Oxycodone In Patients Research Articles

Drug-drug interaction perpetrators of oxycodone in patients with cancer: frequency and clinical relevance.

Oxycodone is known to have numerous drug-drug interactions (DDIs) that can potentially decrease efficacy or lead to adverse drug reactions (ADRs). However, there is limited research on the frequency of DDIs associated with oxycodone, which is important in optimising pharmacovigilance and the need for additional research on certain DDIs. In this study, the frequency of pharmacologically and clinically relevant DDI perpetrators was studied in patients with cancer. This was a cross-sectional study using hospital pharmacy records of patients with cancer who were prescribed oxycodonebetween September 2021 and September 2022. Medication records of patients prescribed oxycodone during a period of ≥ 5 consecutive days (= oxycodone treatment episodes) were reviewed to identify the concomitant use of pharmacologically relevant perpetrators, based on reference sources (Lexicomp®, Micromedex®, the Dutch Kennisbank and the Dutch Commentaren Medicatiebewaking). The clinical relevance was examined by a clinical pharmacologist and a medical oncologist. Additionally, the frequency of double interactions-concomitant oxycodone use with two CYP3A4 and / or CYP2D6 perpetrators-was studied. Overall, 254 oxycodone treatment episodes were included, of which 227 (89.4%) were found to contain at least one pharmacologically relevant DDI perpetrator. Of these, 210 (82.7%) were considered to be clinically relevant. A total of 80 different pharmacologically relevant perpetrators were identified, with 65 (81.3%) being considered clinically relevant. Double interactions were observed in 21 (8.3%) oxycodone treatment episodes. A high frequency of pharmacologically and clinically relevant perpetrators of oxycodone was observed in our cohort. Moreover, a high number of double interactions involving oxycodone was registered. More intense monitoring of DDIs may be needed to improve medication safety of patients with cancer taking oxycodone.

Comparison of different sustained-release opioids and acute respiratory conditions in patients with cancer and chronic kidney disease.

Few data are available on the association between the use of oxycodone in patients with chronic kidney disease (CKD) and acute respiratory conditions. The aim of this study was to investigate whether oxycodone is associated with an increased risk of acute respiratory conditions in patients with cancer and CKD compared with other opioids. The data were obtained from a claims database in Japan. Patients with cancer and CKD who had received sustained-release opioids, including oral oxycodone, oral morphine, or transdermal fentanyl, between April 2014 and May 2021 were selected. The primary outcome was defined as an acute respiratory condition. Data for age and sex, morphine equivalent daily dose, concomitant use of specified medications, comorbidities defined based on the modified Charlson comorbidity index, substance use disorder, and lung cancer or metastatic lung cancer were investigated as covariates. Distribution of acute respiratory conditions was compared among the three sustained-release opioid groups using the log-rank test. Estimates of the incidence of acute respiratory conditions were compared among the groups using a Cox proportional hazards model with time-varying variables. A significant difference in the distribution of acute respiratory conditions was found among the three groups (p < 0.01). Cox regression analysis showed a significantly higher risk of acute respiratory conditions with morphine (hazard ratio [HR]: 3.04, 95% confidence interval [CI]: 1.07-8.65, p = 0.04) compared with oxycodone but no significant difference in risk with oxycodone (HR 0.67, 95% CI: 0.32-1.38, p = 0.27) compared with fentanyl. The findings suggest that the risk of acute respiratory conditions may be lower in patients with CKD who use oxycodone for cancer pain than in those who use morphine. Additionally, no difference in the risk of acute respiratory conditions was found between oxycodone and fentanyl use.

