Tetracosactide 250micrograms/1ml solution for injection ampoules

Abstract Objectives Rotator cuff tendinitis (RCT) is a tendon inflammation often following subacromial impingement syndrome. One of the non-surgical management modalities for RCT is subacromial injection of corticosteroids. Some studies have claimed a correlation between ACTH (Adrenocorticotropic Hormone) deficiency and rotator cuff lesions; hence, intramuscular ACTH analogue injection has been recommended as an option. This research aimed to compare the effectiveness of these two treatment methods. Methods We conducted a study with 86 patients suffering from RCT. The patients were randomly divided into two groups of 43; one group received a subacromial injection of 40 mg of triamcinolone acetonide, while the other group received 1 mg of intramuscular tetracosactide injection. We recorded the Constant–Murley (CM) and visual analogue scale (VAS) scores for each patient before and 4 weeks after injections to measure pain acuity and joint functionality. Later, we compared and analysed the two scores in each group. Results Based on the statistical analysis, the mean ages of the participants in the triamcinolone and tetracosactide groups were 53.21 ± 11.37 and 54.56 ± 11.98, respectively. Both groups demonstrated an improvement in VAS for pain and CM scores (P < 0.05). However, the VAS for pain score decreased, and the CM score increased more significantly in the triamcinolone group than in the tetracosactide group (P < 0.05). Conclusion Although both treatment methods exhibit promise for pain relief, subacromial injection of triamcinolone appears more efficacious than intramuscular injection of tetracosactide in patients with RCT, based on a 4-week follow-up. Trial registration Iranian Registry of Clinical Trials, https://irct.behdasht.gov.ir, IRCT20240110060673N1.

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Abstract Background Undifferentiated shock is recognized as a criticality state that is transitional in immune-mediated topology for casual risk of lethal microcirculatory dysfunction. This was a sensitivity analysis of a drug (tetracosactide; TCS10) targeting melanocortin receptors (MCRs) in a phase 3 randomized controlled trial to improve cardiovascular surgical rescue outcome by reversing mortality and hemostatic disorders. Methods Sensitivity analysis was based on a randomized, two-arm, multicenter, double-blind, controlled trial. The Naïve Bayes classifier was performed by density-based sensitivity index for principal strata as proportional hazard model of 30-day surgical risk mortality according to European System for Cardiac Operative Risk Evaluation inputs-outputs in 100 consecutive cases (from August to September 2013 from Emilia Romagna region, Italy). Patients included an agent-based TCS10 group (10 mg, single intravenous bolus before surgery; n = 56) and control group (n = 44) and the association with cytokines, lactate, and bleeding-blood transfusion episodes with the prior-risk log-odds for mortality rate in time-to-event was analyzed. Results Thirty-day mortality was significantly improved in the TCS10 group vs. control group (0 vs. 8 deaths, P < 0.0001). Baseline levels of interleukin (IL)-6, IL-10, and lactate were associated with bleeding episodes, independent of TCS10 treatment [odds ratio (OR) = 1.90, 95% confidence interval (CI) 1.39–2.79; OR = 1.53, 95%CI 1.17–2.12; and OR = 2.92, 95%CI 1.40–6.66, respectively], while baseline level of Fms-like tyrosine kinase 3 ligand (Flt3L) was associated with lower bleeding rates in TCS10-treated patients (OR = 0.31, 95%CI 0.11–0.90, P = 0.03). For every 8 TCS10-treated patients, 1 bleeding case was avoided. Blood transfusion episodes were significantly reduced in the TCS10 group compared to the control group (OR = 0.32, 95%CI 0.14–0.73, P = 0.01). For every 4 TCS10-treated patients, 1 transfusion case was avoided. Conclusions Sensitivity index underlines the quality target product profile of TCS10 in the runway of emergency casualty care. To introduce the technology readiness level in real-life critically ill patients, further large-scale studies are required. Trial registration European Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2007-006445-41 ).

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AbstractBackgroundPost-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients’ general activity and increases the length of hospital stays and the use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment for PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence has suggested that adrenocorticotropic hormone (ACTH) is effective in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, for PDPH treatment in patients who receive neuraxial anaesthesia during labour.MethodsThis randomised, double-blind, placebo-controlled, parallel-arm trial, is performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomised to receive either 1 mg of tetracosactide intravenously over 20 min or to 0.9% saline (placebo). The primary endpoint is the rate of epidural blood patch within a 15-day follow-up period. Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration) and number of blood patches per patient in each group are recorded.DiscussionWe expect a decrease in the use of epidural blood patch in those receiving tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a non-invasive alternative to blood patch for PDPH treatment.Trial registrationPrimary Registry ClinicalTrials.gov Protocol Registration and Results SystemDate of Registration 24 June 2016Unique Protocol ID 69HCL15_0429 Secondary IDs EudraCT Number 2015–003357-17ClinicalTrials.gov ID NCT02813655ANSM 160214A-31 Protocol version V4 28/09/2018

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Background: The effect of etomidate administration on the adrenal cortex in obese patients is still unclear. The objective of the study was to determine the influence of a single dose of etomidate on cortisol secretion in the morbidly obese. Methods: 127 healthy patients were enrolled into the study. Data from 82 patients scheduled for elective laparoscopic surgery were analyzed. 62 of them were morbidly obese, while 20 had normal body mass. The participants were divided equally into etomidate and thiopental groups, depending on the kind of intravenous anaesthetic used for the induction of anaesthesia. Each patient’s serum cortisol concentration was measured five times: on the day before surgery (sample A), two hours after the induction of anaesthesia (sample B), after a short tetracosactide test (sample C), 24 hours after the induction of anaesthesia (sample D), and after a second short stimulation test (sample E). Results: The mean cortisol concentration in obese patients in the etomidate group was lower two hours after the induction of anaesthesia (sample B, P < 0.001), and 30 minutes after the first tetracosactide test (sample C, P < 0.001) compared to obese patients in the thiopental group. There were no differences between the groups in sample A (P = 0.833), D (P = 0.614) and E (P = 0.769). We found no changes in haemodynamic parameters between both groups. Conclusions: Etomidate decreased serum cortisol concentration and decreased reactivity to tetracosactide both in morbidly obese and in normal weight patients. This effect was reversible within 24 hours.Background: The effect of etomidate administration on the adrenal cortex in obese patients is still unclear. The objective of the study was to determine the influence of a single dose of etomidate on cortisol secretion in the morbidly obese. Methods: 127 healthy patients were enrolled into the study. Data from 82 patients scheduled for elective laparoscopic surgery were analyzed. 62 of them were morbidly obese, while 20 had normal body mass. The participants were divided equally into etomidate and thiopental groups, depending on the kind of intravenous anaesthetic used for the induction of anaesthesia. Each patient’s serum cortisol concentration was measured five times: on the day before surgery (sample A), two hours after the induction of anaesthesia (sample B), after a short tetracosactide test (sample C), 24 hours after the induction of anaesthesia (sample D), and after a second short stimulation test (sample E). Results: The mean cortisol concentration in obese patients in the etomidate group was lower two hours after the induction of anaesthesia (sample B, P < 0.001), and 30 minutes after the first tetracosactide test (sample C, P < 0.001) compared to obese patients in the thiopental group. There were no differences between the groups in sample A (P = 0.833), D (P = 0.614) and E (P = 0.769). We found no changes in haemodynamic parameters between both groups. Conclusions: Etomidate decreased serum cortisol concentration and decreased reactivity to tetracosactide both in morbidly obese and in normal weight patients. This effect was reversible within 24 hours

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