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Joachim Nadstawek - One of the best experts on this subject based on the ideXlab platform.
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gastrointestinal symptoms under opioid therapy a prospective comparison of oral sustained release Hydromorphone transdermal fentanyl and transdermal buprenorphine
European Journal of Pain, 2009Co-Authors: Stefan Wirz, Maria Wittmann, Michael Schenk, Andreas Schroeck, Nico Schaefer, Marcus Mueller, Jens Standop, Norbert Kloecker, Joachim NadstawekAbstract:Abstract Introduction The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation. Patients and methods Randomly selected outpatients with cancer pain receiving one of the study medications were enrolled in a prospective, open-labeled, controlled trial ( n = 174). Mobility, pain, and gastrointestinal symptoms were assessed directly and per selected item on the ECOG (Eastern Cancer Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer) questionnaires, NRS (Numerical Rating Scales), and analyzed statistically. Results Demographic and medical data were comparable in all groups. Only 15% of patients suffered from constipation. 59% took the prescribed laxatives. The incidence of stool free periods >72 h was significantly higher with transdermal opioids (transdermal fentanyl: 22%; transdermal buprenorphine: 21%; oral Hydromorphone: 2%; p = 0.003). 21% of patients revealed nausea and emesis. The mean NRS for nausea (transdermal fentanyl:1.3; transdermal buprenorphine: 1.2; oral Hydromorphone: 1.5; p = 0.6), the consumption of antiemetics (transdermal fentanyl: 42%; transdermal buprenorphine: 33%; oral Hydromorphone: 36%; p = 0.6) and laxatives (transdermal fentanyl:53%; transdermal buprenorphine:66%; oral Hydromorphone: 61%; p = 0.2) did not differ significantly, in contrast to the score for emesis (transdermal fentanyl: 16%; transdermal buprenorphine:13%; oral Hydromorphone: 33%; p = 0.02). Morphine equivalent opioid doses differed (mg/d transdermal fentanyl: 183; transdermal buprenorphine: 89; oral Hydromorphone: 143; p = 0.001), because of obvious tolerance varying after long-term treatment. Conclusions Gastrointestinal symptoms of cancer pain patients undergoing an opioid therapy are related to multifactorial causes. Transdermal opioids showed no benefit over oral controlled-release Hydromorphone with regard to gastrointestinal symptoms. The conversion ratios for transdermal fentanyl, transdermal buprenorphine, and oral Hydromorphone did not accord to the literature, because of differing occurrences of opioid tolerance after long-term therapy.
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Gastrointestinal symptoms under opioid therapy: A prospective comparison of oral sustained‐release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine
European journal of pain (London England), 2008Co-Authors: Stefan Wirz, Maria Wittmann, Michael Schenk, Andreas Schroeck, Nico Schaefer, Marcus Mueller, Jens Standop, Norbert Kloecker, Joachim NadstawekAbstract:Abstract Introduction The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation. Patients and methods Randomly selected outpatients with cancer pain receiving one of the study medications were enrolled in a prospective, open-labeled, controlled trial ( n = 174). Mobility, pain, and gastrointestinal symptoms were assessed directly and per selected item on the ECOG (Eastern Cancer Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer) questionnaires, NRS (Numerical Rating Scales), and analyzed statistically. Results Demographic and medical data were comparable in all groups. Only 15% of patients suffered from constipation. 59% took the prescribed laxatives. The incidence of stool free periods >72 h was significantly higher with transdermal opioids (transdermal fentanyl: 22%; transdermal buprenorphine: 21%; oral Hydromorphone: 2%; p = 0.003). 21% of patients revealed nausea and emesis. The mean NRS for nausea (transdermal fentanyl:1.3; transdermal buprenorphine: 1.2; oral Hydromorphone: 1.5; p = 0.6), the consumption of antiemetics (transdermal fentanyl: 42%; transdermal buprenorphine: 33%; oral Hydromorphone: 36%; p = 0.6) and laxatives (transdermal fentanyl:53%; transdermal buprenorphine:66%; oral Hydromorphone: 61%; p = 0.2) did not differ significantly, in contrast to the score for emesis (transdermal fentanyl: 16%; transdermal buprenorphine:13%; oral Hydromorphone: 33%; p = 0.02). Morphine equivalent opioid doses differed (mg/d transdermal fentanyl: 183; transdermal buprenorphine: 89; oral Hydromorphone: 143; p = 0.001), because of obvious tolerance varying after long-term treatment. Conclusions Gastrointestinal symptoms of cancer pain patients undergoing an opioid therapy are related to multifactorial causes. Transdermal opioids showed no benefit over oral controlled-release Hydromorphone with regard to gastrointestinal symptoms. The conversion ratios for transdermal fentanyl, transdermal buprenorphine, and oral Hydromorphone did not accord to the literature, because of differing occurrences of opioid tolerance after long-term therapy.
