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Russell K. Portenoy - One of the best experts on this subject based on the ideXlab platform.

  • National Breakthrough Pain Study: prevalence, characteristics, and associations with health outcomes.
    Pain, 2015
    Co-Authors: Arvind Narayana, Alicia C. Shillington, Judith J. Stephenson, Qing Harshaw, Carla B. Frye, Nathaniel P. Katz, Russell K. Portenoy
    Abstract:

    : The National Breakthrough Pain Study is a large observational study that assessed Breakthrough Pain (BTP) in a population of commercially insured community-dwelling patients with opioid-treated chronic Pain. Eligible patients were identified from an administrative claims database, and consenting patients were asked to complete a structured telephone interview and several validated questionnaires. Questionnaires assessed Pain interference with function (Brief Pain Inventory-Short Form), health status (Short Form 12 [SF-12] Health Survey), disability (Sheehan Disability Scale), work performance (World Health Organization Health and Work Performance Questionnaire), and mood (Generalized Anxiety Disorder-7 Screener [GAD-7] and Patient Health Questionnaire-2 [PHQ-2]). Of 2198 patients interviewed, 1278 patients had persistent Pain controlled with opioid therapy; 1023 (80%) of these patients reported BTP. Patients had a median of 2.0 episodes of BTP per day (range, 1-50) and a median duration of BTP of 45 minutes (range, 1-720). Compared with patients without BTP, patients with BTP had more Pain-related interference in function (Brief Pain Inventory, mean ± SD: 34.2 ± 15.6 vs 25.0 ± 15.7 [P < 0.001]), worse physical health (SF-12 physical component score: 29.9 ± 9.6 vs 35.1 ± 10.4 [P < 0.001]) and mental health (SF-12 mental component score: 47.4 ± 11.3 vs 49.3 ± 10.4 [P < 0.001]), more disability (Sheehan Disability Scale global impairment score: 15.1 ± 9.1 vs 10.6 ± 8.5; World Health Organization Health and Work Performance Questionnaire absolute absenteeism: 12.4 ± 59.9 vs 7.7 ± 44.9 hours [both P < 0.001]), and worse mood (GAD-7 score: 7.4 ± 5.9 vs 5.9 ± 5.4; PHQ-2 anhedonia score: 1.2 ± 1.1 vs 0.9 ± 1.0 [both P < 0.001]). In this population of community-dwelling patients with opioid-treated chronic Pain, BTP was highly prevalent and associated with negative outcomes. This burden of illness suggests the need for specific treatment plans.

  • a novel 12 week study with three randomized double blind placebo controlled periods to evaluate fentanyl buccal tablets for the relief of Breakthrough Pain in opioid tolerant patients with noncancer related chronic Pain
    Pain Medicine, 2010
    Co-Authors: John T. Farrar, John Messina, Fang Xie, Russell K. Portenoy
    Abstract:

    Objective.  To evaluate the time of onset, overall efficacy, and safety of fentanyl buccal tablet (FBT) for noncancer-related Breakthrough Pain (BTP) in opioid-tolerant adults over 12 weeks. Design.  A novel 12-week study that mimicked clinical practice with dose titration to effective dose, open-label treatment, and three randomized, double-blind, placebo-controlled, multiple-crossover periods at weeks 4, 8, and 12. For each double-blind period, study patients received nine doses (FBT = 6, placebo = 3) in a randomized sequence. Setting.  Twenty-one study centers in the United States. Population. Opioid-tolerant adults with noncancer-related chronic Pain and BTP. Outcome Measures.  The primary outcome was the sum of the Pain intensity differences (PID) 5–60 minutes post dose (SPID60) during the final double-blind period. Secondary outcomes included Pain relief (PR), meaningful PR, and proportion of episodes with a PID of ≥33% and ≥50%. Results.  Of 148 patients who entered the titration phase, 105 (71%) achieved a successful dose and 81 (55%) participated in all three assessment periods in the study. The final RCT assessment period results demonstrated continued efficacy of FBT vs placebo (P < 0.05) for SPID60 (mean [SD]: 7.7 [6.2] vs 4.6 [4.7]). The average onset of PR began at 5 minutes, with meaningful PR by ≤10 minutes. The proportion of episodes with ≥33% improvement in PI was 7% with FBT vs 3% with placebo at 5 minutes and with ≥50% was 17% vs 10% at 15 minutes. All periods showed similar results. Adverse events and patient discontinuations were generally typical of clinical opioid use. Conclusions.  FBT showed continued clinically important analgesic effects and was generally well tolerated over 12 weeks of treatment.

  • Breakthrough Pain in community dwelling patients with cancer Pain and noncancer Pain part 2 impact on function mood and quality of life
    Journal of opioid management, 2010
    Co-Authors: Russell K. Portenoy, Psyd Daniel Bruns, Bonnie Shoemaker, Steven Shoemaker
    Abstract:

