Download Susannah Hall, ExcelleRx, Inc, Rollin M. Gallagher

187
Abstracts
Clinical Research
THE CORRELATION BETWEEN THE
FIBROMYALGIA IMPACT QUESTIONNAIRE AND
THE HEALTH STATUS QUESTIONNAIRE:
IMPLICATIONS FOR USE IN PAIN STUDIES
In recent years, there has been increased attention to
quantifying psychosocial variables associated with fibromyalgia and other pain populations. It is widely recognized that patient perception of functioning has a great
influence on overall adaptation to chronic pain and motivation for rehabilitation. Two psychometric scales have
been used for this purpose, the Fibromyalgia Impact
Questionnaire (FIQ) and the Health Status Questionnaire (HSQ). The FIQ was developed as a specific measure of the impact of fibromyalgia has across several do-
mains. These include specific physical symptoms, physical
functioning, ability to work and perform activities of
daily living, and emotional functioning. The FIQ has
good psychometric properties and has been well validated in a number of studies. By its nature however, its
use is confined to this specific pain population. The
HSQ has been designed to be a measure of perceived
health and functioning in a more general medical population. In our experience with both of these measures it
seemed that there would be significant overlap in the
measured constructs. This study compared the subscales
of the FIQ with the Physical Functioning Subscale and
the Mental Health Subscale from the HSQ. All comparisons using a Pearson Correlation were significant at p 0.001. These results indicate a high degree of overlap
between these two measures. This overlap further confirms the construct validity of the FIQ. Further, since
these two measures appear closely related, the use of the
HSQ in other pain populations could be considered a
valid measure of functioning and perceived health status.
Both of these measures have adequate reliability and
show changes when used as treatment outcome variables.
Research
A DESCRIPTIVE ANALYSIS OF LONG-ACTING
OPIOID USE IN END-STAGE CANCER PATIENTS:
CORRELATION OF AGE, GENDER, AND PRIMARY
SITE WITH DOSE
Susannah Hall, ExcelleRx, Inc, Rollin M. Gallagher,
MCP Hahnemann School of Medicine, Calvin
Knowlton, ExcelleRx, Inc, and Douglas Weschules,
ExcelleRx, Inc.
Long-acting opioids are considered to be the cornerstone of cancer pain treatment, especially in the hospice
patient. Increasing age has been associated with decreased opioid requirements in cancer and post-operative patients, although published reports do not agree
about the age at which this decreased requirement appears. In terminal cancer patients, there are mixed reports as to whether an association between gender and
opioid dose exists. Possibly the presence of relatively
more or less painful gender-specific cancers contributed
to those differing results. Some studies suggest that certain primary cancer sites require higher opioid doses
than others, but few have controlled for age. The objective of this retrospective analysis is to describe the correlation of age, gender, and primary cancer site with longacting opioid doses prescribed for hospice patients at the
end of life, defined as the last long-acting prescription
written prior to death. All hospice patients admitted to a
North American palliative care specialty pharmacy between 4/1/00 and 3/31/01 with the primary diagnosis of
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Emergency room visits by chronic pain patients who experience episodic pain flares are an expensive, time-consuming public health problem. Available opioid agents
for at-home, patient self-treatment consist of short-acting oral, suppository, or injectable compounds which
have delayed, inconsistent, or unpredictable analgesic effects. Oral transmucosal fentanyl citrate (OTFC) is a
new potent, opioid preparation used by buccal or sublingual routes, and it produces potent analgesic effects
equal to intravenous morphine within 5 to 10 minutes.
To determine if OTFC is effective and safe for at-home
treatment of emergency pain flares, 90 chronic pain patients with a variety of painful conditions were treated
with a long-acting opioid consisting of transdermal fentanyl, methadone, or a sustained release oxycodone or
morphine preparation. All additionally used a short-acting oral, suppository, or injectable opioid for self-treatment of emergency flares. All were given OTFC to alternatively substitute for their current opioid to self-treat
emergency flares. Patients were surveyed after three or
more months of OTFC use, and 86 (95.6%) believed
they could safely and effectively treat their emergency
pain flares with OTFC. Seventy-one (78.8%) believed
OTFC had prevented the necessity to attend an emergency room or enter a hospital for pain control. Fortyfive (50.0%) patients had collectively used OTFC for
375 months and during this period could specifically estimate, based on their previous experience, they had
avoided 474 emergency room and 220 hospital admissions. This translates to 1.26 emergency room and 0.6
in-patient admissions per month per patient. There were
no emergency visits in the entire group during the study
period, and 76 (84.4%) preferred OTFC over their current emergency opioid. OTFC warrants further study
for self-treatment of emergency flares to improve patient
care and reduce costs.
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0.510; and AUC0–24h (nghr/mL) 6.911 ( 2.558) vs.
