A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN β-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis

2004 ◽  
Vol 10 (6) ◽  
pp. 636-642 ◽  
Author(s):  
M Patricia Leuschen ◽  
Mary Filipi ◽  
Kathleen Healey

Multiple sclerosis (MS) patients initiating IFN b-1a, Avonex, therapy (Group 1, n-30) or experiencing side effects after 6 months on therapy (Group 2, n-30) were randomized for 5 weeks open label adjunct therapy to naproxen (Aleve®), acetaminophen (Tylenol®)or ibuprofen (Advil®). Our hypothesis was that non-prescription pain medications are effective in decreasing or alleviating the side effects associated with IFN b-1a therapy. Contrary to the hypothesis, most patients in both groups continued to report side effects on all pain medications. After 5 weeks, headache, fever, chills and injection site pain were low in5-50% of patients. Moderate to significant fatigue, muscle or joint pain continued in most patients. As a quality of life measure, the Modified Fatigue Impact Scale (mFIS) improved for Group 1 on naproxen or ibuprofen with greatest improvement in physical subset (P-0.002 for naproxen and PB-0.01 for ibuprofen). Total mFIS for Group 1 on acetaminophen improved (P-0.04) due to improved cognitive subset rather than physical subset. Group 2, with side effects initially, reported less significant fatigue (severity 5-10) but more moderate fatigue (severity 2-4) at study end for all three medications. All medications improved cognitive subset (P=0.05). Physical mFIS subset did not improve for Group 2 on acetaminophen, but did with naproxen (P=0.05) or ibuprofen (P=0.03). Naproxen and ibuprofen were more effective than acetaminophen in minimizing physical side effects of IFN b-1a. None of the three pain medications tested were as effective as hypothesized for minimizing fatigue or muscle and joint pain.

Cephalalgia ◽  
2002 ◽  
Vol 22 (4) ◽  
pp. 309-312 ◽  
Author(s):  
AV Krymchantowski ◽  
JS Barbosa

Rizatriptan is an effective and fast acting drug for the acute treatment of migraine. As with any other acute treatment for migraine, headache recurrence may occur in up to one-third of responders. Combination with non-steroidal anti-inflammatory drugs (NSAIDs) seems to reduce the incidence of headache recurrence in clinical practice. Rofecoxib is a member of a new class of NSAIDs, which selectively inhibits the COX-2 enzyme and therefore is associated with a lower risk of gastrointestinal side-effects; the drug has a long plasma half-life (17 h). This open label study compared rizatriptan with rizatriptan plus rofecoxib in the acute treatment of migraine. Fifty-six triptan naive patients from a tertiary centre (37 women and 19 men, ages 16-55 years, mean 35 years) with International Headache Society migraine were randomized into two groups. They were instructed to treat three consecutive moderate or severe attacks with either 10 mg rizatriptan (group 1: 18 women and 10 men) or with 10 mg rizatriptan plus 25 mg rofecoxib (group 2: 19 women and 9 men). The presence of headache and nausea at 1, 2 and 4 h, and of side-effects, use of rescue medication and recurrence were compared. Fifty-four patients completed the study. Group 1 treated 76 attacks and group 2 treated 81 attacks. Absence of headache at 1 h was seen in 19 attacks (25%) in group 1 and in 34 attacks (42%) in group 2 ( P = 0.082); at 2 h absence of headache was seen in 60% of group 1 attacks and in 76% of group 2 attacks ( P = 0.115). At 4 h, 75% of group 1 attacks and 88% of group 2 attacks were pain free ( P = 0.122). With regard to nausea, of those who had nausea at baseline, 31% and 49% of attacks in groups 1 and 2, respectively, were nausea free at 1 h ( P = 0.091), 75% and 79% at 2 h ( P = 0.736) and 82% and 91% ( P = 0.479) at 4 h. Recurrence, based on all attacks of those patients who achieved pain free at 4 h, was observed in 53% of group 1 and 20% of group 2 attacks ( P< 0.001). Sustained pain- free rates (for the 4-h time point) were 45.6% of group 1 and 78.9% of group 2 attacks. There were no significant differences with regard to rescue medication consumption after 4 h and side-effects in both groups. There was a non-significant trend for the combination group to have a higher response rate. The group treated with rizatriptan and rofecoxib had a lower recurrence rate than the group treated with rizatriptan. This study demonstrated that combining a fast acting triptan such as rizatriptan with rofecoxib reduced headache recurrence rates, was well tolerated and may be more effective than the use of rizatriptan alone. Double-blind, placebo-controlled studies are necessary to confirm these observations.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5451-5451 ◽  
Author(s):  
Amina Kurtovic Kozaric ◽  
Erna Islamagic ◽  
Jerald P. Radich ◽  
Emina Suljovic Hadzimesic ◽  
Azra Hasic ◽  
...  