Risk of Opioid Overdose Associated With Concomitant Use of Oxycodone and Selective Serotonin Reuptake Inhibitors

Some selective serotonin reuptake inhibitors (SSRIs) inhibit the enzymes responsible for the metabolism of oxycodone, a potent prescription opioid. The clinical consequences of this interaction on the risk of opioid overdose have not been elucidated. To compare opioid overdose rates in patients initiating oxycodone while taking SSRIs that are potent inhibitors of the cytochrome-P450 2D6 enzyme (CYP2D6) vs SSRIs that are not. This cohort study included adults who initiated oxycodone while receiving SSRI therapy between 2000 and 2020 whose data were included in 3 US health insurance databases. Use of SSRIs that strongly inhibit CYP2D6 enzyme (fluoxetine or paroxetine) vs use of other SSRIs at the time of oxycodone initiation. Opioid overdose hospitalization or emergency department visit. Outcomes were assessed within 365 days of oxycodone initiation; in primary analyses, patients were followed up until the discontinuation of either oxycodone or their index SSRI group. Propensity score matching weights were used to adjust for confounding. Crude and weighted (adjusted) incidence rates and hazard ratios were estimated using Cox regression models, separately within each database and overall, stratifying on database. A total of 2 037 490 initiated oxycodone while taking SSRIs (1 475 114 [72.4%] women; mean [SD] age, 50.1 [15.3] years). Most (1 418 712 [69.6%]) were receiving other SSRIs at the time of oxycodone initiation. In the primary analysis, we observed 1035 overdose events (0.05% of the study cohort). The adjusted incidence rate of opioid overdose in those using inhibiting SSRIs at the time of oxycodone initiation (9.47 per 1000 person-years) was higher than in those using other SSRIs (7.66 per 1000 person-years), indicating a greater risk of overdose among patients using CYP2D6-inhibiting SSRIs (adjusted hazard ratio, 1.23; 95% CI, 1.06-1.31). Results were consistent across multiple subgroup and sensitivity analyses. In this cohort study of US adults, initiating oxycodone in patients treated with paroxetine or fluoxetine was associated with a small increased risk of opioid overdose.

Effect and Safety of Prophylactic Parecoxib for Pain Control of Transarterial Chemoembolization in Liver Cancer: A Single-Center, Parallel-Group, Randomized Trial.

Pain is one of the most common side effects of transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma. The goal of this study is to compare the analgesic effect among celecoxib, parecoxib, and oxycodone in patients undergoing TACE. This prospective study was a randomized, paralleled trial in which 213 patients were enrolled. Patients were assigned at the ratio of 1:1:1 to receive celecoxib, parecoxib, or controlled-release oxycodone 1 hour before TACE (T0) and once every 12 hours for 2 days after TACE. Pain scores, pain intensity, and adverse events in each time interval were evaluated and compared among the 3 groups. The mean pain score 12 hours after T0 in the parecoxib group (2.8) was lower than that in the celecoxib (4.4; P= .001) and oxycodone groups (4.2; P= .005). The number of patients suffering severe pain was 10 (14.7%) in the parecoxib, 25 (36.8%) in the celecoxib, and 23 (32.9%) in the oxycodone groups (P= .009). Twelve hours after T0, the incidence of grade 3 vomiting in the parecoxib group (2.9%) was significantly lower than that in the oxycodone group (17.1%; P= .006). In the multivariate analysis, nonparecoxib prophylactic analgesia (odds ratio [OR], 4.620; 95% confidence interval [CI], 1.877-11.370; P= .001) as well as embolization of the gallbladder (OR, 8.666; 95% CI, 2.402-31.262; P= .001) and normal liver parenchyma (OR, 3.278; 95% CI, 1.409-7.627; P= .006) were the independent factors of severe pain intensity 12 hours after T0. Parecoxib is superior to oxycodone and celecoxib for pain control with fewer adverse events. Therefore, we recommend parecoxib as a priority strategy for TACE-related pain control.

Effect of Renin-Angiotensin System Inhibitors on the Comparative Nephrotoxicity of NSAIDs and Opioids during Hospitalization.

