Need For Rescue Medication Research Articles

Clinical Outcomes of Topical 0.1% Ciclosporin Cationic Emulsion Used on Label in Children with Vernal Keratoconjunctivitis.

The purpose of this short article is to report the clinical outcomes of topical 0.1% ciclosporin cationic emulsion (CsA-CE) used on label in children with vernal keratoconjunctivitis (VKC). In this prospective, non-comparative, observational study children affected by active severe VKC were treated for at least 12months with topical 0.1% CsA-CE. The drug was instilled in both eyes 4 times daily. Data collected from medical charts for the baseline visit (T0) and 1-year follow-up visit (T1) included symptomatic score (0-15), clinical score (0-15), side effects, rescue therapy (need and total number of courses with 0.1% dexamethasone 4times daily for 5days), ocular complications and tolerability (visual analog scale [0-100]). Data from 25 children (20 boys, 5 girls; mean [± standard deviation] age 8.40 ± 2.54 years) were included in the study. Of the 25 patients, 23 (92%) used 0.1% CsA-CE eye drops as per label recommendations, including four patients who had prematurely stopped using topical galenic CsA due to side effects. Symptomatic and clinical scores decreased significantly after treatment, with the mean symptomatic score decreasing from 9.76 ± 1.27 at T0 to 3.80 ± 1.08 at T1, and the mean clinical score decreasing from 9.20 ± 1.32 at T0 to 3.44 ± 1.00 at T1; both P < 0.0001). Five patients (20%) required at least one course of rescue medication (mean 3.4 ± 4.8 courses/year). No patients experienced ocular complications during the study, and treatment tolerability was very high (mean score 89.40 ± 5.46). Our findings confirm that topical CsA-CE is an effective on-label option for children with VKC in the real-life setting. In our pediatric patient population, CsA-CE provided good clinical outcomes with a limited need for rescue medication, and it was well tolerated by almost all patients, including those who were intolerant to galenic formulations.

The benefits and risks of non-steroidal anti-inflammatory drugs for postoperative analgesia in sinonasal surgery: a systematic review and meta-analysis.

Non-steroidal anti-inflammatory drugs (NSAIDs) have emerged as an alternative to opioids for optimal postoperative pain management. However, the adoption of NSAIDs in sinonasal surgery has been impeded by a theoretical concern for postoperative bleeding. Our objective is to systematically review the efficacy and safety of NSAIDs for patients undergoing sinonasal surgery. MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, CINAHL, and the WHO International Clinical Trials Registry Platform were searched from inception to January 27, 2022. Randomized controlled trials (RCTs) and comparative observational studies in any language were considered. Screening, data extraction, and risk of bias assessment were performed in duplicate. Our outcomes were postoperative pain scores, requirement for rescue analgesia, and postoperative adverse events (epistaxis, nausea/vomiting). Out of 4661 records, 15 RCTs (enrolling 1210 patients) and two observational studies were included. Following endoscopic sinus surgery, there was no difference in pain scores between NSAIDs and non-NSAIDs groups (standardized mean differences [SMD] 0.44 units better, 95% CI -0.18 to 1.05). Following septorhinoplasty, NSAIDs decreased pain scores compared to non-NSAID regimens (SMD 1.14 units better, 95% CI 0.61 to 1.67 units better). Overall, NSAIDs reduced the need for rescue medication with a relative risk (RR) of 0.45 (95% CI 0.24 to 0.84). In addition, NSAIDs decreased the risk of nausea with an RR of 0.62 (95% CI 0.42 to 0.91) and did not increase the risk of epistaxis (RR 0.72, 95% CI 0.23-2.22). Among patients undergoing sinonasal surgery, NSAIDs are beneficial in postoperative pain management and avoidance of postoperative nausea without increasing the risk of postoperative epistaxis.