    Background: Prior studies of Breakthrough Pain (BTP) largely focus on patients with advanced cancer or those receiving inpatient care. Very few studies have evaluated BTP in populations with chronic noncancer Pain. Data that illuminate the impact of BTP may not generalize to other, less selected patient populations. Aim: The aim of this study was to evaluate the impact of BTP in opioid-treated ambulatory patients with chronic cancer Pain or noncancer Pain treated in community practices. Methods: Eligible patients—those with any diagnosis who reported chronic Pain for at least 3 months, who were receiving long-term opioid therapy, and who met criteria for controlled baseline Pain—were recruited for a cross-sectional observational study by primary care physicians or community-based oncologists at 17 sites in the United States. The patients responded to a structured interview for Breakthrough Pain and also completed the Brief Pain Inventory-Modified Short Form (BPI-SF) and the Brief Battery for Health Improvement 2 (BBHI 2). Results: Of 355 patients screened, 191 were eligible and 177 (93 percent) provided data for analysis. Twenty-six of the 78 with cancer Pain (33 percent) and 48 of the 99 with noncancer Pain (48 percent) had BTP. Compared with those without BTP, both patients with cancer (p = 0.004) and patients without cancer (p = 0.019) with BTP had increased Pain interference in function, as measured by the BPI-SF, and patients without cancer were more impaired than patients with cancer. On the BBHI 2, BTP was associated with increased somatic complaints (p = 0.036 cancer and p = 0.024 noncancer) and Pain complaints (p = 0.037 cancer and p = 0.037 noncancer); among patients without cancer, BTP was also associated with increased difficulties with functioning (p = 0.023), depression (p = 0.039), and decreased quality of life (p = 0.003). Conclusions: These data extend published observations about the association between BTP and adverse effects on mood and function to populations undergoing routine treatment in the community setting and provide evidence that these associations are greater in those with noncancer Pain. They suggest the need for additional studies to clarify causality and determine whether undertreatment of BTP is a factor contributing to adverse Pain-related outcomes.

  • Breakthrough Pain in community dwelling patients with cancer Pain and noncancer Pain part 1 prevalence and characteristics
    Journal of opioid management, 2010
    Co-Authors: Russell K. Portenoy, Psyd Daniel Bruns, Bonnie Shoemaker, Steven Shoemaker
    Abstract:

    Background: Most Breakthrough Pain (BTP) studies assess patients with advanced cancer or those receiving inpatient care. Studies in noncancer populations are limited to surveys of Pain clinics and patients with other advanced diseases. To better understand BTP, data are needed from less selected populations. Aim: The aim of this study was to evaluate BTP in opioid-treated ambulatory patients with chronic cancer or noncancer Pain treated in community practices. Methods: Primary care physicians or community-based oncologists recruited a convenience sample for a cross-sectional study of BTP at 17 sites in the United States. Physicians could not be Pain specialists. Patients were eligible if they had any type of Pain for ≥3 months and were receiving an opioid drug on a regular basis that controlled the Pain. The patients responded to a structured interview comprising items that assessed the baseline Pain and items that assessed BTP, if present. Results: In total, 355 patients were screened, 191 were eligible and 177 (93 percent) provided data for analysis. Seventy-eight patients had cancer Pain and 99 had noncancer Pain. Patients with cancer were older (mean ± SD age 61.3 ± 11.2 years vs 51.4 ± 13.6 years, p < 0.001), and patients without cancer had more neuropathic Pain (21 vs 12 percent, p < 0.05) and a longer Pain duration (median 3.5 vs 1 years, p < 0.001). BTP occurred in 33 percent with cancer and 48 percent with noncancer Pain (p = 0.042). BTP did not vary by diagnosis, but neuropathic Pain was more common in those with BTP (27 vs 10 percent, p < 0.001). In patients with and without cancer, the median daily number of episodes was 1, the median time to maximum Pain was 1-2 minutes, and the median duration was 45-60 minutes. There were fewer BTP precipitants in the patients with cancer (46 vs 80 percent of Pains, p < 0.05), and they had less predictable Pain (p < 0.05). Conclusions: The prevalence of BTP among community-dwelling patients is lower than that found in prior studies of more selected populations. BTP is more prevalent among patients with noncancer Pain than patients with cancer Pain, and although there are many similarities, some differences may be relevant to treatment strategies.

  • fentanyl buccal tablet fbt for relief of Breakthrough Pain in opioid treated patients with chronic low back Pain a randomized placebo controlled study
    Current Medical Research and Opinion, 2007
    Co-Authors: Russell K. Portenoy, John Messina, Fang Xie, John Peppin
    Abstract:

    ABSTRACTBackground: Short-acting opioids are commonly used to treat Breakthrough Pain (BTP) and rapid-onset formulations are being developed to improve the effectiveness of this approach. Fentanyl buccal tablet (FBT) is a new formulation of fentanyl that enhances transbuccal drug delivery via an effervescent reaction and may provide relatively rapid-onset analgesia. FBT was evaluated for BTP in opioid-treated patients with chronic low back Pain – the first such study in a population with chronic non-cancer Pain.Design: Randomized, double-blind, placebo-controlled.Patients and setting: Patients with chronic low back Pain receiving long-term opioid therapy at 16 Pain treatment centers in the United States.Procedures: Following open-label titration to identify an effective FBT dose, patients were randomly assigned to one of three double-blind dose sequences (six doses of FBT, three placebo) to treat nine BTP episodes. Pain intensity (PI), measured on an 11-point scale (0 = no Pain; 10 = worst Pain), and othe...

Andrew Davies - One of the best experts on this subject based on the ideXlab platform.

