Severe Side-effects (severe + side-effect)

Distribution by Scientific Domains

Selected Abstracts

Peginterferon-alpha-2b plus ribavirin therapy in patients with chronic hepatitis C as assessed by a multi-institutional questionnaire in Japan

Tatsuya Ide
Background and aim:, There has so far been no questionnaire report on patients who were treated with peginterferon plus ribavirin (PEG IFN+RBV) therapy. The purpose of this study was to investigate the problems of this therapy by a questionnaire survey. Patients and methods:, A survey of 681 patients with chronic hepatitis C who received treatment with PEG IFN+RBV was conducted in the Kyushu region of Japan. Using an original questionnaire, the survey was conducted prior to the treatment, during the third month of treatment, at the completion of treatment or the discontinuation of treatment, and at 6 months after the completion of treatment. Results:, It was indicated that the patients had a high level of comprehension and understanding of chronic hepatitis C and PEG IFN+RBV treatment. However, the results also indicated that patients had a high level of anxiety. Side effects were adequately dealt with by physicians. However, dermatological symptoms were not adequately explained to the patients, although they were the second most severe side-effect. It was also revealed that side-effects were most distressing during the first and second months after the start of treatment. Conclusion:, The questionnaire survey provided new information that has never been reported. It is believed that understanding this information is important for future treatment. [source]

Side-effects and treatment with clozapine: A comparison between the views of consumers and their clinicians

Kay Hodge
ABSTRACT:, This study sought to clarify the prevalence of various side-effects experienced by consumers taking clozapine (n = 27) and to elucidate the impact of clozapine on their quality of life. Responses of consumers were contrasted with those of clinicians to highlight any discrepancies between the two groups, thus providing a focus for the improvement of clinical practice. Consumers completed a demographic questionnaire, the Liverpool University Neuroleptic Side-Effect Rating Scale. They next took part in a semistructured interview, which explored their attitudes to clozapine treatment. File searches provided historical data for antipsychotic use before the prescription of clozapine. Clinicians completed the same instruments and submitted them by mail. Most clinicians overestimated the prevalence and severity of clozapine side-effects. Consumers reported drooling mouth as the most prevalent and severe side-effect, whereas clinicians estimated that difficulty staying awake was the most prevalent side-effect, and the most severe side-effect was sleeping too much. Clinicians and consumers agreed that clozapine lifts mood. Only 19% of consumers were unhappy about blood tests, whereas 52% of clinicians estimated that consumers were unhappy about blood tests. This study suggests that despite significant side-effects and regular blood tests, most stable consumers taking clozapine were happier and more satisfied with their treatment than many of their clinicians believed they were. The study also highlights the need for clinicians to ask consumers about the different side-effects they may be experiencing, so they can provide clinical support to improve their quality of life. [source]

Adverse events during use of intranasal desmopressin acetate for haemophilia A and von Willebrand disease: a case report and review of 40 patients

HAEMOPHILIA, Issue 1 2000
We report our experience with the incidence of adverse events during the use of Stimate® brand intranasal desmopressin acetate (IN DDAVP) for patients with haemophilia A (HA) or von Willebrand disease (vWD) after noting two severe adverse events in one adult patient. All patients with documented vWD (type 1 or 2 A) or haemophilia A (mild, moderate or symptomatic carrier) from the Emory Comprehensive Hemophilia Center who had IN DDAVP challenge testing or were using Stimate® for treatment of bleeding were evaluated for adverse events by patient report or nursing observation of clinical signs and symptoms. Forty patients were studied. Sixty-eight per cent (27/40) experienced clinical signs and/or symptoms. The majority of these symptoms were mild, however several patients reported moderate to severe side-effects and one adult patient required medical intervention for symptomatic hyponatraemia. In our experience, two-thirds of patients tested experienced adverse signs and/or symptoms with the use of Stimate®; considerably higher than that reported from preliminary results in the literature. Young age did not correlate positively with adverse reactions. Severe adverse events requiring medical intervention were rare, however symptoms such as moderate to severe headache, nausea, vomiting and weakness may necessitate evaluation for hyponatraemia. This is the first report of symptomatic hyponatraemia in an adult patient with recommended dosing of Stimate®. Side-effects may be minimized if patients adhere to instructions regarding fluid intake and composition while using IN DDAVP. [source]

Current antiviral therapies for chronic hepatitis B

Mari Inada
Among current treatment options for chronic hepatitis B, nucleoside/nucleotide analog therapy has better tolerability and most patients respond to the therapy, while interferon (IFN) therapy has rather severe side-effects and a lower response rate. However, nucleoside/nucleotide analog therapies have problems of the emergence of drug resistance and poor sustainability of response after discontinuation. After the first nucleoside/nucleotide analog lamivudine, adefovir and entecavir are now utilized in many countries. Adefovir has efficacy for lamivudine resistant patients and current data suggests that adding adefovir to ongoing lamivudine is better than switching to adefovir in terms of viral suppression and the occurrence of resistance. Entecavir can be the first choice for naďve patients, although cross-resistance has been known for lamivudine resistant patients and mutational screening should take place before using entecavir with such patients. Many other new nucleoside/nucleotide analogs are being developed such as telbivudine, clevudine and tenofovir; the details of each drug will be disclosed in near future. [source]