A comparative study of efficacy and safety of montelukast versus acebrophylline as add-on therapy to inhaled corticosteroids in bronchial asthma

Background: Non-responding to standard doses of inhalational corticosteroids (ICS) remains a challenge in the management of asthma, requiring add-on therapy. Acebrophylline, a theophylline derivative, with multiple mechanisms of action and properties, could work as a suitable alternative to montelukast as an add-on therapy. Aims and Objectives: The aim of this study was to compare the efficacy and safety of montelukast versus acebrophylline as an add-on therapy to ICS in the treatment of bronchial asthma. Materials and Methods: One hundred bronchial asthma patients, fulfilling inclusion/exclusion criteria, were enrolled and randomized in a 1:1 ratio into two groups of 50 each to receive either oral montelukast 10 mg OD or oral acebrophylline 200 mg OD with budesonide. Inhaled salbutamol was permitted as rescue medication during acute exacerbations. Primary outcome measures were change in pulmonary function test (PFT) parameters and asthma control questionnaire (ACQ) scores at baseline and 12 weeks. Adverse events, if any were recorded. Results: There was a statistically significant difference in the improvement of mean PFT parameters at the end of 12 weeks in the montelukast group (P &lt; 0.001), but not in acebrophylline group (P = 0.253). Montelukast was more efficacious than acebrophylline in improving PFT parameters at 6 and 12 weeks. Both treatment modalities significantly improved ACQ score at 12 weeks (P &lt; 0.001), the difference between two groups was not statistically significant (1.4 ± 0.53 in Group A vs. 1.32 ± 0.44 in Group B, P = 0.436). No significant adverse effects were seen in both groups. Conclusion: Montelukast, with low-dose ICS, had better efficacy over acebrophylline. Both montelukast and acebrophylline improved the quality of life in mild-to-moderate persistent asthma patients by decreasing nocturnal symptoms and the need for rescue medications.

DEVELOPMENT OF A MOBILE APPLICATION TO MONITOR THE CLINICAL RESPONSE TO IMMUNOTHERAPY IN PATIENTS WITH ALLERGIC RHINITIS AT A REFERENCE CENTER IN SOUTHERN BRAZIL

Allergic rhinitis (AR) is a worldwide public health problem as it affects the quality of life of patients. There is great concern with its correct diagnosis, as well as with the development of suitable instruments for its monitoring. The use of apps on smartphones and tablets has had a profound impact on medicine. A natural trend of modern medicine is to empower patients, while encouraging and educating them so that they are able to better understand and treat their condition. This is an original study aimed at the development of a specific application to monitor the clinical response to immunotherapy in patients with allergic rhinitis. Based on studies already validated in the literature, such as the ISAAC and ARIA questionnaires, three questionnaires were included in the developed application with simple and accessible questions for patients. Through the data collected by the application, stratification will be possible regarding allergic and non-allergic symptoms, age group at the onset of the disease, triggering factors for AR, environmental context, comorbidities, in addition to factors related to the use of immunotherapy, frequency of use, adverse events, and need for rescue medication.

Comparison of efficacy and frequency of akathisia and dystonia between olanzapine, metoclopramide and prochlorperazine in ED headache patients

Study objectiveTo compare the efficacy and frequency of akathisia and dystonia between the dopamine antagonist headache medications olanzapine, metoclopramide and prochlorperazine. MethodsThis was a retrospective observational cohort study of patients presenting to a large urban level one trauma center between 2010 and 2018. Inclusion criteria was age ≥ 18 who presented to the emergency department with a chief complaint of headache who received either olanzapine, metoclopramide or prochlorperazine. The primary outcome was need for rescue medication. Secondary outcomes were receiving medication for either akathisia or dystonia. Logistic regression was used to identify differences between the three cohorts up to 72 h from initial presentation. ResultsThere were 5643 patients who met inclusion criteria. Olanzapine was the most commonly used drug (n = 2994, 53%) followed by prochlorperazine (n = 2100, 37%) and metoclopramide (n = 549, 10%). After adjusting for age and gender, there were no differences in risk for receiving rescue therapy or developing akathisia or dystonia. ConclusionDuring initial ED visit and up to 72 h after receiving olanzapine, metoclopramide or prochlorperazine, we found no difference in risk for requiring rescue medication or developing akathisia or dystonia.

