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Post-traumatic injury pain is commonly treated with oral nonsteroidal anti-inflammatory drugs (NSAIDs). However, oral NSAIDs causes several adverse events, with topical formulations arising as an important alternative. Therefore, we aimed to evaluate the efficacy and safety of loxoprofen patch in the treatment of patients with post-traumatic pain. This phase III, randomized, double-blind, non-inferiority study enrolled Brazilian patients aged 18-65 years diagnosed with lower and upper limbs post-traumatic injury who were experiencing moderate or severe pain. Patients were assigned to active loxoprofen patch (LX-P) or to loxoprofen tablet (LX-T) and pain intensity was measured based on a Visual Analog Scale (VAS) score variation after seven days of treatment. Data on clinical symptoms, rescue medication use, and adverse events were also collected. VAS score variation was compared using a 10% non-inferiority margin. Two hundred and forty-two patients were randomly assigned to the LX-P (n=123) or to LX-T (n=119). The results showed a reduction in pain after seven days of treatment: -49.96 (n=118; SE 1.7) in the LX-P and -47.71 (n=117; SE 1.6) in the LX-T groups (difference of -2.25; 95% CI: -5.97 – 1.47; p=0.23). On the safety analysis, LX-T group presented twice as many patients with treatment-emergent adverse events as the LX-P group (30.8% and 14.2%, respectively). A sensitivity analysis demonstrated that rescue medication use has not affected the primary endpoint. This study showed that LX-P has a comparable efficacy to LX-T, but with a better safety profile, being a therapeutic option for the treatment of post-traumatic injury pain.
Learn More >Many Osteoarthritis (OA) patients report with clinical features to their pain that cannot be explained by purely peripheral mechanisms. Yet, the analgesic agents available that tackle centrally driven chronic pain often provide only partial pain relief, or have dose-limiting side effects. We explored a combination therapy of the centrally acting analgesic agents tapentadol and pregabalin, to investigate if they could be used in combination to provide superior analgesia.
Learn More >Calcitonin-gene-related peptide (CGRP), a neuropeptide broadly distributed in neuronal and non-neuronal regions throughout the body, plays a fundamental role in migraine and cluster headache (CH) pathophysiology. CGRP functional blockade alleviates neurogenic inflammation and reduces pain pathway sensitization. Two types of CGRP function-blocking modalities, monoclonal antibodies (MAbs), and small molecules (gepants), have been designed to target the CGRP ligands and CGRP receptors. In this narrative review, we summarized the latest clinical trials on gepants and CGRP function-blocking MAbs for migraine and CH prevention. At the time of writing, newer gepants are currently under Federal Drug Administration (FDA) review for migraine management, but there is no study yet on the usage of gepants for CH. Erenumab, fremanezumab, and galcanezumab have been approved by the FDA for migraine prevention while eptinezumab is under FDA review. CGRP MAbs are as effective as and more tolerable than conventional migraine preventives. For CH prevention, galcanezumab has shown some promising findings and was recently approved for use in episodic cluster prevention. CGRP function-blocking therapy not only demonstrates high efficacy and superior safety profile, but also improves headache frequency and quality of life. Convenient monthly dosing for the MAbs can further improve medication adherence, hence better headache control. With CGRP function-blocking therapy showing efficacy even in individuals who failed other preventives, it has become an exciting new therapeutic option in the field of migraine and CH.
Learn More >Patients with high-frequency episodic migraine (HFEM) have a greater disease burden than those with low-frequency episodic migraine (LFEM). Acute treatment overuse increases the risk of migraine chronification in patients with HFEM. Galcanezumab, a humanized monoclonal antibody binding calcitonin gene-related peptide (CGRP), is effective for migraine prevention with a favorable safety profile. Here, we investigate whether there are differences in galcanezumab efficacy in patients with LFEM or with HFEM.
Learn More >To inform feasibility and design of a future randomised controlled trial (RCT) using brain functional MRI (fMRI) to determine the mechanism of action of gabapentin in managing chronic pelvic pain (CPP) in women.