Abstract Introduction Imatinib mesylate (Glivec, Novartis) is the first tyrosine kinase inhibitor (TKI) targeting the BCR-ABL1 fusion protein responsible for the pathogenesis of chronic myeloid leukemia (CML). Low cost generic alternatives to imatinib are an integral part of cost effective healthcare strategies for developing countries. However, the use of generics has been associated with different clinical outcomes. In this study, we compared outcomes of two groups of patients who received Glivec as first-line therapy (Group 1) to patients who received generic imatinib as first-line therapy (Group 2) in Bosnia and Herzegovina. Material and methods This was a multicenter retrospective cohort study of BCR-ABL1 positive CML patients (n = 53) in the Federation of Bosnia and Herzegovina between 1 June 2005 and 31 March 2016. Glivec was used from 01 June 2005 until 30 September 2013, when all patients had to switch to generics, which was mandated by the Federal Solidarity Fund that allocates targeted cancer therapies. The following generic imatinib was available: Anzovip (Zdravlje, Actavis) from 09/2013 to 09/2014, Meaxin (Krka) from 09/2014 to 12/2015, and Plivatinib (Pliva) from 12/2015. Patient data was collected from the database of the Federal Solidarity Fund, a subsidiary of the Federal Health Insurance Agency. Branded and generic imatinib was administered orally at dosage of 400 mg/day. Patients who were switched to nilotinib received orally 400 mg/day. Patients on Glivec included in this study started therapy from 0-6 months from time of diagnosis, while patients who started with generics did not wait for therapy. Patient variables that were collected included age, gender, town, date of diagnosis, date of start of therapy, monthly TKI dosage, adverse side effects, progression, lethal outcome, prognostic factors and diagnostic parameters, including cytogenetics and molecular testing. In September 2013, Glivec stopped being available in Bosnia and all CML patients were switched to generic therapy Anzovip. Median duration of each therapy is given in Table 1. Results We compared patients on Glivec as first-line therapy (Group 1, n=26) to patients on first-line generic imatinib (Group 2, n=27) with the follow-up period of at least three years for each group. When we compare Groups 1 and 2 using intention to treat analysis, Kaplan-Meier estimated rate of overall survival at 24 months of therapy was 88% vs. 68%, respectively (p=0.14), while 69% vs. 70% achieved CCyR (p=0.12), respectively. In Group 1, 27% (7/26) patients switched to nilotinib (treatment failure in 2 patients and side effects in 5 patients), 54% (14/26) patients switched to generics because Glivec was no longer available, and 19% (5/26) patients stopped therapy (2 patients stopped therapy and 3 patients died). Of the 7 patients who switched to nilotinib, 71% (5/7) achieved CCyR, 29% (2/7) achieved MMR and none died. Of 19 patients who stayed on imatinib, 68% (13/19) achieved CCyR, 63% (12/19) achieved MMR and 3/19 (16%) died. Of the 54% (14/26) patients who were switched from branded imatinib to generic imatinib, one patient (7%) lost complete cytogenetic response. Regarding Group 2, 52% (14/27) of patients switched to nilotinib due to treatment failure (n=8) and side effects (n=6), while 48% (13/27) of patients stayed on generics. Of patients who switched to nilotinib, 43% (6/14) achieved CCyR and 15% (2/14) achieved MMR. Of the patients who stayed on generic imatinib, 100% (13/13) achieved CCyR and 85% (11/13) achieved MMR. Conclusion Our results suggest that there was no obvious difference in the treatment efficacy between generic and branded imatinib. At 3 years, there was no significant difference in the overall suvival and achievement of CCyR between first-line Glivec and first-line generic imatinib (p=0.14, and p=0.12, respectively). * Median duration of therapy on generic imatinib Table Table. Disclosures Radich: Bristol-MyersSquibb: Consultancy; Pfizer: Consultancy; ARIAD: Consultancy; TwinStrand: Consultancy; Novartis: Consultancy, Other: laboratory contract.