Effects of Preoperative Acupuncture on Prevention of Nausea and Vomiting and Plasma Serotonin Values in the Hysterectomy Postoperative Period: a Randomized Clinical Trial.

Nausea and vomiting are frequent complications of anesthesia in the postoperative period. Acupuncture at the pericardium point 6 (PC6) is known to be effective in preventing postoperative nausea and vomiting (PONV). The objective of the present study is to investigate the effects of acupuncture performed at the PC6 point in the prevention of PONV in women undergoing elective open hysterectomy under general inhalational anesthesia and to assess its association with plasma serotonin levels. 97 patients undergoing elective open hysterectomy were randomly divided into two groups: acupuncture group (bilateral acupuncture at PC6, n = 49), and a control group (no acupuncture, n = 48). All patients prophylactically received ondansetron and dexamethasone and, as rescue medication, metoclopramide in case of occurrence of PONV. The primary outcome evaluated was occurrence of nausea and vomiting within 24 hours after surgery. Serotonin plasma levels were measured before and after acupuncture prior to anesthesia induction. For the control group, the repeat measurement was performed 30 minutes after admission to the preoperative unit. Acupuncture at PC6 significantly reduced the incidence of nausea (29.2% vs. 6.1%; p > 0.003), and the need of rescue medication (metoclopramide) (33.3% vs. 10.2%; p > 0.006), but not vomiting (4.2 vs. 4.1; p > 0.98). The plasma serotonin levels between control and acupuncture groups did not differ. This study shows that acupuncture at PC6 resulted in a lower incidence of postoperative nausea in patients undergoing hysterectomy.

Effects of Palmitoylethanolamide (PEA) on Nociceptive, Musculoskeletal and Neuropathic Pain: Systematic Review and Meta-Analysis of Clinical Evidence.

Some 30–50% of the global population and almost 20% of the European population actually suffer from chronic pain, which presents a tremendous burden to society when this pain turns into a disability and hospitalization. Palmitoylethanolamide (PEA) has been demonstrated to improve pain in preclinical contexts, but an appraisal of clinical evidence is still lacking. The present study aimed at addressing the working hypothesis for the efficacy of PEA for nociceptive musculoskeletal and neuropathic pain in the clinical setting. The systematic search, selection and analysis were performed in agreement with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 recommendations. The primary outcome was pain reduction, as measured by a pain assessment scale. The secondary outcome was improvement in quality of life and/or of parameters of function. The results obtained for a total of 933 patients demonstrate the efficacy of PEA over the control (p < 0.00001), in particular in six studies apart from the two randomized, double-blind clinical trials included. However, the results are downgraded due to the high heterogeneity of the studies (I2 = 99%), and the funnel plot suggests publication bias. Efficacy in achieving a reduction in the need for rescue medications and improvement in functioning, neuropathic symptoms and quality of life are reported. Therefore, adequately powered randomized, double-blind clinical trials are needed to deepen the domains of efficacy of add-on therapy with PEA for chronic pain. PROSPERO registration: CRD42022314395.

The add-on effect of an intranasal antihistamine with an intranasal corticosteroid in Japanese cedar pollinosis

ObjectiveCombination intranasal drugs with a corticosteroid and antihistamine are available in several countries with better effect than treatments with single agents. However, it remains unclear whether this effect is also seen in Japanese cedar pollinosis (JCP), the most prevalent seasonal allergic rhinitis in Japan. We investigated the effect of an add-on intranasal antihistamine with an intranasal corticosteroid in JCP during the pollen dispersal period. (UMIN000025508) MethodsWe performed a double-blinded, randomized, placebo-controlled trial from March 1 to 14, 2017. Patients (n = 20 per group) received either a mometasone furoate nasal spray (MFNS) plus a levocabastine nasal spray (levocabastine group) or MFNS plus a placebo nasal spray (placebo group). The primary endpoint was the difference in the total nasal symptom score (TNSS) after treatment between the two groups. Differences in the total ocular symptom score, total symptom score, total medication score, total symptom-medication score, and five individual symptoms as well as safety were the secondary endpoints. ResultsThe change in the TNSS from baseline was significantly greater in the levocabastine group than in the placebo group. A significant reduction in the TNSS was observed more than 6 days earlier in the levocabastine group than in the placebo group. Such add-on effects were also seen in the secondary endpoints. Both treatments were well-tolerated. ConclusionThe intranasal antihistamine provided better control of not only nasal symptoms, but also of ocular symptoms, and decreased the need for rescue medications when added to intranasal corticosteroid treatment in JCP patients.

