Effects of tapentadol: A Synthesis of Findings from 22 Studies

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Original Abstract of the Article

Major Research Findings

Tapentadol is a new centrally acting analgesic with a dual mode of action as an agonist of the µ-opioid receptor and as a norepinephrine reuptake inhibitor. 22 , 2 , 4 , 6 This dual mechanism of action results in synergistic analgesic effects and potentially less side effects. 4 Tapentadol has been shown to have less gastrointestinal side effects and less respiratory depression compared to other opioids, such as oxycodone. 1 , 18 , 5 Tapentadol is also approximately two to three times more potent than tramadol and two to three times less potent than morphine. 6 The pharmacokinetics of tapentadol are affected by age, liver function, and albumin/bilirubin ratio. 17 The metabolism of tapentadol is involved in the CYP2C19 enzyme. 20

Benefits and Risks

Benefits Summary

Tapentadol, in addition to the pain-relieving effects of opioids, may reduce pain and improve mood due to the noradrenaline reuptake inhibition effect. 22 , 4 Tapentadol is also believed to have fewer gastrointestinal side effects and less respiratory depression compared to other opioids. 1 , 18 , 5

Risks Summary

Tapentadol, like other opioids, can cause side effects such as constipation, drowsiness, and respiratory depression. 2 , 15 , 6 Tapentadol may also cause side effects such as serotonin syndrome and seizures. 6 The pharmacokinetics of tapentadol are affected by age, liver function, and albumin/bilirubin ratio, so the dosage needs to be adjusted by taking these factors into account. 17

Comparison of Studies

Commonalities of Studies

These studies indicate that tapentadol is a new centrally acting analgesic with a dual mode of action as an agonist of the µ-opioid receptor and as a norepinephrine reuptake inhibitor. 22 , 2 , 4 , 6 The studies also indicate that tapentadol may have fewer gastrointestinal side effects and less respiratory depression compared to other opioids. 1 , 18 , 5

Differences of Studies

These studies use different methodologies to evaluate the effectiveness and safety of tapentadol. 19 , 22 , 2 , 4 , 18 , 1 , 3 , 8 , 7 , 5 , 10 , 15 , 14 , 12 , 17 , 11 , 21 , 20 The studies also target different types of subjects. 19 , 22 , 2 , 4 , 18 , 1 , 3 , 8 , 7 , 5 , 10 , 15 , 14 , 12 , 17 , 11 , 21 , 20

Consistency and Contradictions of Results

These studies indicate that tapentadol may have fewer gastrointestinal side effects and less respiratory depression compared to other opioids. 1 , 18 , 5 However, more research is needed to evaluate the effectiveness and safety of tapentadol. 19 , 22 , 2 , 4 , 18 , 1 , 3 , 8 , 7 , 5 , 10 , 15 , 14 , 12 , 17 , 11 , 21 , 20

Considerations for Real-Life Applications

Tapentadol may be an effective analgesic for chronic pain and pain caused by cancer. 2 , 4 , 11 However, like other opioids, tapentadol has the potential for addiction and abuse. 2 , 15 , 6 Therefore, it is important to use tapentadol under the guidance of a doctor at the appropriate dosage. 6 The pharmacokinetics of tapentadol are affected by age, liver function, and albumin/bilirubin ratio, so the dosage needs to be adjusted by taking these factors into account. 17

Limitations of Current Research

Many studies on tapentadol have been conducted with small sample sizes. 19 , 22 , 2 , 4 , 18 , 1 , 3 , 8 , 7 , 5 , 10 , 15 , 14 , 12 , 17 , 11 , 21 , 20 Therefore, the results of these studies may not be generalizable. 19 , 22 , 2 , 4 , 18 , 1 , 3 , 8 , 7 , 5 , 10 , 15 , 14 , 12 , 17 , 11 , 21 , 20 Furthermore, the studies may not be applicable to other types of pain or populations, as they focus on specific types of pain and specific populations. 19 , 22 , 2 , 4 , 18 , 1 , 3 , 8 , 7 , 5 , 10 , 15 , 14 , 12 , 17 , 11 , 21 , 20

