tapentadol and Pain--Postoperative

Opioid-related harm remains a serious public health issue in Australia, where there is a strong focus on judicious use of opioids to optimize postoperative patient outcomes. The risks associated with preoperative opioid use (worsened postoperative pain, surgical outcomes, increased length of stay and financial costs) must be balanced with the risks of sub-optimal post-surgical pain management (development of chronic pain, persistent postsurgical opioid use and opioid dependence). In addition to significantly lower rates of gastrointestinal adverse effects (nausea, vomiting, constipation), tapendatol (vs oxycodone) is less likely to cause excessive sedation and opioid-induced ventilatory impairment, may be associated with less withdrawal symptoms of mild to moderate intensity and significantly lower odds of 3-month persistent postoperative opioid use in certain patient populations. Studies included in this review were phase III/meta-analyses, referenced in Australian clinical guidelines and/or published ≤5 years), except for cost-effectiveness analyses, where all known, relevant published analyses were included.. Patient harms from medicines related to morphine, which is part of a group of pain-relieving drugs called opioids, is a serious public health issue in Australia, as such, there is a strong focus on the cautious use of these medicines. Using opioids before surgery is associated with risks such as worse pain after surgery and longer hospital stays, however, when pain after surgery is not managed sufficiently, this can result in long-term pain and therefore the need to use these medicines for longer than recommended. Tapentadol is an opioid that has less stomach/gut side effects, causes less sleepiness, is less likely to cause serious breathing impairment, may have less symptoms when stopping the medication and less chance of long-term (more than 3 months) use compared with a more commonly used opioid (oxycodone).

Topics: Analgesics, Opioid; Australia; Chronic Pain; Humans; Opioid-Related Disorders; Pain, Postoperative; Phenols; Tapentadol

Recovery from ambulatory surgical procedures can be limited by postoperative pain. Inadequate analgesia may delay or prevent patient discharge and can result in readmission. More frequently, postoperative pain produces discomfort and interrupts sleep, contributing to postoperative fatigue. The development of effective analgesic regimens for the management of postoperative pain is a priority especially in patients with impaired cardiorespiratory, hepatic, or renal function. Tramadol and tapentadol hydrochloride are novel in that their analgesic actions occur at multiple sites. Both agents are reported to be mu-opioid receptor agonists and monoamine-reuptake inhibitors. In contrast to pure opioid agonists, both drugs are believed to have lower risks of respiratory depression, tolerance, and dependence. The Food and Drug Administration has approved both drugs for the treatment of moderate-to-severe acute pain in adults. This article provides an evidence-based account of the role of tramadol and tapentadol in modern clinical practice.

Topics: Analgesics; Animals; Cytochrome P-450 CYP2D6; Humans; Injections, Spinal; Pain, Postoperative; Perioperative Care; Phenols; Receptors, Opioid, mu; Serotonin Syndrome; Tapentadol; Tramadol

Pain after total knee arthroplasty is a prevalent condition. This study compared the effectiveness of tapentadol extended-release (ER) 50 mg × 2, oxycodone controlled-release (CR) 10 mg × 2, and placebo, as added to a multimodal analgesic regime both in-hospital and at home the first week after total knee arthroplasty. The study was randomized and blinded for investigators, staff, outcome assessors, and patients. Follow-up included pain intensity on mobilization, pain at rest, worst pain in the previous 24 hours, and adverse effects measured on 0 to 10 numerical rating scales. A total of 134 patients in 3 study groups received their allocated intervention and were included in the analysis. The primary outcome pain on mobilization the 7 first postoperative days reported as area under the curve was 528.1 (SD 267.5, interquartile range (IQR) 356.6-665.4) for placebo, 427.2 (SD 203.9, IQR 303.6-544.3) for tapentadol ER, and 507.9 (SD 243.7, IQR 292.4-686.8) for oxycodone CR (P = 0.12). With the exception of constipation being less prevalent in the tapentadol ER group (P = 0.02), we found no significant differences between treatment groups for the secondary outcomes. Tapentadol ER as an add-on to multimodal analgesia did not significantly improve pain relief when compared to oxycodone CR or placebo. Constipation was lowest in the tapentadol ER group.

