Adherence, clinical benefits, and adverse effects of endocrine therapies among women with nonmetastatic breast cancer in developing countries: A systematic review and meta-analysis.

BACKGROUND: Despite significant advances in breast cancer control and survival with endocrine therapies (ETs), treatment utilization and outcomes in developing countries have not been adequately explored. This review evaluated ET adherence, potential benefits, and harms in populations across developing countries. METHODS: A literature search was conducted through August 2023 in five databases: PubMed, Cochrane Library, Web of Science, Global Health, and WHO Global Index Medicus. Retrieved records were screened to identify observational research presenting at least one outcome in women with nonmetastatic breast cancer in developing countries who received ET (tamoxifen or aromatase inhibitors). A random effects model was used to compute the rates of adherence, discontinuation, adverse events (AEs), disease progression, and death. RESULTS: A total of 104 studies met the inclusion criteria. Risk of bias was low in most studies, and a large portion of the patients involved Asians. The overall heterogeneity between studies was partially attributed to variations in study design or outcome measurement method. Results showed a pooled adherence rate of 75% (95% confidence interval [CI], 67%-81%) and a discontinuation rate of 16% (95% CI, 10%-25%). Treatment side effects and young age consistently emerged as significant predictors of nonadherence. A wide range of AEs was identified in our analysis. The estimated average rates of cancer recurrence and mortality at 5-years were 16% and 8%, respectively. CONCLUSIONS: The findings of this study underscore suboptimal ET use in developing countries and provide comprehensive insights into treatment experiences in the real-world setting. Targeted strategies are warranted to enhance adherence and subsequently optimize treatment benefits.

Effectiveness and Feasibility of Telehealth-Based Dietary Interventions Targeting Cardiovascular Disease Risk Factors: Systematic Review and Meta-Analysis.

BACKGROUND: Telehealth-based dietary interventions were recommended for cardiovascular disease (CVD) management during the COVID-19 pandemic; however, data regarding their effectiveness and feasibility are limited. OBJECTIVE: We aimed to examine (1) the effectiveness of telehealth-based dietary interventions in improving clinical CVD risk factors and (2) the feasibility of these interventions among individuals with CVD. METHODS: To conduct this systematic review and meta-analysis of randomized controlled trials (RCTs), 2 investigators searched PubMed, Cochrane Library, Web of Science, and ClinicalTrials.gov databases based on predetermined search terms and included English-language RCTs published between January 2000 and July 2022. The Cochrane Risk of Bias tool was used to assess RCT quality. To evaluate intervention effectiveness, weight, BMI, systolic and diastolic blood pressure, and levels of total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, or blood glucose were compared postintervention in telehealth and usual care (UC) groups. Feasibility was determined through the number of participants retained in intervention and UC groups. Pooled data for each CVD outcome were analyzed using a random effects model. Mean difference (MD), standardized MD, or risk ratio were calculated using R software. RESULTS: A total of 13 RCTs with 3013 participants were included in the analysis to assess the effectiveness and feasibility of telehealth-based dietary interventions among individuals with CVD. Participants had a mean age of 61.0 (SD 3.7) years, and 18.5% (n=559) were women. Approximately one-third of RCTs were conducted in the United States (n=4, 31%). Included studies used telephone, app, text, audio-visual media, or website-based interventions. Of the 13 included studies, 3 were of high quality, 9 were of moderate quality, and only 1 was of low quality. Pooled estimates showed systolic blood pressure (MD -2.74, 95% CI -4.93 to -0.56) and low-density lipoprotein cholesterol (standardized MD -0.11, 95% CI -0.19 to -0.03) to be significantly improved among individuals with CVD as a result of telehealth-based dietary interventions compared to UC. No significant difference in effectiveness was detected for weight, BMI, and levels of diastolic blood pressure, total cholesterol, high-density lipoprotein, and triglycerides between telehealth-based dietary interventions and UC among those with CVD. There was no significant difference between the feasibility of telehealth-based dietary interventions versus UC. Significant I2 indicated moderate to considerable heterogeneity. CONCLUSIONS: Telehealth-based dietary interventions show promise in addressing CVD risk factors.

Safety and efficacy of sofosbuvir-based medication regimens with and without ribavirin in hepatitis C patients: A systematic review and meta-analysis.

WHAT IS KNOWN AND OBJECTIVE: Sofosbuvir (SOF) is a new and highly effective medication that dramatically improved hepatitis C virus (HCV) management. However, ribavirin (RBV) is still added to SOF-based medication regimens in several clinical scenarios, despite its well-known toxicities. The aim of our study is to systematically review and analyse the impact of adding RBV to SOF-based medication regimens on clinical outcomes among HCV patients. METHODS: Included studies were randomized trials comparing the same SOF-based medication regimens with and without RBV in HCV patients and measuring serious adverse events (SAEs) and/or sustained virologic response at 12 weeks post-treatment (SVR-12). Two investigators independently searched PubMed and Cochrane Library through September 2021. The Cochrane Risk of Bias tool was used to assess trials quality. Clinical outcomes were analysed as risk ratios (RR) using a random effects model using R version 4.1.2. RESULTS AND DISCUSSION: Our study included a total of 26 trials with 5058 HCV patients. Quality assessment showed moderate risk of bias for most trials. Upon adding RBV, there was no significant difference in SAEs (RR 1.07, 95% CI: 0.77-1.48, I2  = 10%), nor an impact on SVR-12 (RR 1.00, 95% CI: 0.98-1.01, I2  = 41%). There was no evidence of publication bias for either outcome. Subgroup analysis consistently showed lack of benefit among HCV subgroups. Additionally, NCT01826981 was identified as the main source of heterogeneity in the SVR-12 outcome. WHAT IS NEW AND CONCLUSION: Our findings suggest nonsignificant differences in safety and efficacy between SOF-based medication regimens with and without RBV which should be considered in clinical practice.

Pharmacovigilance in developing countries (part II): a path forward.

In recent years, attention to pharmacovigilance has gained momentum in developing countries, however awareness of, and policies or systems for pharmacovigilance in most developing countries still lags sharply behind developed countries. This article proposes different strategies to encourage the introduction and sustain the advancement of robust pharmacovigilance systems in developing countries. To this end, this article seeks to accomplish the ultimate goal of pharmacovigilance in a developing country context; ensuring patient safety and promoting safe and rational use of drugs.

Pharmacovigilance in developing countries (part I): importance and challenges.

The thalidomide disaster was the significant historical event that acted as a catalyst for pharmacovigilance activity. Following this event developed countries initiated drug monitoring systems that evolved and now extend their scope to broader drug-related safety issues; however, this was not the case in developing countries. Pharmacovigilance is still a relatively new concept with low priority in developing countries although various issues are raising concerns that magnify the need for systems to monitor post marketing drug safety in these countries. This article analyzes the barriers to introducing robust pharmacovigilance systems in developing countries.