Vol. 13 ( 2022-6-8)
    Details
    In: Frontiers in Pharmacology, Frontiers Media SA, Vol. 13 ( 2022-6-8)
    Abstract: Purpose: Secukinumab was approved for the treatment of psoriasis, psoriatic arthritis, and ankylosing spondylitis. However, the long-term safety of secukinumab in large sample population was unknown. The current study was to evaluate the secukinumab-assocaited adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Reports in the FAERS from the first quarter of 2015 (FDA approval of secukinumab) to the third quarter of 2021 were collected and analyzed. Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms, were employed in data mining to quantify the signals of secukinumab-related AEs. Results: A total of 89,228 reports of secukinumab as the “primary suspected (PS)” and 254,886 AEs induced by secukinumab were identified. Secukinumab-induced AE occurrence targeted 27 system organ classes (SOCs). A total of 257 signals of secukinumab-induced AEs in 19 SOCs were detected after conforming to the four algorithms simultaneously. Common significant signals of infections, respiratory disorders, skin and subcutaneous tissue disorders, immune system disorders, and ear and labyrinth disorders have emerged. Unexpected significant AEs such as injection site pain, vessel puncture site haemorrhage, arthralgia, hypokinesia, Bell’s palsy, parotid gland enlargement, and stress might also occur. The median onset time of secukinumab-associated AEs was 56 days (interquartile range [IQR] 5–214 days), and most of the onsets occurred within the first 1, 2, 3, and 4 months after initiation of secukinumab. Conclusion: Our study found potential new AE signals and provided a broader understanding of secukinumab’s safety profiles, supporting its rational use in chronic systemic inflammatory diseases.
    Type of Medium: Online Resource
    ISSN: 1663-9812
    URL: Article
    URL: Article
    DOI: 10.3389/fphar.2022.862508
    DOI: 10.3389/fphar.2022.862508.s001
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2587355-6
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 5
    Online Resource
    Online Resource
    Table_1.DOCX
    Frontiers Media SA ; 2022
    In:  Frontiers in Public Health Vol. 10 ( 2022-10-20)
    Details
    In: Frontiers in Public Health, Frontiers Media SA, Vol. 10 ( 2022-10-20)
    Abstract: Semaglutide was approved for treatment of type 2 diabetes mellitus (T2DM) and chronic weight management in obesity or overweight adults. However, real-world data regarding its long-term gastrointestinal safety and tolerability in large sample population are incomplete. We evaluated semaglutide-associated gastrointestinal safety signals by data mining of the FDA pharmacovigilance database. Methods Reporting odds ratio (ROR) was employed to quantify the signals of semaglutide-related gastrointestinal adverse events (AEs) from 2018 to 2022. Serious and non-serious cases were compared by Mann-Whitney U test or Chi-squared (χ 2 ) test, and signals were prioritized using a rating scale. Results We identified 5,442 cases of semaglutide-associated gastrointestinal AEs, with 45 signals detected, ranging from a ROR 025 of 1.01 (hypoaesthesia oral) to 42.03 (eructation), among which 17 AEs were identified as new and unexpected signals. Patient age ( p & lt; 0.001) and body weight ( p = 0.006) rather than sex ( p = 0.251) might be associated with an increased risk of gastrointestinal AEs severity. Notably, the association between semaglutide and gastrointestinal disorders remained when stratified by age, body weight, sex and reporter type. One strong, 22 moderate and 22 weak clinical priority signals were defined. The median time-to-onset (TTO) for strong clinical priority signal was 23 days, while for moderate and weak, they were 6 and 7 days, respectively. All of the disproportionality signals had early failure type features, suggesting that the risk of gastrointestinal AEs occurrence gradually decreased over time. Conclusion Our study provided a deeper and broader understanding of semaglutide's gastrointestinal safety profiles, which would help healthcare professionals to mitigate the risk of gastrointestinal AEs in clinical practice.
    Type of Medium: Online Resource
    ISSN: 2296-2565
    URL: Article
    URL: Article
    DOI: 10.3389/fpubh.2022.996179
    DOI: 10.3389/fpubh.2022.996179.s001
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2711781-9
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