Fr172 LOW RATES OF GLUCOCORTICOID-RELATED ADVERSE EFFECTS WITH LONG-TERM TREATMENT OF EOSINOPHILIC ESOPHAGITIS WITH FLUTICASONE PROPIONATE ORALLY DISINTEGRATING TABLET (APT-1011): RESULTS FROM 52 WEEKS OF EXPOSURE IN A PHASE 2B TRIAL.

Abstract Background The toxicity of azathioprine (AZA) includes myelosuppression, infections, pancreatitis, photosensitivity, and hepatotoxicity. The aim of this study was to describe the adverse effects profile of azathioprine as long-term treatment in paediatric inflammatory bowel disease (IBD). Methods An observational, descriptive and retrospective study was performed in the paediatric IBD Unit of a tertiary care hospital from September 2008 to December 2018. It was included patients under 18 diagnosed with IBD who were treated with AZA during their follow-up. We recorded epidemiological data, thiopurine methyltransferase (TPMT) enzyme activity, AZA side effects, and the dosage the patients were receiving when these effects took place. Bone marrow suppression (BMS) was defined as leukopenia, thrombocytopenia and/or anaemia. Acute pancreatitis (AP) induced by azathioprine was considered when two of these criteria (Atlanta 2012) were met: lipase increase (> 3 times normal value), congruent signs and symptoms and/or echographic findings, without other possible aetiology and with complete recovery after AZA withdrawal. Results We included 52 patients, being 31 men (59.6%). They were diagnosed with Crohn′s disease (CD) (73%), ulcerative colitis (UC) (21%) and IBD-unclassified (6%). The median TPMT activity was 17 U/ml (14.2–19.2). Up to 63.5% developed adverse effects by AZA with a median time from the beginning of treatment of 11.4 months (2.6–26.4) and a median dosage of 2 mg/kg/day (1.7–2.3). The most frequent side effect was BMS (52%). These patients had a median TPMT activity of 16.9 U/ml (14.2–18.9), the median duration of treatment was 14 months (3.9–27.7), and the median dosage was 2 mg/kg/d (1.8–2.5). BMS was more frequent in patients with UC (p 0.04) and longer treatment (p 0.08). No differences were found according to age, sex or TPMT activity. Up to 11.5% developed AP, the median duration of treatment until its appearance was 1.5 months (0.7–43.3) and the median dosage was 2 mg/kg/d (1.5–2.5). No differences were found related to age, sex, diagnosis or dosage. Other side effects were: 3 flu-like symptoms, 3 opportunistic infections, 2 hypertransaminasemia, and 1 patient with elevated pancreatic enzymes and hyperbilirubinemia. AZA was discontinued in 14 patients (43.8%): in 6 due to AP, in 4 due to severe lymphopenia, in 2 because of Epstein-Barr virus infection, in 1 due to flu-like symptoms and in 1 with several adverse effects. Conclusion More than half of the patients treated with AZA presented side effects, mainly BMS, although most of them were mild and temporary, and the withdrawal of the drug was not necessary. It seems that TPMT activity is not useful to predict BMS, but this adverse effect could be related to a longer treatment.

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Galantamine in long-term treatment formild cognitive impairment: Efficacy and safety

European Psychiatry ◽

10.1016/s0924-9338(11)73001-2 ◽

2011 ◽

Vol 26 (S2) ◽

pp. 1296-1296

Author(s):

J. Zarra ◽

L. Schmidt ◽

B. Grecco

Keyword(s):

Cognitive Impairment ◽

Adverse Effects ◽

Acetylcholine Receptors ◽

Well Being ◽

Cognitive Disorder ◽

Term Treatment ◽

Open Label ◽

Global Deterioration Scale ◽

Long Term Treatment

IntroductionTo evaluate the efficacy of galantamine in patients with Mild Cognitive Impairment. So there is a possible benefit in the deficit in executive and cognitive cerebral function (cholinergic system) with treatment with Galantamine.PurposeGalantamine is a reversible, competitive cholinesterasa inhibitor that also allosterically modulates nicotine acetylcholine receptors. Inhibition of acetylcholinesterase, the enzyme responsible for hydrolisis of acetylcholine at the cholinergic cognitive impairment. To evaluate the efficacy, safety and tolerability of galantamine in long-term in Mild Cognitive Disorder.MethodsA multicenter, open label, prospective, observational study enrolled 1028 patients, more 55 years old with Mild Neurocognitive Disorder (DSM IV criteria), during 30 months of treatment with galantamine 16 mg./day. Assessments included the MMSE, CDR, ADAS-GOG, FAQ, GCI, Trail making test, Global Deterioration Scale, and UKU scale of Adverse Effects.ResultsA total 1028 outpatients were treated with 16 mg./day galantamine during 30 months, the therapeutic response evaluated with CDR, MMSE and the tests and scales of function cognitive measuring, GCI and UKU scale of adverse effects, comparing the baseline to final scores.ConclusionMild Cognitive Disorder is being examined, so there aren’t enought treatment for this. A long-term treatment (30 months) galantamine improves cognition and global function, behavioural symptoms and the general state well being of patients with MCD. With incidence of adverse effects not significant and a very good profile of safety, the final results of the study suggest that galantamine may be particularly appropiate in the Mild Cognitive Disorder.