Persistent dystonia induced by fluoxetine

. Bilen
Abstract Serotonin-selective re-uptake inhibitors are prescribed widely because they are regarded as having less severe side-effects compared with tricyclics and monoamine oxidase inhibitors. With this popularity, increasing attention has been drawn to their adverse effects. Development of extrapyramidal symptoms has been reported in some patients while taking fluoxetine, a commonly used serotonin-selective re-uptake inhibitor. Here, we report a case of persistent dystonia, thought to be associated with short-term fluoxetine use, which required treatment with botulinum toxin type A. [source]

Prevention and treatment of glucocorticoid-induced osteoporosis in daily dermatologic practice

Hester Vermaat
Background Systemic glucocorticoids (GCs) are often needed to treat dermatologic patients. The long-term use of GCs, however, is associated with potentially severe side-effects. GC-induced osteoporosis (GIO) is one of the most serious complications, but the risk of the occurrence of GIO seems to be generally underestimated. Aim To provide an update of the recent advances in the prevention of GIO in dermatologic practice. Methods Review of the literature and several European and US guidelines up to August 2007. Results Data regarding the prevention and treatment of GIO are limited and guidelines for the prevention of GIO are not fully consistent. Conclusion The prophylaxis of osteoporosis needs to be started early during treatment with GCs. Calcium and vitamin D supplements in all patients on systemic GCs and bisphosphonates in patients who take GCs for more than 3 months are practical and effective measures. [source]

Methotrexate in psoriasis: 26 years' experience with low-dose long-term treatment

U-F. Haustein
Abstract Objective,To evaluate the efficacy, safety and side-effects of methotrexate (MTX) in psoriasis. Design,A 26-year retrospective study. Setting,Department of Dermatology, Leipzig University, Leipzig, Germany. Patients,One hundred and fifty-seven patients with extensive plaque psoriasis, erythrodermic, pustular and arthropathic forms, were treated with low-dose methotrexate (15,20 mg maximum weekly dosage [Weinstein schedule]), the majority for long-term periods. The mean cumulative dose was 3394 mg, the mean duration 237 weeks. Results,The effect of MTX treatment was good in 76%, moderate in 18% and poor in 6% of subjects; 61% experienced side-effects, most frequently due to liver function abnormalities, bone marrow suppression, nausea, gastric complaints and hair loss. In 20% of cases the subjects were forced to discontinue therapy; 9% refused therapy due to physical and psychological discomfort, 2% wanted to become pregnant, 16% were lost to follow-up, 6% died from multimorbidity and old age. Three subjects (2%) developed cancer of the lung, breast or cervix uteri, possibly in relation to long-term MTX treatment. Altogether there were no deaths or life-threatening side-effects attributable to MTX treatment, and no cases of progressive liver cirrhosis apart from two extensive skin necroses due to overdosage (misunderstanding, suicidal attempt) that were treated successfully with citrovorum factor. Conclusion,Low-dose MTX (<15,20 mg/week) is an effective therapy for extensive and severe forms of psoriasis if patients are selected carefully and monitored regularly, particularly with respect to liver and bone marrow toxicity. This helps to reduce severe side-effects even during long-term treatment. Drug interactions must be avoided. MTX therapy according to the guidelines is relatively safe and still has a place in the systemic treatment of psoriasis with 40 years of experience and an acceptable safety record. [source]

Challenges and strategies: The immune responses in gene therapy

Hai-sheng Zhou
Abstract The host immune responses, including T lymphocytes mediated immune response and humoral immune responses are the important parts of the challenges in gene therapy. There are some potential immunostimulants in gene delivery systems, such as viral and non-viral vectors. Viral gene products, transgene products, viral proteins derived from viral particles required by dead-end infection, and CpG DNA in plasmid may play important roles in inducing the host immune responses when foreign genes are transferred into the targeted tissues. The immune responses should lead to many problems in gene therapy: transient expression of therapeutic gene, non-efficient re-administration of the same vectors, and severe side-effects in clinical trials. Although RNAi may act as gene therapeutic agent for suppression of specific gene expression, little attention has been given to the potential non-specific effects that might be induced. It was reported that small interfering RNAs (siRNAs) can induce the host interferon response following transfected to mammalian cells. Facing these challenges, a number of studies have been focused on taking measures to solve them, such as immunosuppression, selection of different administration routes and dose of the vectors, using the tissue-specific promoters and modifying the vectors. © 2004 Wiley Periodicals, Inc. Med Res Rev, 24, No. 6, 748,761, 2004 [source]

