Other adverse events: tendon rupture
The overall incidence of the AE term, tendon rupture, was low, occurring in six patients (0.3/100 PY) in the bempedoic acid group and no cases in the placebo group. These reports of tendon rupture are from CLEAR Harmony and CLEAR Wisdom trials, as no incidence of tendon rupture was reported in the CLEAR Serenity or CLEAR Tranquility trials. Although not a prespecified TEAE of special interest, the US Food and Drug Administration conducted a separate analysis of the data and identified 10 cases of what they considered to be tendon rupture or injury (
Supplemental Table 3)
17; of these, six patients had an AE term of tendon rupture, three patients had rotator cuff syndrome, and one patient had tendon injury (confirmed by the investigator to not be a rupture). The majority of patients with tendon rupture had sustained injury in the setting of trauma or other mechanical stress and/or had a medical history of tendon rupture or injury. Beyond hypercholesterolemia present in all patients, additional risk factors present for tendon rupture included male sex (n = 9), diabetes (n = 4), renal impairment (n = 1), and statin use (n = 10).