Between Patient Global Impression of Improvement and Changes in
Clinical Symptoms and Function: A Pooled Analysis of 4 Randomized
Placebo-controlled Trials of Duloxetine.
J Rheumatol. 2009 Oct 15. [Epub ahead of print]
Hudson JI, Arnold LM, Bradley LA, Choy EH, Mease PJ, Wang F, Ahl J,
Wohlreich MM.
From Harvard Medical School/McLean Hospital, Belmont, Massachusetts;
Women's Health Research Program, Department of Psychiatry, University
of Cincinnati College of Medicine, Cincinnati, Ohio; Division of
Clinical Immunology and Rheumatology, University of Alabama School of
Medicine, Birmingham, Alabama, USA; Sir Alfred Baring Garrod Clinical
Trials Unit, Department of Academic Rheumatology, Kings College,
London, UK; Division of Rheumatology Research, Swedish Medical Center
, and University of Washington, Seattle, Washington; and Lilly USA,
LLC, Indianapolis, Indiana, USA.
PMID: 19833743
OBJECTIVE: To investigate the relationship between changes in
clinical rating scale items and endpoint Patient Global Impression of
Improvement (PGI-I).
METHODS: Data were pooled from 4 randomized, double-blind,
placebo-controlled studies of duloxetine in patients with
fibromyalgia (FM). Variables included in the analyses were those that
assessed symptoms in FM domains of pain, fatigue, sleep, cognitive
difficulties, emotional well-being, physical function, and impact on
daily living. The association of endpoint PGI-I with changes from
baseline in individual variables was assessed using Pearson
product-moment correlations (r). Stepwise linear regression was used
to identify those variables for which changes from baseline were
statistically significant independent predictors of the endpoint
PGI-I ratings.
RESULTS: Changes in pain variables and interference of symptoms with
the ability to work were highly correlated (r >/= 0.5 or r </= -0.5)
with endpoint PGI-I. Moderate correlation with endpoint PGI-I (0.30
</= r < 0.5 or -0.5 < r </= -0.30) included changes in variables that
assessed physical functioning, depression, anxiety, fatigue, and
several variables related to impact on daily living. Independent
predictor variables of endpoint PGI-I identified by stepwise linear
regression included assessments for pain, physical function,
vitality, anxiety, social function, and tender point thresholds.
CONCLUSION: In addition to pain reduction, what makes patients with
FM feel better may include improvement in fatigue, physical
functioning, mood, and impact on daily living. An assessment of these
domains may be important in clinical trials of FM and in the
management of patients with FM.
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