TEDDI - Knee Pain

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Extended-Release Tramadol Reduces Symptoms of Chronic Knee Pain

Emma Hitt, PhD

Oct. 27, 2002 (New Orleans) — In patients with knee osteoarthritis, a

once-a-day extended-release (ER) formulation of tramadol (Ultram)

appears to improve symptoms of chronic pain, new research suggests. The

findings were presented here Saturday at the American College of

Rheumatology (ACR) 66th Annual Scientific Meeting.

The current form of tramadol, marketed as Ultram, has a short half-life

that necessitates dosing every four to six hours. In contrast,

once-daily tramadol ER " offers the advantage of patient convenience and

should minimize peak-to-trough fluctuation, " said Albert, PhD,

senior author and researcher with Biovail Technologies in Chantilly,

Virginia.

Tramadol ER is " on target " to receive US Food and Drug Administration

approval in mid-2003, Dr. Albert told Medscape.

To evaluate the efficacy of tramadol ER compared with placebo, Dr.

Albert and colleagues conducted a randomized trial of 246 patients with

radiographically confirmed knee osteoarthritis. All patients were at

least 50 years of age and experienced morning stiffness of less than 30

minutes in duration or crepitus, or both.

Patients underwent a two- to seven-day washout period during which they

stopped taking any analgesics. When pain at the knee joint reached a

level of 40 mm on a visual analogue scale (VAS) scale of 0 to 100 mm,

they were randomized to receive tramadol ER (n=124) or placebo (n=122).

Tramadol ER was first given at a dose of 100 mg once daily, and this was

increased to 200 mg once daily after one week. When necessary,

subsequent doses of 300 mg or 400 mg per day were given. Overall, the

mean study dose was 275 mg per day.

Various measures of arthritis pain and functional ability were assessed,

including arthritis pain intensity VAS, WOMAC VAS, stiffness, physical

function subscale scores, patient and physician global assessment of

therapy, and sleep quality.

Over 12 weeks, average decrease from baseline in arthritis pain

intensity VAS was 30.1 mm in patients receiving tramadol ER compared

with 16.1 mm in patients receiving placebo (P<.001), the researchers

report.

Other measures of arthritis pain and disability were also improved with

tramadol ER compared with placebo, with significance levels of

differences ranging from P<.001 to P<.05. Differences from placebo were

evident as early as week one, they point out.

Regarding safety, " over 90% of adverse events were rated mild or

moderate in severity, " the researchers report.

However, the incidence of adverse events was significantly greater in

patients receiving tramadol ER compared with those receiving placebo,

and included nausea, vomiting, fatigue, and dizziness.

Sidney Block, MD, an ACR member and rheumatologist in private practice

in Bangor, Maine, told Medscape that the study does indicate that

tramadol ER is effective and relieves pain more than placebo. He also

pointed out that the extended-release version is likely to result in a

more even dose and a potential reduction in adverse effects such as

dizziness and grogginess compared with the current form of tramadol.

However, Dr. Block noted that the study did not directly compare the

effectiveness of tramadol ER to tramadol or other medications, " for

example, we don't know how its efficacy compares to that of codeine,

nonsteroidal anti-inflammatory drugs, and other pain medications, " he

said.

" Tramadol ER will be used, " he said, " but my prediction is that its use

will be limited because of cost. " Attempts to change diet and lifestyle

and less expensive treatments such as acetaminophen, glucosamine, and

propoxyphene napsylate (Darvocet) are indicated before the use of

tramadol, he said.

The study was funded by Biovail Corporation.

ACR 66th Annual Meeting: Abstract 331. Presented Oct. 26, 2002.

Reviewed by D. Vogin, MD

Emma Hitt, PhD, is a freelance writer for Medscape.

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