  • disparities between clinician and patient perception of Breakthrough Pain control
    Journal of Pain and Symptom Management, 2016
    Co-Authors: Katherine Webber, Andrew Davies, Martin R Cowie
    Abstract:

    Abstract Context There are disparities in the level of symptom severity as perceived by patients and health professionals. There is limited information about patients' and clinicians' global assessment of Breakthrough Pain control, the need to change analgesics, and change in Breakthrough Pain over time. Objectives To establish whether patients and clinicians independently agree on adequacy of Breakthrough Pain control, management strategy, and impression of change over time. Methods One hundred patients with Breakthrough cancer Pain were assessed and followed up one week later by a palliative medicine specialist. The patient and clinician independently answered the same questions about the adequacy of the patient's Breakthrough Pain control and Breakthrough Pain management. The results were compared with items on the Breakthrough Pain Assessment Tool (BAT). Results At initial consultation, 35% of patients rated their Breakthrough cancer Pain as inadequately controlled compared with 72% of clinicians. Breakthrough Pain analgesics were changed in 68% of cases. At one-week follow-up consultation, 62% of patients considered their Breakthrough cancer Pain to be better, and in 57% of cases, the clinicians also categorized the Pain this way. Conclusion There are significant differences in global impressions of Breakthrough Pain between patients and Pain clinicians that become less disparate as a therapeutic relationship evolves. Therapeutic decisions were based on clinical rather than patient perceptions.

  • opioids for the management of Breakthrough Pain in cancer patients
    Cochrane Database of Systematic Reviews, 2015
    Co-Authors: Giovambattista Zeppetella, Andrew Davies
    Abstract:

    Background This review is an update of a previously published review in the Cochrane Database of Systematic Reviews (Issue 1, 2006). Breakthrough Pain is a transient exacerbation of Pain that occurs either spontaneously or in relation to a specific predictable or unpredictable trigger despite relative stable and adequately controlled background Pain. Breakthrough Pain usually related to background Pain and is typically of rapid onset, severe in intensity and generally self limiting with a mean duration of 30 minutes. Breakthrough Pain has traditionally been managed by the administration of supplemental oral analgesia (rescue medication) at a dose proportional to the total around-the-clock (ATC) opioid dose. Objectives To determine the efficacy of opioid analgesics given by any route, used for the management of Breakthrough Pain in patients with cancer, and to identify and quantify, if data permitted, any adverse effects of this treatment. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and trial registries in January 2005 for the original review, and again on 6 February 2013 for this update. Selection criteria We included randomised controlled trials (RCTs) of opioids used as rescue medication against active or placebo comparator in patients with cancer Pain. Outcome measures sought were reduction in Pain intensity measured by an appropriate scale, adverse effects, attrition, patient satisfaction and quality of life. We applied no language restrictions. Data collection and analysis Two review authors independently selected and examined eligible studies. We retrieved full text if any uncertainty about eligibility remained. We screened non-English texts. We conducted quality assessment and data extraction using standardised data forms. We compared drug and placebo dose, titration, route and formulation and recorded details of all outcome measures (if available). Main results The original review included four studies (393 participants), all concerned with the use of oral transmucosal fentanyl citrate (OTFC) in the management of Breakthrough Pain. Two studies examined the titration of OTFC, one study compared OTFC versus normal-release morphine and one study compared OTFC versus placebo. Fifteen studies (1699 participants) met the inclusion criteria for this update. All studies reported on the utility of seven different transmucosal fentanyl formulations, five of which were administered orally and two nasally. Eight studies compared the transmucosal fentanyl formulations versus placebo, four studies compared them with another opioid, one study was a comparison of different doses of the same formulation and two were randomised titration studies.  Oral and nasal transmucosal fentanyl formulations were an effective treatment for Breakthrough Pain. When compared with placebo or oral morphine, participants gave lower Pain intensity and higher Pain relief scores for transmucosal fentanyl formulations at all time points. Global assessment scores also favoured transmucosal fentanyl preparations. One study compared intravenous with the transmucosal route and both were effective. Authors' conclusions Oral and nasal transmucosal fentanyl is an effective treatment in the management of Breakthrough Pain. The RCT literature for the management of Breakthrough Pain is relatively small. Given the importance of this subject, more trials, including head-to-head comparisons of the available transmucosal fentanyl formulations are required.

  • Breakthrough cancer Pain a comparison of surveys with european and canadian patients
    Supportive Care in Cancer, 2015
    Co-Authors: Gillian Bedard, Andrew Davies, Philippa Hawley, Edward Chow, Alison Buchanan, Rachel Mcdonald, Marko Popovic, Erin Wong
    Abstract:

    Breakthrough cancer Pain is defined as a transient exacerbation of Pain that occurs spontaneously or in response to a trigger, despite stable and controlled background Pain. Breakthrough Pain often causes significant functional impairments for patients and can decrease quality of life. The objective of the study was to determine differences between Breakthrough cancer Pain incidence and management in Canada and Europe. Data collected from previous studies of Breakthrough cancer Pain in Canada and Europe was compared. A standard survey with identical inclusion/exclusion criteria was utilized for both patient populations. Both groups of patients had a similar number and duration of Breakthrough Pain episodes, and similar Pain intensity and Pain interference with their daily activities. European patients reported better analgesic efficacy and satisfaction with management, and a greater percentage of European patients were prescribed a transmucosal fentanyl formulation (19.1 vs 2.9 %). More European patients (55 %) than Canadian patients (32.5 %) took their rescue medication every time they had a Breakthrough Pain episode. Breakthrough cancer Pain in both Canadian and European patients greatly impacts their daily living, and both groups of patients had similar experiences with Breakthrough cancer Pain. Currently, this Pain is not adequately managed for many patients. The role for new analgesic treatments in management of Breakthrough cancer Pain needs further study.

