scholarly journals Opioid-Induced Constipation in Patients with Cancer Pain in Japan (OIC-J Study): A Post Hoc Analysis

2021 ◽  
Vol 10 (18) ◽  
pp. 4193
Author(s):  
Akihiro Tokoro ◽  
Hisao Imai ◽  
Soichi Fumita ◽  
Toshiyuki Harada ◽  
Toshio Noriyuki ◽  
...  
Keyword(s):  
Cancer Pain ◽  
Pain Treatment ◽  
Bowel Function ◽  
Opioid Therapy ◽  
Pain Patient ◽  
Post Hoc Analysis ◽  
Patients With Cancer ◽  
Bowel Movements ◽  
Ecog Ps ◽  
Post Hoc

Opioid-induced constipation (OIC) can limit the clinical benefit of opioid treatment. This post-hoc analysis evaluated the association between the Rome IV diagnostic criteria and other measures for OIC, including the Bowel Function Index (BFI), correlation between demographics and OIC onset, impact of OIC on pain treatment, and impact of patient–healthcare professional (HCP) communication on patient satisfaction. Patients recorded bowel habits in paper diaries for 14 days following opioid initiation. Study-specific questionnaires were used to evaluate patient awareness of OIC and satisfaction. Patients were ≥20 years old, initiating strong opioid therapy for cancer pain, had an ECOG PS ≤ 2, and had no constipation (≥3 bowel movements within 7 days of enrollment). A total of 220 patients were enrolled. The sensitivity and specificity of BFI for identifying OIC were 81.2% and 54.7%, respectively. Age <65 versus ≥65 years (odds ratio (OR) = 0.510, 95% confidence interval (CI): 0.267–0.977) and the presence or absence of comorbidities (OR = 0.443, 95% CI: 0.221–0.885) were correlated with OIC onset. The proportion of inpatients with sustainable pain control at week 2 was similar in patients with or without OIC (60.0% vs. 67.2%, respectively). By patient assessment, there was a significant correlation between an adequate level of patient–HCP communication and satisfaction with OIC treatment (OR = 9.538 (95% CI: 1.577–57.681)). Using BFI to screen for OIC represents a valid approach in patients with cancer pain. Patient–HCP communication is essential for effective management of OIC in patients with cancer pain.

scholarly journals Opioid-induced constipation in patients with cancer pain in Japan (OIC-J study): a post hoc subgroup analysis of patients with gastrointestinal cancer

2020 ◽  
Vol 26 (1) ◽  
pp. 104-110 ◽  
Author(s):  
Toshiyuki Harada ◽  
Hisao Imai ◽  
Soichi Fumita ◽  
Toshio Noriyuki ◽  
Makio Gamoh ◽  
...  
Keyword(s):  
Diagnostic Criteria ◽  
Bowel Function ◽  
Opioid Therapy ◽  
Common Side Effect ◽  
Post Hoc Analysis ◽  
Patients With Cancer ◽  
Gi Cancer ◽  
Bowel Movements ◽  
Baseline Characteristics ◽  
Post Hoc

Abstract Background Constipation is a common side effect of opioid therapy. An observational study of opioid-induced constipation (OIC) in Japanese patients with cancer (OIC-J) included 212 patients with various tumor types. This post hoc analysis of OIC-J evaluated a subgroup of patients with gastrointestinal (GI) cancer. Methods Patients were aged ≥ 20 years, starting strong opioid therapy, had an ECOG PS of ≤ 2, and must have had ≥ 3 bowel movements during the week before enrollment. OIC was evaluated for 2 weeks after opioid initiation using the Rome IV diagnostic criteria for colorectal disorders, as well as physician’s diagnosis, number of spontaneous bowel movements, Bowel Function Index score, and patient’s self-assessment. Relationships between baseline characteristics and OIC incidence, and the effects of OIC on quality of life (QOL) were also explored. Results Fifty patients from OIC-J who had GI cancer [colon (50%), stomach (28%), and esophageal (22%)] were included. OIC incidence varied by which diagnostic criteria were used (46.0–62.0%) and occurred rapidly after initiating opioid therapy. The use of prophylactic laxatives reduced the overall incidence rate of OIC from 71.0% to 47.4%. No baseline characteristics, except comorbidities, were associated with OIC incidence. Change from baseline to day 15 in PAC-SYM total score was significantly greater for patients with OIC versus those without OIC (0.188 versus −0.362; P = 0.0011). Conclusions This post hoc analysis suggests that OIC occurs rapidly in patients with GI cancer after initiating opioid therapy, and negatively impacts QOL. Early and effective intervention strategies may be particularly useful in this group. Additional Information Coauthor Makio Gamoh is deceased.

scholarly journals Opioid-induced constipation in patients with cancer pain in Japan (OIC-J study): a post hoc subgroup analysis of patients with lung cancer

2020 ◽  
Author(s):  
Hisao Imai ◽  
Soichi Fumita ◽  
Toshiyuki Harada ◽  
Toshio Noriyuki ◽  
Makio Gamoh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Cancer Pain ◽  
Diagnostic Criteria ◽  
Bowel Function ◽  
Early Management ◽  
Patients With Cancer ◽  
Bowel Movements ◽  
Post Hoc