Topics: Analgesics, Opioid; Arthroplasty, Replacement, Knee; Delayed-Action Preparations; Double-Blind Method; Humans; Osteoarthritis, Knee; Oxycodone; Pain, Postoperative; Phenols; Tapentadol

Tapentadol is an opioid, which acts as a μ-opioid receptor agonist and inhibits noradrenaline reuptake in the central nervous system. This dual mechanism of action results in synergistic analgesic effects and potentially less side effects. This has been shown in treatment of chronic pain but postoperative studies are sparse.. The main aim was to compare the analgesic effect of tapentadol with oxycodone after laparoscopic hysterectomy. Opioid side effects were recorded as secondary outcomes.. Randomised, blinded trial.. Single-centre, Oslo University Hospital, Norway, December 2017 to February 2019.. Eighty-six opioid-naïve American Society of Anesthesiologists physical status 1 to 3 women undergoing laparoscopic hysterectomy for nonmalignant conditions.. The patients received either oral tapentadol (group T) or oxycodone (group O) as part of multimodal pain treatment. Extended-release study medicine was administered 1 h preoperatively and after 12 h. Immediate-release study medicine was used as rescue analgesia.. Pain scores, opioid consumption and opioid-induced side effects were evaluated during the first 24 h after surgery.. The groups scored similarly for pain at rest using a numerical rating scale (NRS) 1 h postoperatively (group T 4.4, 95% CI, 3.8 to 5.0, group O 4.6, 95% CI, 3.8 to 5.3). No statistically significant differences were found between the groups for NRS at rest or while coughing during the 24-h follow-up period (P = 0.857 and P = 0.973). Mean dose of oral rescue medicine was similar for the groups (P = 0.914). Group T had significantly lower odds for nausea at 2 and 3 h postoperatively (P = 0.040, P = 0.020) and less need for antiemetics than group O. No differences were found for respiratory depression, vomiting, dizziness, pruritus, headache or sedation.. We found tapentadol to be similar in analgesic efficacy to oxycodone during the first 24 h after hysterectomy, but with significantly less nausea.. ClinicalTrials.gov, NCT03314792.

Topics: Analgesia; Analgesics, Opioid; Chronic Pain; Double-Blind Method; Female; Humans; Hysterectomy; Laparoscopy; Oxycodone; Pain, Postoperative; Phenols; Tapentadol

High post-operative pain scores after "minor" orthopedic/trauma surgery are in part attributed to inadequate prescription of opioid analgesics. Novel concepts aiming to achieve sufficient analgesia while minimizing opioid-related side effects by avoiding fluctuating plasma levels are based on perioperative oral administration of extended-release opioids beginning with the first dose pre-operatively. This is the first study to evaluate analgesic efficacy and side effect rates of extended-release tapentadol compared to oxycodone/naloxone following orthopedic/trauma surgery.. This randomized, observer-blinded, active-controlled prospective clinical trial had 2 co-primary endpoints: (1) Analgesic efficacy: Mean pain level on a numeric rating scale (NRS) from 0 to 10 during exercise over 5 days. (2) Safety: Side effect sum score of the following events: Nausea, vomiting, constipation, sedation, vertigo, somnolence. The study was powered to detect superiority of tapentadol for at least one endpoint pending statistical proof of non-inferiority for both endpoints in a first step.. Two hundred sixty-six trauma patients were randomized to receive either tapentadol (n = 133) or oxycodone/naloxone (n = 133). Analgesic efficacy: Mean (±SD) daily pain levels in the first five post-operative days were 2.8 ± 1.3 in both groups. Mean maximum pain intensity during exercise in the first 24 h after surgery was 3.8 ± 1.9 (tapentadol) and 3.8 ± 2.1 (oxycodone/naloxone). Statistically tapentadol was non-inferior but not superior to oxycodone/naloxone.. Vomiting on day 1 occurred in 11%, constipation in 35% of the tapentadol patients and in 16% and 30% of the oxycodone/naloxone patients (p = 0.60 and 0.33), respectively. The incidence of sedation/ vertigo was <10%, that of somnolence <2% in both groups (p > 0.3, respectively). The sum score of side effect events was 51% in the tapentadol vs. 49% in the oxycodone/naloxone group; risk difference 3% [95% CI, -8 to 14%]; p = 0.6). Non-inferiority of tapentadol could not be concluded as the pre-defined non-inferiority margin was exceeded.. With both concepts, mean maximum pain intensity during exercise within the first 24 h after orthopedic/trauma surgery was reduced to a score of <4. This analgesic efficacy came at the cost of mainly gastro-intestinal side effects. Thus, we now use a prophylaxis against nausea and vomiting and pre-emptive laxatives as part of these concepts.. https://eudract.ema.europa.eu (EudraCT- Nr. 2011-003238-15 ); October 24th, 2012.

