Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECiSE 3 study.

BACKGROUND: The efficacy and safety of certolizumab pegol (CZP) in moderate-to-severe Crohn's disease were demonstrated in two 26-week double-blind studies (PRECiSE 1 & 2). AIM: To report the safety and efficacy outcomes of long-term, CZP therapy from PRECiSE 3, in which patients received treatment up to 7 years treatment. METHODS: Patients completing PRECiSE 1 or 2 were eligible to enter PRECiSE 3 in which they received CZP 400 mg, open-label, every 4 weeks (without additional induction therapy) for up to 7 years, for up to 91 doses from study start. Safety (adverse events, including infections and malignancies) and efficacy (Harvey-Bradshaw Index, faecal calprotectin, C-reactive protein) were prospectively monitored. Remission was analysed using observed cases, last observation carried forward imputation and nonresponder imputation. RESULTS: A total of 595 patients entered the study; 117 (20%) completed 7 years. Discontinuation rates were 29.2%, 13.6%, 16.1%, 7.9%, 5.0%, 4.5% and 3.9% (years 1-7 respectively). During 1920 patient-years of exposure to CZP, no new safety signals were observed. Incidence rates (new cases/100 patient-years) for serious infections and malignant neoplasms were 4.37 and 1.06 respectively. No lymphoproliferative malignancies were reported. Clinical remission rates were ≥68% at each year (observed cases); rates by last observation carried forward and nonresponder imputation were 58% and 45% at year 1, 56% and 26% at year 3 and 55% and 13% at year 7 respectively. CONCLUSION: Certolizumab pegol was well tolerated in the long-term treatment of Crohn's disease, with sustained remission in some patients continuing in the study for up to 7 years. ClinicalTrials.gov identifier NCT00552058.

[Comparison between German and Turkish descent in ischemic stroke. Risk factors, initial findings, rehabilitative therapy, and social consequences]. / Vergleich deutscher und türkischer Patienten mit ischämischem Schlaganfall. Risikofaktoren, Befunde bei Aufnahme, poststationäre Therapie und soziale Konsequenzen.

BACKGROUND: Until now no data has been available on possible specific features of the Turkish minority in Germany with respect to stroke. PATIENTS AND METHODS: We compared 20 Turkish stroke patients with matched German controls analyzing risk factors, findings at admission, rehabilitative treatments, and psychosocial aspects. RESULTS: In the Turkish group the interval between onset of symptoms and admission was longer (532 min vs 255 min, P < 0.01). All other findings during acute treatment and rehabilitation were comparable. At follow-up after 22 months, the Barthel index was 90 for the Turks and 100 for the Germans. The Turkish patients reported more consultations with physicians than their German counterparts (68 vs 12 per year, P < 0.01). Scores for quality of life and outcome did not differ. The Turkish patients more frequently required care and had a higher degree of disability. CONCLUSIONS: Turkish stroke patients have a longer time to admission. Risk factors, findings at admission, and treatment in the acute phase and rehabilitation are comparable. Several findings point towards a different health behavior. These results highlight the need for specific education of the Turkish population in Germany.

Pseudoaneurysm following high lateral myocardial infarction: a case report.

Male patient with a history of high lateral myocardial infarction experienced 45 days before admission was accepted to our clinic with the initial diagnosis of congestive heart failure. Physical examination revealed 2-3 degrees/6 systolic murmur in the mesocardiac region. Telecardiography revealed a mass of 12 x 6 cms in the left hilus. Pseudoaneurysm was diagnosed by transthoracic echocardiography and followed by left ventriculography. The symptoms of heart failure disappeared after successful surgical repair.

Transsternal transpericardial approach for the repair of bronchopleural fistula with empyema.

BACKGROUND: Numerous surgical approaches have been reported for the repair of bronchopleural fistula. Recently the transsternal transpericardial approach has shown great promise with its positive results in cases of bronchopleural fistula complicated with empyema. The aim of this retrospective study was to assess the results of bronchopleural fistula treatment using the transsternal transpericardial approach. METHODS: Bronchopleural fistula developed in 16 of the 172 patients who had pneumonectomy between 1982 and 1996. In one case closure with fibrin sealant by bronchoscopy was tried. In the remaining cases fistula was closed by the transsternal transpericardial approach. RESULTS: The interval between pneumonectomy and fistula occurrence was 10 days or less in 5 patients and 10 days to 1 month in 11 patients. In all patients the empyema space was treated by continued drainage through the thoracostomy tube. Fibrin sealant was tried unsuccessfully for closure of moderate-sized bronchopleural fistula in one case. In three cases of right bronchopleural fistula, carinal resection and anastomosis of the trachea to the left main stem bronchus were performed. In the remaining cases bronchopleural fistula was closed using a hand suture technique. One patient died within 30 days after operation (6.25%) because of renal insufficiency. There was no recurrence of bronchopleural fistula. CONCLUSIONS: Transsternal transpericardial approach seems to be a safe and effective method with an easier technique in cases of bronchopleural fistula complicated with empyema. It has the added advantage of less recurrent fistula formation and enables resection in cases without sufficient bronchial stump.

Aorto-left atrial fistula with bicuspid aortic valve and coronary artery origin anomaly.

Published reports of aorto-left atrial fistula are very rare. We report a 20-year-old man who had an aorto-left atrial fistula with bicuspid aortic valve and coronary artery origin anomaly. Because acquired etiologic factors were not detected, we believe that the lesions were structural defects of congenital origin.