Nonsteroidal anti-inflammatory drugs (NSAIDS) are increasingly important alternatives to opioids for analgesia during hospitalization as health systems implement opioid-minimization initiatives. Increasing NSAID use may increase AKI rates, particularly in patients with predisposing risk factors. Inconclusive data in outpatient populations suggests that NSAID nephrotoxicity is magnified by renin-angiotensin system inhibitors (RAS-I). No studies have tested this in hospitalized patients. Retrospective, active-comparator cohort study of patients admitted to four hospitals in Philadelphia, Pennsylvania. To minimize confounding by indication, NSAIDs were compared to oxycodone, and RAS-I were compared to amlodipine. We tested synergistic NSAID+RAS-I nephrotoxicity by comparing the difference in AKI rate between NSAID versus oxycodone in patients treated with RAS-I to the difference in AKI rate between NSAID versus oxycodone in patients treated with amlodipine. In a secondary analysis, we restricted the cohort to patients with baseline diuretic treatment. AKI rates were adjusted for 71 baseline characteristics with inverse probability of treatment-weighted Poisson regression. The analysis included 25,571 patients who received a median of 2.4 days of analgesia. The overall AKI rate was 23.6 per 1000 days. The rate difference (RD) for NSAID versus oxycodone in patients treated with amlodipine was 4.1 per 1000 days (95% CI, -2.8 to 11.1), and the rate difference for NSAID versus oxycodone in patients treated with RAS-I was 5.9 per 1000 days (95% CI, 1.9 to 10.1), resulting in a nonsignificant interaction estimate: 1.85 excess AKI events per 1000 days (95% CI, -6.23 to 9.92). Analysis in patients treated with diuretics produced a higher, albeit nonsignificant, interaction estimate: 9.89 excess AKI events per 1000 days (95% CI, -5.04 to 24.83). Synergistic nephrotoxicity was not observed with short-term NSAID+RAS-I treatment in the absence of concomitant diuretics, suggesting that RAS-I treatment may not be a reason to choose opioids in lieu of NSAIDs in this population. Synergistic nephrotoxicity cannot be ruled out in patients treated with diuretics.

Analgesic efficacy and safety of tapentadol in comparison with oxycodone in patients after open abdominal hysterectomy.

Analgesic efficacy and safety of tapentadol in comparison with oxycodone in patients after open abdominal hysterectomy.

Analysis of Optimizing Effects of Dexmedetomidine and Oxycodone on Cytokine Levels in Patients with Laparoscopic Radical Gastrectomy

This study was designed to analyze the effects of dexmedetomidine combined with oxycodone in patients underwent laparoscopic radical gastrectomy for stomach carcinomas. A total of one hundred and twenty (120) patients were recruited and divided into A, B and C groups, using a random number table method, 40 cases in each group. After surgery patients in group A received oxycodone alone, patients in group B received dexmedetomidine combined with oxycodone and patients in group C received dexmedetomidine alone respectively. The Visual Analog Scale score and Ramsay sedative score at 2h, 6h, 24h and 48h after surgery were observed and the effective compressions number of controlled intravenous analgesia was documented. The incidence of side effects was recorded. TNF-α, CRP and IL-6 were evaluated by enzymelinked immunosorbent assay on the day before surgery and in the morning of 1st and 3rd d after surgery. VAS scores in group B were lower than group A and C, the effective compressions number of CIA in group B was less than group A and C, the occurrence of adverse reactions in group B was lower than group A and group C. The postoperative levels of TNF-α, CRP and IL-6 at 72h in group B were lower than group A and C. Dexmedetomidine combined with oxycodone showed improve sedative and analgesic effects with fewer adverse reactions. It can lessen the release of inflammatory cytokines of TNF-α, CRP and IL-6 in the body and has certain clinical application value.

Protective Effects of Dexmedetomidine and Oxycodone in Patients Undergoing Limb Ischemia-Reperfusion.