Prophylactic antiemetics for adults receiving intravenous opioids in the acute care setting.

Physicians often prescribe opioids for pain in the acute care setting. Nausea and vomiting are well-described adverse events, occurring in over one-third of patients. Prophylactic antiemetics may be one option to reduce opioid-associated nausea and vomiting. However, these medications also have their own adverse effects, so it is important to understand their efficacy and safety prior to routine use. This is a review of randomized controlled trials comparing prophylactic antiemetics versus placebo or standard care for preventing opioid-associated nausea and vomiting. To assess the effects of prophylactic antiemetics for nausea and vomiting in adults (aged 16 years or older) receiving intravenous opioids in the acute care setting. We searched CENTRAL (the Cochrane Library), MEDLINE (OVID), Embase (OVID) from inception to January 2022, and Google Scholar (17 January 2022). We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and screened reference lists. We included randomized controlled trials of prophylactic antiemetics versus placebo or standard care in adults prior to receiving an intravenous opioid. Two review authors (MG, JNC) independently determined the eligibility of each study according to the inclusion criteria. Two review authors (MG, GDP) then independently extracted data, assessed risk of bias, and determined the certainty of evidence using GRADE. Our primary outcomes were the occurrence of nausea, vomiting, and adverse events. Secondary outcomes included nausea severity, number of vomiting episodes, and number of participants requiring antiemetic rescue therapy. We presented outcomes as risk ratios (RR) for dichotomous data (e.g. presence of vomiting, presence of nausea, number of participants requiring rescue medication, adverse events) and mean difference (MD) or standardized mean difference for continuous data (e.g. number of vomiting episodes, nausea severity) with 95% confidence intervals (CI). We included three studies involving 527 participants (187 women and 340 men) with a mean age of 42 years. All studies used intravenous metoclopramide (10 mg) as the intervention and a placebo for the comparator. No studies assessed any other antiemetic or compared the intervention to standard care. Compared to placebo, metoclopramide did not reduce vomiting (RR 1.18, 95% CI 0.26 to 5.32; low-certainty evidence) or nausea (RR 0.55; 95% CI 0.15 to 2.03; low-certainty evidence) and there was no difference in adverse events (RR 2.34, 95% CI 0.47 to 11.61; low-certainty evidence). No data were available regarding the number of vomiting episodes. Metoclopramide did reduce the severity of nausea compared with placebo (MD -0.49, 95% CI -0.75 to -0.23; low-certainty evidence) but did not reduce the need for rescue medication (RR 1.86, 95% CI 0.17 to 20.16; low-certainty evidence). Two studies were at unclear risk of bias for random sequence generation, one for blinding of outcome assessors, one for incomplete outcome data, and two for selective reporting. The studies were at low risk of bias for all remaining components. There was no evidence that prophylactic metoclopramide affected the risk of vomiting, nausea, or the need for rescue medication when provided prior to intravenous opioids in the acute care setting. There was a clinically insignificant difference in nausea severity when comparing prophylactic metoclopramide with placebo.Overall, the evidence was of low certainty. Future research could better delineate the effects of prophylactic antiemetics on specific populations, and new studies are needed to evaluate the use of other prophylactic antiemetic agents, for which there were no data.

Comparative Study Between Fosaprepitant and Palonosetron in the Prophylaxis of Postoperative Nausea and Vomiting in Women Undergoing Laparoscopic Cholecystectomy: Prospective, Randomized and Double-Blind Study.