Topics: Analgesics, Opioid; Constipation; Delayed-Action Preparations; Female; Humans; Male; Middle Aged; Naloxone; Orthopedic Procedures; Oxycodone; Pain Measurement; Pain, Postoperative; Phenols; Postoperative Nausea and Vomiting; Prospective Studies; Single-Blind Method; Tapentadol

To evaluate the efficacy and safety of tapentadol immediate-release (IR) for treating acute pain following orthopedic bunionectomy surgery in a Taiwanese population.. This was a phase 3, randomized, double-blind, placebo-controlled, parallel-group bridging study in which Taiwanese patients (N = 60) with moderate-to-severe pain following bunionectomy were randomized (1:1:1) to receive tapentadol IR 50 or 75 mg or placebo orally every 4-6 hours over a 72 hour period. The primary endpoint was the sum of pain intensity difference over 48 hours (SPID48), analyzed using analysis of variance.. Out of 60 patients randomized (mainly women [96.7%]; median age 44 years), 41 (68.3%) completed the treatment. Mean SPID48 values were significantly higher for tapentadol IR (p ≤ 0.006: 50 mg, p ≤ 0.004: 75 mg) compared with placebo. Between-group differences in LS means of SPID48 (vs. placebo) were tapentadol IR 50 mg: 105.6 (95% CI: 32.0; 179.2); tapentadol IR 75 mg: 126.6 (95% CI: 49.5; 203.7). Secondary endpoints including SPID at 12, 24, and 72 hours, time to first use of rescue medication, cumulative distribution of responder rates, total pain relief and sum of total pain relief and sum of pain intensity difference at 12, 24, 48, and 72 hours, and patient global impression of change showed numerically better results supporting that tapentadol IR (50 and 75 mg) was more efficacious than placebo in relieving acute pain. The most frequent treatment emergent adverse events reported in ≥ 10% patients in either group were dizziness, nausea, and vomiting. A limitation of this study may possibly include more controlled patient monitoring through 4-6 hour dosing intervals, which reflects optimal conditions and thus may not approximate real-world clinical practice. However, all treatment groups would be equally affected by such bias of frequent monitoring, if any, since it was a randomized and double-blind study.. Tapentadol IR treatment significantly relieved acute postoperative pain and was well tolerated in a Taiwanese population. ClinicalTrials.gov identifier: NCT01813890.

Topics: Acute Pain; Adult; Analgesics, Opioid; Double-Blind Method; Female; Humans; Longitudinal Studies; Male; Middle Aged; Nausea; Orthopedic Procedures; Pain Measurement; Pain, Postoperative; Phenols; Taiwan; Tapentadol; Vomiting

To broaden the ethnic groups in which tapentadol IR is evaluated for treating acute postoperative pain to include Asians.. In this phase 3, multicenter, double-blind, randomized study, 352 Korean adults with moderate-to-severe pain following hallux valgus surgery received tapentadol IR 50 or 75 mg or placebo orally every 4-6 hours for 72 hours. Patients requesting other (rescue) analgesics during this period were discontinued for lack of efficacy. The primary endpoint, sum of pain intensity difference (SPID) over 48 hours, was evaluated based on the difference between tapentadol IR and placebo in least squares (LS) mean change from baseline using analysis of covariance (ANCOVA). Secondary endpoints included the time to first rescue medication use and the distribution of responder rates.. A treatment effect, favoring tapentadol IR, was observed for SPID48 (p < 0.001 for both doses vs. placebo, ANCOVA). The between-group difference (vs. placebo) in LS means of SPID48 was 76.4 (95% CI: 51.0, 101.7) for tapentadol IR 50 mg and 90.6 (95% CI: 65.1, 116.1) for tapentadol IR 75 mg. Time to first rescue medication use was delayed for tapentadol IR (p < 0.001 for both doses vs. placebo; log-rank test). The distribution of responders at 12, 24, 48, and 72 hours favored tapentadol IR (p ≤ 0.001 for both doses vs. placebo; Cochran-Mantel-Haenszel test). Dizziness, nausea, and vomiting were each reported in ≥ 10% tapentadol-treated patients and at an incidence ≥ 2-fold higher vs. placebo. The study findings may be limited by study drug dosing every 4 to 6 hours and frequent monitoring during treatment, neither of which mimic pain treatment in clinical practice. However, any potential bias based on this systematic monitoring of patients would be mitigated by the randomized, double-blind nature of the study, with all treatment groups similarly affected by such biases, if any.. Tapentadol IR reduced acute pain intensity, significantly more than placebo, after orthopedic surgery in Korean patients.. NCT01516008.