Abstract Objective To evaluate the opioid-induced constipation burden in the subgroup of patients with lung cancer who participated in the observational Opioid-Induced Constipation in Patients with Cancer Pain in Japan (OIC-J) study. Methods The prospective, observational study, OIC-J, included 212 patients with various tumour types, 33% of whom had lung cancer. The incidence of opioid-induced constipation was evaluated using several diagnostic criteria, as well as the physician’s diagnosis and patient’s subjective assessment. Following initiation of opioids, patients recorded details of bowel movements (i.e. date/time, Bristol Stool Scale form, sensations of incomplete evacuation or anorectal obstruction/blockage and degree of straining) in a diary for 2 weeks. Relationships between patient characteristics and opioid-induced constipation onset and effects of opioid-induced constipation on quality of life were explored. Results In total, 69 patients were included in this post hoc analysis. The incidence of opioid-induced constipation varied (39.1–59.1%) depending on which diagnostic criteria was used. Diagnostic criteria that included a quality component or a patient’s feeling of bowel movement as an evaluation item (i.e. Rome IV, physician’s diagnosis, Bowel Function Index, patient’s assessment) showed higher incidences of opioid-induced constipation than recording the number of spontaneous bowel movements alone. Opioid-induced constipation occurred rapidly after initiating opioids and had a significant impact on Patient Assessment of Constipation Symptoms total score (P = 0.0031). Patient baseline characteristics did not appear to be predictive of opioid-induced constipation onset. Conclusions In patients with lung cancer, opioid-induced constipation can occur quickly after initiating opioids and can negatively impact quality of life. Early management of opioid-induced constipation, with a focus on quality-of-life improvement and patient’s assessments of bowel movements, is important for these patients.

Predictors of clinical outcomes in metastatic castration-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate or placebo: An exploratory post-hoc analysis of COU-AA-302 trial data.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16529-e16529
Author(s):  
Dominic Pilon ◽  
Ajay S. Behl ◽  
Rhiannon Kamstra, ◽  
Yongling Xiao ◽  
Marie-Helene Lafeuille ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Gleason Score ◽  
Group Performance ◽  
Trial Data ◽  
Cox Models ◽  
Post Hoc Analysis ◽  
Opiate Use ◽  
Psa Progression ◽  
Ecog Ps ◽  
Post Hoc

e16529 Background: A post-hoc analysis of COU-AA-302 trial data showed that brief pain inventory (BPI), lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and bone metastases were predictors for overall survival in men with mCRPC treated with AA+P. This study aimed to identify baseline predictors of other clinical outcomes. Methods: COU-AA-302 trial data were used to develop predictive models for prostate-specific antigen (PSA) progression, Eastern Cooperative Oncology Group performance status (ECOG PS) deterioration, and opiate use. Associations between baseline factors and outcomes were first assessed using multivariable Cox models among AA+P patients (Step 1). In Step 2, interaction testing was conducted between treatment (AA+P vs. placebo) and each potential predictor (P < 0.2) identified in Step 1. Final Cox models included predictors and any significant interactions (p < 0.05). Results: A total of 1,034 men (525 AA+P; 509 placebo) were included in the analysis. Baseline BPI, PSA, LDH, and ALP were predictors of PSA progression and opiate use regardless of AA+P or placebo with higher values indicating higher risks (all P < 0.05). Younger age, shorter time from luteinizing hormone-releasing hormone to randomization, higher Gleason score, and lower PSA at diagnosis were also associated with higher risks of opiate use: (all P < 0.05). For ECOG PS deterioration, higher baseline BPI, PSA, LDH, and Gleason score, older age, and lower baseline ECOG were associated with higher risks regardless of AA+P or placebo (all P < 0.05). Baseline ALP and site of metastasis also predicted ECOG PS deterioration but the effect varied by treatment (lower risk in AA+P versus placebo; both interactions’ P < 0.05). Conclusions: Predictors of PSA progression, ECOG PS deterioration, and opiate use were identified in AA+P and placebo-treated men with mCRPC. No predictors were associated with worse outcomes for AA+P versus placebo, while the negative impact of certain predictors on ECOG PS was favorably modified by AA+P. Further study is needed on the relationship between AA+P and prognostic factors.