BackgroundTourniquet-related complications are a common clinical problem. In the present study, we compared the effects of dexmedetomidine vs. oxycodone in patients undergoing limb ischemia-reperfusion.Material/MethodsFifty-four patients undergoing unilateral lower-extremity surgery under combined spinal and epidural anesthesia were randomly assigned to a control (ischemia-reperfusion, I/R) group, a dexmedetomidine (Dex) group, and an oxycodone (Oxy) group. Tourniquet-induced hemodynamic parameters changes among groups were compared. The serum concentration of malondialdehyde (MDA), superoxide dismutase (SOD), tumor necrosis factor-a (TNF-α), interleukin-6 (IL-6), fatty acid binding protein 3 (FABP3), endothelin-1 (ET-1), and brain-derived neurotrophic factor (BDNF) were measured using ELISA before anesthesia and at 30 min and at 6 h after tourniquet release.ResultsIn the control group, tourniquet use caused significant increases in systolic arterial pressure (SAP), mean arterial pressure (MAP), diastolic arterial pressure (DAP), and rate-pressure product. Compared with Oxy, Dex significantly decreased heart rate (HR). Both Dex and Oxy lowered SAP compared with the control group. No significant difference was observed in DAP between Dex and Oxy. The levels of MDA, TNF-α, IL-6, FABP3, and ET-1 were significantly higher, while the SOD and BDNF were significantly lower compared to baseline in the I/R group, but the variation range of those agents was significantly smaller in the Dex and Oxy groups, and the measured values were comparable between the 2 groups.ConclusionsCompared with Dex, Oxy was not inferior in mitigating tourniquet-induced hyperdynamic response, ameliorating the inflammatory reaction, and protecting remote multiple organs in lower-extremity surgery patients.

A randomized controlled trial comparing tapentadol with oxycodone in non-breastfeeding women post elective cesarean section

Background: Tapentadol may allow greater pain relief with reduced “opioid load” compared to oxycodone. Its use has not been studied in the obstetric population. The objective of this study was to compare the efficacy and side effect profile of tapentadol with oxycodone in patients who received spinal anesthesia for elective cesarean section. The trial was registered with EU Clinical Trials Register with CT number 2016-001621-33.Methods: This was a multicenter, randomized controlled trial. Randomized patients (n = 68) received either 50 mg tapentadol or oxycodone 10 mg 12 hourly postoperatively. The primary endpoint was the sum of pain intensity difference over the first 48 hours of treatment (SPID48). Secondary outcomes included time to rescue medications, SPID36, total pain relief (TOTPAR) scores, patient satisfaction scores, sum of total pain relief and pain intensity difference (SPRID) scores, time to rescue medications and side effects experienced. An analysis of covariance model with baseline pain intensity score as a covariate was used for statistical analysis.Results: There was no significant difference in the primary endpoint of SPID48 with adjusted mean difference -11.45 (95% CI -35.35, 12.45) p = .34). Oxycodone showed significantly greater SPID36 scores compared to tapentadol with increased time to rescue medication. Side effects experienced were similar between groups.Conclusion: Tapentadol did not provide superior pain control or improved tolerability compared to oxycodone post cesarean section. Results should be interpreted however with consideration of administration of intrathecal opioids to all patients in this study and debate over the optimal dose of tapentadol for acute pain.Trial registration: EU Clinical Trials Register identifier: 2016-001621-33.

Pharmacokinetics of oxycodone/naloxone and its metabolites in patients with end-stage renal disease during and between haemodialysis sessions

The pharmacokinetics of oxycodone in patients with end-stage renal disease (ESRD) requiring haemodialysis are largely unknown. Therefore, we investigated the pharmacokinetics of oxycodone/naloxone prolonged release and their metabolites in patients with ESRD during and between haemodialysis sessions. Single doses of oxycodone/naloxone (5/2.5 or 10/5 mg) were administered in nine patients with ESRD using a cross-over design on the day of dialysis and on a day between dialysis sessions. Plasma, dialysate and urine concentrations of oxycodone, naloxone and their metabolites were determined up to 48 h post-dosing using a liquid chromatography-tandem mass spectrometry system. Haemodialysis performed 6-10 h after dosing removed ∼10% of the administered dose of oxycodone predominantly as unconjugated oxycodone and noroxycodone or conjugated oxymorphone and noroxymorphone. The haemodialysis clearance of oxycodone based on its recovery in dialysate was (mean ± SD) 8.4 ± 2.1 L/h. The geometric mean (coefficient of variation) plasma elimination half-life of oxycodone during the 4-h haemodialysis period was 3.9 h (39%) which was significantly shorter than the 5.7 h (22%) without haemodialysis. Plasma levels of the active metabolite oxymorphone in its unconjugated form were very low. Oxycodone is removed during haemodialysis. The pharmacokinetics including the relatively short half-life of oxycodone in patients with ESRD with or without haemodialysis and the absence of unconjugated active metabolites indicate that oxycodone can be used at usual doses in patients requiring dialysis.