Topics: Acute Pain; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Asian People; Double-Blind Method; Female; Hallux Valgus; Humans; Male; Middle Aged; Orthopedic Procedures; Pain Measurement; Pain, Postoperative; Phenols; Republic of Korea; Tapentadol; Young Adult

This study evaluated tapentadol immediate release (IR) for pain relief following orthopedic bunionectomy surgery.. This randomized, double-blind, placebo- and active-controlled, phase III study included patients with moderate-to-severe pain following bunionectomy. Randomized patients (N = 603) received tapentadol IR 50, 75, or 100 mg; oxycodone HCl IR 15 mg; or placebo orally every 4-6 hours over a 72-hour period following bunionectomy. The primary endpoint was the sum of pain intensity difference (SPID) over 48 hours. Secondary endpoints included SPID over 12, 24, and 72 hours; total pain relief, and sum of total pain relief and sum of pain intensity difference (SPRID) over 12, 24, 48, and 72 hours; use of rescue medication; patient global impression of change; and onset of action assessment. Possible limitations of this study were that the intense dose monitoring and thorough nursing care were unlikely to represent actual use situations and could introduce similar bias across all treatment groups.. NCT00364247.. Mean SPID(48) values were significantly higher for tapentadol IR (50, 75, and 100 mg) and oxycodone HCl IR 15 mg compared with placebo (all p

Topics: Adult; Double-Blind Method; Humans; Middle Aged; Oxycodone; Pain, Postoperative; Phenols; Placebos; Tapentadol

Tapentadol is a new, centrally acting analgesic with two mechanisms of action, combining μ-opioid agonism and norepinephrine reuptake inhibition in a single molecule. This study assessed tapentadol immediate release (IR) in patients with postsurgical orthopedic pain.. This randomized, double-blind, phase II study involved patients with moderate-to-severe pain after bunionectomy surgery (first metatarsal with osteotomy). Patients (N = 269) were randomly assigned to receive tapentadol IR 50 or 100 mg, oxycodone HCl IR 10 mg, or placebo; the study drug was taken every 4-6 h, over a 72-h period starting 1 day after surgery (Evaluation Day 2). The primary endpoint was the sum of pain intensity over 24 h (SPI-24) on the second day after randomization (Evaluation Day 3). Potential limitations of this study included the use of rescue medication and the fact that it was not powered to statistically compare between-group differences in tolerability measures.. Mean (standard deviation [SD]) SPI-24 values on Evaluation Day 3 were significantly lower for tapentadol IR (50 mg: 33.6 [19.7], p = 0.0133; 100 mg: 29.2 [15.2], p = 0.0001) and oxycodone HCl IR 10 mg (35.7 [17.2]; nominal p = 0.0365) compared with placebo (41.9 [17.7]). The most common treatment-emergent adverse events for all treatment groups were characteristic of drugs with μ-opioid agonist activity. While providing similar analgesic efficacy, tapentadol IR 50 mg was associated with lower rates of nausea (46.3% vs. 71.6% for oxycodone HCl IR 10 mg), dizziness (32.8% vs. 56.7%), vomiting (16.4% vs. 38.8%), and constipation (6.0% vs. 17.9%), and a similar rate of somnolence (28.4% vs. 26.9%) compared with oxycodone HCl IR 10 mg.. Tapentadol IR 50 and 100 mg and oxycodone HCl IR 10 mg were effective in this study for the relief of acute postoperative pain following bunionectomy. The study results suggest improved gastrointestinal tolerability of tapentadol IR 50 mg compared with oxycodone at a dose showing comparable efficacy.