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Compliance During Long-Term Treatment with Fluticasone Propionate in Subjects with Early Signs of Asthma or Chronic Obstructive Pulmonary Disease (COPD): Results of the Detection, Intervention, and Monitoring Program of COPD and Asthma (DIMCA) Study

Journal of Asthma ◽

10.3109/02770900009055445 ◽

2000 ◽

Vol 37 (3) ◽

pp. 225-234 ◽

Cited By ~ 31

Author(s):

Pierre M. van Grunsven ◽

Constant P. van Schayck ◽

Miriam van Deuveren ◽

Cees L. A. van Herwaarden ◽

Reinier P. Akkermans ◽

...

Keyword(s):

Chronic Obstructive Pulmonary Disease ◽

Fluticasone Propionate ◽

Pulmonary Disease ◽

Monitoring Program ◽

Term Treatment ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Early Signs ◽

Long Term Treatment

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Left-Right Comparison Study of the Combination of Fluticasone Propionate and UV-A vs Either Fluticasone Propionate or UV-A Alone for the Long-term Treatment of Vitiligo

Archives of Dermatology ◽

10.1001/archderm.135.9.1061 ◽

1999 ◽

Vol 135 (9) ◽

Cited By ~ 75

Author(s):

Wiete Westerhof ◽

Ludmila Nieuweboer-Krobotova ◽

Paul G. H. Mulder ◽

Eltjo J. Glazenburg

Keyword(s):

Fluticasone Propionate ◽

Term Treatment ◽

Comparison Study ◽

Long Term Treatment

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Attention deficit and hyperactivity disorder in people with epilepsy: diagnosis and implications to the treatment

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2010000100023 ◽

2010 ◽

Vol 68 (1) ◽

pp. 107-114 ◽

Cited By ~ 29

Author(s):

Julio A.S. Koneski ◽

Erasmo B. Casella

Keyword(s):

Adverse Effects ◽

Attention Deficit ◽

Clinical Studies ◽

Social Life ◽

Term Treatment ◽

Hyperactivity Disorder ◽

The Social ◽

Long Term Treatment ◽

Epilepsy Diagnosis

The association between attention deficit and hyperactivity disorder (ADHD) and epilepsy can cause significant impact on the social life of affected individuals and their families. Clinical studies suggest that 30-40% of people with epilepsy also have ADHD. There are no studies which demonstrate that short or long-term treatment with methylphenidate increases the risk of seizures. Some studies attempt to relate drug interactions between methylphenidate and antiepileptic drugs, but adverse effects of methylphenidate have not been shown clearly. This review presents some neurobiological and physiopathogenic aspects, common to ADHD and epilepsy, from recent research studies, related to pharmacology, neuroimaging and electroencephalography. Possible risk of occurrence of seizures associated with the use of methylphenidate are also discussed.

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Usefulness of Nonvalved Spacers for Administration of Inhaled Steroids in Young Children with Recurrent Wheezing and Risk Factors for Asthma

Canadian Respiratory Journal ◽

10.1155/2018/3095647 ◽

2018 ◽

Vol 2018 ◽

pp. 1-5

Author(s):

Carlos Kofman ◽

Alejandro Teper

Keyword(s):

Risk Factors ◽

Fluticasone Propionate ◽

Young Children ◽

Respiratory Symptoms ◽

Term Treatment ◽

Recurrent Wheezing ◽

Inhaled Steroids ◽

Long Term Treatment ◽

Metered Dose

Background. In vitro and scintigraphic studies have suggested that effectiveness of metered-dose inhalers (MDI) with nonvalved spacers (NVS) is similar to that of MDI with valved holding chambers (VHC). Nevertheless, there are no clinical studies that compare these techniques in long-term treatment with inhaled steroids in young children with recurrent wheezing and risk factors for asthma. Objective. To compare the efficacy of a long-term treatment with Fluticasone Propionate administered by an MDI through both type of spacers, with and without valves, in young children with recurrent wheezing and risk factors for asthma. Patients and Methods. Outpatient children (6 to 20 months old) with recurrent wheezing and risk factors for asthma were randomized to receive a 6-month treatment with metered-dose inhaler (MDI) of Fluticasone Propionate 125 mcg BID through an NVS or through a VHC. Parents recorded daily their child’s respiratory symptoms and rescue medication use. Results. 46 patients of 13.4 ± 5 months old were studied. During the study period, the NVS group (n=25) experienced 3.9 ± 2.4 obstructive exacerbations, and the VHC group (n=21) had 2.6 ± 1.6 (p=0.031). The NVS group had 17.4 ± 14% of days with respiratory symptoms, and the VHC group had 9.7 ± 7% (p=0.019). The NVS group spent 29.8 ± 22 days on albuterol while the VHC group spent 17.9 ± 11 days (p=0.022). Conclusion. Long-term treatment with inhaled steroids administered by MDI and NVS is less effective than such treatment by MDI and VHC in infants with recurrent wheezing and risk factors for asthma.

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