Romiplostim for Primary Immune Thrombocytopenia in Routine Clinical Practice: Results from a Multicentre Observational Study in Germany.

INTRODUCTION: The effectiveness and safety of romiplostim were evaluated by immune thrombocytopenia (ITP) phase (newly diagnosed/persistent/chronic) at romiplostim initiation. METHODS: This is a post hoc analysis of a prospective, German, multicentre, observational study in adults with ITP who received ≥1 dose of romiplostim. Follow-up data were collected for ≤2 years. Outcomes included overall platelet response (≥1 platelet count ≥50 × 109/L at 2-24 weeks after romiplostim initiation) or durable platelet response (≥75% of measurements ≥50 × 109/L at 14-24 weeks) and adverse drug reactions (ADRs), evaluated by ITP phase. RESULTS: Data from 96 patients were analysed (newly diagnosed, n = 18; persistent, n = 25; chronic, n = 53). During the 2- to 24-week follow-up, overall platelet response was achieved in 100% (95% confidence interval: 81.5-100), 100% (86.3-100), and 96.2% (87.0-99.5) of patients with newly diagnosed, persistent, or chronic ITP, respectively, and platelet responses were durable in 88.2% (63.6-98.5), 65.0% (40.8-84.6), and 69.4% (54.6-81.7) of patients. During the 2-year follow-up, ADRs occurred in 24.0-35.8% of patients across phases. Two patients with chronic ITP experienced bone marrow ADRs; no thrombotic ADRs occurred. CONCLUSION: Romiplostim was effective and well tolerated in patients with newly diagnosed, persistent, or chronic ITP in routine clinical practice.

Treatment patterns in adults with immune thrombocytopenia before, during and after use of thrombopoietin receptor agonists: a longitudinal prescription database study from Germany.

OBJECTIVE: To assess real-world treatment patterns in patients with immune thrombocytopenia (ITP) who received thrombopoietin receptor agonists (TPO-RAs) in Germany. METHODS: This was a longitudinal, retrospective study using anonymized patient-level data (IQVIA healthcare prescription database, covering 82% of German statutory prescriptions). Eligible patients (aged ≥18 years) had received ≥1 TPO-RA prescription (romiplostim/eltrombopag) from July 2016 to June 2019 (treatment duration ≥30 days). ITP medication use was assessed for 18 months prior to, during and for ≥6 months after TPO-RA treatment. RESULTS: A total of 3553 patients (median age 64 years) were included. Median persistence on TPO-RAs was 12 months (range 1-34). In the periods before, during and after TPO-RA treatment, oral corticosteroids were the most commonly used therapy (64.4%, 43.4% and 36.1% of patients, respectively); median cumulative doses across each period were 2521.9, 2000.0 and 2277.8 mg. The median total duration of corticosteroid use before, during and after TPO-RA therapy was 15, 18 and 32 weeks, respectively. The total median cumulative corticosteroid dose was 6799.7 mg. CONCLUSION: We identified a potential overuse of corticosteroids in patients with ITP in Germany. Earlier use of TPO-RA therapy after a short course of corticosteroids could avoid side effects associated with long-term use.

Unusual Primary Ocular Manifestation of Sarcoidosis.

A 23-year-old male patient presented with very mild visual disturbances, but a distinct prominence of the optic discs, more pronounced in the right than in the left eye. The ophthalmic symptoms initially seemed trivial, but a large-scale interdisciplinary workup later identified them as the presenting symptoms of sarcoidosis affecting lung and eyes. A standard steroid monotherapy successfully caused regression of the ophthalmic findings.

Clinical Efficacy of Simulated Vitreoretinal Surgery to Prepare Surgeons for the Upcoming Intervention in the Operating Room.

PURPOSE: To evaluate the efficacy of the virtual reality training simulator Eyesi to prepare surgeons for performing pars plana vitrectomies and its potential to predict the surgeons' performance. METHODS: In a preparation phase, four participating vitreoretinal surgeons performed repeated simulator training with predefined tasks. If a surgeon was assigned to perform a vitrectomy for the management of complex retinal detachment after a surgical break of at least 60 hours it was randomly decided whether a warmup training on the simulator was required (n = 9) or not (n = 12). Performance at the simulator was measured using the built-in scoring metrics. The surgical performance was determined by two blinded observers who analyzed the video-recorded interventions. One of them repeated the analysis to check for intra-observer consistency. The surgical performance of the interventions with and without simulator training was compared. In addition, for the surgeries with simulator training, the simulator performance was compared to the performance in the operating room. RESULTS: Comparing each surgeon's performance with and without warmup trainingshowed a significant effect of warmup training onto the final outcome in the operating room. For the surgeries that were preceeded by the warmup procedure, the performance at the simulator was compared with the operating room performance. We found that there is a significant relation. The governing factor of low scores in the simulator were iatrogenic retinal holes, bleedings and lens damage. Surgeons who caused minor damage in the simulation also performed well in the operating room. CONCLUSIONS: Despite the large variation of conditions, the effect of a warmup training as well as a relation between the performance at the simulator and in the operating room was found with statistical significance. Simulator training is able to serve as a warmup to increase the average performance.