6.123 ( 2.452). The incidence of the most common adverse events (asthenia, vasodilatation, headache, nausea,
and somnolence) was similar between treatments. No serious AEs were reported.
Conclusion: The PK and safety of ACTIQ administered as two simultaneous 400 g doses are comparable
to a single 800 g dose. These results support expediting
titration of ACTIQ by allowing patients to use two doses
simultaneously to match the effect derived from an
equivalent single higher dose. This may allow more
rapid and efficient management of BTP.
Support: This study was supported by Cephalon, Inc.,
West Chester, PA.
Clinical Cases
THE PHARMACOKINETICS (PK) AND SAFETY OF
ORAL TRANSMUCOSAL FENTANYL CITRATE
(OTFC®) ADMINISTERED TO HEALTHY
VOLUNTEERS AS TWO 400 g ACTIQ® DOSES OR
AS A SINGLE 800 g ACTIQ® DOSE
THE SUCCESSFUL APPLICATION OF MEDITATIVE
PRINCIPLES TO TREATMENT REFRACTORY
PAIN CONDITIONS
Talmage Egan, MD, Steven E. Kern, PhD, University
of Utah, University Hospital, Salt Lake City, UT,
Kiumars Q. Vadiei, PhD, RPh, FCP, Medical Affairs,
Cephalon, Inc., West Chester, PA
The potential psychological mechanisms mediating physically expressed pain are investigated through separate
yet related means in case studies. In case 1, pt BI suffered
from RSD/CRPS I and was treated with GSR and thermal, while in case 2 TT experienced a number of difficult conditions including biofeedback sciatica, acid reflux,
breast soreness, anxiety and headaches and was treated
with hypnotically induced meditation and self-induced
meditation. At three months into treatment, BI had reduced pain ratings by 40%, increased sleep time by a
factor of two. At four months into treatment, TT had
decreased pain ratings by 40% and decreased pain medications intake by 50%.
Although the treatment modalities themselves appear
disparate, they both involve the common underlying
theme of regulating attentional thought processes from
an intentional and conscious perspective. As applied to
pain states this is useful because each thought, feeling,
idea or perception involves some type of physical or
physiological response. Uncontrolled and unregulated
thought process of the mind can create (and through habituation maintain) offensive physiological conditions.
Extant examples include angina, hypertension, and tension headache. Specific methodology applied to the
above cases involved training in elements of Hinduist 1,
Buddhist2 and Taoist3 meditative principles with the goal
being the increase in and volitional directing of attention. This involved quieting the thought processes of the
mind and was accomplished in a variety of ways, including the utilization of external devices such as biofeedback
Background: Breakthrough pain (BTP) is a transient
exacerbation of pain that occurs on top of a background
of stable but persistent pain. ACTIQ® (oral transmucosal fentanyl citrate; OTFC®) is a novel product designed to deliver rapid analgesia for the treatment of
BTP. ACTIQ is available in 6 dosage strengths (200–
1600 g) to allow individualization of dosing. The effective dose is determined by titration and, an efficient titration process can maximize patient satisfaction. Titration could be expedited and made more efficient by
simultaneously dosing with two units instead of a single
equivalent higher dosage unit. This study evaluated the
PK and safety of simultaneous administration of two
ACTIQ 400 g doses compared with a single 800 g
dose.
Methods: An open-label, randomized, 2-period, crossover study was conducted in 12 healthy opioid-naïve volunteers. Treatments, separated by a 1-week washout period, were: two simultaneous ACTIQ 400 g doses and a
single 800 g dose. Venous fentanyl blood concentrations (serum) were assayed by validated LC/MS/MS.
Results: The disposition of fentanyl did not differ between treatments, as supported by the following PK parameters for the 2400 g and 1800 g ACTIQ
doses, respectively: mean ( sem) Cmax (ng/mL) 1.090 (
0.228) vs. 1.097 ( 0.508); median Tmax (hr) 0.582 vs.
Daniel M. Rockers, Ph.D. University of California,
Davis, Sacramento, CA
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cancer and who were prescribed transdermal fentanyl,
sustained release oral morphine, or sustained release oxycodone were included in this analysis. A total of 7201
patients met the inclusion criteria. Age was a highly significant determinate of dose (p 0.0001) with patients
prescribed increasingly lower long-acting opioid doses
with each decade of life. The final morphine equivalent
dose of long-acting opioid prescribed prior to death was
60 mg/day in 25.7% of patients 40–49 years, 29.1% of
patients 50–59 years, increasing to 57.8% of patients
80–89 years, and 69.6% of patients 90 year. The sexes
were compared for lung, colorectal, and pancreatic cancer separately and no significant difference between the
sexes was found by Chi-square test, nor by logistic regression with age controlled. The correlation of the primary site of cancer with the final prescribed long-acting
opioid dose will be presented.
Abstracts