RESEARCH - OTC naproxen trumps OTC ibuprofen for knee OA pain

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OTC naproxen trumps OTC ibuprofen for knee OA pain

Rheumawire

Aug 23, 2004

Mann

Denver, CO - Over-the-counter naproxen sodium at usual doses of 440 or

660 mg/day is better than ibuprofen (1200 mg/day) at relieving symptoms

of mild to moderate knee osteoarthritis (OA), according to a Hoffmann-La

Roche-funded study in the July 2004 issue of the Journal of

Rheumatology. The benefits of naproxen were particularly evident in

older patients, Dr Schiff (Denver Arthritis Clinic, CO) and Dr

Milos Minic (Hoffmann-La Roche AG, Basel, Switzerland) report [1]. " OTC

NSAIDs are a choice for our patients with mild OA, " Schiff tells

rheumawire. " Their safety is very good, and naproxen sodium has a good

dosing and efficacy profile. " (Roche markets nonprescription Anaprox and

Naprosyn naproxen products.)

The new study was a secondary analysis of 2 identical multicenter,

randomized, double-blind, placebo-controlled, multidose, parallel-design

studies conducted in the US. Both trials were completed in May and

October of 1996. In these trials, patients aged >25 years with OA were

randomized to receive daily doses of naproxen, ibuprofen, or placebo.

The naproxen dose was 660 mg, except that patients >65 years received

naproxen sodium at 440 mg. The ibuprofen dose was 1200 mg. Patients

received the blinded treatment or placebo for 7 days. They were observed

for 8 days.

The initial cohort included 461 patients with radiographic knee OA

changes documented within the previous 3 years and including at least 1

of the following: subchondral sclerosis; joint-space narrowing; presence

of osteophytes or marginal lipping; or cyst formation in the knee joint

typical of OA stage 1-3. All had episodic knee OA flares with at least

moderate pain on weight bearing. Nine patients either did not take study

medication or were lost to follow-up, leaving 452 patients in the safety

analysis: 148 randomized to naproxen, 152 randomized to ibuprofen, and

152 randomized to placebo. In the efficacy analysis 8 patients were

excluded for various reasons.

In the total population both investigator assessments and patient

assessments of knee joint pain showed that naproxen and ibuprofen were

better than placebo at relieving pain on passive motion, pain on weight

bearing, stiffness after rest, day pain, and 50-foot walk time. Only

naproxen significantly improved pain at rest and night pain compared

with placebo. Both treatments reduced the mean symptom score by 30% to

45%, compared with a 20% to 25% reduction with placebo.

For the subgroup of patients aged >65 years, naproxen sodium 440 mg was

significantly superior to placebo in all symptoms except pain on weight

bearing, while ibuprofen significantly reduced only day pain.

According to patient diaries, naproxen sodium and ibuprofen were both

effective in reducing all 6 symptoms (which included overall arthritis

pain control from study medication, overall pain last night,

difficulties experienced walking 1 block or climbing 1 flight of steps,

difficulties in walking several blocks or climbing several flights of

stairs, and difficulties in bending, lifting, and stooping). There was a

(nonsignificant) trend toward higher efficacy for nighttime pain with

naproxen compared with ibuprofen.

There were no significant differences in adverse events, the most common

of which were gastrointestinal side effects in all groups. The most

frequent single adverse effect was headache. One case of rectal

hemorrhage in the ibuprofen group was rated as mild and probably related

to study medication.

The researchers note, " Pain, especially during the night, is the most

common reason patients with OA seek medical help. " They conclude: " These

data indicate that in short-term management of OA of the knee, naproxen

sodium 440/660 mg on an as-needed basis provides patients with effective

analgesia, potentially enabling them to lead an active life and sleep

sufficiently at night. "

Source

Schiff M and Minic M. Comparison of the analgesic

efficacy and safety of nonprescription doses of naproxen sodium and

Ibuprofen in the treatment of osteoarthritis of the knee. J Rheumatol.

2004; 31:1373-83.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org