Fast-track cardiac anesthesia: efficacy and safety of remifentanil versus sufentanil.

OBJECTIVE: The purpose of this study was to compare the safety and efficacy of fast-track cardiac anesthesia with remifentanil (group R) versus sufentanil (group S). DESIGN: Prospective, single-blinded, randomized study. SETTING: University hospital. PARTICIPANTS: One hundred twenty patients undergoing coronary artery bypass graft surgery and/or cardiac valve surgery. INTERVENTIONS: After routine standardized anesthesia induction, anesthesia was maintained with isoflurane (0.4-0.8 vol%) together with either remifentanil (group R) (1 microg/kg/min) or sufentanil (group S) (1 microg/kg for induction, 0.5 microg/kg for skin incision, and then 0.02 microg/kg/min). After surgery, which included cardiopulmonary bypass in all cases, postoperative sedation was achieved in both groups with propofol until the patient was deemed ready for extubation. Additionally, patients in group R received remifentanil, 0.25 microg/kg/min. MEASUREMENTS AND MAIN RESULTS: Recovery profile in group R patients was faster (p < 0.05), with a median time interval between end of surgery and eligibility for extubation of 295 minutes versus 375 minutes. Time from end of surgery to being eligible for discharge from intensive care unit was similar in both groups, with 22.9 hours in group R versus 26.3 hour in group S. Remifentanil provided a better protection against intraoperative stimuli at skin incision and maximal sternal spread (p < 0.05). The incidence of adverse events was comparable in both groups. Postoperative pain scores during the first hour of weaning were higher in group R (p < 0.05). CONCLUSIONS: Remifentanil for fast-track cardiac anesthesia provided safe and stable operating conditions and facilitated earlier tracheal extubation. However, postoperative pain management should be planned carefully.

Sedation in the intensive care unit with remifentanil/propofol versus midazolam/fentanyl: a randomised, open-label, pharmacoeconomic trial.

INTRODUCTION: Remifentanil is an opioid with a unique pharmacokinetic profile. Its organ-independent elimination and short context-sensitive half time of 3 to 4 minutes lead to a highly predictable offset of action. We tested the hypothesis that with an analgesia-based sedation regimen with remifentanil and propofol, patients after cardiac surgery reach predefined criteria for discharge from the intensive care unit (ICU) sooner, resulting in shorter duration of time spent in the ICU, compared to a conventional regimen consisting of midazolam and fentanyl. In addition, the two regimens were compared regarding their costs. METHODS: In this prospective, open-label, randomised, single-centre study, a total of 80 patients (18 to 75 years old), who had undergone cardiac surgery, were postoperatively assigned to one of two treatment regimens for sedation in the ICU for 12 to 72 hours. Patients in the remifentanil/propofol group received remifentanil (6- max. 60 microg kg(-1) h(-1); dose exceeds recommended labelling). Propofol (0.5 to 4.0 mg kg(-1) h(-1)) was supplemented only in the case of insufficient sedation at maximal remifentanil dose. Patients in the midazolam/fentanyl group received midazolam (0.02 to 0.2 mg kg(-1) h(-1)) and fentanyl (1.0 to 7.0 microg kg(-1) h(-1)). For treatment of pain after extubation, both groups received morphine and/or non-opioid analgesics. RESULTS: The time intervals (mean values +/- standard deviation) from arrival at the ICU until extubation (20.7 +/- 5.2 hours versus 24.2 h +/- 7.0 hours) and from arrival until eligible discharge from the ICU (46.1 +/- 22.0 hours versus 62.4 +/- 27.2 hours) were significantly (p < 0.05) shorter in the remifentanil/propofol group. Overall costs of the ICU stay per patient were equal (approximately euro1,700 on average). CONCLUSION: Compared with midazolam/fentanyl, a remifentanil-based regimen for analgesia and sedation supplemented with propofol significantly reduced the time on mechanical ventilation and allowed earlier discharge from the ICU, at equal overall costs.