Stefan Wirz - One of the best experts on this subject based on the ideXlab platform.
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gastrointestinal symptoms under opioid therapy a prospective comparison of oral sustained release Hydromorphone transdermal fentanyl and transdermal buprenorphine
European Journal of Pain, 2009Co-Authors: Stefan Wirz, Maria Wittmann, Michael Schenk, Andreas Schroeck, Nico Schaefer, Marcus Mueller, Jens Standop, Norbert Kloecker, Joachim NadstawekAbstract:Abstract Introduction The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation. Patients and methods Randomly selected outpatients with cancer pain receiving one of the study medications were enrolled in a prospective, open-labeled, controlled trial ( n = 174). Mobility, pain, and gastrointestinal symptoms were assessed directly and per selected item on the ECOG (Eastern Cancer Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer) questionnaires, NRS (Numerical Rating Scales), and analyzed statistically. Results Demographic and medical data were comparable in all groups. Only 15% of patients suffered from constipation. 59% took the prescribed laxatives. The incidence of stool free periods >72 h was significantly higher with transdermal opioids (transdermal fentanyl: 22%; transdermal buprenorphine: 21%; oral Hydromorphone: 2%; p = 0.003). 21% of patients revealed nausea and emesis. The mean NRS for nausea (transdermal fentanyl:1.3; transdermal buprenorphine: 1.2; oral Hydromorphone: 1.5; p = 0.6), the consumption of antiemetics (transdermal fentanyl: 42%; transdermal buprenorphine: 33%; oral Hydromorphone: 36%; p = 0.6) and laxatives (transdermal fentanyl:53%; transdermal buprenorphine:66%; oral Hydromorphone: 61%; p = 0.2) did not differ significantly, in contrast to the score for emesis (transdermal fentanyl: 16%; transdermal buprenorphine:13%; oral Hydromorphone: 33%; p = 0.02). Morphine equivalent opioid doses differed (mg/d transdermal fentanyl: 183; transdermal buprenorphine: 89; oral Hydromorphone: 143; p = 0.001), because of obvious tolerance varying after long-term treatment. Conclusions Gastrointestinal symptoms of cancer pain patients undergoing an opioid therapy are related to multifactorial causes. Transdermal opioids showed no benefit over oral controlled-release Hydromorphone with regard to gastrointestinal symptoms. The conversion ratios for transdermal fentanyl, transdermal buprenorphine, and oral Hydromorphone did not accord to the literature, because of differing occurrences of opioid tolerance after long-term therapy.
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Gastrointestinal symptoms under opioid therapy: A prospective comparison of oral sustained‐release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine
European journal of pain (London England), 2008Co-Authors: Stefan Wirz, Maria Wittmann, Michael Schenk, Andreas Schroeck, Nico Schaefer, Marcus Mueller, Jens Standop, Norbert Kloecker, Joachim NadstawekAbstract:Abstract Introduction The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation. Patients and methods Randomly selected outpatients with cancer pain receiving one of the study medications were enrolled in a prospective, open-labeled, controlled trial ( n = 174). Mobility, pain, and gastrointestinal symptoms were assessed directly and per selected item on the ECOG (Eastern Cancer Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer) questionnaires, NRS (Numerical Rating Scales), and analyzed statistically. Results Demographic and medical data were comparable in all groups. Only 15% of patients suffered from constipation. 59% took the prescribed laxatives. The incidence of stool free periods >72 h was significantly higher with transdermal opioids (transdermal fentanyl: 22%; transdermal buprenorphine: 21%; oral Hydromorphone: 2%; p = 0.003). 21% of patients revealed nausea and emesis. The mean NRS for nausea (transdermal fentanyl:1.3; transdermal buprenorphine: 1.2; oral Hydromorphone: 1.5; p = 0.6), the consumption of antiemetics (transdermal fentanyl: 42%; transdermal buprenorphine: 33%; oral Hydromorphone: 36%; p = 0.6) and laxatives (transdermal fentanyl:53%; transdermal buprenorphine:66%; oral Hydromorphone: 61%; p = 0.2) did not differ significantly, in contrast to the score for emesis (transdermal fentanyl: 16%; transdermal buprenorphine:13%; oral Hydromorphone: 33%; p = 0.02). Morphine equivalent opioid doses differed (mg/d transdermal fentanyl: 183; transdermal buprenorphine: 89; oral Hydromorphone: 143; p = 0.001), because of obvious tolerance varying after long-term treatment. Conclusions Gastrointestinal symptoms of cancer pain patients undergoing an opioid therapy are related to multifactorial causes. Transdermal opioids showed no benefit over oral controlled-release Hydromorphone with regard to gastrointestinal symptoms. The conversion ratios for transdermal fentanyl, transdermal buprenorphine, and oral Hydromorphone did not accord to the literature, because of differing occurrences of opioid tolerance after long-term therapy.
