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Oct. 12, 2004 (Stockholm) — Patients with fibromyalgia get
relief of their symptoms from a controlled-release formulation of
paroxetine (Paxil), according to investigators who presented their
findings here at the 17th congress of the European College of Neuropsychopharmacology.
These findings could represent a turning point for patients, because
their symptoms typically do not respond to other pharmaceutical
strategies, said principal investigator Ashwan A. Patkar, MD, in
a presentation. "Most patients in the treatment group had a
25% or greater reduction in the impact of fibromyalgia compared
to those on placebo," said Dr. Patkar, an instructor in the
Department of Psychiatry and Human Behavior at Thomas Jefferson
University in Philadelphia, Pennsylvania. "Therefore, paroxetine
may have a role in the treatment of fibromyalgia."
Dr. Patkar and coinvestigators investigated the efficacy and tolerability
of paroxetine controlled release for fibromyalgia in a 12-week randomized,
placebo-controlled, double-blind design. They screened 180 patients
and randomized 116 to receive paroxetine controlled release or placebo
for 12 weeks. Of the 74 patients excluded, nearly half (48%) had
a current depressive disorder.
Of the subjects, 94% were women and 71% were white. They were an
average of 48 years old, with 58% married and 63% employed. The
investigators found no significant differences in baseline characteristics
between patients in the drug and placebo groups. Those in the treatment
group received doses of 12.5 mg to 62.5 mg per day, with an average
dose of 32.3 mg per day.
The study design defined the primary efficacy measure as at least
a 25% reduction in scores on the Fibromyalgia Impact Questionnaire
(FIQ) from randomization to the study's end. The investigators also
used the Clinical Global Impression-Improvement (CGI-I) and Clinical
Global Impression-Severity (CGI-S) instruments, as well as the visual
analogue scale (VAS) for pain.
Of the 116 enrollees, 85 (73%) completed the study. Of these, 57%
in the treatment group had at least a 25% reduction in the FIQ compared
with 33% in the placebo group (P = .016). When the investigators
used the FIQ score in a survival analysis, results showed that controlled-release
paroxetine was superior to placebo during the study period (P =
.001).
The treatment group had an average improvement of 58% on CGI-I
scores compared with an average improvement of 25% in the placebo
group (P = .002). However, the investigators saw no significant
differences between the drug and placebo groups on their rates of
25% and 50% reductions in their VAS scores. Despite the similarity
on this measure, the lessened impact of the disease in the treatment
group shows the drug's potential in fibromyalgia, Dr. Patkar said.
The adverse-effect profile was generally mild, with 31% in the
treatment group and 6% in the placebo group reporting drowsiness
(P = .012). Patients in the treatment group also were more likely
to have dry mouth (36% of paroxetine patients vs 9% of placebo patients;
P = .009).
ECNP 17th Congress: Abstract P.3.037. Presented Oct. 11, 2004.
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