  • development and validation of the Breakthrough Pain assessment tool bat in cancer patients
    Journal of Pain and Symptom Management, 2014
    Co-Authors: Andrew Davies, Giovambattista Zeppetella, Katherine Webber, Martin R Cowie
    Abstract:

    Abstract Context The successful management of Breakthrough Pain depends on a combination of adequate assessment, appropriate (individualized) treatment, and adequate re-assessment. Currently, there is no fully validated clinical assessment tool for Breakthrough Pain in cancer patients. Objectives The aim of this project was to develop and validate a Breakthrough Pain assessment tool (the BAT) for use in the clinical setting. Methods The content of the BAT was determined by reviewing the medical literature, conducting a Delphi process with experts in Breakthrough Pain and/or Pain assessment and conducting semi-structured interviews with cancer patients with Breakthrough Pain. The tool was then subjected to a series of standard psychometric tests to assess its factor structure, validity (i.e., content validity, construct validity), reliability (i.e., internal consistency, test-retest reliability), and responsiveness to change. Results The BAT comprised two pages with 14 questions. Factor analysis confirmed the presence of two underlying factors. Psychometric testing confirmed that the tool is valid, reliable, and responsive to change. Conclusion This study provides initial evidence for the validity and reliability of the Breakthrough Pain assessment tool which may be used to facilitate the management of patients with Breakthrough cancer Pain in the clinical setting.

  • Breakthrough cancer Pain an observational study of 1000 european oncology patients
    Journal of Pain and Symptom Management, 2013
    Co-Authors: Andrew Davies, Giovambattista Zeppetella, Alison Buchanan, Josep Portasales, Rudolf Likar, Wolfgang Weismayr, Ondrej Slama, Tarja Korhonen, Marilene Filbet, Philippe Poulain
    Abstract:

    Abstract Context Breakthrough Pain is common in patients with cancer and is a significant cause of morbidity in this group of patients. Objectives The aim of this study was to characterize Breakthrough Pain in a diverse population of cancer patients. Methods The study involved 1000 cancer patients from 13 European countries. Patients were screened for Breakthrough Pain using a recommended diagnostic algorithm and then questioned about the characteristics and management of their Pain. Results Of the 1000 patients, 44% reported incident Pain, 41.5% spontaneous Pain, and 14.5% a combination. The median number of episodes was three a day. The median time to peak intensity was 10 minutes, with the median for patients with incident Pain being five minutes (P  Conclusion Breakthrough cancer Pain is an extremely heterogeneous condition.

John Messina - One of the best experts on this subject based on the ideXlab platform.

  • the efficacy and safety of fentanyl buccal tablet compared with immediate release oxycodone for the management of Breakthrough Pain in opioid tolerant patients with chronic Pain
    Anesthesia & Analgesia, 2011
    Co-Authors: Michael A Ashburn, Kieran A Slevin, John Messina, Fang Xie
    Abstract:

    BACKGROUND:Current clinical guidelines have identified the need for studies comparing the effect of different short-acting or rapid-onset opioids for the treatment of Breakthrough Pain (BTP). In this study we evaluated the efficacy and safety of treatment with fentanyl buccal tablet (FBT) in compari

  • aberrant drug related behavior observed during clinical studies involving patients taking chronic opioid therapy for persistent Pain and fentanyl buccal tablet for Breakthrough Pain
    Journal of Pain and Symptom Management, 2011
    Co-Authors: Steven D Passik, John Messina, Anthony Golsorkhi, Fang Xie
    Abstract:

    Abstract Context Information on aberrant drug-related behaviors in the clinical study setting is limited. Objectives This retrospective analysis was designed to identify the types and frequency of aberrant drug-related behaviors (including misuse and abuse) and associated patient characteristics in opioid-tolerant patients with chronic Pain. Methods Data from opioid-tolerant patients participating in clinical studies of fentanyl buccal tablet (FBT) for Breakthrough Pain (up to 18 months of clinical study case-report forms) were retrospectively reviewed and coded for abuse, overdose, and aberrant behavior. Aberrant behaviors were categorized as those involving FBT (overuse, lost or stolen study drug) and those not involving FBT (patients seeking prescriptions from other sources, not returning for follow-up). Results Of the 1,160 patients evaluated, 10 ( P P P Conclusion The incidence of drug abuse events and aberrant drug-related behaviors was relatively low, probably because of the implementation of universal precautions and the controlled clinical study setting. Even in this setting, events occurred, highlighting the limits of screening and the need for ongoing monitoring of aberrant behavior.

