Læknablaðið : fylgirit - 01.05.1978, Page 81

passive hip movement in flexion, in internal, and
in external rotation; intermalleolar distance,
time (in seconds) to walk 50 feet, the investiga-
tor's rating as to overall disease activity as well
as globai response.
Of 91 patients entered into the study, only 70
were used for analysis of efficacy. Ten patients
were excluded because 4 investigators failed to
enter at least 2 patients into each treatment group.
Another 11 were excluded, 6 because of high
salicylate levels, 3 for technical reasons, and 2
because of adverse reactions.
Of the 70 patients, 22 received sulindac b.i.d. ,
23 sulindac q.i.d. , and 25 placebo.
The significance level for the sulindac placebo
comparisons achieved a p value of less than 0.05
to 0.01 for 11 of the 15 parameters tested.
These are listed here. The variable analyzed
for each parameter was the change from flare
to the last available examination, using the
Kruskal-Wallis nonparametric analysis of variance.
In only 4 parameters did we fail to distinguish one
or both sulindac groups from the placebo. These
were: a specific function, flexion deformity,
external rotation, and time to walk 50 feet.
The optimal dose of sulindac proved to be 300
mg, as all but 11 patients needed this amount
for maximum benefit.
As for adverse reactio'is, there were no
differences among the 3 treatment groups. These
occurred in 6 patients on sulindac b.i.d. , in 10
on sulindac q.i.d. , and in 7 on placebo.
Adverse reactions were cerebral in 12 in-
stances, with headache and tinnitus confined to
patients receiving sulindac. Dizziness and
insomnia were noted with both sulindac and
placebo.
There were 14 gastrointestinal reactions;
except for diarrhea, these occurred only with
sulindac.
Of the remaining side effects, mucocutaneous
reactions were Umited to patients receiving
sulindac. The others were found primarily
among patients on placebo. Only 2 patients
were dropped from the study because of adverse
reactions.
Our battery of laboratory tests revealed no
evidence of renal, hepatic, or hematopoietic
abnormalities due to sulindac.
The results of this trial clearly demonstrate
that sulindac is a safe and effective agent in
the therapy of patients with osteoarthritis of the
hip. A long-term multi-clinic trial is currently
in progress.
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