Topics: Acute Disease; Adolescent; Adult; Aged; Analgesics, Opioid; Dose-Response Relationship, Drug; Double-Blind Method; Female; Hallux Valgus; Humans; Male; Middle Aged; Orthopedic Procedures; Pain, Postoperative; Phenols; Placebos; Tapentadol; Treatment Outcome; Young Adult

Tapentadol is a novel, centrally acting analgesic with two modes of action, combining mu-opioid agonism and norepinephrine reuptake inhibition in a single molecule. We compared the efficacy and tolerability of tapentadol and a standard dose of morphine with placebo in a model of moderate-to-severe postoperative dental pain.. Patients undergoing mandibular third molar extraction and experiencing moderate-to-severe pain postsurgery were randomized to receive single, oral doses of tapentadol HCl (25, 50, 75, 100, or 200 mg), morphine sulfate (60 mg), ibuprofen (400 mg; used to establish model sensitivity), or placebo. Mean total pain relief over 8 h (TOTPAR-8) was the primary end point. Secondary end points included mean total pain relief over 4 h (TOTPAR-4) and onset of analgesia. Pairwise comparisons of study drug to placebo were assessed using the Fisher least significant difference test. Adverse events were recorded.. Four hundred patients were randomized to treatment and completed the study. Compared with placebo, mean TOTPAR-8 was significantly greater for tapentadol HCl 50 mg (P = 0.041), 75 mg (P = 0.001), 100 mg (P < 0.001), and 200 mg (P < 0.001); morphine sulfate 60 mg (P < 0.001); and ibuprofen 400 mg (P < 0.001) in a nonparametric analysis of the primary end point. The significantly higher TOTPAR-8 score for ibuprofen compared with placebo established the sensitivity of the model. Mean TOTPAR-4 was higher and onset of action appeared more rapid for tapentadol HCl 200 mg than morphine sulfate 60 mg. Pain relief scores with morphine sulfate 60 mg were between those of tapentadol HCl 100 and 200 mg. The incidence of nausea and vomiting appeared to be lower with all doses of tapentadol HCl compared with morphine sulfate 60 mg, but was not statistically significant.. Single oral doses of tapentadol 75 mg or higher effectively reduced moderate-to-severe postoperative dental pain in a dose-related fashion and were well-tolerated relative to morphine. These data suggest that tapentadol is a highly effective, centrally acting analgesic with a favorable side effect profile and rapid onset of action.

Topics: Adult; Analgesics; Double-Blind Method; Female; Humans; Ibuprofen; Male; Morphine; Pain, Postoperative; Phenols; Receptors, Opioid, mu; Tapentadol; Toothache

Topics: Analgesia; Analgesics, Opioid; Female; Humans; Hysterectomy; Morphine; Pain, Postoperative; Phenols; Prospective Studies; Tapentadol; Vertigo

To evaluate the cost-effectiveness of tapentadol immediate-release (IR) versus oxycodone IR for post-operative pain after a major hip surgery.. This study has been conducted using an Australian societal perspective, focusing on adult patients after a major hip surgery. A cost-effectiveness analysis was conducted using a decision-analytic model. The model incorporated drug and other resource costs, the probability of opioid-related adverse events, and quality-adjusted life months (QALM) in each treatment arm. A willingness to pay (WTP) threshold of AU$2500 was used per QALM gained. A probabilistic sensitivity analysis was conducted to examine the uncertainty of the assumptions. The primary outcome was the incremental cost-effectiveness ratio (ICER) of tapentadol IR versus oxycodone IR, expressed as Australian dollars (AU$) per QALM gained.. Tapentadol IR dominated oxycodone IR, with a cost savings of AU$201 and an increase in QALM by 0.014. The ICER was -13,946 AU$/QALM (negative value attributed to numerator). In the probabilistic sensitivity analysis, 84.2% of the simulations were in favour of tapentadol IR at the WTP threshold.. Tapentadol IR may be more cost-effective than oxycodone IR for the treatment of acute postoperative pain after major hip surgeries.