  • aberrant drug related behavior observed during clinical studies involving patients taking chronic opioid therapy for persistent Pain and fentanyl buccal tablet for Breakthrough Pain
    Journal of Pain and Symptom Management, 2011
    Co-Authors: Steven D Passik, John Messina, Anthony Golsorkhi
    Abstract:

    CONTEXT: Information on aberrant drug-related behaviors in the clinical study setting is limited. OBJECTIVES: This retrospective analysis was designed to identify the types and frequency of aberrant drug-related behaviors (including misuse and abuse) and associated patient characteristics in opioid-tolerant patients with chronic Pain. METHODS: Data from opioid-tolerant patients participating in clinical studies of fentanyl buccal tablet (FBT) for Breakthrough Pain (up to 18 months of clinical study case-report forms) were retrospectively reviewed and coded for abuse, overdose, and aberrant behavior. Aberrant behaviors were categorized as those involving FBT (overuse, lost or stolen study drug) and those not involving FBT (patients seeking prescriptions from other sources, not returning for follow-up). RESULTS: Of the 1,160 patients evaluated, 10 (<1%) patients had an abuse-related event, 18 (<2%) had a positive urine drug screening (nonprescribed drug or illicit substance), and 12 (1%) had an event consistent with opioid overdose; 124 (11%) had aberrant behaviors related to FBT, and 68 (6%) had aberrant behaviors that were not. Aberrant behaviors were more frequent in men (odds ratio [OR]: 1.5; 95% confidence interval [CI]: 1.1, 2.1; P<0.01), in patients 42 years or younger (OR: 2.5; 95% CI: 1.6, 4.0; P<0.01), and in patients 43 years to 49 years (OR: 1.9; 95% CI: 1.2, 3.1; P<0.01). CONCLUSION: The incidence of drug abuse events and aberrant drug-related behaviors was relatively low, probably because of the implementation of universal precautions and the controlled clinical study setting. Even in this setting, events occurred, highlighting the limits of screening and the need for ongoing monitoring of aberrant behavior.

  • long term safety and tolerability of fentanyl buccal tablet for the treatment of Breakthrough Pain in opioid tolerant patients with chronic Pain an 18 month study
    Journal of Pain and Symptom Management, 2010
    Co-Authors: Perry G Fine, John Messina, Fang Xie, James P Rathmell
    Abstract:

    Abstract Context Breakthrough Pain (BTP) is highly prevalent in patients with chronic cancer and noncancer Pain, commonly requiring treatment with short-acting or rapid-onset opioids. This is the first report of an analysis of long-term safety from combined clinical trials of a rapid-onset transmucosal formulation of fentanyl, the fentanyl buccal tablet (FBT). Objectives This long-term (18-month), open-label study assessed the safety and tolerability of FBT for the treatment of BTP in a large cohort (n=646) of opioid-tolerant patients receiving around-the-clock (ATC) opioids for persistant noncancer Pain. Methods This was a long-term, multicenter, open-label safety study that accepted patients naive to FBT (new patients) as well as rollover patients from one of two previous short-term, randomized, placebo-controlled studies involving opioid-tolerant adults with chronic noncancer Pain. All patients gave written informed consent, and the study was conducted according to Good Clinical Practice and with Independent Ethics Committee or Institutional Review Board approval. Results During maintenance treatment, 70 of 646 patients (11%) discontinued because of adverse events (AEs), 69 of 646 (11%) because of withdrawn consent, and 57 of 646 (9%) because of noncompliance. A total of 571 of 646 patients (88%) had one or more AEs; most were mild to moderate in intensity and typical of AEs associated with opioid use in a noncancer chronic Pain population. Serious AEs were seen in 118 of 646 patients (18%); most were considered by the investigators to be unrelated or unlikely to be related to FBT. There were six deaths (three myocardial infarction, two cardiac arrest, and one pneumonia) that were considered by investigators to be unrelated or unlikely to be related to FBT. There were two reports of accidental overdose contained within nine reports of nonfatal overdose (FBT and/or ATC and/or other medications). Four patients had AEs of abuse or drug dependence, two in association with FBT. Drug withdrawal syndrome occurred in 23 patients after discontinuation of FBT alone or in combination with other opioids. Secondary assessments showed that average Pain ratings, as assessed by the Brief Pain Inventory, remained relatively stable throughout the study and that consistent improvements were noted in functional measures. Conclusion FBT was generally safe and well tolerated, with self-reported functional improvement observed in most of the opioid-tolerant patients with BTP in association with chronic noncancer Pain.

  • a novel 12 week study with three randomized double blind placebo controlled periods to evaluate fentanyl buccal tablets for the relief of Breakthrough Pain in opioid tolerant patients with noncancer related chronic Pain
    Pain Medicine, 2010
    Co-Authors: John T. Farrar, John Messina, Fang Xie, Russell K. Portenoy
    Abstract:

    Objective.  To evaluate the time of onset, overall efficacy, and safety of fentanyl buccal tablet (FBT) for noncancer-related Breakthrough Pain (BTP) in opioid-tolerant adults over 12 weeks. Design.  A novel 12-week study that mimicked clinical practice with dose titration to effective dose, open-label treatment, and three randomized, double-blind, placebo-controlled, multiple-crossover periods at weeks 4, 8, and 12. For each double-blind period, study patients received nine doses (FBT = 6, placebo = 3) in a randomized sequence. Setting.  Twenty-one study centers in the United States. Population. Opioid-tolerant adults with noncancer-related chronic Pain and BTP. Outcome Measures.  The primary outcome was the sum of the Pain intensity differences (PID) 5–60 minutes post dose (SPID60) during the final double-blind period. Secondary outcomes included Pain relief (PR), meaningful PR, and proportion of episodes with a PID of ≥33% and ≥50%. Results.  Of 148 patients who entered the titration phase, 105 (71%) achieved a successful dose and 81 (55%) participated in all three assessment periods in the study. The final RCT assessment period results demonstrated continued efficacy of FBT vs placebo (P < 0.05) for SPID60 (mean [SD]: 7.7 [6.2] vs 4.6 [4.7]). The average onset of PR began at 5 minutes, with meaningful PR by ≤10 minutes. The proportion of episodes with ≥33% improvement in PI was 7% with FBT vs 3% with placebo at 5 minutes and with ≥50% was 17% vs 10% at 15 minutes. All periods showed similar results. Adverse events and patient discontinuations were generally typical of clinical opioid use. Conclusions.  FBT showed continued clinically important analgesic effects and was generally well tolerated over 12 weeks of treatment.