John Thipphawong - One of the best experts on this subject based on the ideXlab platform.
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long term safety tolerability and efficacy of oros Hydromorphone in patients with chronic pain
Journal of opioid management, 2018Co-Authors: Mark S. Wallace, R Skowronski, S Khanna, Iulia Cristina Tudor, Dwight E Moulin, Richard Rauck, John ThipphawongAbstract:Objective: To assess the safety and efficacy of long-term repeated dosing of OROS® Hydromorphone in chronic pain patients. Design: This multicenter, open-label extension trial enrolled patients from three short-term OROS® Hydromorphone trials. Setting: Fifty-six centers in the United States and Canada. Patients: Adults with chronic cancer pain or chronic nonmalignant pain who were receiving stable doses of OROS® Hydromorphone (≥8 mg/day). Three hundred and eighty-eight patients were enrolled, 106 patients completed at least 12 months of therapy. Interventions: OROS® Hydromorphone (individualized doses) was administered once daily. Main outcome measures: Safety and efficacy (Brief Pain Inventory and patient and investigator global evaluations) were assessed at monthly visits. Results: The median duration of extended OROS® Hydromorphone therapy was 274 days. The median daily dose of study medication was 32.0 mg at extension-study baseline, 40.0 mg at month 3, and 48.0 mg at months 6, 9, and 12, respectively. The most frequently reported adverse events were nausea (n = 93, 24.0 percent) and constipation (n = 75, 19.3 percent). The analgesic effects of OROS® Hydromorphone, assessed using the Brief Pain Inventory, were maintained throughout the extension. At 12 months, 72.4 percent of patients and 75.9 percent of investigators rated overall treatment as good, very good, or excellent. Conclusions: Once-daily OROS® Hydromorphone is an osmotically driven, controlled-release preparation that may be particularly well suited to long-term use, because it provides consistent plasma concentrations and sustained around-the-clock analgesia. In this study, the benefits of OROS® Hydromorphone attained in short-term studies were maintained in the long-term when daily administration was continued.
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conversion from standard opioid therapy to once daily oral extended release Hydromorphone in patients with chronic cancer pain
Journal of International Medical Research, 2008Co-Authors: Mark S. Wallace, John Thipphawong, S Khanna, Dwight E Moulin, Richard Rauck, Iulia Cristina TudorAbstract:This open-label, multicenter study assessed the efficacy and tolerability of conversion to once-daily OROS Hydromorphone from previous opioid agonist therapy in patients with chronic cancer pain. Patients were stabilized on their previous therapy before conversion at a 5:1 ratio of morphine sulfate to Hydromorphone hydrochloride. The OROS Hydromorphone dose was titrated over 3 - 21 days to achieve effective analgesia and was maintained for up to 14 days. Efficacy was assessed using the Brief Pain Inventory (BPI). Adverse events and vital signs were monitored. Dose stabilization was achieved in 119 of the 127 (94%) patients who received the study medication; in 77%, stabilization was achieved with no titration steps. Mean BPI pain intensity ratings and BPI pain interference scores decreased significantly after OROS Hydromorphone treatment compared with pretreatment values. Mean pain-relief level remained stable after conversion and throughout treatment with OROS Hydromorphone. Adverse events were as expected for cancer patients receiving opioid agonists. There were no clinically significant changes in vital signs.
