my personal edition > geriatrics > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Tramadol/Acetaminophen Effective in Elderly Patients with Chronic Back Pain: Presented at AGS

By Emma Hitt

BALTIMORE, MD -- May 20, 2003 -- The combination tablet of tramadol/acetaminophen appears to be safe and effective for treating lower back pain in patients 65 years or older, new research suggests.

According to the researchers, tramadol/acetaminophen has been shown to be effective for the treatment of pain associated with osteoarthritis flare in the elderly, while causing a low incidence of constipation. "Tramadol has a mixed analgesic profile, with mild mu-opioid activity and serotonin/norepinephrine reuptake inhibition, and has demonstrated efficacy for treatment of low back pain," they note.

Paul Peloso, MD, with the University of Iowa, Iowa City, reported the study findings here on May 16^th at the Annual Meeting of the American Geriatrics Society.

To evaluate tramadol/acetaminophen (37.5 mg/325 mg) for the treatment of back pain in the elderly, Dr. Peloso and colleagues conducted a pooled analysis of 2 multi-centre studies involving 660 patients. The subset analysis of elderly patients included 175 intent-to-treat patients, aged 65 years or older. Patients had back pain symptoms for at least 3 months and a Pain Visual Analog (PVA) score of at least 40 on a 0 to 100 scale. Mean PVA scores were 67.1 (tramadol/acetaminophen) and 67.5 (placebo).
Patients were randomised to receive tramadol/acetaminophen or placebo for 91 days.

Compared to patients receiving placebo, those receiving tramadol/acetaminophen had significantly improved PVA scores (mean score 44.9 versus 63.3 in treated versus placebo group, respectively; p<0.01). In addition, a greater number of patients receiving tramadol/acetaminophen reported "complete," "a lot," or "moderate" pain relief (58.2% versus 27.5%; p<0.01).

Other measures of pain relief and efficacy, including scores on the Short-Form McGill Questionnaire Present Pain Index and the Roland Disability Questionnaire were also significantly improved in the tramadol/acetaminophen group. Furthermore, the proportion of subjects discontinuing due to lack of efficacy was 23.5% in the tramadol/acetaminophen group versus 51.0% in the placebo group (p<0.01).

Overall, tramadol/acetaminophen appeared to be well tolerated. The most common adverse events in elderly patients were nausea (14.8% treated versus 2.1% untreated), dizziness (7.4% versus 2.1%), and vomiting (6.2% versus 2.1%).

"The incidence of treatment-limiting nausea, constipation, and vomiting among patients receiving tramadol/acetaminophen was higher for the elderly group than for the patients <65 years old," the researchers note.

"These results suggest that the combination tablet tramadol/acetaminophen is effective and safe for treating chronic lower back pain in the elderly," they conclude.

The study was funded by Ortho-McNeil Pharmaceuticals, marketers of Ultracet™ (37.5 mg tramadol/325 mg of acetaminophen).


[Study Title: A Pooled Analysis of Tramadol/Acetaminophen Tablets for Treatment of Lower Back Pain in an Elderly Patients Population. Abstract P301]

E-Mail this DGDispatch to a colleague

To print, use this version