Comparison of the effects of different doses of oxycodone on endotracheal intubation during general anesthesia induction period

Objective To compare the clinical effect of different doses of oxycodone on endotracheal intubation during general anesthesia induction period. Methods Ninety-five patients with endotracheal intubation general anesthesia were selected as the research subjects, and the patients were randomly divided into group A, group B and group C. 31 patients in group A received intravenous administration of oxycodone 0.20mg/kg, 32 patients in group B received intravenous administration of oxycodone 0.25mg/kg, and 32 patients in group C received intravenous administration of oxycodone 0.30mg/kg.The adrenaline, norepinephrine, dopamine concentration, as well as mean arterial pressure and heart rate at different time points were compared among the three groups. Results The mean arterial pressure and heart rate at T0 time point were decreased to varying extent compared with those at T1 time point(t=23.618, 7.412; 22.928, 9.063; 32.636, 9.422, P=0.000, 0.000; 0.000, 0.000; 0.000, 0.000). The heart rate, mean arterial pressure at T2, T3 and T4 time points in group A were increased compared with T0 time point(t=13.834, 6.506, 7.015; 17.604, 14.796, 16.323, P=0.000, 0.000, 0.000; 0.000, 0.000, 0.000). The adrenaline, norepinephrine and dopamine at T2, T3 and T4 time points in group A were increased compared with T0 time point(t=121.662, 64.533, 15.687; 31.498, 16.933, 9.286; 39.712, 116.049, 147.102, P=0.000, 0.000, 0.000; 0.000, 0.000, 0.000; 0.000, 0.000, 0.000). The heart rate, mean arterial pressure, adrenaline, norepinephrine and dopamine at T2, T3 and T4 time points in group B and group C were decreased significantly compared with those in group A(t=19.586, 31.972, 16.844, 27.087; 14.046, 14.822, 15.377, 23.826; 7.756, 14.396, 13.268, 23.342, 100.573, 104.010, 37.612, 38.892, 107.377, 117.969; 56.135, 56.757, 24.223, 25.300, 95.057, 82.088; 22.878, 25.731, 5.532, 5.934, 134.763, 83.628, P=0.000, 0.000, 0.000, 0.000, 0.000, 0.000; 0.000, 0.000, 0.000, 0.000, 0.000, 0.000; 0.000, 0.000, 0.000, 0.000, 0.000, 0.000; 0.000, 0.000, 0.000, 0.000; 0.000, 0.000, 0.000, 0.000; 0.000, 0.000, 0.000, 0.000), and the differences were statistically significant(all P<0.05). Conclusion During the induction of general anesthesia, the appropriate dose of oxycodone in patients with endotracheal intubation was 0.25mg/kg, which could effectively maintain the hemodynamic stability, such as mean arterial pressure, and could reduce the stress response. Key words: Anesthesia, intratracheal; Dose-response relationship, drug; Oxycodone

Analgesic efficacy and safety of epidural oxycodone in patients undergoing total hip arthroplasty: a pilot study.

Background and objectivesOxycodone is poorly studied as an adjuvant to central blockades. The aim of this pilot study was to assess the efficacy and safety of oxycodone hydrochloride in epidural blockade among patients undergoing total hip arthroplasty (THA).Patients and methodsIn 11 patients (American Society of Anesthesiologists physical status classification system II/III, age range: 59–82 years), THA was conducted with an epidural blockade using 15 mL 0.25% bupivacaine (37.5 mg) with 5 mg oxycodone hydrochloride and sedation with propofol infusion at a dose of 3–5 mg/kg/h. After the surgery, patients received ketoprofen at a dose of 100 mg twice daily. In the first 24 hours postoperative period, pain was assessed by numerical rating scale at rest and on movement; adverse effects (AEs) were recorded; and plasma concentrations of oxycodone, noroxycodone, and bupivacaine were measured.ResultsThe administration of epidural oxycodone at a dose of 5 mg in patients undergoing THA provided analgesia for a mean time of 10.3±4.89 h. In one patient, mild pruritus was observed. Oxycodone did not evoke other AEs. Plasma concentrations of oxycodone while preserving analgesia were >2.9 ng/mL. Noroxycodone concentrations in plasma did not guarantee analgesic effect.ConclusionThe administration of epidural oxycodone at a dose of 5 mg prolongs the analgesia period to ~10 hours in patients after THA. Oxycodone may evoke pruritus. A 5 mg dose of oxycodone hydrochloride used in an epidural blockade seems to be a safe drug in patients after THA.