2012 ◽  
Vol 18 (9) ◽  
pp. 1229-1238 ◽  
Author(s):  
T Kümpfel ◽  
L-A Gerdes ◽  
T Wacker ◽  
A Blaschek ◽  
J Havla ◽  
...  

Background: Familial Mediterranean fever (FMF) is an inherited autoinflammatory disease caused by mutations in the MEFV gene and characterized by recurrent febrile polyserositis. A possible association of FMF and multiple sclerosis (MS) has been suggested in cohorts from Turkey and Israel. Objective: The objective of this study was to investigate the prevalence of MEFV mutations in subjects with MS and in controls in Germany. Methods: One-hundred and fifty seven MS patients with at least one symptom or without symptoms suggestive of FMF from our outpatient clinic were investigated for mutations in exons 2, 3, and 10 of the MEFV gene (group 1). 260 independent MS patients (group 2) and 400 unrelated Caucasian controls (group 3) were screened selectively for the low-penetrance pyrin mutations E148Q and K695R Results: In group 1, 19 MS patients (12.1%) tested positive for a mutation in the MEFV gene, mainly the E148Q ( n=7) substitution. Fifteen of the 19 mutation-positive individuals reported at least one symptom suggestive of FMF. In three cases, we could identify additional family members with MS. In these pedigrees, the E148Q exchange co-segregated with MS ( p=0.026). Frequencies of the pyrin E148Q and K695R mutations were not statistically different between MS group 2 and controls but they occurred with a surprisingly high frequency in the German population. Conclusion: The MEFV gene appears to be another immunologically relevant gene locus which contributes to MS susceptibility. In particular, the pyrin E148Q mutation, which co-segregated with disease in three MS families, is a promising candidate risk factor for MS that should be further explored in larger studies.


2021 ◽  
Vol 19 (1) ◽  
pp. 39-57
Author(s):  
K.V. Zhdanov ◽  
◽  
R.F. Khamitov ◽  
V.V. Rafalsky ◽  
M.P. Mikhaylusova ◽  
...  

