RESUMO
OBJECTIVE: To describe the trends in use of antidepressants (ADs), atypical antipsychotics (AAPs), and benzodiazepines (BZDs) among high-, middle-, and low-income countries. METHODS: A cross-sectional time-series analysis by country from July 2014 to December 2019 utilizing IQVIA's Multinational Integrated Data Analysis database was conducted. Population-controlled rates of use were calculated in number of standard units of medications per drug class per population size. The United Nations' 2020 World Economic Situation and Prospects was used to group countries into high-, middle-, and low-income. Percent change in rates of use per drug class was calculated from July 2014 to July 2019. Linear regression analyses were conducted to assess the predictability of percent change in use utilizing a country's baseline rate of use per drug class and economic status as predictor variables. RESULTS: A total of 64 countries were included: 33 high-, 6 middle-, and 25 low-income. Average baseline rates of use for ADs in high-, middle-, and low-income countries were 2.15, 0.35, and 0.38 standard units per population size, respectively. For AAPs, rates were 0.69, 0.15, and 0.13, respectively. For BZDs, rates were 1.66, 1.46, and 0.33, respectively. Average percent changes in use for ADs by economic status were 20%, 69%, and 42%, respectively. For AAPs, they were 27%, 78%, and 69%, respectively. For BZDs, they were -13%, 4%, and -5%, respectively. Some associations were found demonstrating that as a country's economic status increases, percent change of AD (p = 0.916), AAP (p = 0.23), and BZD (p = 0.027) use decreases. Similarly, as baseline rate of use for ADs and AAPs increases, percent change in use decreases with p-values of 0.026 and 0.054, respectively. For BZDs, as baseline rate of use increases, percent change in use increases (p = 0.038). CONCLUSIONS: High-income countries have a higher rate of treatment utilization compared to low- and middle-income countries (LMICs) with treatment utilization increasing in all countries of interest.
Assuntos
Antipsicóticos , Benzodiazepinas , Benzodiazepinas/uso terapêutico , Antipsicóticos/uso terapêutico , Estudos Transversais , Antidepressivos/uso terapêutico , Fatores SocioeconômicosRESUMO
BACKGROUND: Many cancer therapies are now approved based on surrogate endpoints such as progression-free survival (PFS) to ensure that patients have speedy access to life-saving cancer medicines. However, the link between surrogate endpoints and overall survival (OS) is not well established in many cancers. OBJECTIVE: To characterize trends in endpoints used in pivotal trials leading to approval for US Food and Drug Administration (FDA)-approved solid tumor therapies and their efficacy from 1995 to 2021. METHODS: We reviewed the FDA Oncology (Cancer)/Hematologic Malignancies Approval Notifications webpage to extract data on median OS and PFS among solid tumor therapy approvals from 1995 to 2021. We summarized trends in percentage of trials reporting OS vs PFS, median OS and PFS, and trial designs. We conducted subgroup analyses for lung and breast cancer therapies. RESULTS: Median OS was reported more frequently until 2010 to 2012, when median PFS and OS were reported in 65.2% and 60.9% of trials, respectively. Between 1995 and 2021, there were no observable trends in median OS over time for solid tumor therapy approvals. Median PFS increased by 3.0 months over time. For lung cancer therapies, median OS increased by 6.8 months between the time periods of 1998-2000 and 2019-2021, whereas median PFS increased by 5.0 months between the time periods of 2007-2009 and 2019-2021. For breast cancer therapy, median OS slightly decreased over time, whereas median PFS has increased by 3.4 months since 1995. There has been a recent shift in use of single-arm trials leading to oncology drug approvals. CONCLUSIONS: There has been a transition from reporting OS to PFS, and median PFS has increased by 3 months while median OS has remained stable. The different trends in overall and progression-free survival highlights the challenge and importance of measuring the value of oncology drugs. DISCLOSURES: Dr Suh reports personal fees from Bayer US LLC.