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Opioid induced constipation negatively impacts pain management

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Opioid induced constipation negatively impacts pain management Powered By Docstoc
					                                                      Opioid-induced constipation compromises pain management
                                                                   and impacts patient quality of life
                                                                                                    John Leslie, MD, MBA1; Timothy Bell, MHA2; Katherine Annunziata, MA3; Deborah Freedman3
                                                                                         1
                                                                                          Mayo Clinic College of Medicine, Scottsdale, AZ, USA; 2GlaxoSmithKline, Research Triangle Park, NC, USA; 3Consumer Health Sciences, Princeton, NJ, USA




Updated abstract                                                                                   Objective                                                                                Pain severity                                                                                                                                         Figure 4. Presence of ≥1 other opioid-induced side effect in respondents with
                                                                                                                                                                                                                                                                                                                                                  opioid-induced constipation and without opioid-induced constipation
                                                                                                   G The objective of this analysis of the large National Health and Wellness Survey        G Pain severity was significantly greater in individuals reporting opioid-induced
Objective: Constipation is the most common of the opioid-induced bowel                                                                                                                                                                                                                                                                                                                                p<0.0001
                                                                                                      (NHWS) 2004 was to determine the impact of opioid-induced constipation on                constipation than in those without opioid-induced constipation (Figure 1).                                                                                          100
dysfunction (OBD) symptoms associated with opioid use for chronic pain.                                                                                                                                                                                                                                                                                                                                                                   No

This study documents the impact of opioid-induced constipation on                                     chronic pain management, work productivity, and patient health-related quality        Work productivity                                                                                                                                                                         21%                                                 Yes (≥1 other side effects)
                                                                                                      of life (HRQOL).
chronic pain management, work productivity, and patient health-related                                                                                                                      G Compared with individuals without opioid-induced constipation, those individuals                                                                                          75
quality of life (HRQOL).                                                                           Methods                                                                                     with opioid-induced constipation reported:




                                                                                                                                                                                                                                                                                                                                                      Respondents (%)
                                                                                                                                                                                               – higher percentage of work time missed                                                                                                                                                                                   78%
Methods: The effects of opioid-induced constipation on these patient-                              G The NHWS 2004 is a comprehensive, annual, cross-sectional study of a wide range           – greater impairment while working                                                                                                                                       50
reported outcomes have been evaluated using data from the National                                    of healthcare situations in the USA and three major European markets, in terms           – greater overall work impairment
                                                                                                      of demographics, resource utilization, and consumer attitudes and behaviors.                                                                                                                                                                                                    79%
Health and Wellness Survey 2004. This is a comprehensive, annual,                                                                                                                              – greater activity impairment (Figure 2).
                                                                                                      This poster focuses on US results only.                                                                                                                                                                                                                           25
cross-sectional study of a wide range of healthcare situations in the USA                                                                                                                   HRQOL
and three major European markets, in terms of demographics, resource                               G Data were collected via an internet survey from individuals in the USA receiving
                                                                                                                                                                                                                                                                                                                                                                                                                         22%
                                                                                                      opioids for chronic pain, and were analyzed according to those who reported           G On the mental and physical health components of the SF-8, mean scores were
utilization, and consumer attitudes and behaviors. Data were collected                                                                                                                                                                                                                                                                                                  0
                                                                                                      opioid-induced constipation and those who did not.                                       significantly worse in individuals with opioid-induced constipation than in those
from 2,137 individuals in the USA receiving opioids for chronic pain,                                                                                                                          without constipation (Figure 3).                                                                                                                                                With opioid-induced               Without opioid-induced
                                                                                                   G Pain severity was assessed by asking respondents to rate their pain as mild,                                                                                                                                                                                                  constipation                       constipation
and were analyzed according to those who reported opioid-induced
                                                                                                      moderate, or severe.                                                                  Other opioid-induced side effects
constipation (n=300) and those who did not (n=1,837). Pain severity was
assessed by asking respondents to rate their pain as mild, moderate,                               G Work productivity was evaluated using the Work Productivity and Activity Impairment    G Of those individuals experiencing opioid-induced constipation, 79% also had ≥1
                                                                                                      Questionnaire. 6
                                                                                                                                                                                               other opioid-induced side effect, including GI side effects (Figure 4).
or severe. Work productivity was evaluated using the Work Productivity
and Activity Impairment Questionnaire, and HRQOL was evaluated using                               G HRQOL was evaluated using the Short-Form 8 (SF-8) health survey.7                      Figure 1. Pain severity in respondents with opioid-induced constipation
the Short-Form 8 (SF-8) health survey.                                                             G Limitations of this methodology include:
                                                                                                                                                                                            and without opioid-induced constipation                                                                                                               Conclusions
                                                                                                      – potential misclassification bias as a result of self-reported opioid use and                          100
                                                                                                                                                                                                                                                                p<0.0001
                                                                                                                                                                                                                                                                                                                                                  G Chronic opioid recipients with associated opioid-induced constipation
Results: There were significant differences between the groups in terms                                                                                                                                                                                                                                            Severe
                                                                                                        opioid-induced constipation by respondents                                                                                                                                                                                                                    p<0.0001
                                                                                                                                                                                                                                                                                                                                                           have significantly more severe pain and impaired HRQOL, compared
                                                                                                                                                                                                                                                                                                                   Moderate                100%
of age (p<0.0001), race (p=0.0013), and education (p<0.0001), but not in                              – potential for sampling bias due to self-selection for participation                                                                                                                                        Mild                                    with those without constipation.
gender or income. The majority of respondents (99% with opioid-induced                                – unknown frequency/strength of opioid dosing.                                                               75                                                                       48%
                                                                                                                                                                                                                                        59%                                                                                                                               48%
constipation and 98% without opioid-induced constipation) experienced                                                                                                                                                                                                                                                                       75%