Relationships between oxycodone pharmacokinetics, central symptoms, and serum interleukin-6 in cachectic cancer patients.

Elevated serum proinflammatory cytokines are associated with the reduction of cytochrome P450 enzyme (CYP) activity. This study aimed to evaluate the oxycodone pharmacokinetics, central symptoms, and serum proinflammatory cytokines based on cachexia stage in cancer patients. Forty-seven cancer patients receiving extended-release oxycodone were enrolled. Predose plasma concentrations of oxycodone and its metabolites were normalized with the daily dose and body weight. The central symptoms and serum level of proinflammatory cytokines were investigated at each cachexia stage. The plasma concentrations of oxycodone in patients with cachexia and refractory cachexia were significantly higher than that in patients with precachexia. The metabolic ratio to noroxycodone in patients with cachexia was significantly lower than that in patients with precachexia. The patients with a higher cachexia stage had a higher serum level of interleukin-6 (IL-6), but not tumor necrosis factor-α and interleukin-1β. The serum IL-6 level was correlated with the plasma concentration of oxycodone and inversely with the metabolic ratio to noroxycodone. The incidence of somnolence was not associated with the plasma oxycodone concentration. In contrast, the cachexia stage and its associated serum IL-6 level were correlated with the incidence of somnolence. Cancer cachexia raised the plasma exposure of oxycodone through the reduction of CYP3A metabolic pathway. The reduction of CYP3A in cachectic cancer patients was associated with an elevation of serum IL-6. Although cachectic cancer patients with higher serum IL-6 levels had the symptom of somnolence, the alterations in oxycodone pharmacokinetics were not related to the incidence of symptom.

Treatment With Prolonged-Release Oxycodone/Naloxone Improves Pain Relief and Opioid-Induced Constipation Compared With Prolonged-Release Oxycodone in Patients With Chronic Severe Pain and Laxative-Refractory Constipation

PurposeLaxative-refractory opioid-induced constipation (OIC) is defined as OIC despite using 2 laxatives with a different mechanism of action (based on the Anatomical Therapeutic Chemical Classification System level 4 term [contact laxatives, osmotically acting laxatives, softeners/emollients, enemas, and others]). OIC has a significant impact on the treatment and quality of life of patients with severe chronic pain. This noninterventional, observational, real-life study in Belgium investigated the efficacy of prolonged-release oxycodone/naloxone combination (PR OXN) treatment regarding pain relief and OIC compared with previous prolonged-release oxycodone (PR OXY) treatment for laxative-refractory OIC in daily clinical practice. MethodsLaxative-refractory OIC patients with severe chronic pain were treated with PR OXN for 12 weeks (3 visits). Pain relief (assessed on a numerical rating scale) and OIC (assessed by using the Bowel Function Index [BFI]) were evaluated at each visit. A responder was defined as a patient who had: (1) no worsening of pain at the last visit compared with visit 1 or a numerical rating scale ≤4 at visit 3/last visit; and (2) a reduction in BFI ≥12 units at visit 3/last visit compared with visit 1; or (3) a BFI ≤28.8 at visit 3/last visit. FindingsSixty-eight laxative-refractory OIC patients with severe chronic pain (mean (sd) age 59.8 (13.3) years, 67.6% female and 91.2% non-malignant pain) were treated for 91 days with PR OXN (median daily dose, 20 mg). Treatment with PR OXN resulted in a significant and clinically relevant decrease of pain of 2.1 units (P < 0.001; 95% CI, 1.66–2.54) and of BFI by 48.5 units (P < 0.001; 95% CI, 44.4–52.7) compared with PR OXY treatment; use of laxatives was also significantly reduced (P < 0.001). Approximately 95% of patients were responders, and quality of life (as measured by using the EQ-5D) improved significantly. Adverse events were opioid related, and PR OXN treatment was well tolerated. ImplicationsTreatment with PR OXN resulted in a significant and clinically relevant reduction in OIC compared with previous PR OXY treatment for these patients with severe chronic pain and laxative-refractory OIC. Treatment with PR OXN also resulted in a significant improvement in pain relief and quality of life. ClinicalTrials.gov identifier: NCT01710917.

