scholarly journals Tapentadol in acute pain: a review of the results of international studies

2021 ◽  
Vol 15 (4) ◽  
pp. 113-119
Author(s):  
V. V. Nikoda
Keyword(s):  
Acute Pain ◽  
Opioid Analgesics ◽  
Immediate Release ◽  
Early Postoperative Period ◽  
Tolerability Profile ◽  
International Studies ◽  
Efficacy And Safety ◽  
Opioid Receptor Agonist ◽  
Fundamental Goal ◽  
Phase Ii And Iii

The treatment of acute pain is a fundamental goal for doctors of various specialties. Tapentadol, which combines the properties of an opioid receptor agonist and a noradrenalin reuptake inhibitor, is one of the most popular analgesics in the world that is effective in severe acute pain. We provide a review of international publications about pharmacological properties, efficacy and safety of tapentadol immediate release (IR) in acute pain. Data from phase II and III of randomized controlled trials (RCTs), in which tapentadol IR (50, 75 and 100 mg) was used for moderate to severe pain in surgical and therapeutic practice is discussed. A number of studies have compared tapentadol with placebo groups and classical opioids (oxycodone, morphine). The results of two meta-analyzes and systematic reviews of efficacy and safety of this analgesic in patients with acute pain are presented.International multicenter RCTs have demonstrated high efficacy of tapentadol IR 50, 75 and 100 mg in patients in the early postoperative period. Comparison with other opioid analgesics showed that tapentadol was superior to placebo and comparable to oxycodone in analgesic effect.It was concluded that tapentadol has a better safety and tolerability profile than classical opioids. The incidence of adverse events on this drug is lower than on oxycodone or morphine.

Oxymorphone and oxymorphone extended release: A pharmacotherapeutic review

2018 ◽  
Vol 4 (3) ◽  
pp. 131 ◽  
Author(s):  
Paul Alexander Sloan, MD ◽  
Robert L. Barkin, PharmD, MBA
Keyword(s):  
Chronic Pain ◽  
Extended Release ◽  
Analgesic Efficacy ◽  
Opioid Analgesics ◽  
Immediate Release ◽  
The United States ◽  
Efficacy And Safety ◽  
Open Label ◽  
Opioid Agonist ◽  
Noncancer Pain

The treatment of chronic pain remains an enormous challenge in the United States. Opioid analgesics are an important component of pharmacotherapy for chronic pain and have proven efficacy in the management of cancer and noncancer chronic pain. The newest addition to oral opioid pharmacotherapy is oral oxymorphone, a semisynthetic opioid agonist that is now available in oral immediate-release (IR) and extended-release (ER) formulations. This review discusses the pharmacology, pharmacokinetics, pharmacodynamics, pharmacotherapeutics, and clinical use of oral oxymorphone IR and ER formulations for the management of moderate to severe pain for different types of patients in a variety of settings. Two published studies evaluated the efficacy and safety of oxymorphone IR in patients with moderate to severe postoperative pain and demonstrated that it provides rapid and effective analgesia and is generally well tolerated. Six published randomized controlled trials and three published open-label studies evaluated the efficacy and safety of oxymorphone ER for chronic cancer or noncancer pain. These trials found analgesic efficacy and tolerability comparable to that provided by morphine controlled release (CR) or oxycodone CR; treatment effects with oxymorphone ER were durable for treatment periods of 12 weeks at the same dose or up to 1 year with little dose escalation. Titrated doses of oxymorphone ER were effective and generally well tolerated in both opioid-experienced and opioid-naïve patients. Aspects of oxymorphone metabolism and limited protein binding may simplify treatment in certain populations.