Targeting the MHC class II pathway of antigen presentation enhances immunogenicity and safety of allergen immunotherapy

ALLERGY, Issue 1 2009
J. M. Martínez-Gómez
Background:, Current s.c. allergen-specific immunotherapy (SIT) leads to amelioration of IgE-mediated allergy, but it requires numerous allergen injections over several years and is frequently associated with severe side-effects. The aim of this study was to test whether modified recombinant allergens can improve therapeutic efficacy in SIT while reducing allergic side-effects. Methods:, The major cat allergen Fel d 1 was fused to a TAT-derived protein translocation domain and to a truncated invariant chain for targeting the MHC class II pathway (MAT-Fel d 1). The immunogenicity was evaluated in mice, while potential safety issues were assessed by cellular antigen stimulation test (CAST) using basophils from cat-dander-allergic patients. Results:, MAT-Fel d 1 enhanced induction of Fel d 1-specific IgG2a antibody responses as well as the secretion of IFN-, and IL-2 from T cells. Subcutaneous allergen-specific immunotherapy of mice using the modified Fel d 1 provided stronger protection against anaphylaxis than SIT with unmodified Fel d 1, and MAT-Fel d 1 caused less degranulation of human basophils than native Fel d 1. Conclusion:, MAT-Fel d 1 allergen enhanced protective antibody and Th1 responses in mice, while reducing human basophil degranulation. Immunotherapy using MAT-Fel d 1 allergen therefore has the potential to enhance SIT efficacy and safety, thus, shortening SIT. This should increase patient compliance and lower treatment costs. [source]

The Management of Pain From Collapse of Osteoporotic Vertebrae With Continuous Intrathecal Morphine Infusion

Maria Rita Saltari MD
ABSTRACT Objectives., Vertebral fractures are the most common consequences of severe osteoporosis. The chronic pain from collapse of osteoporotic vertebrae affects quality of life (QoL) and autonomy of patients. The management of pain with oral or transdermal opiates can cause severe side-effects. Continuous intrathecal administration of morphine through an implantable pump might represent an alternative therapy to conventional oral or transdermal administration of opioids and has some advantages and disadvantages for pain relief and improvement in QoL when compared to conventional opioid delivery. It is our objective to report our experience using intrathecal delivery of analgesics in a population of patients with refractory pain due to vertebral fractures. Materials and Methods., In 24 patients, refractory to conventional delivery of opioids, we used intrathecal analgesic therapy. To test for efficacy and improvement in QoL, we administered the visual analog scale (VAS) for pain and the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Before patients were selected for pump implantation, an intraspinal drug delivery trial was performed to monitor side-effects and responses to intrathecal therapy. Results., Significant pain relief was obtained in all implanted patients. Using the QUALEFFO, we observed significant improvement of all variables such as QDL (quality of daily life), DW (domestic work), ambulation, and PHS (perception of health status), before and after one year after pump implantation. With intrathecal morphine infusion, none of the 24 patients required additional systemic analgesic medication. The mean morphine dose during the spinal trial was 11.28 mg/day, 7.92 mg/day at pump implantation, and 16.32 mg/day at one-year follow-up. Conclusions., Our results show that intrathecal administration of morphine efficiently relieves the symptoms of pain and improves QoL. Continuous intrathecal administration of morphine appears to be an alternative therapy to conventional analgesic drug delivery and has advantages in those patients who have severe side-effects with systemic administration of analgesics. [source]

Rituximab in refractory autoimmune bullous diseases

E. Schmidt
Summary Treatment of autoimmune blistering diseases consists of systemic glucocorticosteroids usually in combination with additional immunosuppressants such as azathioprine and mycophenolate mofetil or immunomodulators such as dapsone, antibiotics, intravenous immunoglobulins, and immunoadsorption. In some patients, these treatment regimens are not sufficient to control disease activity and/or lead to intolerable adverse events. Rituximab, originally developed for the treatment of non-Hodgkin's lymphoma, is an anti-CD20 humanized monoclonal antibody leading to transitory B-cell depletion. For this indication, rituximab is widely employed, and severe side-effects rarely observed. Subsequently, the B-cell-depleting effect of rituximab has been exploited successfully in various autoimmune disorders, including autoimmune blistering diseases. Here, we review the effect of rituximab in such diseases. To date, application of rituximab has been reported in 26 treatment-resistant patients with the vulgaris, foliaceus, and paraneoplastic variants of pemphigus as well as in bullous pemphigoid and epidermolysis bullosa acquisita. All but a single patient showed clinical improvement with reduction of lesion formation. In about a third, a clinical remission requiring further immunsuppressive medication was achieved, and in about a quarter, complete remission was induced. In addition, the mode of action and adverse events of rituximab as well as adjuvant immunosuppressive treatments, and the effect on levels of circulating autoantibodies in these patients are discussed. [source]