Long-term safety of azathioprine for treatment of neuromyelitis optica spectrum disorders

2021 ◽  
Vol 79 (3) ◽  
pp. 229-232
Author(s):  
Ana Beatriz Ayroza Galvão Ribeiro GOMES ◽  
Milena Sales PITOMBEIRA ◽  
Douglas Kazutoshi SATO ◽  
Dagoberto CALLEGARO ◽  
Samira Luisa APÓSTOLOS-PEREIRA
Keyword(s):  
Neuromyelitis Optica ◽  
Sao Paulo ◽  
Term Treatment ◽  
São Paulo ◽  
Duration Of Treatment ◽  
International Consensus ◽  
First Line Therapy ◽  
Long Term Treatment ◽  
Record Review

ABSTRACT Background: Azathioprine is a common first-line therapy for neuromyelitis optica spectrum disorder (NMOSD). Objective: The aim of this study was to determine whether long-term treatment (>10 years) with azathioprine is safe in NMOSD. Methods: We conducted a retrospective medical record review of all patients at the School of Medicine of the University of São Paulo (São Paulo, Brazil) who fulfilled the 2015 international consensus diagnostic criteria for NMOSD and were treated with azathioprine for at least 10 years. Results: Out of 375 patients assessed for eligibility, 19 were included in this analysis. These patients’ median age was 44 years (range=28-61); they were mostly female (17/19) and AQP4-IgG seropositive (18/19). The median disease duration was 15 years (range=10-39) and most patients presented a relapsing clinical course (84.2%). The median duration of treatment was 11.9 years (range=10.0-23.8). The median annualized relapse rates (ARR) pre- and post-treatment with azathioprine were 1 (range=0.1-2) and 0.1 (range=0-0.35); p=0.09. Three patients (15.7%) had records of adverse events during the follow-up, which consisted of chronic B12 vitamin deficiency, pulmonary tuberculosis and breast cancer. Conclusion: Azathioprine may be considered a safe agent for long-term treatment (>10 years) of NMOSD, but continuous vigilance for infections and malignancies is required.

scholarly journals P709 Is azathioprine safe as long-term treatment in paediatric patients with inflammatory bowel disease?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S573-S573
Author(s):  
M A Martínez Ibeas ◽  
I Bacelo Ruano ◽  
S Rodríguez Manchón ◽  
M Velasco Rodríguez-Belvís ◽  
J F Viada Bris ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Adverse Effects ◽  
Term Treatment ◽  
Tpmt Activity ◽  
Duration Of Treatment ◽  
Median Dosage ◽  
Long Term Treatment ◽  
Inflammatory Bowel

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.

Natural course of neuromyelitis optica (NMO) in patients with no long-term treatment

2015 ◽  
Vol 357 ◽  
pp. e321
Author(s):  
A. Altintas ◽  
M. Nalbantoglu ◽  
U. Uygunoglu ◽  
G. Gozubatik-Celik ◽  
S. Akkas-Yazici ◽  
...  
Keyword(s):  
Neuromyelitis Optica ◽  
Term Treatment ◽  
Natural Course ◽  
Long Term Treatment

Immunosuppressive therapy is more effective than interferon in neuromyelitis optica

2007 ◽  
Vol 13 (2) ◽  
pp. 256-259 ◽  
Author(s):  
C Papeix ◽  
J-S Vidal ◽  
J De Seze ◽  
C Pierrot-Deseilligny ◽  
A Tourbah ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Immunosuppressive Therapy ◽  
Neuromyelitis Optica ◽  
Interferon Beta ◽  
Term Treatment ◽  
Therapeutic Options ◽  
Long Term Treatment

To determine long-term treatment (LTT) of neuromyelitis optica (NMO), we retrospectively reviewed therapies of 26 patients with NMO followed in five French neurological departments. To assess LTT efficacy, the probability of relapse free after LTT was analysed. Patients were divided into two groups according to the first treatment receiving interferon beta (IFN Group, seven patients) or immunosuppressants (IS Group, 19 patients). The probability of relapse was significantly lower in the IS Group (P = 0.0007). From our results, interferon beta is not recommended, and one of the best current therapeutic options for NMO appears to be immunosuppressants. Multiple Sclerosis 2007; 13: 256–259. http://msj.sagepub.com