Clinical Efficacy and Safety of Tapentadol Immediate Release in the Postoperative Setting

2012 ◽  
Vol 102 (2) ◽  
pp. 139-148 ◽  
Author(s):  
Stephen E. Daniels ◽  
Michael Golf
Keyword(s):  
Postoperative Pain ◽  
Adverse Effects ◽  
Single Molecule ◽  
Negative Impact ◽  
Opioid Analgesics ◽  
Immediate Release ◽  
Tolerability Profile ◽  
Gastrointestinal Tolerability ◽  
Podiatric Surgery ◽  
Postoperative Setting

The appropriate treatment for postoperative pain remains a common dilemma for podiatric surgeons and patients undergoing surgery of the foot and ankle. The treatment of moderate to severe acute pain typically relies heavily on the use of opioid analgesics, such as hydrocodone and oxycodone, which are often associated with adverse effects, including nausea and vomiting. These adverse effects may have a negative impact on postoperative outcomes and reduce patient compliance with analgesic therapy. Tapentadol is a novel, centrally acting analgesic with two mechanisms of action—μ-opioid receptor agonism and norepinephrine reuptake inhibition—in a single molecule. Tapentadol immediate release has been evaluated in a series of clinical trials in patients with postoperative pain after bunionectomy. The results of these studies demonstrate that tapentadol immediate release is associated with an improved gastrointestinal tolerability profile relative to oxycodone immediate release at doses providing comparable analgesia. Therefore, tapentadol immediate release may offer an improved analgesic option for the relief of postoperative pain after podiatric surgery. (J Am Podiatr Med Assoc 102(2): 139–148, 2012)

Efficacy and Safety of Tapentadol Immediate Release for Acute Pain

2020 ◽  
Vol 36 (5) ◽  
pp. 399-409 ◽  
Author(s):  
Xinyi Wang ◽  
Sujita W. Narayan ◽  
Jonathan Penm ◽  
Asad E. Patanwala
Keyword(s):  
Acute Pain ◽  
Immediate Release ◽  
Efficacy And Safety

scholarly journals Three Newly Approved Analgesics: An Update

2013 ◽  
Vol 60 (4) ◽  
pp. 178-187 ◽  
Author(s):  
Mana Saraghi ◽  
Elliot V. Hersh
Keyword(s):  
Acute Pain ◽  
Opioid Analgesics ◽  
Immediate Release ◽  
Opioid Agonist ◽  
Gelatin Capsules ◽  
Drug Classes ◽  
Fda Approval ◽  
Soft Gelatin Capsules ◽  
Norepinephrine Reuptake Inhibitor ◽  
New Formulation

Abstract Since 2008, three new analgesic entities, tapentadol immediate release (Nucynta) diclofenac potassium soft gelatin capsules (Zipsor), and bupivacaine liposome injectable suspension (EXPAREL) were granted US Food and Drug Administration (FDA) approval to treat acute pain. Tapentadol immediate-release is a both a mu-opioid agonist and a norepinephrine reuptake inhibitor, and is indicated for the treatment of moderate to severe pain. Diclofenac potassium soft gelatin capsules are a novel formulation of diclofenac potassium, which is a nonsteroidal anti-inflammatory drug (NSAID), and its putative mechanism of action is through inhibition of cyclooxygenase enzymes. This novel formulation of diclofenac allows for improved absorption at lower doses. Liposomal bupivacaine is a new formulation of bupivacaine intended for single-dose infiltration at the surgical site for postoperative analgesia. Bupivacaine is slowly released from this liposomal vehicle and can provide prolonged analgesia at the surgical site. By utilizing NSAIDs and local anesthetics to decrease the transmission of afferent pain signals, less opioid analgesics are needed to achieve analgesia. Since drug-related adverse events are frequently dose related, lower doses from different drug classes may be employed to reduce the incidence of adverse effects, while producing synergistic analgesia as part of a multimodal analgesic approach to acute pain.

Sending out Biased Signals: an Appropriate Proposition for Pain?

2019 ◽  
Vol 32 (2) ◽  
pp. 108-110 ◽  
Author(s):  
E. Besserer-Offroy ◽  
P. Sarret
Keyword(s):  
Side Effects ◽  
Acute Pain ◽  
Gold Standard ◽  
Pain Treatment ◽  
Opioid Analgesics ◽  
Mu Opioid Receptor ◽  
Clinical Development ◽  
Mu Opioid ◽  
Development Stages ◽  
The Past

In the past few years, several biased ligands acting at the mu-opioid receptor were reported in the literature. These agonists are aimed at reducing pain while having fewer side effects than morphine, the gold standard of opioid analgesics. In this mini-review, we describe and discuss the recent advances in mu-biased ligands actually in preclinical and clinical development stages, including the latest U.S. Food and Drug Administration review of oliceridine, a biased mu-agonist for moderate to severe acute pain treatment developed by the company Trevena.