Objective. A multicenter open-label randomized controlled clinical trial was aimed to compare the efficacy of the study drug (SD) containing technologically processed affinity purified antibodies (high dilutions) to IFN-γ, CD4 receptor and histamine (Ergoferon) with oseltamivir, and evaluate the influence of SD on the antiviral immune response in adults with seasonal influenza. Patients and methods. 184 outpatients aged 18–70 with confirmed influenza of mild/moderate severity were included and randomized into 2 groups (in a 1:1 ratio). Patients received SD (Group 1, n = 92) or oseltamivir (Group 2, n = 92), according to the instructions for medical use for 5 days. As the primary endpoint, the percentage of patients with recovery/improvement was assessed (according to the data of the patient's diary on days 2–7 and according to the clinical examination on days 3 and 7). Additionally, the duration and severity of influenza symptoms, the percentage of patients with virus elimination (according to RT-PCR of nasopharyngeal samples), the percentage of patients with complications, the percentage of patients prescribed antipyretic drugs, the change in concentration of T cell (IL-2, IL-18, IFN-γ) and B cell antigen-specific (IL-4, IL-16) immune response regulators in serum, the leukocyte phenotypes on days 1, 3 and 7 were evaluated. Statistical analysis was performed using a “Non-Inferiority” design (or no less efficiency/safety). Intention-to-Treat (ITT) analysis data are presented. Results. According to patients’ self-assessment, 53.3% of patients in Group 1 recovered/improved on the 6th day in the morning and 65.2% – in the evening (vs. 53.3% and 57.6% in Group 2, respectively). There were 73.9% recovered/ improved patients on the 7th day in the morning (vs. 67.4% in Group 2). A generalized analysis showed that the treatment results in both groups were comparable (p < 0.0001). According to objective medical examination, 79.3% of patients in the SD group and 74.0% of patients in the Оseltamivir group recovered/improved on the 7th day (p < 0.0001). The antiviral efficacy of SD was not inferior to oseltamivir, which was confirmed by comparable periods of virus elimination, duration and severity of fever and other influenza symptoms. A moderate activating effect of SD on the immune system was evaluated. A significant, compared to oseltamivir, increase in the concentration of IL-2 and IL-4 on the 3rd day of treatment (p = 0.03 and p = 0.04 vs. the oseltamivir group), and IFN-γ on the 3rd and the 7th days (p = 0.012 and p < 0.0001, respectively, vs. the oseltamivir group). No stimulating effect of SD on the growth and differentiation of immune cells was found. Conclusion. SD is effective and safe in the treatment of patients with influenza. The therapeutic and antiviral efficacy of SD is comparable to that of oseltamivir. The antiviral activity of SD affects the interferon system and the concentration of the cytokines IL-2 and IL-4, regulators of the T and B cell immune response. At the same time, there is no significant stimulation of interferon production with further development of hyporeactivity. Key words: influenza, oseltamivir, therapy, cytokines, Еrgoferon


Author(s):  
Tetiana Pohuliaieva

For the fi rst time in Ukraine, was explored the eff ect of pregnancy, childbirth and the postpartum period on the further course of multiple sclerosis (MS) in sporadic and family forms of women giving birth at the preclinical stage (group 1) and against the background of the disease (group 2). Through the use of questioning method and clinical and neurological examination the following phenomena were studied. Namely, premonitory history; features of the course of the disease; the duration between labor and development of the onset of the illness in women of the 1st group and between the onset and labor in women of the 2nd group; obstetric and gynecological history; the eff ect of pregnancy and childbirth on the further course of MS. A total of 82 women were examined, 51 of them were giving birth at preclinical stage (group 1) and 31 — against the background of MS (group 2). In the 1st group with remitting course (RC), 26 women had a sporadic form and 5 — a family form; with progressive course (PC) — in 14 — sporadic and in 6 — family form. In the 2nd group with RC, 23 women had sporadic and 1 family form; with PC — 6 had sporadic and 1 family. Research has shown, the disease of majority of women from the first group has been developed after childbirth. Women from the second group with RC were giving birth most often after 5—10 years of the disease onset; with PC — after more than 10 years. According to the obstetric and gynecological history, differences were obtained during pregnancy, childbirth and the postpartum period between two groups of women with different types of course. An assessment of the effects of pregnancy, childbirth and the postpartum period of women from the 2nd group made it possible to identify criteria for various options for the further course of MS (such as improvement, stabilization, improvement through worsening, worsening), which are closely interrelated with the types of course of the disease. To sum up, an integrated analysis of the above mentioned outcome shows a positive eff ect of pregnancy and childbirth in the vast majority of women with RC and a high incidence of decline of women with PC. Key words: multiple sclerosis, types of course, sporadic and familial form, pregnancy and childbirth, obstetric and gynecological history, complications during pregnancy and childbirth


2008 ◽  
Vol 14 (4) ◽  
pp. 440-445 ◽  
Author(s):  
Romain Marignier ◽  
Jérôme De Sèze ◽  
Sandra Vukusic ◽  
Françoise Durand-Dubief ◽  
Hélène Zéphir ◽  
...  