Future Research Directions

Larger-scale studies are needed to evaluate the effectiveness and safety of tapentadol. 19 , 22 , 2 , 4 , 18 , 1 , 3 , 8 , 7 , 5 , 10 , 15 , 14 , 12 , 17 , 11 , 21 , 20 Tapentadol's effectiveness and safety should also be evaluated in different types of pain and populations. 19 , 22 , 2 , 4 , 18 , 1 , 3 , 8 , 7 , 5 , 10 , 15 , 14 , 12 , 17 , 11 , 21 , 20

Conclusion

Tapentadol may be an effective analgesic for chronic pain and pain caused by cancer. 2 , 4 , 11 However, like other opioids, tapentadol has the potential for addiction and abuse. 2 , 15 , 6 Therefore, it is important to use tapentadol under the guidance of a doctor at the appropriate dosage. 6 Further research on tapentadol is expected to provide more information about the effectiveness and safety of this drug. 19 , 22 , 2 , 4 , 18 , 1 , 3 , 8 , 7 , 5 , 10 , 15 , 14 , 12 , 17 , 11 , 21 , 20

Literature analysis of 22 papers
Positive Content
21
Neutral Content
1
Negative Content
0
Article Type
9
2
3
0
22
1.

A randomised, placebo-controlled trial comparing the effects of tapentadol and oxycodone on gastrointestinal and colonic transit in healthy humans.

Author: JeongI D, CamilleriM, ShinA, IturrinoJ, BoldinghA, BusciglioI, BurtonD, RyksM, RhotenD, ZinsmeisterA R

Pain relief
GI side effects

This study investigates the effects of tapentadol, a mu-opioid receptor agonist and norepinephrine reuptake inhibitor, on gastrointestinal and colonic transit. The study aims to understand the impact of tapentadol on digestion and bowel movements.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

[Undesired side effects of tapentadol in comparison to oxycodone. A meta-analysis of randomized controlled comparative studies].

Author: MerkerM, DingesG, KochT, KrankeP, MorinA M

Less GI side effects
Pain relief

This study reviewed randomized controlled trials comparing tapentadol and oxycodone for pain management. The objective was to evaluate the relative amount of adverse effects associated with each drug.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : German

3.

Miotic and subject-rated effects of therapeutic doses of tapentadol, tramadol, and hydromorphone in occasional opioid users.

Author: StoopsWilliam W, GlaserPaul E A, RushCraig R

Tapentadol analgesia
Tramadol side effects

Tapentadol, a novel analgesic, produced a profile of positive effects comparable to hydromorphone. Tramadol, another analgesic, produced both positive and negative subject-rated effects.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Tapentadol versus oxycodone analgesia and side effects after laparoscopic hysterectomy: A randomised controlled trial.

Author: ComelonMarlin, RaederJohan, DrægniTomas, LiengMarit, LenzHarald

Reduced side effects
Synergistic analgesia

Tapentadol, an opioid with a dual mechanism of action, was investigated for its effectiveness in postoperative pain management.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Tapentadol results in less deterioration of gastrointestinal function and symptoms than standard opioid therapy in healthy male volunteers.

Author: MarkEsben Bolvig, NedergaardRasmus Bach, HansenTine Maria, NissenThomas Dahl, FrøkjaerJens Brøndum, ScottS Mark, KroghKlaus, DrewesAsbjørn Mohr

Improved pain management
Reduced GI side effects

This study aims to investigate the effects of tapentadol and oxycodone on gastrointestinal motility and side effects, focusing on a more precise assessment of mechanistic effects and comparisons with other opioids or placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Effects of acetaminophen, naproxen, and acetylsalicylic acid on tapentadol pharmacokinetics: results of two randomized, open-label, crossover, drug-drug interaction studies.

