Objective: We aimed to evaluate alirocumab- and evolocumab-related adverse events (AEs) in real-world compared with all other drugs, overall and by gender and age subgroups; we also aimed to compare their risks of cognitive impairment, musculoskeletal disorders and diabetes with various statins and ezetimibe.Methods: We retrospectively extracted AE reports from the FDA Adverse Event Reporting System (FAERS) database during July 2015-June 2021. Disproportionality analyses were performed using reporting odds ratios (RORs) to detect AE signals of alirocumab and evolocumab in the overall population and in different age and gender subgroups, respectively.Results: Compared with all other drugs, both alirocumab and evolocumab had a significant signal in “musculoskeletal and connective tissue disorders” (ROR1 = 2.626, 95% CI 2.552–2.702; ROR2 = 2.575, 95% CI 2.538–2.613). The highest ROR value of 2.311 (95% CI 2.272–2.351) was for “injury, poisoning and procedural complications” and was found in patients aged ≥65 years on evolocumab. The most frequent AEs were “general disorders and administration site conditions” and “musculoskeletal and connective tissue disorders” for all subpopulations. At the preferred term level, the most frequent AE signal was myalgia for alirocumab and injection site pain for evolocumab, overall and by subgroups. Compared with statins/ezetimibe, PCSK9 inhibitors exhibited lower ROR values for adverse events associated with SOC “nervous system disorders”, “psychiatric disorders” and “metabolism and nutrition disorders” (all RORs < 1), but mixed results for musculoskeletal disorders. Compared with all other drugs, undocumented AEs, such as acute cardiac event (ROR = 30.0, 95% CI 9.4–95.3) and xanthoma (ROR = 9.3, 95% CI 3.4–25.5), were also reported.Conclusion: Real-world evidence showed that PCSK9 inhibitors were associated with an increased risk of musculoskeletal and connective tissue disorders and general disorders and administration site conditions, overall and by subgroups. Muscle toxicity, injection site reactions, and influenza-like illness were significant AE signals. Compared with various statins and ezetimibe, PCSK9 inhibitors have shown a favorable safety profile in muscle-related events, cognitive impairment and diabetes. Some undocumented AE signals were also reported. Due to the limitations of spontaneous reporting databases, further studies are still needed to establish causality and validate our results.

(1) Objective: To assess the reliability and validity of the simplified Chinese version of the brief Diabetes Quality of Life (DQoL) questionnaire in measuring health-related quality of life (HRQoL) in Chinese type 2 diabetes (T2D) patients. (2) Methods: A cross-sectional validation study including 277 patients was conducted at a tertiary hospital in Shanghai, China during April–May, 2018. The English brief DQoL was forward and back-translated into simplified Chinese. The expert interview, exploratory factor analysis (EFA), and Spearman correlation with the 5-level version of EuroQoL-5 (EQ-5D-5L) were employed to establish its validity. The internal reliability was assessed by Cronbach’s alpha. Participants were also stratified into subgroups to evaluate if the Chinese brief DQoL had more test effectiveness in a specific subpopulation. (3) Results: No items were removed from the original English brief DQoL based on the results of factor analysis and expert interview. The Spearman coefficient revealed a low-moderate inverse correlation between DQoL and EQ-5D-5L index and visual analogue scale (VAS), respectively (ρ1 = −0.364, p < 0.0001; ρ2 = −0.514, p < 0.0001). The Cronbach’s alpha coefficient of the final scale was 0.731. (4) Conclusions: The simplified Chinese version of the brief DQoL questionnaire showed reasonable reliability and validity, suggesting its potential appropriateness for evaluating quality of life in Chinese T2D patients. More future efforts should be made to generalize the application of the findings.

ObjectivesTo describe the development of pharmaceutical retail market and community pharmacists in mainland China and identify challenges from both government and business perspectives.DesignA retrospective cross-sectional study.SettingCommunity pharmacies providing primary care in mainland China.ParticipantsCommunity pharmacies and community pharmacists in all 31 provincial units in mainland China registered in the National Medical Products Administration during 2014–2020. Number of community pharmacies ranged from 433 529 (2014) to 553 892 (2020). Number of community pharmacists ranged from 129 895 (2014) to 541 264 (2020).Primary and secondary outcome measuresChanges in pharmaceutical retail market and accessibility of community pharmacists over the study period. We also examined the qualification of pharmacists and regional differences.ResultsDuring 2014–2020, the total number of retail companies and pharmacies increased by 47.6% and 27.4%, respectively. The national retail chain rate boosted from 39.4% to 56.5%, and average number of stores per company increased from 40.2 to 49.7. The number of community pharmacists rose by 316.7%. Regarding accessibility, number of pharmacy stores per 10 000 inhabitants increased from 3.2 to 3.9; the average number of pharmacists per store and per 10 000 residents rose from 0.30 to 0.98 and from 0.95 to 3.83. However, the proportion holding a postgraduate or bachelor’s degree dropped to one-third. Pharmacy resources were unevenly distributed across the country. Correlations were observed between economic indicators and number of pharmacy stores and pharmacists (p<0.05).ConclusionsIn general, the accessibility and centralisation of retail pharmacies in China have shown a steady growth with a sign of regional disparities. The availability of community pharmacists has increased significantly, although with an unreasonable composition of academic qualifications and a shortage of personnel. Further efforts are necessary to provide sufficient pharmacy resources for community settings and resolve regional disparities.

Background Individuals with diabetes have increased risk of depression, but there are limited nationally representative studies on this topic. We aimed to investigate the prevalence and predictors of depression, as well as its impact on all-cause and cardiovascular mortality in adults with type 2 diabetes (T2DM) using a prospective cohort study and a representative sample of the U.S. population. Methods We analyzed National Health and Nutrition Examination Survey (NHANES) data from 2005 to 2018 and linked it with the most recent publicly available National Death Index (NDI) data. Individuals aged 20 years or old who had depression measurements were included. Depression was defined as a Patient Health Questionnaire (PHQ-9) score ≥ 10, and categorized into moderate (10–14 points) and moderately severe to severe (≥ 15 points). Cox proportional hazard models were used to estimate the association between depression and mortality. Results Among 5695 participants with T2DM, 11.6% had depression. Depression was associated with female gender, younger age, overweight, lower education, being unmarried, smoking, and a history of coronary heart disease and stroke. During a mean follow-up period of 78.2 months, 1161 all-cause deaths occurred. Total depression and moderately severe to severe depression significantly increased all-cause mortality (adjusted hazard ratio [aHR] 1.36, 95% CI [1.09–1.70]; 1.67 [1.19–2.34]) and non-cardiovascular mortality (aHR 1.36, 95% CI [1.04–1.78]; 1.78, 95% CI [1.20–2.64]), but not cardiovascular mortality. Subgroup analysis showed a significant association between total depression and all-cause mortality in males (aHR 1.46, 95% CI [1.08–1.98]) and those aged 60 years or older (aHR 1.35, 95% CI [1.02–1.78]). Any severity of depression was not significantly associated with cardiovascular mortality in age- or gender- stratified subgroups. Conclusions In a nationally representative sample of U.S. adults with T2DM, approximately 10% experienced depression. Depression did not significantly associate with cardiovascular mortality. However, comorbid depression in T2DM patients increased the risk of all-cause and non-cardiovascular mortality. The impact of depression on mortality varied across subgroups. Therefore, healthcare providers should consider incorporating depression screening and management into routine care, especially for subgroups with specific risk factors, due to the increased risk of all-cause mortality in T2DM patients with depression.