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pharmacokinetic profile of a 24 hour controlled release oros formulation of Hydromorphone in the presence of alcohol
Current Medical Research and Opinion, 2008Co-Authors: Gayatri Sathyan, K Sivakumar, John ThipphawongAbstract:ABSTRACTObjective: The purpose of this study was to investigate the pharmacokinetic properties of a novel, once-daily, controlled-release formulation of Hydromorphone (OROS Hydromorphone) in the presence of alcohol. * OROS is a registered trade name of ALZA Corporation, Mountain View, CA, USAResearch design and methods: In a single-centre, open-label, four-treatment, four-period, four-sequence, crossover study, two groups of 24 healthy subjects (fasted or fed) were randomised to receive four single doses of OROS Hydromorphone 16 mg with solutions of either 0%, 4%, 20% or 40% alcohol, and with a naltrexone block.Main outcome measures: Plasma samples taken predose and at regular intervals up to 48 h after dosing were assayed for Hydromorphone concentrations; a mixed-effect analysis of variance was done on log-transformed data. Bioequivalence was concluded if 90% confidence intervals of treatment mean ratios were between 80% and 125%.Results: Plasma Hydromorphone concentrations were slightly higher after dos...
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efficacy and safety evaluation of once daily oros Hydromorphone in patients with chronic low back pain a pilot open label study do 127
Current Medical Research and Opinion, 2007Co-Authors: Mark S. Wallace, R Skowronski, S Khanna, Iulia Cristina Tudor, John ThipphawongAbstract:ABSTRACTObjective: To evaluate the safety, tolerability, and efficacy of once-daily osmotic controlled-release oral delivery system (OROS) Hydromorphone in patients with chronic low back pain of moderate-to-severe intensity.Research design and methods: This was a 6-week, multicenter, nonrandomized, noncomparative, open-label, repeat-dose study of chronic (≥ 6 weeks) low back pain. The study comprised three periods: prior opioid stabilization (2–7 days); OROS Hydromorphone conversion, titration, and stabilization (3–14 days); and OROS hydromorphone maintenance (28 days). Patients were evaluated weekly. Baseline pain assessment was performed at the end of prior opioid stabilization. For pain relief rating, endpoint was defined as the mean pain relief score from the last 2 nonmissing days before study termination. For other assessments, endpoint was defined as the last post-baseline evaluation.Results: Of the 207 patients who received the study drug, 131 completed the trial. Scores (mean ± SD) for Brief P...
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pharmacokinetic profile of a 24 hour controlled release oros formulation of Hydromorphone in the presence and absence of food
BMC Clinical Pharmacology, 2007Co-Authors: Gayatri Sathyan, John Thipphawong, Emily Xu, Suneel K. GuptaAbstract:Background The objective of this study was to compare the pharmacokinetic profile of a novel, once-daily, controlled-release formulation of Hydromorphone (OROS® Hydromorphone) under fasting conditions with that immediately after a high-fat breakfast in healthy volunteers. The effect of the opioid antagonist naltrexone on fasting Hydromorphone pharmacokinetics also was evaluated.
Jens Standop - One of the best experts on this subject based on the ideXlab platform.
