Editorial Material
Health Care Sciences & Services
Victoria R. Cornelius, Rachel Phillips
Summary: Analyzing treatment harm in randomized controlled trials (RCTs) is important but challenging due to small sample sizes. While good analysis practices exist for efficacy outcomes, there has been limited progress in analyzing adverse events (AEs). This commentary identifies four key issues in AE analysis and suggests strategies to address them. It proposes reframing the research question to focus on detecting adverse reactions, aligning statistical practice with unsatisfactory current methods, using Bayesian analyses for cumulative harm assessment, and providing comprehensible summaries based on core outcome sets. The analysis of AEs in clinical trials requires attention and improvement.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2022)
Review
Pharmacology & Pharmacy
Ziqi Ye, Wenchao Yang, Bixia Xuan, Xiaofang Li, Jiana He, Haiyan Si, Wenhua Ma
Summary: Meta-analysis reveals that Sintilimab treatment in cancer can significantly improve overall survival and progression free survival, with better safety profile.
FRONTIERS IN PHARMACOLOGY
(2022)
Review
Cardiac & Cardiovascular Systems
Yun Huang, YuYu Zhang, Lili Ma, Hua Zhou, Chongbo Fang, Chaolin Chen
Summary: This review summarized the adverse events during the use of sacubitril/valsartan versus ACEI/ARB, showing that sacubitril/valsartan reduced the risk of death and certain adverse events compared to ACEI/ARB, but increased the risk of hypotension.
JOURNAL OF CARDIOVASCULAR PHARMACOLOGY
(2021)
Review
Clinical Neurology
Flavia Rossano, Claudio Caiazza, Nicolas Zotti, Luca Viacava, Antonella Irano, Niccolo Solini, Luca Pistone, Rosanna Pezone, Flavia Cilmi, Claudio Ricci, Michele De Prisco, Felice Iasevoli, Taro Kishi, Marco Solmi, Andrea de Bartolomeis, Michele Fornaro
Summary: We conducted a systematic review and meta-analysis to evaluate the viability of azapirones in the treatment of anxiety disorders. The results showed that azapirones were more effective than placebo in the treatment of generalized anxiety disorder (GAD), but did not outperform placebo in panic and social anxiety disorders. They had similar symptom reduction effects as benzodiazepines, but slightly lower response rates. Azapirones were also found to be relatively well-tolerated compared to benzodiazepines and selective serotonin reuptake inhibitors (SRIs).
EUROPEAN NEUROPSYCHOPHARMACOLOGY
(2023)
Review
Gastroenterology & Hepatology
Nauzer Forbes, Sunil Gupta, Levi Frehlich, Zhao Wu Meng, Yibing Ruan, Sheyla Montori, Benjamin R. Chebaa, Kerry B. Dunbar, Steven J. Heitman, Linda A. Feagins, Eduardo Albeniz, Heiko Pohl, Michael J. Bourke
Summary: This study performed a meta-analysis of individual patient data to evaluate the efficacy of prophylactic clipping in preventing adverse events after EMR of proximal large nonpedunculated colorectal polyps.
GASTROINTESTINAL ENDOSCOPY
(2022)
Editorial Material
Endocrinology & Metabolism
Mei Qiu, Li-Min Zhao, Ze-Lin Zhan
Summary: The study showed that the use of SGLT2is was not significantly associated with the occurrence of 980 types of serious adverse events, but was significantly associated with a lower risk of 29 types of serious adverse events, particularly including several important respiratory diseases.
FRONTIERS IN ENDOCRINOLOGY
(2021)
Article
Gastroenterology & Hepatology
Vineet S. Rolston, Jessica Kimmel, Violeta Popov, Brian P. Bosworth, David Hudesman, Lisa B. Malter, Simon Hong, Shannon Chang
Summary: The meta-analysis found that there was no significant difference in rates of serious or mild/moderate adverse events between Ustekinumab and placebo in randomized controlled trials.
DIGESTIVE DISEASES AND SCIENCES
(2021)
Article
Dentistry, Oral Surgery & Medicine
Belen Retamal-Valdes, Ana Paula Laranjeira Tavares, Sarah Monique, Helio Doyle Pereira da Silva, Maria Josefa Mestnik, Poliana Mendes Duarte, Tamires S. Miranda, Ivan Borges, Geisla Mary Silva Soares, Marcelo Faveri, Nidia Castro dos Santos, Yasmin Teixeira das Gracas, Maria Luisa Silveira Souto, Marcela Giudicissi, Giuseppe Alexandre Romito, Luciana Saraiva, Claudio Mendes Pannuti, Luciene C. Figueiredo, Magda Feres
Summary: This study evaluated the frequency of side effects associated with MTZ + AMX intake in periodontal treatment and explored the relationship between these events and patients' characteristics. The frequency of side effects varied between the antibiotic and placebo groups, with diarrhea and metallic taste being more common in the antibiotic group. Factors such as diabetes, taking antibiotics during the healing phase of treatment, and being a female patient aged ≤49 significantly increased the chances of reporting adverse events.
JOURNAL OF CLINICAL PERIODONTOLOGY
(2022)
Article
Critical Care Medicine
Eleanor K. Mishra, Sanjeevan Muruganandan, Allan Clark, Rahul Bhatnagar, Nick Maskell, Gary Lee, Najib M. Rahman
Summary: Breathlessness, measured using VASD at baseline and postprocedure, is a predictor of survival in patients with MPE. This includes baseline VASD and mean 7-day and total VASD. Other predictors of survival include serum C-reactive protein level and tumor type.