Objective: To test the hypothesis that the single use of fosaprepitant is not inferior to the use of palonosetron as antiemetic prophylaxis in the first 48 h after surgery in women undergoing laparoscopic cholecystectomy. Method: Eighty-eight nonsmoking women (American Society of Anesthesiologists physical status I or II) aged between 18 and 60 years who underwent laparoscopic cholecystectomy received 150 mg of fosaprepitant or 75 μg of palonosetron, administered intravenously after the induction of general anesthesia. Results: In the fosaprepitant group and in the palonosetron group, 13.6 and 18.2% of the patients, respectively, vomited in the first 48 h after surgery (p = 0.560). There were no differences between groups in the total frequency and intensity of nausea, number of complete responders, need for rescue medication, time required for the first rescue medication dose or number of adverse events. Conclusion: The administration of a single dose of fosaprepitant after the induction of anesthesia was as effective as the administration of a single dose of palonosetron for the prophylaxis of vomiting in the first 48 h after surgery in women undergoing laparoscopic cholecystectomy.

Evaluation of a single-shot of a high-density viscoelastic solution of hyaluronic acid in patients with symptomatic primary knee osteoarthritis: the no-dolor study

BackgroundPronolis®HD mono 2.5% is a novel, one-shot, high-density sterile viscoelastic solution, recently available in Spain, which contains a high amount of intermediate molecular weight hyaluronic acid (HA), highly concentrated (120 mg in 4.8 mL solution: 2.5%). The objective of the study was to analyze the efficacy and safety of this treatment in symptomatic primary knee osteoarthritis (OA).MethodsThis observational, prospective, multicenter, single-cohort study involved 166 patients with knee OA treated with a single-shot of Pronolis®HD mono 2.5% and followed up as many as 24 weeks.ResultsCompared with baseline, the score of the Western Ontario and McMaster Universities Arthritis Osteoarthritis Index (WOMAC) pain subscale reduced at the 12-week visit (primary endpoint, median: 9 interquartile range [IQR]: 7–11 versus median: 4; IQR: 2–6; p < 0.001). The percentage of patients achieving > 50% improvement in the pain subscale increased progressively from 37.9% (at 2 weeks) to 66.0% (at 24 weeks). Similarly, WOMAC scores for pain on walking, stiffness subscale, and functional capacity subscale showed significant reductions at the 12-week visit which were maintained up to the 24-week visit. The EuroQol visual analog scale score increased after 12 weeks (median: 60 versus 70). The need for rescue medication (analgesics/nonsteroidal anti-inflammatory drugs) also decreased in all post-injection visits. Three patients (1.6%) reported local adverse events (joint swelling) of mild intensity.ConclusionsIn conclusion, a single intra-articular injection of the high-density viscoelastic gel of HA was associated with pain reduction and relief of other symptoms in patients with knee OA.Trial registrationClinicalTrial# NCT04196764

Efficacy of ketorolac in the treatment of acute migraine attack: A systematic review and meta-analysis.

This review was designated to evaluate the efficacy of parenteral ketorolac in treating acute migraine headache. We searched databases Cochrane Central Register of Controlled Trials (CENTRAL), Medline, and Google Scholar up to January 2021 and identified randomized controlled trials comparing ketorolac to any other medications in treating patients presenting with migraine headache. Thirteen trials were included in our review, comprising 944 participants. We derived seven comparisons: ketorolac versus phenothiazines, metoclopramide, sumatriptan, dexamethasone, sodium valproate, caffeine, and diclofenac. There were no significant differences in the reduction of pain intensity at 1h under the comparisons between ketorolac and phenothiazines (standard mean difference [SMD]= 0.09, p= 0.74) or metoclopramide (SMD= 0.02, p= 0.95). We also found no difference in the outcome recurrence of headache (ketorolac vs. phenothiazines (risk ratio [RR]=0.98, p= 0.97)], ability to return to work or usual activity (ketorolac vs. metoclopramide [RR= 0.64, p= 0.13]), need for rescue medication (ketorolac vs. phenothiazines [RR= 1.72, p= 0.27], ketorolac vs. metoclopramide [RR 2.20, p= 0.18]), and frequency of adverse effects (ketorolac vs. metoclopramide [RR= 1.07, p= 0.82]). Limited trials suggested that ketorolac offered better pain relief at 1h compared to sumatriptan and dexamethasone; had lesser frequency of adverse effects than phenothiazines; and was superior to sodium valproate in terms of reduction of pain intensity at 1h, need for rescue medication, and sustained headache freedom within 24h. Ketorolac may have similar efficacy to phenothiazines and metoclopramide in treating acute migraine headache. Ketorolac may also offer better pain control than sumatriptan, dexamethasone, and sodium valproate. However, given the lack of evidence due to inadequate number of trials available, future studies are warranted.

Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial

Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of mesalamine with corticosteroids during hospitalization is superior to corticosteroids alone is unknown. This was a randomized controlled, investigator-blinded, clinical trial conducted in 10 centers in 7 countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid+ mesalamine (4 g/day mesalamine) by a stratified randomization according to mesalamine use before admission. The primary outcome was the percentage of patients who responded to treatment by day 7, defined by a drop >3 points in the Lichtiger score and an absolute score <10 without the need for rescue medications or colectomy. Three hundred forty-six patients were screened, and 149 were included (70/149 female; median age, 41 years). Of these, 73 received corticosteroids+ mesalamine, and 76 received corticosteroids alone. For the primary outcome, 53 of 73 patients (72.6%) receiving corticosteroids with mesalamine responded versus 58 of 76 patients (76.3%) on corticosteroids alone (odds ratio, 0.82; 95% confidence interval, 0.39-1.72; P= .60). There was no difference between groups in duration of hospitalization, C-reactive protein normalization rate, or colectomy rate up to day 90. The need for biologics among patients receiving combination of corticosteroids with mesalamine was numerically lower by day 30 (P= .11) and day 90 (P= .07). In this randomized controlled trial, combination of mesalamine with corticosteroids did not benefit hospitalized patients with ASUC more than corticosteroids alone. An exploratory signal for a reduced need for biologics at 90 days in the mesalamine group merits further evaluation. gov ID: NCT01941589.

Efficacy of Remimazolam for Procedural Sedation in American Society of Anesthesiologists (ASA) I to IV Patients Undergoing Colonoscopy: A Systematic Review and Meta-Analysis.

Remimazolam is made by combining midazolam and remifentanil as an alternative to conventional sedatives. To evaluate the efficacy of remimazolam for sedation in patients undergoing colonoscopy, we conducted a systematic review and meta-analysis of the available randomized controlled trials (RCTs) comparing remimazolam and midazolam. A search was conducted using PubMed, Cochrane Library, and clinicaltrial.gov from inception till December 26, 2021, for RCTs that investigated the efficacy of remimazolam during the above-mentioned procedure. There was no restriction of language. A quality assessment was performed using the Cochrane Risk-of-Bias tool. The data were pooled, and a meta-analysis was completed. The systemic review was conducted in accordance with the Preferred Reporting Items for Systemic Reviews and Meta-Analysis (PRISMA) guideline statement. Three randomized controlled trials involving 539 patients were included in the meta-analysis. Compared with midazolam during colonoscopy, remimazolam results in reduced need for top-up doses (RR= 3.45, 95% CI=1.07 to 11.14; P=0.04, I2=84%). The need for rescue medication was reduced with remimazolam as compared to midazolam (RR=2.42, 95%CI=1.04 to 5.61; P=0.04, I2=96%). There was no significant difference observed between the two drugs on completion of colonoscopy and the overall procedural sedation, but the sensitivity analysis favored remimazolam over midazolam for procedural sedation (RR=4.08, 95%CI=2.35 to 7.09; P<0.00001, I2=39%). This analysis demonstrates the advantages of remimazolam over other agents and sets a platform for relevant future studies.

