Postmarketing Surveillance for $Ultracet^{\circledR}$(Tramadol 37.5mg/Acetaminophen 325mg)

울트라셋$^{\circledR}$(Tramadol 37.5mg/Acetaminophen 325mg)정 시판 후 조사

Background: This is postmarketting surveillance to evaluate the efficacy and safety of tramadol/acetaminophen in patients with painful musculoskeletal diseases. Methods : A total of 890 patients (male 157, female 733) were included in the department of rheumatology at 24 hospitals from January, 2003 to November, 2003 who had taken tramadol/acetaminophen at least 2 weeks to manage the pain. Outcome measure was pain relief examined through numeric rating scale (NRS), and adverse events were monitored. We analyzed the relation between adverse events development and age, sex diagnosis, combined analgesics or NSAIDs, and drug dose by multiple logistic regression method. Results : Patients with osteoarthritis (69.1%), rheumatoid arthritis (17.1%), fibromyalgia syndrome (2.8%), ankylosing spondylitis (1.0%), systemic lupus erythematosus (0.7%), Behcet's disease (0.7%), and other diseases were included in order. Pain examined by NRS was significantly lowered after use of tramadol/acetaminophen medication; before $6.58{\pm}1.45$, after $4.17{\pm}1.78$ ($p=2.15{\times}10^{-22}$). This effect on pain relief was apparent in subgroups with moderate (NRS 4-6) and severe (NRS 7-10) pain before use of tramadol/acetaminophen, but not in subgroup with mild (NRS $1{\sim}3$) pain. The adverse events occurred in 75 patients (8.4%), and were nausea (32), vomiting (18), dizziness (15), abdominal discomfort (10), dyspepsia (6), anorexia (6), malaise (5), constipation (4), and micturition disorder (3) in order. Only age was associated with the development of adverse events in multiple logistic regression analysis. Conclusions : Tramadol/acetaminophen effectively managed pain in various musculoskeletal diseases, especially in patients with moderate to severe painful condition, and no other adverse event was reported except those listed in insert paper.