Review
Pharmacology & Pharmacy
Haihuan Feng, Ying Zhao, Weihong Kuang, Yanping Dai, Xiaobo Cen, Feng Qin
Summary: This meta-analysis examined the adverse events in patients with ankylosing spondylitis treated with tumor necrosis factor alpha inhibitors. The analysis found that while serious adverse events were not significantly increased, common adverse events such as nasopharyngitis, headache, and injection-site reactions were more frequent in patients receiving tumor necrosis factor alpha inhibitors compared to placebo.
FRONTIERS IN PHARMACOLOGY
(2023)
Review
Gastroenterology & Hepatology
Chong Chen, Liyu Chen, Dayong Sun, Cailan Li, Shiheng Xi, Shihua Ding, Rongrong Luo, Yan Geng, Yang Bai
Summary: This systematic review and meta-analysis evaluated the safety of intestinal microbiota transplantation (IMT). The results showed no significant increase in the incidence of serious adverse events and common adverse events with IMT. However, the delivery methods may affect the occurrence of common adverse events. To improve the safety of IMT, a thorough evaluation of patients' conditions and appropriate transplantation methods should be considered.
Review
Clinical Neurology
Leonie Reichelt, Orestis Efthimiou, Stefan Leucht, Johannes Schneider-Thoma
Summary: This study compares the risk of seizures between second-generation antipsychotics and placebo in randomized controlled clinical trials (RCTs), and finds that there is no evidence to suggest that second-generation antipsychotics cause seizures in most diagnostic groups.
EUROPEAN NEUROPSYCHOPHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Yanhong Yao, Zhentao Liu, Hua Zhang, Jian Li, Zhi Peng, Jinyu Yu, Baoshan Cao, Lin Shen
Summary: This study systematically reviewed the reporting of serious adverse events (SAEs) in phase III randomized clinical trials of colorectal cancer treatments and identified pharmaceutical company sponsorship, new drug research, and sample size greater than 1000 as positive influencing factors for SAEs reporting. Despite an increase in the reporting proportion of SAEs over time, further improvement in reporting quality is needed to guide real-world clinical practice.
FRONTIERS IN PHARMACOLOGY
(2021)
Review
Endocrinology & Metabolism
Hongyan Liu, Guoqi Wang, Ting Wu, Yiming Mu, Weijun Gu
Summary: This meta-analysis found that the use of ED-71 could improve bone mineral density (BMD) and fractures at various sites, especially compared with alfacalcidol or a combination with bisphosphonate for patients with osteoporosis. However, the use of ED-71 was associated with an increased risk of increased urine calcium level.
FRONTIERS IN ENDOCRINOLOGY
(2022)
Review
Pharmacology & Pharmacy
Rong He, Fei Lin, Bin Yu, Jingyue Qiu, Lingli Zheng
Summary: This study assessed the clinical efficacy and adverse events of delafloxacin for treating acute bacterial infections. The results showed that delafloxacin was comparable to the comparator antibiotics in terms of clinical cure rate, microbiological eradication rate, and adverse events.
FRONTIERS IN PHARMACOLOGY
(2022)
Meeting Abstract
Economics
C. Lefevre, M. Johnson, A. Maguire, S. Collings, S. Kloss, D. Evans
Meeting Abstract
Cardiac & Cardiovascular Systems
Cinira Lefevre, Michelle Johnson, Shuk-Li Collings, David Evans, Sebastian Kloss, Essra Ridha, Andrew Maguire
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
(2016)
Meeting Abstract
Cardiac & Cardiovascular Systems
Cinira Lefevre, Michelle Johnson, Shuk-Li Collings, David Evans, Sebastian Kloss, Essra Ridha, Andrew Maguire
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
(2016)
Article
Medicine, General & Internal
Michelle E. Johnson, Cinira Lefevre, Shuk-Li Collings, David Evans, Sebastian Kloss, Essra Ridha, Andrew Maguire
Meeting Abstract
Economics
H. Bonnemeier, M. Huelsebeck, S. Kloss
Review
Pharmacology & Pharmacy
John Wise, Angeli Moeller, David Christie, Dipak Kalra, Elia Brodsky, Evelina Georgieva, Greg Jones, Ian Smith, Lars Greiffenberg, Marie McCarthy, Michael Arendt, Olivier Luttringern, Sebastian Kloss, Steve Arlington
DRUG DISCOVERY TODAY
(2018)
Article
Pharmacology & Pharmacy
E. Garbe, S. Kloss, M. Suling, I. Pigeot, S. Schneeweiss
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
(2013)
Article
Public, Environmental & Occupational Health
Edeltraut Garbe, Marc Suling, Sebastian Kloss, Christina Lindemann, Ulrike Schmid
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
(2011)
Meeting Abstract
Economics
F. Volz, S. Kloss, F. Muschaweck, M. Wilke, F. Leverkus
Meeting Abstract
Economics
F. Kleinjung, T. Vaitsiakhovich, A. Gedranovich, V Hedranovich, S. Kloss, Y. Balabanova, B. Schaefer, D. Markouski
Meeting Abstract
Peripheral Vascular Disease
S. Kloss, R. Kreutz, H. Bonnemeier
JOURNAL OF HYPERTENSION
(2019)
Article
Public, Environmental & Occupational Health
Jeremy A. Rassen, Patrick Blin, Sebastian Kloss, Romain S. Neugebauer, Robert W. Platt, Anton Pottegard, Sebastian Schneeweiss, Sengwee Toh
Summary: This article provides an overview of the high-dimensional propensity score (hdPS) method and recommendations for its planning, implementation, and reporting in longitudinal healthcare databases. A checklist is provided as a decision tool to aid researchers and decision-makers in understanding and interpreting studies using hdPS techniques.
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
(2023)
Article
Cardiac & Cardiovascular Systems
Hendrik Bonnemeier, Maria Huelsebeck, Sebastian Kloss
IJC HEART & VASCULATURE
(2019)