Author: SmitJohan W, OhCharles, RengelshausenJens, TerlindenRolf, RavenstijnPaulien G M, WangShean-Sheng, UpmalisDavid, MangoldBernhard

Tapentadol, a centrally acting analgesic, can be safely administered concurrently with acetaminophen, naproxen, or acetylsalicylic acid without requiring dosage adjustments. The co-administration of these medications did not significantly alter the serum concentrations of tapentadol.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Pharmacokinetic and pharmacodynamic modeling of opioid-induced gastrointestinal side effects in patients receiving tapentadol IR and oxycodone IR.

Author: XuXu Steven, EtropolskiMila, UpmalisDavid, OkamotoAkiko, LinRachel, NandyPartha

Reduced gastrointestinal adverse effects

Tapentadol showed a lower risk of opioid-related gastrointestinal adverse effects compared to oxycodone and its active metabolite, oxymorphone, supporting its clinical findings of reduced nausea, vomiting, and constipation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

[Undesired side effects of tapentadol in comparison to oxycodone. A meta-analysis of randomized controlled comparative studies].

Author: MerkerM, DingesG, KochT, KrankeP, MorinA M

Less GI side effects
Pain relief

This study reviewed randomized controlled trials comparing tapentadol and oxycodone for pain management. The objective was to evaluate the relative amount of adverse effects associated with each drug.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : German

11.

[Retrospective Examination of Usefulness and Adverse Effects of Tapentadol in Patients with Cancer Pain during Anticancer Treatment].

Author: ShikadaYasunori, EmiYasunori, KometaniTakuro, OchiaiToshiaki, FujiiMisa, NodaYoko, KajiwaraMie, MiyazakiSanae, AsonumaShinichi, MoriMinami

Low GI symptoms
Suitable for cancer patients
Swallowing disorders

Tapentadol is an opioid medication with a low incidence of gastrointestinal symptoms and minimal drug interactions. This study retrospectively examines 106 cases of tapentadol use in Japan for cancer pain.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Japanese

12.

IMI2-PainCare-BioPain-RCT3: a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by electroencephalography (EEG).

Author: MourauxAndré, Bloms-FunkePetra, BoeslIrmgard, CaspaniOmbretta, ChapmanSonya C, Di StefanoGiulia, FinnerupNanna Brix, Garcia-LarreaLuis, GoetzMarcus, KostenkoAnna, PelzBernhard, Pogatzki-ZahnEsther, SchubartKarin, StouffsAlexandre, TruiniAndrea, TraceyIrene, TroconizIñaki F, Van NielJohannes, VelaJose Miguel, VincentKaty, VollertJan, WanigasekeraVishvarani, WittayerMatthias, PhillipsKeith G, TreedeRolf-Detlef

Analgesic Development
Biomarkers
EEG

IMI2-PainCare-BioPain-RCT3 is a clinical study aiming to profile functional biomarkers of drug effects on the nociceptive system, specifically focusing on biomarkers derived from electroencephalographic (EEG) measures.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

13.

Miotic and subject-rated effects of therapeutic doses of tapentadol, tramadol, and hydromorphone in occasional opioid users.

Author: StoopsWilliam W, GlaserPaul E A, RushCraig R

Tapentadol analgesia
Tramadol side effects

Tapentadol, a novel analgesic, produced a profile of positive effects comparable to hydromorphone. Tramadol, another analgesic, produced both positive and negative subject-rated effects.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

A randomised, placebo-controlled trial comparing the effects of tapentadol and oxycodone on gastrointestinal and colonic transit in healthy humans.

Author: JeongI D, CamilleriM, ShinA, IturrinoJ, BoldinghA, BusciglioI, BurtonD, RyksM, RhotenD, ZinsmeisterA R

Pain relief
GI side effects

This study investigates the effects of tapentadol, a mu-opioid receptor agonist and norepinephrine reuptake inhibitor, on gastrointestinal and colonic transit. The study aims to understand the impact of tapentadol on digestion and bowel movements.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

17.

