3. Results
3.1Characteristic analysis
of AE reports
The FAERS databse contained a total of 55,949 AE reports associated with
pirfenidone and 35,884 reports associated with nintedanib (Figure 1).
These numbers exceeded the corresponding figures reported in the
VigiAccess database (37,187 and 23,134). Furthermore, the occurrence of
cases was more frequent in males than in females for both drugs in both
databases (Pirfenidone: 60.09% vs. 36.73% in the FAERS database;
63.36% vs. 33.45% in the VigiAccess database, Nintedanib: 55.98% vs.
38.66% in the FAERS database; 59.17% vs. 34.94% in the VigiAccess
database). In terms of age distribution in the FAERS database, patients
over the age of 65 were more likely to report AE, accounting for 16,716
(29.88%) in pirfenidone and 20,330 (56.65%) in nintedanib. Similar
results were shown in the VigiAccess database (14,409, 38.75%; 13,245,
57.25%). However, more than half of cases (20,047, 53.91%) lacked age
information for pirfenidone. The main reporting continent was Americas
for both drugs in both databases. Among the all cases, the most severe
outcome was hospitalization (10,869, 19.43% for pirfenidone; 17,433,
48.58% for nintedanib). In addition, AE reports for these drugs showed
an increasing trend over the years.