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gastrointestinal symptoms under opioid therapy a prospective comparison of oral sustained release Hydromorphone transdermal fentanyl and transdermal buprenorphine
European Journal of Pain, 2009Co-Authors: Stefan Wirz, Maria Wittmann, Michael Schenk, Andreas Schroeck, Nico Schaefer, Marcus Mueller, Jens Standop, Norbert Kloecker, Joachim NadstawekAbstract:Abstract Introduction The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation. Patients and methods Randomly selected outpatients with cancer pain receiving one of the study medications were enrolled in a prospective, open-labeled, controlled trial ( n = 174). Mobility, pain, and gastrointestinal symptoms were assessed directly and per selected item on the ECOG (Eastern Cancer Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer) questionnaires, NRS (Numerical Rating Scales), and analyzed statistically. Results Demographic and medical data were comparable in all groups. Only 15% of patients suffered from constipation. 59% took the prescribed laxatives. The incidence of stool free periods >72 h was significantly higher with transdermal opioids (transdermal fentanyl: 22%; transdermal buprenorphine: 21%; oral Hydromorphone: 2%; p = 0.003). 21% of patients revealed nausea and emesis. The mean NRS for nausea (transdermal fentanyl:1.3; transdermal buprenorphine: 1.2; oral Hydromorphone: 1.5; p = 0.6), the consumption of antiemetics (transdermal fentanyl: 42%; transdermal buprenorphine: 33%; oral Hydromorphone: 36%; p = 0.6) and laxatives (transdermal fentanyl:53%; transdermal buprenorphine:66%; oral Hydromorphone: 61%; p = 0.2) did not differ significantly, in contrast to the score for emesis (transdermal fentanyl: 16%; transdermal buprenorphine:13%; oral Hydromorphone: 33%; p = 0.02). Morphine equivalent opioid doses differed (mg/d transdermal fentanyl: 183; transdermal buprenorphine: 89; oral Hydromorphone: 143; p = 0.001), because of obvious tolerance varying after long-term treatment. Conclusions Gastrointestinal symptoms of cancer pain patients undergoing an opioid therapy are related to multifactorial causes. Transdermal opioids showed no benefit over oral controlled-release Hydromorphone with regard to gastrointestinal symptoms. The conversion ratios for transdermal fentanyl, transdermal buprenorphine, and oral Hydromorphone did not accord to the literature, because of differing occurrences of opioid tolerance after long-term therapy.
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Gastrointestinal symptoms under opioid therapy: A prospective comparison of oral sustained‐release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine
European journal of pain (London England), 2008Co-Authors: Stefan Wirz, Maria Wittmann, Michael Schenk, Andreas Schroeck, Nico Schaefer, Marcus Mueller, Jens Standop, Norbert Kloecker, Joachim NadstawekAbstract:Abstract Introduction The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation. Patients and methods Randomly selected outpatients with cancer pain receiving one of the study medications were enrolled in a prospective, open-labeled, controlled trial ( n = 174). Mobility, pain, and gastrointestinal symptoms were assessed directly and per selected item on the ECOG (Eastern Cancer Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer) questionnaires, NRS (Numerical Rating Scales), and analyzed statistically. Results Demographic and medical data were comparable in all groups. Only 15% of patients suffered from constipation. 59% took the prescribed laxatives. The incidence of stool free periods >72 h was significantly higher with transdermal opioids (transdermal fentanyl: 22%; transdermal buprenorphine: 21%; oral Hydromorphone: 2%; p = 0.003). 21% of patients revealed nausea and emesis. The mean NRS for nausea (transdermal fentanyl:1.3; transdermal buprenorphine: 1.2; oral Hydromorphone: 1.5; p = 0.6), the consumption of antiemetics (transdermal fentanyl: 42%; transdermal buprenorphine: 33%; oral Hydromorphone: 36%; p = 0.6) and laxatives (transdermal fentanyl:53%; transdermal buprenorphine:66%; oral Hydromorphone: 61%; p = 0.2) did not differ significantly, in contrast to the score for emesis (transdermal fentanyl: 16%; transdermal buprenorphine:13%; oral Hydromorphone: 33%; p = 0.02). Morphine equivalent opioid doses differed (mg/d transdermal fentanyl: 183; transdermal buprenorphine: 89; oral Hydromorphone: 143; p = 0.001), because of obvious tolerance varying after long-term treatment. Conclusions Gastrointestinal symptoms of cancer pain patients undergoing an opioid therapy are related to multifactorial causes. Transdermal opioids showed no benefit over oral controlled-release Hydromorphone with regard to gastrointestinal symptoms. The conversion ratios for transdermal fentanyl, transdermal buprenorphine, and oral Hydromorphone did not accord to the literature, because of differing occurrences of opioid tolerance after long-term therapy.
Michael Schenk - One of the best experts on this subject based on the ideXlab platform.
