Clinical drug investigation
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Hydrocodone bitartrate extended-release (Hysingla® ER; referred to hereafter as hydrocodone ER) was the first single-entity hydrocodone formulation recognized by the US FDA as having abuse-deterrent properties. It is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Once-daily oral hydrocodone ER provides consistent plasma hydrocodone concentrations and sustained analgesia over the 24-h dosing interval. ⋯ Hydrocodone ER was generally well tolerated, with a safety profile consistent with that seen with other μ-opioid analgesics. However, like other opioids, it is associated with risks of addiction, abuse/misuse and serious adverse events (AEs), including respiratory depression, withdrawal, physical dependence and overdose. Although large postmarketing studies are needed to determine whether the abuse-deterrent properties of hydrocodone ER result in meaningful reductions in abuse, misuse and related adverse clinical outcomes, current evidence indicates that hydrocodone ER is a useful treatment option for patients with chronic pain.
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Sore throat, cough, and hoarseness are the common and severe complications after general anesthesia with tracheal intubation. The efficacy of prophylactic administration of corticosteroids in reducing the incidence of postoperative complications is controversial. Thus, we conducted a meta-analysis to assess the effects of corticosteroids in the prevention of postoperative complications. ⋯ Evidence from this meta-analysis of 18 RCTs indicated that prophylactic administration of corticosteroids is not only effective in reducing the incidence and severity of postoperative sore throat and hoarseness, but also the incidence of laryngeal edema and reintubation.
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Review Meta Analysis
5-HT3 Receptor Antagonists for Propofol Injection Pain: A Meta-Analysis of Randomized Controlled Trials.
5-hydroxytryptamine3 (5-HT3) receptor antagonists have been commonly used to reduce propofol injection pain. The aim of this meta-analysis was to evaluate the efficacy and safety of 5-HT3 receptor antagonists in decreasing the incidence and intensity of propofol injection pain. ⋯ Our meta-analysis indicates that 5-HT3 receptor antagonists can effectively reduce the incidence and severity of propofol injection pain. Additionally, 5-HT3 receptor antagonists may become the alternatives to lidocaine in attenuating propofol injection pain. However, evidence is still limited for the safety of 5-HT3 receptor antagonists on propofol injection pain.
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Hereditary angioedema (HAE), a rare autosomal dominant genetic disorder, is caused by a deficiency in functional C1 esterase inhibitor (C1-INH). This potentially life-threatening condition manifests as recurrent attacks of subcutaneous and submucosal swelling of the skin, gastrointestinal tract and larynx. The management of HAE includes treatment of acute episodes, short-term prophylaxis in preparation for exposure to known triggers and long-term prophylaxis to decrease the incidence and severity of HAE attacks. ⋯ The safety and efficacy of rhC1-INH in the treatment of acute attacks in patients with HAE were demonstrated in three randomized, double-blind, placebo-controlled studies and two open-label extension studies. In a pilot prophylaxis study, weekly administration of rhC1-INH 50 U/kg for 8 weeks reduced the incidence of HAE attacks and was well tolerated. Administration of rhC1-INH has not been associated with the development of anti-drug antibodies or antibodies to anti-host-related impurities.
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Review
Diclofenac sodium injection (akis(®), dicloin (®)): a review of its use in the management of pain.
A novel formulation of diclofenac sodium suitable for subcutaneous or intramuscular injection (Akis(®), Dicloin(®)) has been developed using the complexing agent hydroxypropyl-β-cyclodextrin (HPβCD) as a solubility enhancer. Diclofenac HPβCD is available in several European countries, where it is indicated for use in adults with acute forms of pain, including postoperative pain. Clinical trials have demonstrated the analgesic efficacy of diclofenac HPβCD in terms of relieving moderate to severe postoperative pain in patients undergoing dental surgery or minor orthopaedic surgery. ⋯ The local tolerability of diclofenac HPβCD was consistently rated as 'good' or 'excellent' across all studies. Subcutaneous administration of diclofenac is a valid alternative to intramuscular delivery, with the advantages of easier administration, the availability of additional body sites suitable for injection and the potential for self-administration. Thus, diclofenac HPβCD 25, 50 or 75 mg/mL solution for subcutaneous or intramuscular injection extends the treatment options available for use in the management of pain in adults.