Long-Term Treatment with Romiplostim in Patients with Chronic Immune Thrombocytopenic Purpura (ITP): 3-Year Update from An Open-Label Extension Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 402-402 ◽  
Author(s):  
David J Kuter ◽  
James B Bussel ◽  
Adrian Newland ◽  
Joost TM de Wolf ◽  
Troy Guthrie ◽  
...  
Keyword(s):  
Platelet Count ◽  
Term Treatment ◽  
Duration Of Treatment ◽  
Open Label ◽  
Platelet Counts ◽  
Chronic Itp ◽  
Long Term Treatment ◽  
Open Label Extension ◽  
Grade 3

Abstract Chronic ITP is characterized by increased platelet destruction and suboptimal platelet production. Romiplostim is an investigational Fc-peptide fusion protein (peptibody) being studied for its ability to increase platelet counts in patients with chronic ITP. We report data from an open-label extension study of romiplostim in adult patients with chronic ITP. Collection of safety and efficacy data from long-term treatment of these patients is ongoing. Eligible patients had completed a prior romiplostim study and had platelet counts □50×109/L. Romiplostim was administered subcutaneously once weekly with dose adjustments to maintain a platelet count of 50–250×109/L. As of July 13 2007, 142 patients had been treated with romiplostim. Their median time since diagnosis was 6.4 years (range 0.6–46.4 years). Most were female (67%) and had previously undergone a splenectomy (60%). The median baseline platelet count was 17×109/L (range 1–50×109/L). The median duration of treatment was 65 weeks (range 1–156 weeks). Twenty-nine (20%) patients discontinued the study, 10 (7%) due to adverse events (AEs) [2 each of bone marrow reticulin and thrombosis; 1 each of bleeding, pain, cardiac arrest, pneumonia, hepatic and renal failure, and monoclonal gammopathy of undetermined significance]. Different measures of platelet count response were analyzed; any platelet counts within 8 weeks of receiving rescue medications were excluded from these analyses. Platelet counts were increased from baseline by ≥20×109/L more than 80% of the time in 54% of patients and more than 50% of the time in 73% of patients. Platelet counts remained above 20×109/L more than 90% of the time in 67% of patients and more than 50% of the time in 94% of patients. A platelet count >50×109/L and double baseline was achieved by 30% (42/138) of patients after the first dose, by 51% (71/138) of patients after the third dose, and by 87% (124/142) of patients overall. The durability of platelet count increases was analyzed: platelet counts >50×109/L were sustained for ≥10, ≥25, and ≥52 consecutive weeks in 78% (102/131), 54% (66/122), and 35% (29/84) of patients, respectively. The patient incidence of bleeding events both of any severity and of clinical significance (≥Grade 3) declined over time (Table). AEs were reported in 95% of patients, with most mild to moderate in severity. The most common were headache (37%); nasopharyngitis (32%); and contusion, fatigue and epistaxis (each 30%). AE frequency did not increase with time on study (Table). Bone marrow reticulin was present or increased in 8 patients with no evidence of progression to collagen fibrosis or chronic idiopathic myelofibrosis. Thrombotic events were reported in 7 (5%) patients; 6 had pre-existing risk factors for thrombosis. In conclusion, romiplostim increased platelet counts in most patients for most of the time, and clinically relevant bleeding was reduced over time. Romiplostim was well-tolerated and AEs did not increase with longer duration of treatment. Table. Summary of patient incidence of AEs by study period <24 wks (N=142) n (%) 24 to <48 wks (N=126) n (%) 48 to <72 wks (N=97) n (%) 72 to <96 wks (N=65) n (%) 96 to <120 wks (N=29) n (%) 120 to <144 wks (N=25) n (%) AEs 129 (91) 110 (87) 64 (66) 36 (55) 23 (79) 21 (84) Serious AEs 25 (18) 13 (10) 7 (7) 4 (6) 4 (14) 1 (4) Treatment-related AEs 48 (34) 14 (11) 12 (12) 7 (11) 4 (14) 3 (12) Treatment-related serious AEs 6 (4) 3 (2) 1 (1) 2 (3) 1 (3) 1 (4) Study withdrawals due to AEs 4 (3) 5 (4) 0 (0) 0 (0) 0 (0) 1 (4) Bleeding any grade 60 (42) 37 (29) 22 (23) 13 (20) 11 (38) 8 (32) Bleeding ≥ Grade 2 (moderate) 25 (18) 12 (10) 8 (8) 4 (6) 3 (10) 2 (8) Bleeding ≥ Grade 3 difference in thisresponsebetween refractory (severe) 9 (6) 1 (1) 1 (1) 1 (2) 0 (0) 0 (0)

