Budesonide orodispersible tablets maintain remission in a randomized, placebo-controlled trial of patients with eosinophilic esophagitis

Background & Aims: Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear whether these drugs are effective for long-term maintenance of remission. Methods: We performed a double-blind trial to compare the efficacy and safety of 2 dosages of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histologic relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks. Results: At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. Conclusions: In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029

Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial.

BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE. METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-blind phase were offered 6 weeks of open-label treatment with BOT (1 mg twice daily). RESULTS: At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary end point of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent. CONCLUSIONS: In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99; ClinicalTrials.gov ID NCT02434029

Comparison of short-stem with conventional-stem prostheses in total hip arthroplasty: an 8-year follow-up study

Purpose!#!Coxarthrosis is a common disease of the adult hip joint. Elderly patients have mainly been treated with total hip arthroplasty (THA); however, younger patients are increasingly affected. Short-stem prostheses were developed for this special patient group. There have been few studies on the clinical outcomes of this type of prosthesis. This study compared the mid-term results of a short-stem prosthesis and a standard-stem prosthesis 8 years after implantation.!##!Methods!#!According to our clinical registry, patients who received a short-stem prosthesis before 2011 were identified. Patients in the standard-stem prosthesis group were matched based on the sex, age, height, weight, and degree of arthrosis. At the follow-up time, the modified Harris Hip Score (mHHS), University of California Los Angeles (UCLA) activity score and visual analog scale (VAS) pain score were collected and compared with the preoperative values.!##!Results!#!Fifty-five patients could be matched and analyzed for both groups. No patients needed revision surgery. In both groups, there were significant improvements at the follow-up time. The pre- and postoperative mHHSs, UCLA scores, and VAS scores were 41.9 and 95 (p &amp;lt; 0.0001), 3.75 and 7.9 (p &amp;lt; 0.0001), and 7.6 and 0.9 (p &amp;lt; 0.0001), respectively, in the short-stem group and 44.8 and 96.25 (p &amp;lt; 0.0001), 3.6 and 7.7 (p &amp;lt; 0.0001), and 7.7 and 0.9 (p &amp;lt; 0.0001), respectively, in the control group, with no significant differences between the groups at the follow-up time.!##!Conclusion!#!The short-stem prosthesis provides mid-term results comparable to those of a standard-stem prosthesis. In both groups, excellent patient-reported outcomes were achieved after an average of 8 years.!##!Level of evidence!#!IV

Recreational activity after cementless total hip arthroplasty in patients older than 75 years

Introduction!#!This retrospective study aimed to compare activity levels before and at mid-term follow-up after primary cementless total hip arthroplasty (THA) in patients older than 75 years.!##!Materials and methods!#!A cohort of 79 patients with a mean age at surgery of 78 years (range 76-84 years) was evaluated 6.3 years (range 4-8 years) after cementless THA due to osteoarthritis and was followed up with a questionnaire to determine their activity level. Pre- and post-operative recreational activities were assessed at routine follow-up using the University of California, Los Angeles activity score, and the Schulthess Clinic sports and activity questionnaire. Post-operative health-related quality of life was measured using Veterans Rand 12-item survey (VR-12).!##!Results!#!Six years after THA, 72% of preoperatively active patients had returned to activity. Comparing activity preoperatively (before the onset of symptoms) and 6 years after THA, the number of disciplines and session length has decreased significantly. A significant decline in high-impact activities was observed, while participation in low-impact activities significantly increased.!##!Conclusion!#!The majority of patients maintained a recreational activity level in the mid-term after primary cementless THA. However, a change in disciplines toward low-impact activities was observed

Length doesn’t play a role – Sexual activity in men after short stem Total hip Arthroplasty

Abstract Background Chronic hip pain due to osteoarthritis or hip dysplasia has been shown to negatively affect many daily life aspects. One aspect, however, which persists underestimated is sexual health. The number of total hip arthroplasties (THA) are increasing, especially in young patients who have high functional expectations, not only to pain relief, but to an increase in hip mobility and quality of life as well as sexual activity. Aim (1) to report the demographic factors, (2) the sexual activity before and after THA, as well as the concerns related to sexual activity after THA and (3) the patient-reported outcome measurements (PROMs) in sexually active male patients. Methods We evaluated the results of patients between 18 and 65 years of age following primary cementless short femoral stem THA using a direct anterior approach (DAA) at a midterm follow-up of 4 years. A web-based questionnaire (via SurveyMonkey) was chosen to assess frequency, positions, complaints, fears, dealing with the questions and PROMs. Our patients sexual activity was via The Sexual Health Inventory for Men (SHIM) validated. Results Patients resumed their sexual activities after 6 weeks. The two main causes of difficulty in sexual activity before surgery were pain and limitation of the range of motion of the hip joint. Patients experienced less pain and an improvement in hip range of motion after THA. 89% of patients expressed a desire for more detailed and specific information on the subject. The patients foremost concern about muscle weakness, surgical scar or fear of dislocation. After 4 years follow-up our patients presented a significant improvement of the modified Harris Hip Score (mHHS) from 34.1 preoperative to 92.6 after THA. Conclusion THA improves the quality in sexual life, in relation to less pain and improvement in the range of motion, but not in the frequency of sexual activity. Men’s sexual positions required less mobility and could therefore be considered safer

Pain and rehabilitation after total hip arthroplasty are approach dependent: a multisurgeon, single-center, prospective cohort study

Purpose!#!The aim of this study was to assess perioperative pain and mobilization after total hip arthroplasty (THA) using three different surgical approaches.!##!Methods!#!This was a multisurgeon, prospective, single-center cohort study. A total of 188 patients who underwent hip arthroplasty (THA) between February 2019 and April 2019 were analyzed according to the surgical approach used (direct anterior, lateral, and posterior approach). Outcome parameters were the daily walking distance during the inpatient stay, the pain level according to the visual analog scale (VAS) at rest and motion during the inpatient stay and at 6-week follow-up and the modified Harris Hips Score (mHHS) preoperatively and at 6 weeks.!##!Results!#!The walking distance within the groups increased significantly during the inpatient stay (p &amp;lt; 0.001). The DAA and posterior approach patients had a significantly longer walking distance than the lateral approach patients on the third postoperative day (DAA vs. lateral, p = 0.02; posterior vs. lateral 3, p = 0.03). DAA and posterior approach patients reported significantly less pain during motion on the third postoperative day and at 6-week follow-up than the lateral approach patients (3 postoperative day: DAA vs. lateral, p = 0.011; posterior vs. lateral, p = 0.04; 6 weeks control: DAA vs. lateral, p = 0.001; Posterior vs. lateral 3, p = 0.005). The mHHS demonstrated significant improvement within each group. However, lateral approach patients reported significantly less improvement than the DAA and posterior approach patients (DAA vs. lateral, p = 0.007; posterior vs. lateral, p = 0.021).!##!Conclusion!#!This study analyzed perioperative pain progression and short-term rehabilitation after THA according to the different surgical approaches. Direct anterior and posterior approaches have shown comparable improvements in pain, walking distance, and mHHS. Whether this effect persists over a longer period of time must be clarified in future studies.!##!Study design!#!Prospective cohort study, level of evidence, 2