Risk of Tendon Disease with Third Generation Aromatase Inhibitors Based on FAERS Database Mining and Analysis

OBJECTIVE  To explore the risk of tendon disease with third-generation aromatase inhibitors (AIs) by mining and analyzing the FAERS database.

METHODS  Based on FAERS data from Q1 2004 to Q3 2022, disproportionality analysis and Bayesian analysis were used to detect AIs and tendon disease signals and to analyze the clinical characteristics, onset time, and association of tendinitis, tenosynovitis, and tendon rupture associated with third-generation AIs.

RESULTS  A total of 26129 adverse event reports of AIs and 148 reports of tendon disease were extracted. Positive signals for tendonitis, tenosynovitis and tendon rupture were detected for all three AIs drugs. In contrast to anastrozole and letrozole, exemestane might not correlate with tendon rupture ROR 1.41 (95% CI<1), PRR 1.41 (χ²<4). Anastrozole had the strongest statistical correlation with tendonitis with the highest positive signal values (ROR 7.72, PRR 7.67, IC 2.93, EBGM 7.64) and exemestane had the strongest correlation with tenosynovitis (ROR 10.4, PRR 10.35, IC 3.37, EBGM 10.34). The median onset of anastrozole-associated tendonitis, tenosynovitis, and tendon rupture was 390, 570 and 495 d, respectively; the median onset of letrozole-associated tendonitis and tenosynovitis was 30 and 45 d, respectively, and the median onset of tendon rupture was 765 d; and the median onset of exemestane's tendonitis and tenosynovitis was 360 and 150 d, respectively.

CONCLUSION  This study identifies trends in the risk of tendon disease due to third-generation AIs by analyzing FAERS data, providing reference for identifying adverse events in AIs-induced tendonitis, tenosynovitis, and tendon rupture.