A review of the efficacy and tolerability of venlafaxine

1997 ◽  
Vol 12 (S4) ◽  
pp. 307s-313s ◽  
Author(s):  
M Dierick
Keyword(s):  
Major Depression ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Antidepressant Activity ◽  
Term Treatment ◽  
Selective Serotonin ◽  
First Line Therapy ◽  
Long Term Treatment ◽  
Norepinephrine Reuptake Inhibitor ◽  
Short And Long Term

SummaryVenlafaxine is a selective serotonin norepinephrine reuptake inhibitor with no activity at muscarinic, histaminergic or adrenergic receptors. The antidepressant activity of venlafaxine has been demonstrated in placebo-controlled and active comparator-controlled clinical trials. Venlafaxine was effective in outpatients and hospitalized patients with major depression and in those with melancholia, agitated or retarded symptoms, and refractory or treatment-resistant depression. Venlafaxine was at least as effective as comparative antidepressants and was more effective than fluoxetine or imipramine in some trials. A positive dose-response relationship has been shown with venlafaxine. When doses of venlafaxine are titrated rapidly upward, an onset of antidepressant action has been detected within one week in some studies. Venlafaxine is well tolerated during short- and long-term treatment. The most common adverse effects are nausea, somnolence and dry mouth. The overall tolerability of venlafaxine appears to exceed that of tricyclic antidepressants and compares favorably with that of selective serotonin reuptake inhibitors. Venlafaxine is a novel antidepressant that is appropriate for first-line therapy in patients with major depression.

Which preparation of aspirin?

1978 ◽  
Vol 16 (13) ◽  
pp. 51-52
Keyword(s):  
Rheumatoid Arthritis ◽  
Influenza A ◽  
Term Treatment ◽  
Duration Of Treatment ◽  
First Choice ◽  
Long Term Treatment ◽  
Anti Inflammatory ◽  
Inflammatory Effect

Aspirin is often used to treat complaints expected to be transient, such as toothache, headache and influenza. A rapid analgesic and sometimes anti-pyretic effect is required, and duration of treatment is likely to be short. Aspirin is often considered the first-choice drug for rheumatic disorders, particularly rheumatoid arthritis;1 here the circumstances are quite different because long-term treatment is required at the relatively high dosage necessary to obtain an anti-inflammatory effect.2

SULPHATION FACTOR ACTIVITY AND GROWTH RATE DURING LONG-TERM TREATMENT OF PATIENTS WITH PITUITARY DWARFISM WITH HUMAN GROWTH HORMONE

1972 ◽  
Vol 69 (3) ◽  
pp. 417-433 ◽  
Author(s):  
Kerstin Hall ◽  
Patrick Olin
Keyword(s):  
Growth Hormone ◽  
Growth Rate ◽  
Human Growth Hormone ◽  
Human Growth ◽  
Term Treatment ◽  
Factor Activity ◽  
Duration Of Treatment ◽  
Pituitary Dwarfism ◽  
Long Term Treatment

