ObjectivesTo assess the long term efficacy and optimization of Infliximab (IFX) in refractory Uveitis of Behçet Disease (BD)MethodsMulticentre study of Uveitis associated-BD refractory to conventional immunosupressive drug. Ocular inflammation was evaluated with “SUN criteria” (Am J Ophthalmol 2005;140:509–516) and the macular thickening with OCT. Results are expressed as mean±SD or median [IQR] (comparison, Wilcoxon test)ResultsWe studied 100 patients/180 affected eyes (54M/46W), mean age 40.7±10.1. The ocular pattern was panuveitis (n=62), posterior (27) and anterior uveítis (11). Before IFX they received iv MP (28), cyclosporine (75), azathioprine (56), metotrexate (43) and others (33). IFX dose ranged between 3–5mg/kg/4 or 8 weeks. In patients in remission IFX was optimized (n=28) or stopped (n=20).ConclusionsIFX is an effective long term-treatment in refractory Uveitis of BD. Optimization and even discontinuation of IFX after remission is possible.Disclosure of InterestNone declared
BackgroundMercaptopurine is indicated for the treatment of acute lymphoblastic leukaemia (ALL). In our country, there is no commercial presentation that allows proper dosage in paediatric patients. However, in March 2012, an expensive 20 mg/mL mercaptopurine suspension (100 mL) that may be purchased as a foreign drug was commercialised. In order to meet the needs of these patients using a more cost effective alternative, the pharmacy department developed a mercaptopurine compounded drug.PurposeTo assess the economic impact of the development of a 50 mg/mL mercaptopurine suspension (12 mL) compared with the use of a commercial syrup.Material and methodsMercaptopurine suspension is compounded by adding simple syrup, cherry syrup and sterile water for irrigation to 50 mg of mercaptopurine triturated tablets. It is prepared in a biological safety cabinet, packed in amber glass bottles and its shelf life is 28 days.This was a retrospective study from March 2012 to September 2015. Collected data, from Farmatools and Farmis software, were: number of ALL patients treated with the suspension, number of suspensions dispensed, number of mercaptopurine tablets used and its cost, and treatment phase of the ALL-SEHOP-PETHEMA protocol when the dispensation was done. Mercaptopurine suspension appraisal was done according to the valuation rules of the Regional Health Management. The Ministry of Health website was consulted for the commercial suspension price. Total savings by the development of a compounded medicine instead of buying the commercial presentation was established by comparing the direct costs between both alternatives.ResultsDuring the study period, 40 mercaptopurine suspensions were prepared to treat 3 patients (according to the ALL-SEHOP-PETHEMA protocol, 2 suspensions were dispensed for the consolidation phase of the treatment and 38 for the maintenance phase). Each one cost 28.1€ (16.6€ mercaptopurine suspension, 0.3€ storage, 11.2€ professional fees); total expenditure was 1124€. Each commercial suspension costs 269.36€ and its shelf life is 56 days; total expenditure would have been 5387.2€. Cost savings achieved by developing the mercaptopurine suspension instead of buying the commercial presentation was 4263.2€.ConclusionThe compounded 50 mg/mL mercaptopurine suspension can meet the therapeutic needs of ALL paediatric patients and save costs. It would be useful to assess the addition of a preservative to the compounded suspension to increase its shelf life and save on costs.No conflict of interest.
BackgroundInfliximab (INF) is a chimeric immunoglobulin antibody to tumour necrosis factor (A-TNF) approved for the treatment of Crohn’s disease and ulcerative colitis.Guidelines recommend a 5 mg/kg dose given as induction regimen in weeks 0, 2 and 6, followed by a maintenance regimen of 5 mg/kg every 8 weeks. However, a significant rate of patients with an initial response, later experience the return of the active disease despite ongoing INF maintenance treatment. International guidelines suggest intensifying the INF regimen if the treatment fails, by increasing the dose to 10 mg/kg, or decreasing the interval to 5 mg/kg every 6 weeks.PurposeTo analyse the different intensification strategies used in a tertiary university hospital, and their results.Material and methodsSingle-centre, retrospective, observational study. Information was obtained from both the Farmatools application and clinical histories. Fifty-five patients were included in our study; all of them started INF treatment between 2005 and 2013.ResultsOut of 55 patients enrolled: 60% (33) were responders, 9% (5) were non-responders, 27% (15) loss of response, and (4%) 2 didn’t tolerate INF.The treatment of the 22 patients who didn’t respond satisfactorily was modified: in 73% (16) the interval was shortened, 9% (2) stepped up to 10 mg and 5% (1) the interval were shortened and the dose stepped up to 10 mg. The other 14% (3) were moved to another A-TNF.In our study, shortening the interval was effective in 52% of cases (9/16), stepping up to 10 mg in 100% (2/2), and the combination of the two strategies in 100% (1/1).ConclusionINF induces remission in most of the patients following the usual maintenance regimen.In our hospital the favourite intensification strategy is to shorten the interval. The use of another A-TNF is reserved for hypersensitivity reactions or for failure of the previous intensification.Both intensification strategies were effective, though more information is required to choose the best strategy.References and/or AcknowledgementsNo conflict of interest.
BackgroundLevosimendan is a positive inotropic drug that was approved in our country for the short term treatment of acute decompensation in chronic heart failure in situations where conventional treatment is not sufficient. There are few studies on off-label levosimendan use.PurposeTo analyse the use of levosimendan in medical and surgical patients assigned to cardiology and surgery cardiac care units.Material and methodsDescriptive observational study from January to December 2014 in a general teaching hospital with 717 functioning beds. All patients who received levosimendan infusion were included. The following variables were recorded: age, gender, indication, type of patient, New York Heart Association (NYHA) classification, left ventricular ejection fraction (LVEF), creatinine clearance (CrCl) by Cockcroft-Gault and death from any cause during the study period. The medical records were reviewed by the computer application Clinical Records v.5.41Results145 patients were included (29% female, 71% male), average age 68.5 ± 11.3 years. 46 patients were medical (31.7%) and 99 were surgical (68.3%).In the 46 medical patients, 33 received authorised use of levosimendan infusion; 24 with NYHA III and 9 with NYHA IV. Only 13 patients on the waiting list used levosimendan for its off-label use. Average LVEF was 26% and in 34/46 cases LVEF was <35%.In the 99 surgically treated patients, the main indications were post-surgery low output cardiac syndrome (92%), cardiogenic shock (7%) and right ventricular failure (1%). 19 patients died during the study (19%).In this group, 20% of patients had Clcr <30 mL/min. Thus the use of levosimendan was contraindicated in these cases of renal failure.ConclusionLevosimendan is used according to the label indications in most patients and only off-label use was found for patients on waiting lists for heart transplants. In our study, the majority of uses of levosimendan were in patients after cardiac surgery where one of the most common complications is postoperative renal failure.No conflict of interest.
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