Steven Shoemaker - One of the best experts on this subject based on the ideXlab platform.

  • Breakthrough Pain in community dwelling patients with cancer Pain and noncancer Pain part 2 impact on function mood and quality of life
    Journal of opioid management, 2010
    Co-Authors: Russell K. Portenoy, Psyd Daniel Bruns, Bonnie Shoemaker, Steven Shoemaker
    Abstract:

    Background: Prior studies of Breakthrough Pain (BTP) largely focus on patients with advanced cancer or those receiving inpatient care. Very few studies have evaluated BTP in populations with chronic noncancer Pain. Data that illuminate the impact of BTP may not generalize to other, less selected patient populations. Aim: The aim of this study was to evaluate the impact of BTP in opioid-treated ambulatory patients with chronic cancer Pain or noncancer Pain treated in community practices. Methods: Eligible patients—those with any diagnosis who reported chronic Pain for at least 3 months, who were receiving long-term opioid therapy, and who met criteria for controlled baseline Pain—were recruited for a cross-sectional observational study by primary care physicians or community-based oncologists at 17 sites in the United States. The patients responded to a structured interview for Breakthrough Pain and also completed the Brief Pain Inventory-Modified Short Form (BPI-SF) and the Brief Battery for Health Improvement 2 (BBHI 2). Results: Of 355 patients screened, 191 were eligible and 177 (93 percent) provided data for analysis. Twenty-six of the 78 with cancer Pain (33 percent) and 48 of the 99 with noncancer Pain (48 percent) had BTP. Compared with those without BTP, both patients with cancer (p = 0.004) and patients without cancer (p = 0.019) with BTP had increased Pain interference in function, as measured by the BPI-SF, and patients without cancer were more impaired than patients with cancer. On the BBHI 2, BTP was associated with increased somatic complaints (p = 0.036 cancer and p = 0.024 noncancer) and Pain complaints (p = 0.037 cancer and p = 0.037 noncancer); among patients without cancer, BTP was also associated with increased difficulties with functioning (p = 0.023), depression (p = 0.039), and decreased quality of life (p = 0.003). Conclusions: These data extend published observations about the association between BTP and adverse effects on mood and function to populations undergoing routine treatment in the community setting and provide evidence that these associations are greater in those with noncancer Pain. They suggest the need for additional studies to clarify causality and determine whether undertreatment of BTP is a factor contributing to adverse Pain-related outcomes.

  • Breakthrough Pain in community dwelling patients with cancer Pain and noncancer Pain part 1 prevalence and characteristics
    Journal of opioid management, 2010
    Co-Authors: Russell K. Portenoy, Psyd Daniel Bruns, Bonnie Shoemaker, Steven Shoemaker
    Abstract:

    Background: Most Breakthrough Pain (BTP) studies assess patients with advanced cancer or those receiving inpatient care. Studies in noncancer populations are limited to surveys of Pain clinics and patients with other advanced diseases. To better understand BTP, data are needed from less selected populations. Aim: The aim of this study was to evaluate BTP in opioid-treated ambulatory patients with chronic cancer or noncancer Pain treated in community practices. Methods: Primary care physicians or community-based oncologists recruited a convenience sample for a cross-sectional study of BTP at 17 sites in the United States. Physicians could not be Pain specialists. Patients were eligible if they had any type of Pain for ≥3 months and were receiving an opioid drug on a regular basis that controlled the Pain. The patients responded to a structured interview comprising items that assessed the baseline Pain and items that assessed BTP, if present. Results: In total, 355 patients were screened, 191 were eligible and 177 (93 percent) provided data for analysis. Seventy-eight patients had cancer Pain and 99 had noncancer Pain. Patients with cancer were older (mean ± SD age 61.3 ± 11.2 years vs 51.4 ± 13.6 years, p < 0.001), and patients without cancer had more neuropathic Pain (21 vs 12 percent, p < 0.05) and a longer Pain duration (median 3.5 vs 1 years, p < 0.001). BTP occurred in 33 percent with cancer and 48 percent with noncancer Pain (p = 0.042). BTP did not vary by diagnosis, but neuropathic Pain was more common in those with BTP (27 vs 10 percent, p < 0.001). In patients with and without cancer, the median daily number of episodes was 1, the median time to maximum Pain was 1-2 minutes, and the median duration was 45-60 minutes. There were fewer BTP precipitants in the patients with cancer (46 vs 80 percent of Pains, p < 0.05), and they had less predictable Pain (p < 0.05). Conclusions: The prevalence of BTP among community-dwelling patients is lower than that found in prior studies of more selected populations. BTP is more prevalent among patients with noncancer Pain than patients with cancer Pain, and although there are many similarities, some differences may be relevant to treatment strategies.