                                                                                                                                                                                                 Respondents (%)
                                                                                                                                                                                                                                                                                                                                                  G Whether patients take fewer opioid doses to try and minimize the
                                                                                                                                                                                                                                                                                                                                                       59%
pain of non-malignant origin. Pain severity was significantly greater in                           Results                                                                                                                                                                                                                                                 side effects, or whether opioid-induced constipation itself causes
                                                                                                                                                                                                                   50
individuals reporting opioid-induced constipation versus those without                             Survey respondents                                                                                                                                                                                                                       50%            greater pain, is uncertain.
opioid-induced constipation (59% vs 48% with severe pain, p<0.0001).
                                                                                                   G A total of 2,137 individuals who participated in the survey reported using opioids                                                                                                                                                           G The presence of constipation also limits work productivity and
Individuals with opioid-induced constipation reported a higher percentage                                                                                                                                                                                                                   49%                                          Respondents (%)
                                                                                                      for pain relief: 300 reported opioid-induced constipation and 1,837 did not.                                 25                                                                                                                                                                           49%
of work time missed (21.1% vs 18.8%), greater impairment while working
                                                                                                                                                                                                                                        40%                                                                                                 25%       patients'
                                                                                                                                                                                                                                                                                                                                                          40%
                                                                                                                                                                                                                                                                                                                                                                             abilities to perform daily activities.
                                                                                                   G There were significant differences between the groups with and without opioid-
(39.6% vs 36.7%), and greater overall work impairment (42.3% vs 40.2%).                               induced constipation, in terms of age (p<0.0001), race (p=0.0013), and education                                  1%                                                 4%                                                                     G Effective management of opioid-induced constipation should improve
                                                                                                                                                                                                                   0                                                                                                                         0%               1%                                 4%
Activity impairment was significantly greater in individuals with opioid-                             (p<0.0001), but not in gender or income (Table 1).                                                                       With opioid-induced                                Without opioid-induced                                             these outcomes in patients receiving opioids for chronic pain.
                                                                                                                                                                                                                                                                                                                                                     With opioid-induced Without-opioid-induced
induced constipation versus those without opioid-induced constipation                                                                                                                                                              constipation                                        constipation
                                                                                                   G The majority of respondents in both groups experienced pain of non-cancer origin
                                                                                                                                                                                                                                                                                                                                                             constipation
                                                                                                                                                                                                                                                                                                                                                           – When a side effect constipation opioid-induced constipation is this
                                                                                                                                                                                                                                                                                                                                                                                        such as
(65.6% vs 57.4%; p<0.0001). On the mental health component of the SF-8,                               (Table 1).                                                                            Figure 2. Scores on domains of the Work Productivity and Activity Impairment                                                                                               Mild Moderate Severe
                                                                                                                                                                                                                                                                                                                                                             frequent and of such clinical consequence, it should be routinely
mean scores were significantly worse in individuals with opioid-induced                                                                                                                     Questionnaire in respondents with opioid-induced constipation
                                                                                                   G More individuals in the group with opioid-induced constipation were receiving two or   and without opioid-induced constipation                                                                                                                          prevented and treated when chronic opioids are prescribed.
constipation versus those without constipation (42.5 vs 45.0; p=0.0002).                              more opioids, compared with those in the group without opioid-induced constipation
                                                                                                                                                                                                                                                                                                      p<0.0001                                             – Agents that directly antagonize the effects of opioids on the GI tract
A similar decline was observed on the SF-8 physical health component                                  (25% vs 18%, respectively, p=0.0011; Table 1).                                         Worse 70                                                                                                              With opioid-induced
                                                                                                                                                                                                                                                                                                     65.6                                                    and their potential to treat OBD should be investigated.
(32.4 vs 34.4; p=0.0013). Of the individuals experiencing opioid-induced                                                                                                                                                                                                                                           constipation
                                                                                                   Table 1. Baseline characteristics of respondents with opioid-induced constipation and                           60                                                                                       57.4
constipation, 79% also had ≥1 other opioid induced side effect, including                          without opioid-induced constipation
                                                                                                                                                                                                                                                                                                                   Without
                                                                                                                                                                                                                                                                                                                   opioid-induced
                                                                                                                                                                                                                                                                                                                   constipation
gastrointestinal (GI) side effects.                                                                                                                                                                                50
                                                                                                                                                                                                                                                                           42.3
                                                                                                                           With opioid-induced      Without opioid-induced                                                                        39.6                             40.2




