Related Adverse Events (relate + adverse_event)

Distribution by Scientific Domains


Selected Abstracts


Executive function assessment of patients with schizophrenic disorder residual type in olanzapine treatment: an open study

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 6 2005
Paolo Stratta
Abstract Cognitive deficits are a fundamental feature of the schizophrenic disorder, but the effect of antipsychotic treatment is still debated. The study assesses the effect of olanzapine on neurocognitive functioning and symptomatology of patients with schizophrenic disorder residual type. Executive function evaluation by the Wisconsin card sorting test (WCST) was performed on 39 patients treated with olanzapine (5,20,mg/day); the efficacy of drug in improving symptomatology, safety and quality of life was also evaluated. After 7 months of treatment, the mean number of WCST categories tended to increase. Correct responses increased with a statistically significant change from the baseline. The total and unique errors decreased significantly. At all post-baseline visits a decrease from baseline in the PANSS total, positive and negative scores was seen. The proportion of patients with less severe illness (CGI), increased over the course of the study with a corresponding decrease of patients with more severe illness. The quality of life scores also tended to improve during treatment. The Simpson Angus scale, Barnes-akathisia and abnormal involuntary movement scale scores decreased consistently. The most common treatment emergent drug related adverse events were weight gain, insomnia, agitation and anxiety. Neurocognitive functioning in terms of executive performance and symptomatology improved in people with schizophrenia residual type. Copyright © 2005 John Wiley & Sons, Ltd. [source]


Current safety and tolerability issues in men with erectile dysfunction receiving PDE5 inhibitors

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 9 2007
W. J. G. Hellstrom
Summary Aims:, Treatment of erectile dysfunction (ED) has been greatly advanced by the advent of phosphodiesterase type-5 (PDE5) inhibitors. Upon the introduction of these agents, their cardiovascular (CV) safety was a major concern, mainly due to their vasodilatory effects. We conducted an electronic literature review of data concerning the safety and tolerability issues of men with ED receiving PDE5 inhibitors. Results:, Although safety concerns have been raised, evaluation of CV safety and related adverse events in clinical trials has not revealed any atypical safety issues. Discussion:, No causal association has been established to date between non-arteritic anterior ischaemic optic neuropathy (NAION) and PDE5 inhibitors. In addition, there are established guidelines which provide recommendations for the safe and effective use of these agents in treating men with ED and associated comorbidities. Conclusions:, Clinical trial and postmarketing surveillance data confirm the safety and tolerability profile of the PDE5 inhibitors, even in patients with endothelial dysfunction-associated comorbidities. [source]


Phase II trial of weekly bortezomib in combination with rituximab in untreated patients with Waldenström Macroglobulinemia

AMERICAN JOURNAL OF HEMATOLOGY, Issue 9 2010
Irene M. Ghobrial
This study aimed to determine the activity and safety of weekly bortezomib and rituximab in patients with untreated Waldenström Macroglobulinemia (WM). Patients with no prior therapy and symptomatic disease were eligible. Patients received bortezomib IV weekly at 1.6 mg/m2 on days 1, 8, 15, q 28 days × 6 cycles, and rituximab 375 mg/m2 weekly on cycles 1 and 4. Primary endpoint was the percent of patients with at least a minor response (MR). Twenty-six patients were treated. At least MR was observed in 23/26 patients (88%) (95% CI: 70,98%) with 1 complete response (4%), 1 near-complete response (4%), 15 partial remission (58%), and 6 MR (23%). Using IgM response evaluated by nephlometry, all 26 patients (100%) achieved at least MR or better. The median time to progression has not been reached, with an estimated 1-year event free rate of 79% (95% CI: 53, 91%). Common grade 3 and 4 therapy related adverse events included reversible neutropenia in 12%, anemia in 8%, and thrombocytopenia in 8%. No grade 3 or 4 neuropathy occurred. The combination of weekly bortezomib and rituximab exhibited significant activity and minimal neurological toxicity in patients with untreated WM. Am. J. Hematol., 2010. © 2010 Wiley-Liss, Inc. [source]


Novel treatment of chronic severe hand dermatitis with bexarotene gel

BRITISH JOURNAL OF DERMATOLOGY, Issue 3 2004
J.M. Hanifin
Summary Background Hand dermatitis is an eczematous inflammation of the hands that is related to occupation or to routine activities. It often becomes chronic, and in some patients may become severe and disabling. Topical corticosteroids are effective treatment, particularly for milder forms, but they often lose effectiveness with time and can produce skin atrophy. Objectives To evaluate bexarotene gel topical therapy for safety, tolerability and efficacy in patients with chronic hand dermatitis. Methods A phase I,II open-label randomized clinical study of bexarotene gel, alone and in combination with a low- and a mid-potency steroid, was conducted in 55 patients with chronic severe hand dermatitis at two academic clinics. Results Patients using bexarotene gel monotherapy reached a 79% response rate for ,,50% clinical improvement and a 39% response rate for ,,90% clearance of hands. Adverse events possibly related to treatment in all patients were stinging or burning (15%), flare of dermatitis (16%) and irritation (29%). Thirteen patients (24%) withdrew early, including two for related adverse events and five for inadequate response. Conclusions Bexarotene gel appears to be safe, tolerated by most patients, with useful therapeutic activity in chronic severe hand dermatitis. [source]


Comparison of Adverse Events during Procedural Sedation between Specially Trained Pediatric Residents and Pediatric Emergency Physicians in Israel

ACADEMIC EMERGENCY MEDICINE, Issue 7 2008
Itai Shavit MD
Abstract Objectives:, The aim was to compare the rate of procedural sedation,related adverse events of pediatric residents with specific training in "patient safety during sedation" and pediatric emergency physicians (PEPs) who completed the same course or were teaching faculty for it. Methods:, This prospective single-blinded, nonrandomized study was conducted in two university-affiliated pediatric emergency departments (PEDs) in Israel. Pediatric residents who were authorized to perform unsupervised sedations had previously completed a course in patient safety during sedation. Unsupervised sedations by residents were defined as sedations where the entire procedure was performed independently. Study subjects had autonomy in choosing medications for sedation. Adverse events were defined as transient hypoxia (oxygen saturation , 90%) or apnea. Adverse outcomes were situations where intubation or hospitalization directly related to sedation complications would occur. Sedations over 12 consecutive months were recorded, and rates of adverse events in each group were compared. Results:, A total of 984 eligible sedations were recorded, 635 by unsupervised residents and 349 by PEPs. A total of 512 (80.6%) sedations were performed by residents when attending physicians were not in the ED. The total adverse event rate was 24/984 (2.44%). When the two groups used a similar type drugs, residents had 8/635 (1.26%) events, compared to 11/328 (3.35%) by PEPs. There was no statistically significant difference in the rates of hypoxia or apnea between the two groups (p = 0.29 and p = 0.18, respectively). Adverse outcomes did not occur. Conclusions:, Unsupervised pediatric residents with training in patient safety during sedation performed procedural sedations with a rate of adverse events similar to that of PEPs. [source]