Efficacy variables in patients with cancer versus patients without cancer treated with methylnaltrexone or placebo: An analysis of two placebo-controlled studies.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 1-1
Author(s):  
Bruce Chamberlain ◽  
Michelle Rhiner ◽  
Neal E Slatkin ◽  
Nancy Stambler ◽  
Robert Joseph Israel
Keyword(s):  
Opioid Use ◽  
Advanced Illness ◽  
Open Label ◽  
Double Blind ◽  
Patients With Cancer ◽  
Pooled Data ◽  
Bowel Movements ◽  
Open Label Extension ◽  
Post Hoc ◽  
Clinical Trial Information

1 Background: A post-hoc analysis of pooled data from two randomized, double-blind studies and their open-label extensions evaluated whether baseline characteristics and efficacy endpoints differ between cancer and noncancer adults with advanced illness and opioid-induced constipation treated with methylnaltrexone (MNTX) or placebo. Methods: Patients received SC MNTX 0.15 mg/kg or placebo (study 302) and SC MNTX 8 mg (38≤62 kg), 12 mg (≥62 kg), or placebo (study 4,000) every other day for two weeks and received the same doses of MNTX as needed during the first 2 weeks of the open-label extensions. Double-blind populations were stratified by those with/without cancer. Efficacy endpoints included rescue-free bowel movements (RFBMs) within 4 hours after each dose for ≥2 of the first 4 doses; time to rescue-free laxation; rescue laxatives use; and ≥3 RFBMs/week and ≥1 RFBM/week in ≥3 of 4 weeks. Results: Median baseline opioid use (mg/day) was greater in cancer (187.9 placebo [n=114]; 180.0 MNTX [n=116]) versus noncancer patients (80.0 placebo [n=71]; 120.0 MNTX [n=62]). MNTX significantly ( P<0.0001) improved the proportion of cancer (56.9%) and noncancer (58.1%) patients with an RFBM within 4 hours after each dose for ≥ two of the first four doses versus placebo (5.3% cancer; 11.3% noncancer). Median time to laxation was significantly ( P≤0.0002) shorter in cancer (0.96 hours) and noncancer (1.25 hours) patients 24 hours after the first dose of MNTX versus placebo (22.53 and >24 hours, respectively). Rescue laxatives were used by 39.7% of cancer and 30.6% of noncancer MNTX patients versus 51.8% of cancer and 39.4% of noncancer placebo patients. Of 108 open-label extension double-blind MNTX patients, 79 (73.1%) achieved ≥3 RFBMs/week with ≥1 RFBM/week increase in ≥ three of four weeks versus 48 (46.6%) of 103 double-blind placebo patients (data from double-blind and first two weeks of open-label). Conclusions: MNTX treatment improved the laxation response, with a faster onset of laxation in patients with and without cancer, and reduced the need for rescue laxatives vs placebo. Improvements over placebo continued into the first two weeks of the open-label extensions for MNTX-treated patients. Clinical trial information: NCT00672477, NCT00402038.

scholarly journals Compliance with Opioid Therapy: Distinguishing Clinical Characteristics and Demographics Among Patients with Cancer Pain

Pain Medicine ◽  
2017 ◽  
Vol 19 (7) ◽  
pp. 1469-1477 ◽  
Author(s):  
Dhanalakshmi Koyyalagunta ◽  
Eduardo Bruera ◽  
Mitchell P Engle ◽  
Larry Driver ◽  
Wenli Dong ◽  
...  
Keyword(s):  
Cancer Pain ◽  
Clinical Characteristics ◽  
Opioid Therapy ◽  
Patients With Cancer

Opioid-induced bowel dysfunction in cancer-related pain: Causes, consequences, and a novel approach for its management

2018 ◽  
Vol 5 (3) ◽  
pp. 145 ◽  
Author(s):  
Peter Holzer, PhD ◽  
Sam H. Ahmedzai, BSc, MBChB, FRCP ◽  
Norbert Niederle, MD ◽  
Petra Leyendecker, PhD ◽  
Michael Hopp, MD ◽  
...  
Keyword(s):  
Analgesic Efficacy ◽  
Bowel Function ◽  
Bowel Dysfunction ◽  
Opioid Therapy ◽  
Common Side Effect ◽  
Prolonged Release ◽  
The Novel ◽  
Patients With Cancer ◽  
Novel Approach

Opioids are the mainstay of management for patients with cancer-related pain. Although the analgesic efficacy of opioid therapy is well documented, the recent European Pain in Cancer survey demonstrated that the management of moderate-to-severe pain in patients with cancer is far from optimal. Bowel dysfunction, and importantly constipation, is a common side effect and has a significant impact on the patient’s morbidity and quality of life. Nonpharmacological strategies and laxatives are often not effective in the management of opioid-induced constipation (OIC), making it necessary to search for new strategies for the treatment of opioid-induced bowel dysfunction. One promising strategy is the prevention of OIC with peripherally acting opioid antagonists that specifically target the underlying cause of this condition, without affecting centrally mediated analgesia. In recent studies, the novel combination of prolonged-release oral oxycodone and prolonged-release oral naloxone provided effective analgesia with improved bowel function in patients suffering from severe cancer-related and noncancer-related pain. The combination has the potential to improve the quality of pain management significantly in these patients.

Post hoc analysis of pregabalin vs. non-pregabalin treatment in patients with cancer-related neuropathic pain: better pain relief, sleep and physical health

2011 ◽  
Vol 13 (9) ◽  
pp. 656-663 ◽  
Author(s):  
Ana Mañas ◽  
Juan Pablo Ciria ◽  
María Carmen Fernández ◽  
María Luisa Gonzálvez ◽  
Virginia Morillo ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Pain Relief ◽  
Physical Health ◽  
Post Hoc Analysis ◽  
Patients With Cancer ◽  
Post Hoc
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