Validation of the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) in Acute Low Back Pain

The Short-form McGill Pain Questionnaire (SF-MPQ-2) assesses the major symptoms of both neuropathic and nonneuropathic pain and can be used in studies of epidemiology, natural history, pathophysiologic mechanisms, and treatment response. Previous research has demonstrated its reliability, validity, and responsiveness in diverse samples of patients with chronic pain. However, the SF-MPQ-2 has not been evaluated for use in patients with acute pain. Data were examined from a double-blind, randomized clinical trial of immediate-release tapentadol versus immediate-release oxycodone in patients with acute low back and associated radicular leg pain (N = 666). Analyses of internal consistency, convergent validity, and confirmatory factor structure were conducted using baseline data, and analyses of responsiveness were conducted using baseline and endpoint data. The SF-MPQ-2 total score and its 4 subscale scores (continuous pain, intermittent pain, predominantly neuropathic pain, and affective descriptors) generally showed good psychometric properties and 1) were internally consistent, 2) displayed good convergent validity, 3) fit the a priori factor structure, and 4) were highly responsive to analgesic treatment. These data extend previous evidence of the reliability, validity, and responsiveness of the SF-MPQ-2 in patients with chronic pain to those with acute low back and associated radicular leg pain. PerspectiveConsidered together with the results of other recent studies, the data suggest that the SF-MPQ-2 can provide a valid, responsive, and efficient assessment of both neuropathic and nonneuropathic pain qualities for clinical trials and other clinical research examining patients with various acute and chronic pain conditions.

Indication of Adequate Transdermal Fentanyl Dose in Opioid Switching From Oral Oxycodone in Patients With Cancer.

The present study aimed to examine affecting factors for conversion ratio and to predict adequate fentanyl dose for patients with cancer pain in opioid switching from oral oxycodone. Patient characteristics, biochemical parameters, daily oxycodone dose, and reasons for opioid switching were retrospectively collected. The effect of variables on the conversion ratio was analyzed by multiple regression analysis. Regression analysis for the data from 122 patients suggested that the typical conversion ratio was 95:1; however, this ratio was significantly reduced in patients taking a daily oral morphine-equivalent dose of <45 mg/d and in patients with poor pain control to 52:1 and 64:1, respectively. We should carefully and rapidly control pain in opioid switching based on the adequate dose indicated in this study.

PSY41 - Quality of Life Benefits and Cost Impact of Prolonged Release Oxycodone/Naloxone Versus Prolonged Release Oxycodone in Patients with Moderate to Severe Pain and Opioid-Induced Constipation Despite the Use of 2 Laxatives: A UK Cost Utility Analysis

PSY41 - Quality of Life Benefits and Cost Impact of Prolonged Release Oxycodone/Naloxone Versus Prolonged Release Oxycodone in Patients with Moderate to Severe Pain and Opioid-Induced Constipation Despite the Use of 2 Laxatives: A UK Cost Utility Analysis