Ponatinib: A Review of Efficacy and Safety

2018 ◽  
Vol 18 (9) ◽  
pp. 847-856 ◽  
Author(s):  
Fulvio Massaro ◽  
Matteo Molica ◽  
Massimo Breccia
Keyword(s):  
Kinase Inhibitor ◽  
Tolerability Profile ◽  
Third Generation ◽  
Efficacy And Safety ◽  
Future Perspectives ◽  
General Management ◽  
T315i Mutation ◽  
Baseline Characteristics ◽  
Management Recommendations ◽  
Cardiovascular Profile

Ponatinib is a third generation kinase inhibitor designed to overcome the gatekeeper T315I mutation. In different trials this drug showed inhibitory activity against native BCR-ABL1 kinase and several ABL1 mutations. For this reason, ponatinib is currently indicated for the treatment of chronic myeloid leukaemia (CML) in every phase of disease resistant and/or intolerant to dasatinib and nilotinib and for whom imatinib is not indicated anymore or for patients with T315I mutation. The drug is also indicated for Ph+ acute lymphoblastic leukaemia (ALL). Ponatinib was temporarily suspended in 2013 for the occurrence of cardiovascular thrombotic events. Since then, different investigators analyzed baseline characteristics of patient candidates for ponatinib, especially cardiovascular profile, in order to describe general management recommendations in this setting. In this review, clinical trials data about the use of ponatinib in CML and Ph+ ALL patients will be discussed. It will be focused also about the safety and tolerability profile of the drug and future perspectives of employment.

scholarly journals Efficacy and Safety of Teriflunomide in Multiple Sclerosis across Age Groups: Analysis from Pooled Pivotal and Real-world Studies

2021 ◽  
Vol 13 ◽  
pp. 117957352110287
Author(s):  
Jiwon Oh ◽  
Sandra Vukusic ◽  
Klaus Tiel-Wilck ◽  
Jihad Said Inshasi ◽  
David Rog ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Real World ◽  
Age Groups ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Additional Group ◽  
Disability Status ◽  
Scale Scores ◽  
Post Hoc ◽  
Phase Ii And Iii

Background: Evidence suggests that efficacy and safety of disease-modifying treatments for multiple sclerosis may differ with age. We evaluate efficacy and safety of teriflunomide across age subgroups of patients from pooled clinical trials and real-world studies. Methods: Post hoc analyses of patients who received teriflunomide 14 mg in the pooled phase II and III TEMSO, TOWER, TENERE, and TOPIC core and extension studies (n = 1978), and the real-world Teri-PRO (n = 928) and TAURUS-MS I (n = 1126) studies were conducted. Data were stratified by age at study entry: ⩽25, >25 to ⩽35, >35 to ⩽45, and >45 years. In Teri-PRO and TAURUS-MS I, an additional group, >55 years, was assessed. Results: In the pooled core studies, teriflunomide reduced annualized relapse rate (ARR) versus placebo across all ages. Unadjusted ARRs remained low across age groups in pooled extensions (0.18-0.30), Teri-PRO (0.10-0.35), and TAURUS-MS I (0.14-0.35). Baseline Expanded Disability Status Scale scores were higher with age, but stable through core and extension studies (mean increases over 7 years: ⩽25 years, +0.59; >25 to ⩽35 years, +0.46; >35 to ⩽45 years, +0.35; >45 years, +0.81). Across age groups, adverse event (AE) incidences were 78.4% to 90.7% in pooled core and extension studies and Teri-PRO, and 29.2% to 37.7% in TAURUS-MS I; serious AE incidences were ⩽21.3% in all studies. In pooled phase III and Teri-PRO studies, lymphocyte count decreases over 1 year after initiating teriflunomide, and proportions of patients developing lymphopenia, were small across age groups. Conclusions: Teriflunomide efficacy was demonstrated regardless of age. Safety was generally consistent across age groups.

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