Background A serum autoantibody biomarker, NMO-IgG has been recently described in patients with Devic's neuromyelitis optica (DNMO) and so called `high-risk' patients for this disease. Our objectives were to replicate the test and to assess its usefulness. Methods Indirect immunofluorescence with a substrate of adult rat cerebellum and midbrain was used to identify the distinctive NMO-IgG staining pattern. We tested masked sera from 26 patients with DNMO (group 1), 21 patients with idiopathic acute transverse myelitis (ATM) (group 2), 21 patients with bilateral and/or recurrent idiopathic optic neuritis (group 3), 52 patients with classical multiple sclerosis (MS) (group 4), 36 patients with HTLV-1 infection (group 5) and 7 patients with miscellaneous disorders (group 6). Results We identified a vascular staining pattern typical of NMO-IgG. This particular staining was observed in 14/26 samples in group 1, 7/21 in group 2 (positive only in longitudinally extensive acute transverse myelitis: 7/13), 4/21 in group 3 (with bilateral loss of vision in all seropositive cases), 5/52 in group 4 (none of them suggestive of DNMO), 0/36 in group 5 and 0/7 in group 6. Sensitivity of the test was 54% considering detection of DNMO (group 1), and specificity was respectively 94% and 90% when considering groups 4, 5 and 6 altogether or group 4 of MS patients only. Conclusion Detection of NMO-IgG is contributory to the distinction of DNMO and `DNMO high-risk' syndromes from MS. This test may allow earlier diagnosis and help therapeutic decisions. Multiple Sclerosis 2008; 14: 440—445. http://msj.sagepub.com


2021 ◽  
pp. 54-55
Author(s):  
V.D. Yartsev ◽  
◽  
E.L. Atkova ◽  

Purpose. To estimate the frequency of tearing in patients after high-dose radioiodine therapy. Materials and Methods. The survey was conducted in 500 patients after radioiodine therapy (group 1) and 654 volunteers (group 2). We asked whether the respondent noticed epiphora last month, in case of a positive answer we specified how many times during the day it was necessary to wipe the tear, comparing the result with Munk scale. Results. The patients of group 1 noticed tearing in 232 cases, the respondents of group 2 noticed it in 186 cases. Epiphora was more frequent in patients of group 1 (46 % of cases), rather than in volunteers of group 2 (27 % of cases). Excessive tearing was noticed in 8.8 % of patients of group 1 and 3.5 % of respondents of group 2. The difference was statistically significant. Conclusion. 8.8 % of patients complain about excessive tearing after high-dose radioiodine therapy, which is more frequent than in the general population. This may be related to secondary acquired nasolacrimal duct obstruction. Key words: epiphora, nasolacrimal duct obstruction, radioiodine therapy.


2019 ◽  
Vol 236 (04) ◽  
pp. 425-428
Author(s):  
Mohamed Sherif ◽  
Ciara Bergin ◽  
François-Xavier Borruat

Abstract Background Optic neuritis (ON) is a frequent manifestation of demyelinating attack in multiple sclerosis (MS). Initial visual loss can vary from minimal to complete. Visual improvement occurs in about 95% of patients, some of them recovering to normal [visual acuity (VA), color vision, visual field (VF)]. We analyzed retinal ganglion cell layer (RGCL) thickness in MS patients who recovered their normal vision after ON to determine whether a relative preservation of RGCL existed in these patients. Materials and Methods We conducted a retrospective study of all patients with MS and ON examined by one of us (F. X. B.) between 2013 and 2018. Inclusion criteria were strictly unilateral ON, full recovery of vision, computerized visual field, and OCT examinations. Full recovery of vision was defined as VA ≥ 10/10, Ishihara ≥ 11/13, and VF mean defect (MD) ≤ 2.6 dB. Evaluation of RGCL was obtained with spectral domain optical coherence tomography (SD-OCT). The normal fellow eye of all patients served as the control group. Relative thinning of RGCL, expressed as percentage, was calculated by comparing results from the affected eye to the fellow eye of the same patient. Results Twenty-one patients (21 affected eyes – Group 1, 21 normal fellow eyes – Group 2) satisfying the inclusion criteria were retrieved from our database. All patients exhibited the relapsing-remitting form of MS. There were 16 women and 5 men. Mean age was 39.3 years old. There were no statistically significant differences between Group 1 and Group 2 for either VA (p = 0.3934) or Ishihara (p = 0.140), but a significant difference was found for VF MD (p = 0.0405). A markedly significant difference for RGCL thickness (p = 0.0001) was found, without any correlation with the degree of visual recovery. A subgroup of patients (n = 14) was examined at the time of initial visual loss. We correlated their results of visual function to the final RGCL thickness, and a correlation was found between either the initial VA loss or the initial VF loss and the final loss of RGCL (R2 = 0.4075 and R2 = 0.00739, respectively). Conclusions In our study, all patients with ON lost a significant amount of RGCL despite a full recovery of vision, as defined by our criteria. The percentage of RGCL loss varied from 5 – 27% and could not be correlated with any final visual indices. However, a correlation was found with the degree of initial visual loss. Despite sometimes marked RGCL loss after ON, patients with MS can recover normal visual function, according to standard clinical tests.