Topics: Adult; Analgesics, Opioid; Australia; Cost-Benefit Analysis; Humans; Oxycodone; Pain, Postoperative; Phenols; Tapentadol

Tapentadol, an opioid with mu-opioid receptor agonism and noradrenaline reuptake inhibition, has been increasingly used in Australia since 2011. However, data on hospital prescribing trends and indications are scarce. This study aimed to investigate hospital prescribing trends of tapentadol, oxycodone and tramadol in a Sydney local health district (LHD) and the indications for tapentadol hospital prescriptions in an Australian tertiary hospital.. We analysed 5-year patient dispensing for tapentadol, oxycodone and tramadol from four hospitals in a Sydney LHD with data expressed as oral morphine equivalents (OME). We also conducted a retrospective review of 140 and 54 patients prescribed tapentadol at a tertiary hospital's surgical and spinal units in 2020.. Over 5 years in the Sydney LHD, there was a 19.5% reduction in total dispensing of these opioids from 1 225 210 to 986 477.5 OME milligrams. Decreases were specifically for oxycodone (-37.8% immediate-release, -65.2% sustained-release) and tramadol (-74.6% immediate-release, -70.1% sustained-release). Contrastingly, hospital prescriptions of tapentadol immediate-release increased by 223.2% between 2018-19 and 2020-21 while sustained-release increased by 17.9% from 2016-17 to 2020-21. By 2020-21, tapentadol overtook oxycodone to become the most prescribed opioid in the Sydney LHD (51.4%). At the hospital's surgical units, 137 (97.9%) patients were prescribed tapentadol for acute post-operative pain with the majority (54.0%) prescribed both immediate-release and sustained-release tapentadol, while 71.1% were prescribed for neuropathic pain in the spinal units.. In a Sydney LHD, tapentadol prescriptions increased significantly to become the preferred opioid analgesic. At the hospital's surgical units, off-label prescriptions of tapentadol sustained-release for acute post-operative pain were observed.

Topics: Analgesics, Opioid; Australia; Delayed-Action Preparations; Humans; Morphine; Oxycodone; Pain, Postoperative; Phenols; Tapentadol; Tramadol

The utilization of the proper and safe analgesics was considered a major concern in pain alleviation especially that associated with surgical procedures. Novel analgesics as Tapentadol hydrochloride (TAP) was involved efficiently instead of the common opioids to overcome the subsequent severe and common adverse effects associated with opioids utilization. Unfortunately, the extensive first pass metabolism limits the oral bioavailability of TAP and predisposes to a diminished duration of action, hence larger frequent doses of TAP will be required. Therefore, the target of this study was to lodge TAP into PEGylated transferosomes to boost its transdermal delivery. The PEGylation contemplated to boost both TAP permeability and bioavailability besides offering extra resilience to the vesicles. The impact of diverse variables on the characteristics of the vesicles and distinguishing the optimal formula were implemented adopting 2

Topics: Administration, Cutaneous; Analgesics; Analgesics, Opioid; Animals; Biological Availability; Drug Delivery Systems; Employment; Liposomes; Male; Pain, Postoperative; Particle Size; Polyethylene Glycols; Rats; Rats, Wistar; Tapentadol

Topics: Administrative Claims, Healthcare; Adult; Aged; Analgesics, Opioid; Back Pain; Databases, Factual; Female; Fractures, Bone; Humans; Male; Medicare; Middle Aged; Osteoarthritis; Oxycodone; Pain, Postoperative; Pilot Projects; Retrospective Studies; Tapentadol; United States

New approved options with opioids in the postoperative setting may include new ways of administration, new combinations with other drugs and new opioid drugs. Newly approved devices for administration include sublingual sufentanil dispenser and transdermal iontophoretic fentanyl, with the purpose of almost mimicking the rapid and reliable onset of intravenous (IV) administration, without the problems of an ongoing IV cannula and cumbersome equipment. Still, potential problems of overdosing and misuse must be in focus when these devices come into use. Tapentadol is a new partial µ-receptor opioid agonist with a combined action on norepinephrine-induced analgesia, representing a promising drug in terms of less side effects at equianalgesic doses compared with pure agonists. The mixture of different opioids given together, such as oxycodone and morphine, for oral use may also have some analgesic synergy with an improved side-effect profile, although more studies are needed. Oral oxycodone is a reliable oral opioid option, but when combined with paracetamol in the same tablet or mixture, care should also be taken to avoid serious side effects from inadvertent paracetamol overdose.

