RESULTS
Characteristics Analysis
After data cleaning, we retrieved a total of 11450529 cases from January
2004 to December 2019, 5414695 of which were reported by health
professionals. We screened 35251 PPIs-associated adverse event cases and
326943 dementia cases reported by health professionals (Figure 1). We
further identified 2104 PPI users with dementia events reported by
health professionals (Table 1). No case was identified for
dexrabeprazole.
Among cases reported with age, the proportion of PPI users with dementia
events was larger in below-65-year group than other age groups. Female
cases were reported more than male, the ratio of female proportion
versus male proportion were 1.41.
Other health professional (51.47%) reported the most cases, followed by
physician (35.46%) and pharmacist (13.07%). Great Britain (27.23%)
reported the most cases, followed by France (16.21%) and United States
(15.9%). The number of PPI users with dementia events was almost
increasing year by year (Figure 2).
Signal Detection
We first conducted signal detection based on all PPIs indications,
detected no significant signals between PPIs use and dementia events,
ROR = 0.99, 95%CI 0.94 - 1.03, PRR = 0.99, 95%CI 0.95 - 1.03. We then
conducted signal detection in individual PPI regimens, detected no
significant signals in all the six PPIs as well (Table 2).
We further conducted signal detection based on cases with the indication
of GERD, 303 dementia cases were gathered out of 7537 PPI users with
GERD indication reported by health professionals in FAERS. However, no
significant signal between each PPIs treatment and dementia events was
detected, ROR = 0.65, 95%CI 0.58 - 0.73, PRR = 0.67, 95%CI 0.60 - 0.74
(Table 2).
Time Event Comparison
We estimated the time interval
from PPIs use to adverse events onset, comparing dementia event between
short- and long- time interval groups. 457 dementia cases were
identified out of 8848 PPI users with time interval data reported by
health professionals in FAERS. We divided different short- and long-
time interval with 6 months, 1 year, 3years and 5 year. However, no
significant difference was found between each short- and long- time
interval groups (Table 3). The OR value (95%CI) of the 6 months, 1
year, 3 years and 5 years comparison were 0.85 (0.68 - 1.06), 0.92 (0.71
- 1.18), 0.81 (0.57 - 1.15) and 0.79 (0.52 - 1.22), respectively.