  • impact of Breakthrough Pain on quality of life in patients with chronic noncancer Pain patient perceptions and effect of treatment with oral transmucosal fentanyl citrate otfc actiq
    Pain Medicine, 2007
    Co-Authors: Donald R Taylor, Steven Shoemaker, Lynn R Webster, Steven Y Chun, Jeffrey Reinking, Mary Stegman, Barry Fortner
    Abstract:

    Objective.  To characterize Breakthrough Pain (BTP), its qualitative impact on quality of life (QoL), and the effects of BTP treatment on QoL. Design.  Multicenter patient-reported survey. Setting.  Five Pain treatment centers. Patients.  Fifty-six adults with chronic noncancer Pain using oral transmucosal fentanyl citrate (OTFC®, ACTIQ®). Results.  Forty-three patients qualified for in-depth analysis. BTP had a mean intensity of 9.0 (range 5–10) on an 11-point numerical scale (0 = no Pain to 10 = worst possible Pain), had a mean duration of 83 minutes, and had an adverse effect on multiple QoL domains. The largest negative QoL impacts were on “general activity level” and “ability to work.” OTFC had a positive impact on both controlling BTP and improving QoL. Conclusions.  BTP appears to be a clinically important condition in this population and is associated with an adverse impact on QoL. Understanding those QoL domains most affected by BTP and those potentially improved with treatment should help in developing quantitative QoL assessment tools and other outcome measures for BTP management studies.

  • prevalence and characteristics of Breakthrough Pain in opioid treated patients with chronic noncancer Pain
    The Journal of Pain, 2006
    Co-Authors: Russell K. Portenoy, Daniel S Bennett, Richard Rauck, Steven Simon, Donald H Taylor, Michael J Brennan, Steven Shoemaker
    Abstract:

    Abstract Breakthrough Pain is well-characterized in cancer patients but not in patients with chronic noncancer Pain. We recruited 228 patients with diverse types of chronic noncancer Pain from 9 Pain programs and administered a telephone questionnaire with a Breakthrough Pain assessment algorithm originally designed for cancer patients. All patients had controlled baseline Pain, and 168 (74%) experienced severe to excruciating Breakthrough Pain. Among those with Breakthrough Pain, the most common syndrome was low back Pain (52%), and the underlying pathophysiology was variably characterized as somatic (38%), neuropathic (18%), visceral (4%), or mixed (40%). A total of 189 different types of Breakthrough Pain were reported. The median number of episodes per day was 2 (range, Perspective This article presents results from a survey that demonstrates that Breakthrough Pain is highly prevalent and varied in opioid-treated patients with chronic noncancer Pain. These findings will assist clinicians in assessing and managing this type of Pain.

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  • the efficacy and safety of fentanyl buccal tablet compared with immediate release oxycodone for the management of Breakthrough Pain in opioid tolerant patients with chronic Pain
    Anesthesia & Analgesia, 2011
    Co-Authors: Michael A Ashburn, Kieran A Slevin, John Messina, Fang Xie
    Abstract:

    BACKGROUND:Current clinical guidelines have identified the need for studies comparing the effect of different short-acting or rapid-onset opioids for the treatment of Breakthrough Pain (BTP). In this study we evaluated the efficacy and safety of treatment with fentanyl buccal tablet (FBT) in compari

  • aberrant drug related behavior observed during clinical studies involving patients taking chronic opioid therapy for persistent Pain and fentanyl buccal tablet for Breakthrough Pain
    Journal of Pain and Symptom Management, 2011
    Co-Authors: Steven D Passik, John Messina, Anthony Golsorkhi, Fang Xie
    Abstract:

    Abstract Context Information on aberrant drug-related behaviors in the clinical study setting is limited. Objectives This retrospective analysis was designed to identify the types and frequency of aberrant drug-related behaviors (including misuse and abuse) and associated patient characteristics in opioid-tolerant patients with chronic Pain. Methods Data from opioid-tolerant patients participating in clinical studies of fentanyl buccal tablet (FBT) for Breakthrough Pain (up to 18 months of clinical study case-report forms) were retrospectively reviewed and coded for abuse, overdose, and aberrant behavior. Aberrant behaviors were categorized as those involving FBT (overuse, lost or stolen study drug) and those not involving FBT (patients seeking prescriptions from other sources, not returning for follow-up). Results Of the 1,160 patients evaluated, 10 ( P P P Conclusion The incidence of drug abuse events and aberrant drug-related behaviors was relatively low, probably because of the implementation of universal precautions and the controlled clinical study setting. Even in this setting, events occurred, highlighting the limits of screening and the need for ongoing monitoring of aberrant behavior.

  • long term safety and tolerability of fentanyl buccal tablet for the treatment of Breakthrough Pain in opioid tolerant patients with chronic Pain an 18 month study
    Journal of Pain and Symptom Management, 2010
    Co-Authors: Perry G Fine, John Messina, Fang Xie, James P Rathmell
    Abstract:

    Abstract Context Breakthrough Pain (BTP) is highly prevalent in patients with chronic cancer and noncancer Pain, commonly requiring treatment with short-acting or rapid-onset opioids. This is the first report of an analysis of long-term safety from combined clinical trials of a rapid-onset transmucosal formulation of fentanyl, the fentanyl buccal tablet (FBT). Objectives This long-term (18-month), open-label study assessed the safety and tolerability of FBT for the treatment of BTP in a large cohort (n=646) of opioid-tolerant patients receiving around-the-clock (ATC) opioids for persistant noncancer Pain. Methods This was a long-term, multicenter, open-label safety study that accepted patients naive to FBT (new patients) as well as rollover patients from one of two previous short-term, randomized, placebo-controlled studies involving opioid-tolerant adults with chronic noncancer Pain. All patients gave written informed consent, and the study was conducted according to Good Clinical Practice and with Independent Ethics Committee or Institutional Review Board approval. Results During maintenance treatment, 70 of 646 patients (11%) discontinued because of adverse events (AEs), 69 of 646 (11%) because of withdrawn consent, and 57 of 646 (9%) because of noncompliance. A total of 571 of 646 patients (88%) had one or more AEs; most were mild to moderate in intensity and typical of AEs associated with opioid use in a noncancer chronic Pain population. Serious AEs were seen in 118 of 646 patients (18%); most were considered by the investigators to be unrelated or unlikely to be related to FBT. There were six deaths (three myocardial infarction, two cardiac arrest, and one pneumonia) that were considered by investigators to be unrelated or unlikely to be related to FBT. There were two reports of accidental overdose contained within nine reports of nonfatal overdose (FBT and/or ATC and/or other medications). Four patients had AEs of abuse or drug dependence, two in association with FBT. Drug withdrawal syndrome occurred in 23 patients after discontinuation of FBT alone or in combination with other opioids. Secondary assessments showed that average Pain ratings, as assessed by the Brief Pain Inventory, remained relatively stable throughout the study and that consistent improvements were noted in functional measures. Conclusion FBT was generally safe and well tolerated, with self-reported functional improvement observed in most of the opioid-tolerant patients with BTP in association with chronic noncancer Pain.

  • a novel 12 week study with three randomized double blind placebo controlled periods to evaluate fentanyl buccal tablets for the relief of Breakthrough Pain in opioid tolerant patients with noncancer related chronic Pain
    Pain Medicine, 2010
    Co-Authors: John T. Farrar, John Messina, Fang Xie, Russell K. Portenoy
    Abstract:

    Objective.  To evaluate the time of onset, overall efficacy, and safety of fentanyl buccal tablet (FBT) for noncancer-related Breakthrough Pain (BTP) in opioid-tolerant adults over 12 weeks. Design.  A novel 12-week study that mimicked clinical practice with dose titration to effective dose, open-label treatment, and three randomized, double-blind, placebo-controlled, multiple-crossover periods at weeks 4, 8, and 12. For each double-blind period, study patients received nine doses (FBT = 6, placebo = 3) in a randomized sequence. Setting.  Twenty-one study centers in the United States. Population. Opioid-tolerant adults with noncancer-related chronic Pain and BTP. Outcome Measures.  The primary outcome was the sum of the Pain intensity differences (PID) 5–60 minutes post dose (SPID60) during the final double-blind period. Secondary outcomes included Pain relief (PR), meaningful PR, and proportion of episodes with a PID of ≥33% and ≥50%. Results.  Of 148 patients who entered the titration phase, 105 (71%) achieved a successful dose and 81 (55%) participated in all three assessment periods in the study. The final RCT assessment period results demonstrated continued efficacy of FBT vs placebo (P < 0.05) for SPID60 (mean [SD]: 7.7 [6.2] vs 4.6 [4.7]). The average onset of PR began at 5 minutes, with meaningful PR by ≤10 minutes. The proportion of episodes with ≥33% improvement in PI was 7% with FBT vs 3% with placebo at 5 minutes and with ≥50% was 17% vs 10% at 15 minutes. All periods showed similar results. Adverse events and patient discontinuations were generally typical of clinical opioid use. Conclusions.  FBT showed continued clinically important analgesic effects and was generally well tolerated over 12 weeks of treatment.

  • fentanyl buccal tablet for the treatment of Breakthrough Pain in opioid tolerant patients with chronic cancer Pain a long term open label safety study
    Cancer, 2009
    Co-Authors: Sharon M Weinstein, John Messina, Fang Xie
    Abstract:

    BACKGROUND: This study assessed the long-term safety and tolerability of fentanyl buccal tablet (FBT) in opioid-tolerant patients with cancer and Breakthrough Pain (BTP) who were either naive to FBT or had completed 1 of 2 previous double-blind, placebo-controlled FBT studies (rollover patients). METHODS: Patients who were FBT-naive underwent titration to find a successful FBT dose. Rollover patients used a previously identified successful dose of FBT. Patients who achieved a successful dose were eligible to enter a maintenance phase (≥12 months). Safety assessments included adverse events (AEs), physical and neurologic examinations, and clinical laboratory tests. RESULTS: Two hundred thirty-two patients were enrolled. A total of 112 entered titration; 79 identified a successful FBT dose, and 77 of these patients entered the maintenance phase along with 120 rollover patients (n = 197). AEs resulted in discontinuation of therapy for 33% of patients. The most common AEs were generally typical of opioids administered to cancer patients. All serious AEs were considered to be related to the patients' underlying conditions, except for 1 incident of FBT-related drug withdrawal syndrome. Sixty patients died after enrollment because of disease progression. Fifteen (6%) patients experienced ≥1 application-site AE, all of which were considered by investigators to be related to FBT. CONCLUSIONS: FBT was generally well tolerated and had a favorable safety profile in the long-term (≥12 months) management of patients with persistent cancer Pain and BTP. No unexpected AEs occurred. Safety and tolerability was similar to that observed in short-term studies. Cancer 2009. © 2009 American Cancer Society.