Tolerability and safety of duloxetine in a population of depressed patients with painful physical symptoms: results of a 6-month naturalistic study

Purpose: Safety of duloxetine (DLX) in depressed patients (pts) was observed in routine clinical care. Methods: Multicenter, prospective, 6-month observational study in adult outpatients with a depressive episode (ICD-10) starting DLX treatment, with solicited treatment emergent adverse events (TEAEs) reporting by general question. Results: Of 4,517 pts enrolled at 693 centers in Germany (mean age 52.2yrs, 71.8% fe-male), 4,313 could be included for TEAEs evaluation. 45.2% of the pts had concomitant psychiatric and 72.1% concomitant somatic diseases, and moderate to severe overall pain (VAS >30mm) was reported by 80.0% of pts. Concomitant pain medication was taken by 32.3% (permanent at BL) and 60.9% (on demand last 12 mth) pts. 1404 pts discontinued within 6 months (TEAEs: 119; other reasons: 415; no information: 870). 72.9% of pts started DLX with 30mg/d. At 4 wks 83.2% of pts were treated with ≥60mg/d. TEAEs occurred in 741 pts (17.2%). Related TEAEs (≥1%) included nausea, hyperhidrosis, vertigo, restlessness, sleep disorder and dry mouth. Serious TEAEs were reported by 34 pts (0.8%), including one case of suicidal ideation. Hospitalization for depression occurred in 132 (3.1%) pts. No relevant change in mean weight was observed from BL (77.1±15.6kg) to 6 mths (76.9±14.8kg). Conclusions: The TEAEs reported during DLX treatment in routine clinical use in a de-pressed patient population – with concomitant pain in the majority – were similar to previous studies.

This study was supported by Lilly Deutschland GmbH, Bad Homburg, and Boehringer Ingelheim, Germany.