ABSTRACT Twenty patients with pituitary dwarfism were treated for nine months to 2½ years with human growth hormone (HGH) prepared according to Roos et al. (1963). Eleven of them had previously been given other HGH preparations for one to five years. During the first two years of treatment with HGH in a dose of 0.2 mg (0.4 IU) and 0.3 mg (0.6 IU) per kg body weight per week, the increase in growth rate was two- to threefold, and three- to fivefold, respectively. Long-termed treatment with HGH was accompanied by a decreasing ability of the hormone to stimulate growth. Cortisone acetate, in replacement doses, had no influence on this growth rate. During the present study only one of the 20 patients developed antibodies to HGH. The levels of sulphation factor (SF) activity in serum were low before treatment and increased significantly during treatment with HGH. There was a linear relationship between the SF activity in the serum and the slope of the growth carves. Both increased with the dose of HGH administered but decreased with duration of treatment.

scholarly journals Long-term re-evaluation of primary aldosteronism after medical treatment reveals high proportion of normal mineralocorticoid secretion

2013 ◽  
Vol 168 (4) ◽  
pp. 525-532 ◽  
Author(s):  
Barbara Lucatello ◽  
Andrea Benso ◽  
Isabella Tabaro ◽  
Elena Capello ◽  
Mirko Parasiliti Caprino ◽  
...  
Keyword(s):  
Medical Treatment ◽  
Primary Aldosteronism ◽  
Cross Sectional Study ◽  
Term Treatment ◽  
Duration Of Treatment ◽  
Cross Sectional ◽  
Long Term Treatment ◽  
Suppression Test ◽  
Mineralocorticoid Antagonists

ObjectiveIn most cases of primary aldosteronism (PA), an adrenal aldosterone-secreting tumor cannot be reasonably proven, so these patients undergo medical treatment. Controversial data exist about the evolution of PA after medical therapy: long-term treatment with mineralocorticoid antagonists has been reported to normalize aldosterone levels but other authors failed to find remission of mineralocorticoid hypersecretion. Thus, we planned to retest aldosterone secretion in patients with medically treated PA diagnosed at least 3 years before.DesignRetrospective, cross-sectional study.MethodsThe same workup for PA as at diagnosis (basal aldosterone to renin activity ratio (ARR) and aldosterone suppression test) was performed after stopping interfering drugs and low-salt diet, in 34 subjects with PA diagnosed between 3 and 15 years earlier, by case finding from subgroups of hypertensive patients at high risk for PA. Criteria for persistence of PA were the same as at diagnosis (ARR (pg/ml per ng per ml per h) >400, aldosterone >150 pg/ml basally, and >100 pg/ml after saline infusion) or less restrictive.ResultsPA was not confirmed in 26 (76%) of the patients and also not in 20 (59%) using the least restrictive criteria suggested by international guidelines. Unconfirmed PA was positively associated with female sex, higher potassium levels, longer duration of hypertension, and follow-up, but not with adrenal mass, aldosterone levels at diagnosis, and treatment with mineralocorticoid antagonists.ConclusionsThis study suggests that mineralocorticoid hyperfunction in patients with PA after medical treatment may decline spontaneously. Higher potassium concentration and duration of treatment seem to increase the probability of this event.

Cochlear Function in Adults with Epilepsy and Treated with Carbamazepine

2018 ◽  
Vol 23 (1) ◽  
pp. 63-72 ◽  
Author(s):  
Sherifa A. Hamed ◽  
Amira M. Oseilly
Keyword(s):  
Pure Tone Audiometry ◽  
Otoacoustic Emission ◽  
Term Treatment ◽  
Idiopathic Epilepsy ◽  
Duration Of Treatment ◽  
Cochlear Function ◽  
Duration Of Illness ◽  
Long Term Treatment ◽  
Transient Evoked Otoacoustic Emission

