8-week Safety Profile of Tapentadol Extended Release Tablets Switched from Other Opioids for Well-controlled, Moderate to Severe, Chronic Malignant Tumor-related Pain: Constipation, Nausea, Vomiting and Somnolence

ABSTRACT

It was previously reported the safety and efficacy of oral tapentadol ER switched from other opioids for 8 weeks in subjects with moderate to severe cancer pain, who received opioid analgesics prior to study participation. All treatment emergent adverse events were evaluated in previous safety analysis. In this report, the incidence and timing of opioid specific adverse events related to tapentadol administration were analyzed and compared with those of morphine SR as a reference. Fifty subjects each was randomized to the tapentadol ER group and the morphine SR group. The incidences of major adverse events that are considered related to treatment in the tapentadol ER group and the morphine SR group were nausea (8.0%, 14.0%), vomiting (2.0%, 24.0%), constipation (8.0%, 20.0%), and somnolence (8.0%, 18.0%), the incidences of these events were lower in the tapentadol ER group. These results suggest that tapentadol ER is a orally opioid which has well safety profiles, and is a new option of cancer pain therapy.