Real-world safety of aliskiren in primary hypertension: A cross-database study

by Meirong Shan, Qian Guo, Ruofei Li, Ni Li, Yanhua Fu, Huanyu Qi, Ge Zhang, Qian Wang, Xingli Xu, Jinchuan Lai

Hypertension is one of the main causes of cardiovascular diseases worldwide, affecting over one billion people. Although aliskiren offers a valuable option for inhibiting the renin-angiotensin system, its safety profile in the real world remains insufficiently explored, especially for rare or under-recognized adverse events (AEs), which have not been fully clarified. Therefore, leveraging large-scale post-marketing surveillance data is crucial for identifying rare AEs and guiding safer clinical practice. This study aims to elucidate pharmacovigilance signals associated with aliskiren (an antihypertensive drug) by systematically analyzing the characteristics of adverse events (AEs) from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database and WHO-VigiAccess database, which provides a reliable scientific basis for clinical practice and regulatory decision-making. We conducted a retrospective quantitative analysis of aliskiren-related AE reports from the aforementioned two databases, employing the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) algorithms for signal detection. The results indicate that there were 5,596 and 5,549 aliskiren-related reports in the FAERS and WHO-VigiAccess databases, respectively. The median duration of these AEs during the observation period was 62 days, with an interquartile range (IQR) of 7–282 days. In both databases, signals for aliskiren were distributed across 28 System Organ Classes (SOCs), among which investigations, cardiac disorders, renal and urinary disorders, vascular disorders, and metabolism and nutrition disorders exhibited significant signals based on specific criteria applied across the four algorithms. A total of 607 preferred terms (PTs) with significant disproportionality signals were detected using the four algorithms, including potential AEs not previously well-documented, such as palpitations, myalgia, proteinuria, muscular weakness, pulmonary edema, and pollakiuria. This study not only confirms the known adverse reactions of aliskiren but also uncovers new potential risks, highlighting the importance of strengthening drug safety monitoring to enhance therapeutic efficacy and reduce the risk of adverse reactions. It provides valuable safety insights for physicians considering the use of aliskiren in the management of primary hypertension.

Effect of race and sex on lupus diagnosis in primary care: A randomized factorial survey study

by Alyssa Howren, Quan L. Tran, Sadaf Sediqi, Saadiya Hawa, Douglas K. Owens, Eleni Linos, Titilola O. Falasinnu, Yashaar Chaichian, Julia F. Simard

Background

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune rheumatic disease whose epidemiology and clinical prognosis vary by race and sex. Observed disparities in SLE may be partly attributable to cognitive processes in clinical decision-making, which can influence diagnostic accuracy and clinical management. We aimed to examine variation in primary care physicians’ (PCP) diagnosis and management of SLE when all content of a clinical case is identical, apart from race and sex.

Methods

We distributed an online randomized factorial survey from 04/11/2024–06/10/2024 to PCPs across the US. Participants were presented with one of four possible SLE vignettes – Black female, White female, Black male, White male – for which all other clinical content was identical. Block randomization was used to randomly modify the race (Black/White) and sex (female/male) of the SLE “case”. Primary outcomes were correct text-based responses for SLE diagnosis at initial case presentation and after reviewing additional lab results. Secondary outcomes were participants’ review time and planned next steps (treatment, referral, tests) as a proxy for cognitive bias and certainty, respectively. We calculated descriptive statistics for all outcomes stratified by assigned randomized factor and used chi-square tests to evaluate between-group differences.

Results

1031 PCPs (42.7% women, mean age 52.1 ± 12.1 years) completed the case. At initial presentation, 63.9% of participants correctly identified SLE as a differential diagnosis. An initial diagnosis of SLE significantly differed by the race and sex of the case (p  Conclusion

A patient’s race and sex may influence diagnostic accuracy and clinical decision-making for SLE in primary care. The observed variation in diagnostic accuracy, which aligns with the descriptive epidemiology of SLE, highlights the need for targeted interventions to ensure equitable diagnostic processes.