CORTICOSTEROIDS AND 5ASA VERSUS CORTICOSTEROIDS ALONE FOR ACUTE SEVERE ULCERATIVE COLITIS: A RANDOMIZED CONTROLLED TRIAL

Abstract BACKGROUND Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of 5-aminosalicylates (5ASA) with corticosteroids during hospitalization is superior to corticosteroids alone is unknown METHODS This was a randomized controlled investigator-blinded clinical trial conducted in ten centers in six countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid+5ASA (4gr/day mesalamine) by a stratified randomization according to 5ASA use prior to admission. The primary outcome was the percentage of patients who responded to treatment by day 7, defined by a drop&amp;gt;3 points in the Lichtiger score and an absolute score&amp;lt;10 without the need for rescue medications or colectomy. RESULTS 346 patients were screened and 149 were included (70/149 females, median age 41). Of these, 73 received corticosteriods+5ASA and 76 corticosteroids alone. For the primary outcome, 53/73 (72.6%) of patients receiving corticosteroids with 5ASA responded versus 58/76 (76.3%) of patients on corticosteroids alone (OR 0.82 95%CI 0.39-1.72, p=0.60). There was no difference between groups in duration of hospitalization or CRP normalization rate. Colectomy rate up to day 90 was similar, but the need for biologics among patients receiving combination corticosteroids with 5ASA was numerically lower by day 30 (p=0.11) and day 90 (p=0.07). CONCLUSION In this randomized controlled trial, combination 5ASA with corticosteroids did not benefit hospitalized patients with ASUC more than corticosteroids alone. An exploratory finding of a reduced need for biologics at 90 days in the combination group merits further evaluation.

P312 Combination corticosteroids with, 5-aminosalicylic acid versus corticosteroids alone in the treatment of hospitalized patients with acute severe ulcerative colitis: A multi-center randomized controlled trial

Abstract Background Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of, 5-aminosalicylates (5ASA) with corticosteroids during hospitalization is superior to corticosteroids alone is unknown Methods This was a randomized controlled investigator-blinded clinical trial conducted in ten centers in six countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid+5ASA (4gr/day mesalamine) by a stratified randomization according to, 5ASA use prior to admission. The primary outcome was the percentage of patients who responded to treatment by day, 7, defined by a drop&amp;gt;3 points in the Lichtiger score and an absolute score&amp;lt;10 without the need for rescue medications or colectomy. Results 346 patients were screened and, 149 were included (70/149 females, median age, 41). Of these, 73 received corticosteriods+5ASA and, 76 corticosteroids alone. For the primary outcome, 53/73 (72.6%) of patients receiving corticosteroids with, 5ASA responded versus, 58/76 (76.3%) of patients on corticosteroids alone (OR, 0.82, 95%CI, 0.39–1.72, p=0.60). There was no difference between groups in duration of hospitalization or CRP normalization rate. Colectomy rate up to day, 90 was similar, but in an exploratory analysis the need for biologics among patients receiving combination corticosteroids with, 5ASA was numerically lower by day, 30 (p=0.11) and day, 90 (p=0.07). Conclusion In this prospective randomized controlled trial, combination, 5ASA with corticosteroids during hospitalization did not benefit patients admitted with ASUC more than corticosteroids alone. An exploratory finding of a reduced need for biologics at, 90 days in the combination group merits further evaluation. ClinicalTrials.gov ID: NCT01941589

Comparing the Effect of Ondansetron-dexamethasone and Metoclopramide-dexamethasone on Postoperative Nausea and Vomiting after Gynecological Laparoscopy: A Randomized Double-blind Clinical Trial.

Background:Nausea and vomiting is a common complication after gynecological surgeries, especially laparoscopy, which can lead to discomfort and restlessness in the patients. The aim of the study was to compare the effect of ondansetron–dexamethasone and metoclopramide–dexamethasone on postoperative nausea and vomiting following gynecological laparoscopy.Materials and Methods:In this double-blind clinical trial, 68 females scheduled for gynecological laparoscopy and age range of 18–40 years were randomly divided into two groups. Group OD received ondansetron 4 mg plus dexamethasone 8 mg and group MD received metoclopramide 10 mg plus dexamethasone 8 mg, 15 min before the end of surgery. The incidence of nausea and vomiting and need for rescue medication was assessed during the recovery period, as well as at 2, 4, 6, 12, and 24 h after surgery. The data were analyzed using STATA software version 12 and a significance level of <0.05 was considered in this research.Results:The incidence of nausea in ondansetron and metoclopramide groups was 23.3% and 33.3%, respectively, and the frequency of vomiting was 10% and 16.6%, respectively, which showed no significant difference (P > 0.05). The highest incidence of nausea and vomiting in patients belonged to the metoclopramide group inside 4–6 h after surgery.Conclusion:Our study showed that no significant difference was observed in the incidence of nausea and vomiting between ondansetron–dexamethasone and metoclopramide–dexamethasone groups following laparoscopic gynecological surgery; however, the number of patients with nausea and vomiting was lower in the ondansetron–dexamethasone group.