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gastrointestinal symptoms under opioid therapy a prospective comparison of oral sustained release Hydromorphone transdermal fentanyl and transdermal buprenorphine
European Journal of Pain, 2009Co-Authors: Stefan Wirz, Maria Wittmann, Michael Schenk, Andreas Schroeck, Nico Schaefer, Marcus Mueller, Jens Standop, Norbert Kloecker, Joachim NadstawekAbstract:Abstract Introduction The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation. Patients and methods Randomly selected outpatients with cancer pain receiving one of the study medications were enrolled in a prospective, open-labeled, controlled trial ( n = 174). Mobility, pain, and gastrointestinal symptoms were assessed directly and per selected item on the ECOG (Eastern Cancer Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer) questionnaires, NRS (Numerical Rating Scales), and analyzed statistically. Results Demographic and medical data were comparable in all groups. Only 15% of patients suffered from constipation. 59% took the prescribed laxatives. The incidence of stool free periods >72 h was significantly higher with transdermal opioids (transdermal fentanyl: 22%; transdermal buprenorphine: 21%; oral Hydromorphone: 2%; p = 0.003). 21% of patients revealed nausea and emesis. The mean NRS for nausea (transdermal fentanyl:1.3; transdermal buprenorphine: 1.2; oral Hydromorphone: 1.5; p = 0.6), the consumption of antiemetics (transdermal fentanyl: 42%; transdermal buprenorphine: 33%; oral Hydromorphone: 36%; p = 0.6) and laxatives (transdermal fentanyl:53%; transdermal buprenorphine:66%; oral Hydromorphone: 61%; p = 0.2) did not differ significantly, in contrast to the score for emesis (transdermal fentanyl: 16%; transdermal buprenorphine:13%; oral Hydromorphone: 33%; p = 0.02). Morphine equivalent opioid doses differed (mg/d transdermal fentanyl: 183; transdermal buprenorphine: 89; oral Hydromorphone: 143; p = 0.001), because of obvious tolerance varying after long-term treatment. Conclusions Gastrointestinal symptoms of cancer pain patients undergoing an opioid therapy are related to multifactorial causes. Transdermal opioids showed no benefit over oral controlled-release Hydromorphone with regard to gastrointestinal symptoms. The conversion ratios for transdermal fentanyl, transdermal buprenorphine, and oral Hydromorphone did not accord to the literature, because of differing occurrences of opioid tolerance after long-term therapy.
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Gastrointestinal symptoms under opioid therapy: A prospective comparison of oral sustained‐release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine
European journal of pain (London England), 2008Co-Authors: Stefan Wirz, Maria Wittmann, Michael Schenk, Andreas Schroeck, Nico Schaefer, Marcus Mueller, Jens Standop, Norbert Kloecker, Joachim NadstawekAbstract:Abstract Introduction The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release Hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation. Patients and methods Randomly selected outpatients with cancer pain receiving one of the study medications were enrolled in a prospective, open-labeled, controlled trial ( n = 174). Mobility, pain, and gastrointestinal symptoms were assessed directly and per selected item on the ECOG (Eastern Cancer Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer) questionnaires, NRS (Numerical Rating Scales), and analyzed statistically. Results Demographic and medical data were comparable in all groups. Only 15% of patients suffered from constipation. 59% took the prescribed laxatives. The incidence of stool free periods >72 h was significantly higher with transdermal opioids (transdermal fentanyl: 22%; transdermal buprenorphine: 21%; oral Hydromorphone: 2%; p = 0.003). 21% of patients revealed nausea and emesis. The mean NRS for nausea (transdermal fentanyl:1.3; transdermal buprenorphine: 1.2; oral Hydromorphone: 1.5; p = 0.6), the consumption of antiemetics (transdermal fentanyl: 42%; transdermal buprenorphine: 33%; oral Hydromorphone: 36%; p = 0.6) and laxatives (transdermal fentanyl:53%; transdermal buprenorphine:66%; oral Hydromorphone: 61%; p = 0.2) did not differ significantly, in contrast to the score for emesis (transdermal fentanyl: 16%; transdermal buprenorphine:13%; oral Hydromorphone: 33%; p = 0.02). Morphine equivalent opioid doses differed (mg/d transdermal fentanyl: 183; transdermal buprenorphine: 89; oral Hydromorphone: 143; p = 0.001), because of obvious tolerance varying after long-term treatment. Conclusions Gastrointestinal symptoms of cancer pain patients undergoing an opioid therapy are related to multifactorial causes. Transdermal opioids showed no benefit over oral controlled-release Hydromorphone with regard to gastrointestinal symptoms. The conversion ratios for transdermal fentanyl, transdermal buprenorphine, and oral Hydromorphone did not accord to the literature, because of differing occurrences of opioid tolerance after long-term therapy.
