Research on Beers Criteria and STOPP/START Criteria based on the FDA FAERS database

Abstract

Purpose: Inappropriate medication criteria for the elderly have played an important role in ensuring the safety of medications for the elderly. Too few drugs included in the criteria cannot guarantee the safety of medication for the elderly. Too many drugs included in the criteria will result in less selective medication for the elderly. This paper uses real-world data to evaluate the relationship between antihypertensive drugs and falls, so as to provide references for experts and scholars to revise the criteria of potentially inappropriate medications for the elderly and clinical safe medication.

Method: We use the US Food and Drug Administration Adverse Event Reporting System (FDA FAERS) to evaluate the association between specific antihypertensive drugs in six categories (alpha-1 receptor blockers (α-1 blockers), calcium channel blockers (CCBs), angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), beta-receptor blockers (β-blockers), and diuretics) and falls by data mining algorithms, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), Medicines and Healthcare Products Regulatory Agency (MHRA), and the empirical Bayes geometric mean (EBGM) and compared with the relevant drugs included in the Beers Criteria and STOPP/START Criteria.

Result: There are a total of 5,157,172 co-occurrences found in 973,447 reports aged 65 years or older from 2016 to 2019 in the FDA FAERS database, and the number of co-occurrences of falls is 5917 for the six categories of 51 antihypertensive drugs. Four kinds of mining methods overlap detection of 12 kinds of positive signal drugs, none of which are not included in the Beers Criteria and 7 drugs are included in the STOPP/START Criteria; 1-3 kinds of mining methods overlap detection of positive signal drugs, a total of 12 kinds, and one drug is included in the Beers Criteria and 5 drugs are included in the STOPP/START Criteria; 22 drugs have fall adverse events, but no positive signal is detected, and 13 drugs are included in STOPP/START Criteria; and 5 drugs have no fall adverse events and 3 drugs are included in the STOPP/START Criteria.

Conclusion: The FAERS database was used to confirm the potential connection between some antihypertensive drugs and fall adverse events through data mining algorithms. The Beers Criteria did not clearly indicate the antihypertensive drugs that caused falls, and the antihypertensive drugs included in the STOPP/START Criteria were too extensive and did not include β-blockers and diuretics. It is recommended that experts and scholars use real-world data (such as FAERS, EudraVigilance, WHO VigiBase, and so on) to further explore the relationship between specific antihypertensive drugs and falls in the elderly, so as to revise and improve the criteria for inappropriate medications for the elderly.

Keywords: Antihypertensive drugs; Beers Criteria; FAERS; Fall; STOPP/START Criteria.