Learn More >MicroRNAs (miRs) have emerged as biomarkers of migraine disease in both adults and children. In this study we evaluated the expression of hsa-miR-34a-5p and hsa-miR-375 in serum and saliva of young subjects (age 11 ± 3.467 years) with migraine without aura (MWA), while some underwent pharmacological treatment, and healthy young subjects were used as controls. miRs were determined using the qRT-PCR method, and gene targets of hsa-miR-34a-5p and hsa-miR-375 linked to pain-migraine were found by in silico analysis. qRT-PCR revealed comparable levels of hsa-miRs in both blood and saliva. Higher expression of hsa-miR-34a-5p and hsa-miR-375 was detected in saliva of untreated MWAs compared to healthy subjects (hsa-miR-34a-5p: < 0.05; hsa-miR-375 < 0.01). Furthermore, in MWA treated subjects, a significant decrease of hsa-miR-34a-5p and of hsa-miR-375 was documented in saliva and blood compared to MWA untreated ones. Altogether, these findings suggested thathsa-miR-34a-5p and hsa-miR-375 are expressed equally in blood and saliva and that they could be a useful biomarker of disease and of drug efficacy in patients with MWA.
Learn More >Gabapentin has analgesic efficacy for neuropathic pain and is increasingly used in burn care. This study investigated the effect of a neuropathic pain control protocol, as well as early gabapentin initiation (< 72 hours from injury) on total inpatient opioid use, chronic pain, and itch. This is a single-institution retrospective cohort study of patients over age 14 admitted between 2006 and 2016 with burns. We compared patients who did not receive gabapentin with those who had early gabapentin initiation vs. late initiation. We also compared patients who used gabapentin prior to initiation of a neuropathic pain protocol (February 2015) to those after. Primary outcomes were total inpatient gabapentin, morphine equivalents (MED), longitudinal pain and itch, as well as SF-12v2 Health Survey mental and physical component scores (MCS/PCS) at discharge, 6, 12, and 24 months post-injury. Ordinal logistic regression analysis was used to examine pain and itch scores. Linear regression models examined MCS and PCS between groups. Models were adjusted for age, sex, TBSA burned, area grafted, MED, and ICU stay. There was no significant difference in MED with early initiation, yet inpatient gabapentin use increased from 43.9 g to 59.5 g (p<0.001) with late initiation. The neuropathic pain protocol did not significantly change total gabapentin use (p = 0.184) in patients receiving gabapentin but decreased opioid use from 58.1 g to 17.4 g MED (p = 0.008). Our results suggest neither early gabapentin nor its use in a standardization neuropathic pain protocol improves long-term pain, itch, PCS or MCS scores.
Learn More >We know little about the safety or efficacy of pharmacological medicines for children and adolescents with chronic pain, despite their common use. Our aim was to conduct an overview review of systematic reviews of pharmacological interventions that purport to reduce pain in children with chronic non-cancer pain or chronic cancer-related pain. We searched the Cochrane Database of Systematic Reviews, Medline, EMBASE and DARE for systematic reviews from inception to March 2018. We conducted reference and citation searches of included reviews. We included children (0-18 years of age) with chronic non-cancer pain or chronic cancer-related pain. We extracted the review characteristics and primary outcomes of ≥30% participant-reported pain relief and patient global impression of change. We sifted 704 abstracts and included 23 systematic reviews investigating children with chronic non-cancer pain or chronic cancer-related pain. Seven of those 23 reviews included six trials that involved children with chronic non-cancer pain. There were no RCTs in reviews relating to reducing pain in chronic cancer-related pain. We were unable to combine data in a meta-analysis. Overall, the quality of evidence was very low and we have very little confidence in the effect estimates. The state of evidence of randomized controlled trials in this field is poor; we have no evidence from randomised controlled trials for pharmacological interventions in children with cancer-related pain, yet cannot deny individual children access to potential pain relief. Prospero ID: CRD42017081205. A video accompanying this abstract is available online as Supplemental Digital Content at http://links.lww.com/PAIN/A797.
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