Switch from Omalizumab to Benralizumab in Allergic Patients with Severe Eosinophilic Asthma: A Real-Life Experience from Southern Italy.

Background. The wide availability of monoclonal antibodies for the add-on therapy of severe asthma currently allows for the personalization of biologic treatment by selecting the most appropriate drug for each patient. However, subjects with overlapping allergic and eosinophilic phenotypes can be often eligible to more than one biologic, so that the first pharmacologic choice can be quite challenging for clinicians. Within such a context, the aim of our real-life investigation was to verify whether allergic patients with severe eosinophilic asthma, not adequately controlled by an initial biologic treatment with omalizumab, could experience better therapeutic results from a pharmacologic shift to benralizumab. Patients and methods. Twenty allergic patients with severe eosinophilic asthma, unsuccessfully treated with omalizumab and then switched to benralizumab, were assessed for at least 1 year in order to detect eventual changes in disease exacerbations, symptom control, oral corticosteroid intake, lung function, and blood eosinophils. Results. In comparison to the previous omalizumab therapy, after 1 year of treatment with benralizumab our patients experienced significant improvements in asthma exacerbation rate (p < 0.01), rescue medication need (p < 0.001), asthma control test (ACT) score (p < 0.05), forced expiratory volume in the first second (FEV1) (p < 0.05), and blood eosinophil count (p < 0.0001). Furthermore, with respect to the end of omalizumab treatment, the score of sino-nasal outcome test-22 (SNOT-22) significantly decreased after therapy with benralizumab (p < 0.05). Conclusion. The results of this real-life study suggest that the pharmacologic shift from omalizumab to benralizumab can be a valuable therapeutic approach for allergic patients with severe eosinophilic asthma, not adequately controlled by anti-IgE treatment.

Macrolides versus placebo for chronic asthma.

Macrolides versus placebo for chronic asthma.

Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study.

A significant proportion of triptan users exhibit an insufficient response or inadequate tolerability to a triptan, and some may develop a contraindication. Lasmiditan, a selective 5-HT1F receptor agonist, may be an option for these individuals. We assessed lasmiditan efficacy in a subgroup of patients in CENTURION (Phase 3 migraine consistency study) who exhibited an insufficient response to triptans, including a subgroup with insufficient response due to efficacy only. Patients were randomized to lasmiditan 200 mg for four attacks, lasmiditan 100 mg for four attacks, or placebo for three and lasmiditan 50 mg for one attack. Triptan insufficient responders were pre-defined as patients with insufficient efficacy or tolerability, or who developed a contraindication. In triptan insufficient responders, lasmiditan was superior to placebo (p < 0.05) for pain freedom beginning at 1 h (both doses); pain relief beginning at 0.5 (200 mg) or 1 h (100 mg); migraine-related disability freedom, much/very much better on the Patient Global Impression of Change, and most bothersome symptom freedom at 2 h; sustained pain freedom; and need for rescue medication. Lasmiditan showed benefit for consistency of effect across attacks for 2-h pain freedom and pain relief. Findings were similar in triptan responders and triptan naïve patients and when the triptan insufficient response definition was based on efficacy only. Lasmiditan was efficacious across multiple clinically relevant endpoints in the acute treatment of migraine independent of prior response to triptans.Trial Registration: CENTURION (NCT03670810); SAMURAI (NCT02439320); SPARTAN (NCT02605174).