Pharmacokinetic Analysis, Analgesic Effects, and Adverse Effects of Tapentadol in Cancer Patients with Pain.

Author: HommaMasashi, KokubunHideya, OkuwakiKosuke, KatadaChikatoshi, HayashiNorihito, KanaiAkifumi, KoizumiWasaburo, AtsudaKoichiro

Analgesic effect
Reduced pain
Impaired liver function

Tapentadol (TP) is an opioid with sufficient analgesic effects for cancer patients. However, clearance of TP was significantly reduced in patients with impaired liver function, suggesting the need for dose adjustments in these patients.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

18.

An experimental study comparing the respiratory effects of tapentadol and oxycodone in healthy volunteers.

Author: van der SchrierR, JonkmanK, van VelzenM, OlofsenE, DrewesA M, DahanA, NiestersM

Less respiratory depression

This study compared the respiratory effects of tapentadol, a mu-opioid receptor agonist and noradrenaline reuptake inhibitor, with oxycodone, a selective mu-opioid receptor agonist. It hypothesized that tapentadol 100 mg would have a lesser effect on the control of breathing than oxycodone 20 mg.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

19.

IMI2-PainCare-BioPain-RCT1: study protocol for a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by peripheral nerve excitability testing (NET).

Author: NochiZahra, PiaHossein, Bloms-FunkePetra, BoeslIrmgard, CaspaniOmbretta, ChapmanSonya C, FardoFrancesca, GenserBernd, GoetzMarcus, KostenkoAnna V, LeoneCaterina, LiThomas, MourauxAndré, PelzBernhard, Pogatzki-ZahnEsther, SchilderAndreas, SchnetterErik, SchubartKarin, StouffsAlexandre, TraceyIrene, TroconizIñaki F, TruiniAndrea, Van NielJohannes, VelaJose Miguel, VincentKaty, VollertJan, WanigasekeraVishvarani, WittayerMatthias, TankisiHatice, FinnerupNanna B, PhillipsKeith G, TreedeRolf-Detlef

Analgesic development

This study focuses on biomarkers derived from nerve excitability testing (NET) to accelerate the development of analgesics for chronic pain.

Clinical Trial ProtocolA plan for conducting a clinical trial. It describes in detail the purpose, design, methodology, and statistical considerations of the trial, ensuring the transparency and consistency of the trial.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

20.

Effects of CYP2C19 variants on the metabolism of tapentadol <i>in vitro</i>.

Author: XuRen-Ai, FangPing, YeZhize, HanMingming, CaiJian-Ping, HuGuo-Xin

CYP2C19 alleles
Tapentadol metabolism
Drug interactions

The CYP2C19 *17 allele is the most efficient at metabolizing tapentadol, followed by *1, *17, *3, and *2 alleles.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

21.

Effects of the human SULT1A1 polymorphisms on the sulfation of acetaminophen,O-desmethylnaproxen, and tapentadol.

Author: RasoolMohammed I, BairamAhsan F, GohalSaud A, El DaibaniAmal A, AlherzFatemah A, AbunnajaMaryam S, AlatwiEid S, KurogiKatsuhisa, LiuMing-Cheh

Analgesic efficacy

This study investigated the impact of single nucleotide polymorphisms in the SULT1A1 gene on the sulfation of analgesic compounds.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

22.

Mu-opioid and noradrenergic α(2)-adrenoceptor contributions to the effects of tapentadol on spinal electrophysiological measures of nociception in nerve-injured rats.

Author: BeeLucy A, BannisterKirsty, RahmanWahida, DickensonAnthony H

Neuropathic pain treatment

Tapentadol, a drug that stimulates mu-opioid receptors (MOR) and acts as a noradrenaline reuptake inhibitor (NRI), is effective in reducing neuropathic pain. This study investigated its mechanism of action in an animal model of neuropathic pain.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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