Background: Epilepsy is a chronic medical disease and is associated with comorbid adverse somatic conditions due to epilepsy itself or its long-term treatment. Objectives: This study evaluated cochlear function in patients with idiopathic epilepsy and treated with carbamazepine (CBZ). Patients and Methods: Included were 47 patients (mean age = 34.56 ± 7.11 years and duration of illness = 17.84 ± 7.21 years) and 40 healthy subjects. They underwent pure-tone audiometry and transient evoked otoacoustic emission (TEOAE) analyses. Results: Hearing loss (mainly bilateral mild) was reported in one third of patients. Compared to controls, patients had lower TEOAE amplitudes at 1.0–4.0 kHz particularly at high frequencies (3 and 4 kHz). Significant correlations were identified between TEOAE amplitudes with CBZ dose (at 3 kHz: r = –0.554, p = 0.008; at 4 kHz: r = –0.347, p = 0.01), its serum level (at 4 kHz: r = –0.280, p = 0.045) and duration of treatment (at 3 kHz: r = –0.392, p = 0.008; at 4 kHz: r = –0.542, p = 0.001). Conclusions: Long-term CBZ treatment may result in cochlear dysfunction and auditory deficits.

P15 Melatonin prescribing audit

2018 ◽  
Vol 103 (2) ◽  
pp. e2.17-e2
Author(s):  
See Mun Wong
Keyword(s):  
Community Setting ◽  
Immediate Release ◽  
Term Treatment ◽  
Pharmacy Cost ◽  
Clinical Indication ◽  
Duration Of Treatment ◽  
Regular Treatment ◽  
Long Term Treatment

AimTo investigate the practice of melatonin prescribing amongst clinicians in outpatient setting and whether the treatment has been reviewed regularly.MethodData was collected from JAC (Pharmacy Computer System) report detailing patients receiving melatonin from pharmacy, cost centre, quantity, date between 1 st Nov 2014 and Oct 2015. Data on in-patient supply were excluded as the focus of the audit was around patients who are on long term treatment and are seen in outpatient clinics or in the community setting.A sample of patients was randomly selected from the list. Details about consultant, clinical indication, whether melatonin was reviewed, date of clinic, other sedatives patients received, type of melatonin prescribed, were recorded by reviewing clinic letters between Nov 2014 and Dec 2015.ResultsA total of 774 patients received melatonin dispensed from pharmacy on 4 or more occasions between Nov 2014 and Oct 2015. In-patient supplies were excluded. 404 out of 774 patients were audited. The sample size was large enough to represent our overall population.8% of patients were prescribed Circadin 2 mg tablets; 61% of patients were on a combination of unlicensed immediate release (IR) melatonin 2 mg capsules and Circadin; 31% of patients were on unlicensed IR melatonin 2 mg capsules.238 (59%) patients attended follow up clinics and had their melatonin reviewed; 81 (20%) patients attended clinics but melatonin review was not documented; 42 (10%) patients who were on long term melatonin had not attended a clinic appointment for over a year and another 39 (10%) patients who were newly initiated on melatonin had not attended a follow up appointment since treatment started; 1% of patients were not due a clinic review since starting. Out of those who didn’t have their melatonin reviewed for over a year or since treatment had started, 52 (64%) patients failed to attend their clinic appointments.26 (6.4%) patients were recorded to be on other sedatives concurrently in their clinic letters – 23 patients on chloral hydrate and 3 patients on promethazine.6 (1.5%) patients were advised to either stop melatonin or take a holiday break, but out of these, 3 patients continued to receive melatonin supply from the pharmacy.About 35% of patients have been on melatonin for 1 to 2 years and another 34% for 3 to 5 years. The longest treatment duration was over 9 years (17 patients).ConclusionMelatonin is prescribed across many different specialties both within the hospital and in the community with the greatest proportion being prescribed for sleep disorders in Attention Deficit Hyperactivity Disorder. There was a general lack of clinic review regarding efficacy, doses and duration of treatment. In over 60% of cases this was due to patients failing to attend clinic appointments. It is questionable why melatonin is continued to be prescribed without regular treatment review. The concurrent use of other sedatives in some patients is debatable. This information has been presented to prescribers. Another audit is planned in the end of 2016 to determine whether review of treatment has improved and will include an evaluation of melatonin efficacy.

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