                                                                                                                                                                                                   Score (%)
Conclusions: Chronic opioid recipients with associated opioid-induced                                Respondents (%)       constipation (n=300)     constipation (n=1,837)                                         40                                    36.7
constipation have significantly more severe pain and impaired HRQOL                                                                (%)                        (%)               p-value
compared with those without constipation. Whether patients take fewer                                Gender
                                                                                                                                                                                                                   30
                                                                                                                                                                                                                                                                                                                                                  Summary
                                                                                                                                                                                                                        21.1
                                                                                                        Male                        31                         36                  NS                              20          18.8
opioid doses to try and minimize the side effects or whether opioid-induced                                                                                                                                                                                                                                                                       G Data from the large NHWS 2004 demonstrate that opioid recipients who
                                                                                                        Female                      69                         64
constipation itself causes greater pain is uncertain. The presence of                                Age (years)                                                                                                   10                                                                                                                                experience constipation have significantly more severe pain and
constipation also limits work productivity and patients' abilities to perform                           18–44                       34                         38                <0.0001                                                                                                                                                             impaired quality of life, compared with those without constipation.
                                                                                                        45–64                       54                         42                            Better                0
activities. Effective management of opioid-induced constipation should                                  ≥65                         12                         20                                                       Work time              Impairment              Overall work                    Activity
improve these outcomes in patients receiving opioids for chronic pain.                               Race                                                                                                                missed               while working             impairment                   impairment

When a side effect such as opioid-induced constipation is this frequent, and                            White                       69                         75                0.0013
                                                                                                        Black                        6                          8                           Figure 3. Mean scores on the mental and physical health components of the SF-8 in
of such clinical consequence, it should be routinely prevented and treated                              Hispanic                    17                         10                           respondents with opioid-induced constipation and without opioid-induced constipation
when chronic opioids are prescribed. Agents that directly antagonize the                                Other                        8                          7
                                                                                                     Education                                                                               Better 50                                 p=0.0002                                                                                                   References
effects of opioids on the GI tract and their potential to treat opioid-induced                          <High school                28                         18                <0.0001                                                      45.0
                                                                                                                                                                                                                                                                                                                   With opioid-induced
                                                                                                                                                                                                                                                                                                                   constipation
                                                                                                                                                                                                                   45           42.5
constipation and other specific OBD symptoms should be investigated.                                    High school                 23                         34                                                                                                                                                  Without
                                                                                                                                                                                                                                                                                                                                                  1. Kalso E, Edwards JE, Moore RA, McQuay HJ. Pain 2004;112:372–80.
                                                                                                        >High school                49                         48                                                  40                                                                     p=0.0013                 opioid-induced
                                                                                                     Income ($US)                                                                                                                                                                                    34.4          constipation                   2. Moore RA, McQuay HJ. Arthritis Res Ther 2005;7:R1046–51. Epub 2005 Jun 28.
                                                                                                                                                                                                                   35                                                                32.4
                                                                                                        <25,000                     35                         36                  NS
                                                                                                                                                                                                   Mean score




                                                                                                        25,000–50,000               33                         31                                                  30                                                                                                                             3. Pappagallo M. Am J Surg 2001;182 (Suppl):11S–18S.
                                                                                                        50,000–75,000               16                         16                                                  25
                                                                                                        75,000–100,000               7                          9                                                                                                                                                                                 4. Fallon MT, Hanks GW. Palliat Med 1999;13:159–60.
Introduction                                                                                            >100,000                     9                          7                                                  20

                                                                                                     Pain origin                                                                                                   15                                                                                                                             5. Klepstad P, Borchgrevink PC, Kaasa S. J Pain Symptom Manage 2000;20:19–26.
G Constipation is a common manifestation of opioid-induced bowel dysfunction (OBD)
                                                                                                        Non-cancer                  99                         98                  NS                              10
   reported in patients receiving opioids for chronic non-cancer or cancer-related pain.1–3             Cancer                       1                         2                                                                                                                                                                                  6. Reilly MC, Zbrozek AS, Dukes EM. Pharmacoeconomics 1993;4:353–65.
                                                                                                     Number of opioids used                                                                                        5
G Although OBD can lead to physical or functional deterioration in patients requiring                                                                                                                                                                                                                                                             7. Ware JE, Kosinski M, Dewey JE and Gandek B. A Manual for Users of the SF-8 Health Survey.
                                                                                                        1                           75                         82                0.0011      Worse                 0
   chronic pain relief, the impact of this on patient-reported outcomes has not been
                     4,5
                                                                                                        ≥2                          25                         18                                                                 Mental health                                      Physical health                                                 Lincoln, RI: QualityMetric Incorporated, 2001.
   well quantified.

				
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