Topics: Acetaminophen; Analgesics, Opioid; Drug Combinations; Drug Therapy, Combination; Fentanyl; Humans; Morphine; Oxycodone; Pain, Postoperative; Phenols; Sufentanil; Tapentadol

Tapentadol exerts its analgesic effects through opioid receptor agonism and noradrenaline reuptake inhibition in the central nervous system. Clinical studies show that tapentadol effectively relieves moderate to severe pain in both post-operative and chronic pain. In these trials with equianalgesic doses of tapentadol and oxycodone, treatment with tapentadol was associated with significantly fewer gastrointestinal-related adverse events. Furthermore, in a placebo-controlled study, tapentadol has shown good efficacy in painful diabetic polyneuropathy.

Topics: Analgesics, Opioid; Arthritis; Back Pain; Chronic Disease; Diabetic Neuropathies; Humans; Neuralgia; Pain, Postoperative; Phenols; Tapentadol; Treatment Outcome

Tapentadol HCI is an opioid (narcotic) analgesic, which also inhibits norepinephrine reuptake. While it appears to display a somewhat lower incidence of nausea and constipation than oxycodone 10 mg to 15 mg, its analgesic efficacy in acute postsurgical dental pain is inferior to ibuprofen 400 mg. Like other single-entity opioids, tapentadol should not be used as a first-line agent for postsurgical dental pain but can be employed as an add-on drug for breakthrough pain in patients already using a regimen of a non-steroidal anti-inflammatory drug and/or acetaminophen.

Topics: Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Drug Interactions; Humans; Neurotransmitter Uptake Inhibitors; Oral Surgical Procedures; Pain, Postoperative; Phenols; Tapentadol; Toothache

Tapentadol immediate-release (IR) tablets are indicated for the treatment of moderate to severe acute pain. In clinical trials, tapentadol IR effectively reduced moderate to severe pain with improved tolerability compared with oxycodone IR at doses providing comparable analgesia.. This analysis compared the cost-effectiveness of tapentadol IR with doses of oxycodone IR providing comparable analgesia in the outpatient treatment of acute postsurgical and nonsurgical pain. The perspective was that of a US managed care health plan as third-party payer.. A Markov model was developed to simulate clinical-economic outcomes for tapentadol IR 100 mg compared with oxycodone IR 15 mg in the treatment of acute postsurgical pain (3 days) and for tapentadol IR 50 mg compared with oxycodone IR 10 mg in the treatment of acute nonsurgical pain (10 days). The model simulated changes in pain relief; occurrence of opioid-related adverse events (AEs); opioid switching, discontinuation, and dose change; and number of quality-adjusted life-days (QALDs). Data inputs for the model were obtained from clinical trials, claims databases, surveys, Medicare fee schedules, and other published sources. Only direct costs were included. Drug costs were based on the wholesale acquisition cost. Prescription copayments were set at $5 for oxycodone IR and $25 for tapentadol IR. All costs were in 2008 US dollars. Sensitivity analyses were conducted on key model parameters.. The cost of pain medication per patient was higher for tapentadol IR than for oxycodone IR in both the surgical pain setting ($15.23 vs $9.57, respectively) and the nonsurgical pain setting ($57.17 vs $21.31). However, this cost difference was offset by reductions in pharmacy and medical costs associated with the treatment of AEs and opioid switching/discontinuation, resulting in a lower mean treatment cost per patient for tapentadol IR 100 mg compared with oxycodone IR 15 mg in the treatment of acute surgical pain ($52.90 vs $55.99) and for tapentadol IR 50 mg compared with oxycodone IR 10 mg in the treatment of acute nonsurgical pain ($139.48 vs $144.79). Tapentadol IR also was associated with a greater mean number of treatment days with ≥30% improvement in pain intensity without opioid-related AEs compared with oxycodone IR and a greater mean number of QALDs (surgical pain: 1.73 vs 1.68; nonsurgical pain: 6.03 vs 4.92). Because both doses of tapentadol IR were dominant (ie, lower treatment costs and greater effectiveness) relative to the corresponding doses of oxycodone IR providing com- parable analgesia, incremental cost-effectiveness ratios were not calculated.. The results of this model suggest that at doses providing comparable analgesia, tapentadol IR is a cost-effective alternative to oxycodone IR for the treatment of acute surgical and nonsurgical pain.

Topics: Acute Disease; Analgesics, Opioid; Computer Simulation; Cost-Benefit Analysis; Dose-Response Relationship, Drug; Humans; Markov Chains; Models, Econometric; Oxycodone; Pain; Pain Measurement; Pain, Postoperative; Phenols; Quality-Adjusted Life Years; Solubility; Tablets; Tapentadol