Population Pharmacokinetics of Oxycodone in Patients With Cancer-Related Pain

ABSTRACTOxycodone is an opioid widely prescribed to cancer patients for pain relief. However, the pharmacokinetics of oxycodone has not been sufficiently examined. Therefore the aim of this work was to study population pharmacokinetics of oxycodone in patients with cancer pain. The authors analyzed 108 serum oxycodone samples of 33 individuals with nonlinear mixed-effects model (NONMEM). Population pharmacokinetics was calculated using the one-compartment model of clearance, volume of distribution, bioavailability, absorption constant rate, and lag time. An exponential error model was used to determine interindividual variability and a relative error model was applied to assess residual variability. Population pharmacokinetics of oxycodone at the end point were as follows: CL(L/h) = 10.7 × [1 + (2 − Child-Pugh Classification)] (Class: A = 0, B = 1, C = 2); Vd (L) = 193; ka (h−1) = 0.336; Tlag (h) = 0.859; F (%) = 63.9. Interindividual variability was CL: 30.5%, Vd: 44.6%, and F: 37.0%, and residual variability was 16.2%. As the total clearance in patients with liver dysfunction (Child-Pugh class B) was reduced to 33.3%, serum concentration of oxycodone increased by 1.5. Therefore, it became clear that dose adjustments are essential when treating patients with liver dysfunction. These findings suggest that population parameters are useful for evaluating pharmacokinetics of oxycodone in patients with cancer pain.

Pain Relief and Tolerability Balance of Immediate Release Tapentadol or Oxycodone Treatment for Patients with Moderate to Severe Osteoarthritis or Low Back Pain

Opioid treatment effectiveness may be best compared using definitions of treatment response, which combine measures assessing pain reduction and the occurrence of adverse events (AEs). This analysis of data from two phase III clinical trials was conducted to examine the pain relief and tolerability (PRT) balance of immediate release (IR) tapentadol and oxycodone in patients with moderate to severe osteoarthritis (OA) or low back pain. This was a post hoc analysis of two multicenter, randomized, double-blind studies (10-day and 90-day) that evaluated the efficacy and safety of tapentadol IR in patients with moderate-severe OA pain. PRT was defined as adequate pain reduction (30% or 50% pain intensity improvement from baseline) and no gastrointestinal AE or other type of treatment-emergent AE. The percentage of patients and mean number of days per patient meeting the PRT criteria were summarized. In the 10-day trial, the percentages of patients meeting PRT criteria (30% reduction) for both tapentadol groups were consistently above that for oxycodone 10 mg, although only significantly different for the 50 mg formulation. The mean number of days per patient meeting the PRT criteria was 3.7, 3.2, and 2.3 days for tapentadol 50 mg, 75 mg and oxycodone 10 mg, respectively. No significant difference between the groups was observed using the 50% pain reduction criterion. For the 90-day trial, using multiple definitions, tapentadol IR showed a significantly higher proportion of days meeting PRT criteria. Pain reduction and tolerability are both important attributes of an effective analgesic treatment. Based on data from two trials, tapentadol IR produced an improved PRT balance compared with oxycodone IR.

Controlled release formulation of oxycodone in patients with moderate to severe chronic osteoarthritis: a critical review of the literature

Osteoarthritis (OA) is a physically and emotionally debilitating disease that predominantly affects the aging adult population. Current pharmacologic treatment options primarily consist of nonsteroidal anti-inflammatory drugs and/or acetaminophen, but associated side effects, analgesic limitations, especially in the elderly, and the need for around-the-clock analgesia have led physicians to search for alternative analgesics. Opioids have shown effectiveness at mitigating both chronic cancer and noncancer pain, and their ability to be placed into controlled release (CR) formulations suggests that they may prove efficacious for OA patients. One formulation, oxycodone CR, has shown effectiveness in cancer pain patients and in some trials of noncancer low back pain. In this review, the objective was to synthesize the reported findings by researchers in this field and present an up-to-date look at the efficacy, safety, and tolerability of oxycodone CR in OA patients. Public literature databases were searched using specific keywords (eg, oxycodone CR) for studies assessing the efficacy and safety profile of oxycodone CR and its use in patients with OA. A total of eleven articles that matched the criteria were identified, which included three placebo-controlled trials, six comparative trials, one pharmacokinetic study in the elderly, and one long-term safety trial. Analysis of the studies revealed that oxycodone CR is reasonably efficacious, safe, and tolerable when used to manage moderate to severe chronic OA pain, with similar side effects to that of other opioids.