Author(s):  
Sreeveena Talasani ◽  
Pran Hitha Venkamolla ◽  
Kalpana Betha

Background: Intrauterine fetal death (IUFD) is estimated to occur in 1% of all pregnancies. The advent of prostaglandins has revolutionized the management of IUFD. There are limited studies using a combined regimen of mifepristone and misoprost for induction of labor in IUFD. Hence this study was undertaken to assess the efficacy and safety of combined regimen with misoprostol alone, in the management of IUFD.Methods: This hospital based prospective study included 60 pregnant women with IUFD admitted at Mediciti Institute of Medical Sciences, during the period January 2015 to July 2016. An ultrasound scan was performed to confirm IUFD and localize the placenta. Women were divided alternatively into 2 groups with 30 in each group (group 1- women received 200 mg mifepristone orally followed by misoprostol after 24 hours & in group 2, 100 µg misoprostol  every 6 hourly for a maximum of 4 doses between gestational age  24-26 weeks, 25-50 µg 4 hourly for a maximum of 6 doses beyond 26 weeks).Results: The mean induction to delivery interval was 10 hours in group 1 and 16.3 hours in group 2 (p value 0.007). Mean dose of misoprostol required in group 1 was 1.87 and 2.67 in group 2 (p value 0.008). With respect to side effects, the two groups did not differ significantly.Conclusions: The combined regimen was more effective than misoprostol for the induction of labour in IUFD, in terms of higher rate of successful delivery and shorter induction to delivery interval. 


2005 ◽  
Vol 7 (1) ◽  
pp. 22-27 ◽  
Author(s):  
Jay H. Rosenberg

Fatigue is the most common symptom of multiple sclerosis and is perhaps the symptom with the most devastating impact on patient well-being. It is reported by 75% to 95% of individuals, and more than half describe it as the worst symptom of the disease. The mechanisms underlying the development of fatigue remain unclear; although fatigue is believed to be a primary symptom of MS (ie, related to the demyelinating processes of the disease), fatigue may also occur secondarily to factors such as sleep disturbances, depression, or the effects of medications. The highly variable presentation of MS and the number of agents used for disease modification and symptom management make it important for potential contributors to MS-related fatigue to be identified and managed appropriately. If fatigue continues despite elimination or adequate management of secondary causes, pharmacologic therapy may be required. Several agents have been reported to improve MS-related fatigue; however, only three have been investigated in controlled trials. Amantadine has been studied in several small controlled trials, and appears to be effective in one quarter to one third of those with mild-to-moderate fatigue. It has shown efficacy on a number of scales, including the Visual Analog Scale for Fatigue (VAS-F) and the MS-Specific Fatigue Scale (MS-FS). The central nervous system (CNS) stimulant pemoline has demonstrated limited benefit in clinical trials and is often poorly tolerated, especially in higher doses. Recently, the wake-promoting agent modafinil has been shown to significantly improve MS-related fatigue on a number of commonly used fatigue assessment scales, including the Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS).


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