Search results for "Tolerability"
showing 10 items of 372 documents
Treatment of recurrent and/or metastatic squamous cell head and neck carcinoma with a combination of vinorelbine, cisplatin, and 5-fluorouracil: a mu…
1995
Summary Purpose Vinorelbine has been demonstrated to be active against squamous cell carcinomas of the headneck (SCHNC) and lung. This multicenter phase II trial was carried out to evaluate the activity and tolerability of the combination of vinorelbine, cisplatin, and 5-fluorouracil given on an outpatient schedule in a series of 80 patients with recurrent SCHNC. Patients and methods Eighty patients with recurrent and/ or metastatic SCHNC were treated with a combination of CDDP 80 mg/m2 on day 1, 5-FU 600 mg/m2 as a 4-hour infusion on days 2-5, and vinorelbine 25 mg/m2 on days 2 + 8. This cycle was repeated every 28 days. Most patients had oral cavity, larynx, or oropharynx carcinoma (88%).…
Efficacy and tolerability of multiple-dose SDZ IMM 125 in patients with severe psoriasis.
2006
Although cyclosporin is effective in immunosuppression following organ transplantation and in the treatment of psoriasis, its use is limited by its side-effects, notably impaired renal function and hypertension. As SDZ IMM 125, a new derivative of the cyclosporin family, showed considerable immunosuppressive activity in experimental studies, with less effect on renal function, it was considered a potential successor to cyclosporin for both indications. In this multicentre, double-blind, placebo-controlled study, the efficacy and tolerability of 40, 100, 200 and 400 mg SDZ IMM 125 daily were studied in 59 patients with psoriasis. Patients were followed for a period of 5 weeks (4 weeks treatm…
Safety of etanercept therapy in rheumatoid patients undergoing surgery: preliminary report
2009
This is a preliminary report on a case-series of rheumatoid patients that underwent various kinds of elective surgery but did not withdraw etanercept therapy in spite of physician advise. Elective surgery consisted of right knee surgical prosthesis, bilateral cataract, bilateral hallux valgus, right hip prosthesis, bladder stone by cystoscopy and left inguinal hernia. All the patients had a regular healing rate. During follow-up (6-12 months) no one of these patients were suffering from infective complications after surgery. According to same recent literature results, our data suggest that it is the time to value rheumatoid patient preferences through a correct information about cost-benef…
Efficacy and pharmacological appropriateness of cinnarizine and dimenhydrinate in the treatment of vertigo and related symptoms
2021
Vertigo is not itself a disease, but rather a symptom of various syndromes and disorders that jeopardize balance function, which is essential for daily activities. It is an abnormal sensation of motion that usually occurs in the absence of motion, or when a motion is sensed inaccurately. Due to the complexity of the etiopathogenesis of vertigo, many pharmacological treatments have been tested for efficacy on vertigo. Among these drugs, cinnarizine, usually given together with dimenhydrinate, appears to be the first-line pharmacotherapy for the management of vertigo and inner ear disorders. Based on these considerations, the present non-interventional study aimed to investigate the clinical …
Pharmacokinetics of Droloxifene and Its Metabolites in Breast Cancer Patients
1991
Pharmacokinetics and metabolism of droloxifene, a new antiestrogenic drug, have been investigated by single- and multiple-dose studies in postmenopausal patients with advanced breast cancer. Short terminal elimination half-life, low accumulation, and improved drug tolerability are the most striking features of this safe and effective new antiestrogen. Bioequivalence of film-coated tablet, tablet, and standard solution of droloxifene has been shown. The concentrations of droloxifene and its metabolites have been determined by a highly selective HPLC method.
Analysis of Safety and Tolerability Data Obtained from Over 1,500 Patients Receiving Topiramate for Migraine Prevention in Controlled Trials
2008
Objective. Topiramate is an effective and generally well-tolerated migraine preventive therapy, as shown in three large, randomized, double-blind, placebo-controlled registration trials. Based upon efficacy/tolerability, topiramate 100 mg/day (50 mg BID) is the recommended target dose for most patients with migraine. To further assess the safety and tolerability of topiramate for migraine prevention, we analyzed safety data from 1,580 patients who participated in the three pivotal registration trials or an earlier pilot, randomized, double-blind, placebo-controlled trial. Methods. The safety population consisted of all patients who took ≥1 dose of study medication during the double-blind …
Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis
2020
IntroductionNatalizumab (NTZ) is one of the most effective treatment options for multiple sclerosis (MS) treatment. Our study aimed to evaluate the effectiveness of NTZ when administered according to the extended dosing strategy compared with standard 4-weekly administration in a large Italian MS population.Materials and methodsThis retrospective multicentre study included patients with relapsing-remitting MS (RR-MS) who received NTZ administrations between the 1 June 2012 and the 15 May 2018 and were followed by the ‘Italian MS Register’. All patients with MS were stratified into two groups based on NTZ administration schedule: standard interval dosing (SID) patients who received infusions…
Upper-Body Exercises With External Resistance Are Well Tolerated and Enhance Muscle Activity in People With Hemophilia
2019
Abstract Background Conventional nonresisted therapeutic exercises for people with hemophilia involve a careful, low-intensity approach to avoid injuries. Externally resisted exercise is highly efficient for increasing muscle strength in healthy adults but its feasibility for people with hemophilia remains unknown. Objective The purpose of this study was to evaluate muscle activity during upper-body rehabilitation exercises with 2 types of external resistance and without external resistance (conventional) and to examine tolerability, kinesiophobia, and possible adverse effects derived from the session. Design This was a cross-sectional study. Methods Twelve people with hemophilia A/B (11 wi…
Feasibility, safety and muscle activity during flywheel vs traditional strength training in adult patients with severe haemophilia
2021
INTRODUCTION: Eccentric training has been associated with several specific physiological adaptations. The flywheel machine is one of the easiest ways of performing eccentric overload training. However, no studies evaluated its feasibility, safety and muscle activity in patients with haemophilia (PWH).AIM: To evaluate feasibility and safety and compare muscle activity during flywheel vs weight machine knee extension exercise in severe PWH.METHODS: Eleven severe PWH [mean age of 33.5 (8.1) years] participated in this cross-sectional study after receiving prophylactic treatment. Surface electromyography (EMG) signals were recorded for the rectus femoris during the knee extension exercise perfo…
A multicenter, double-blind, randomized, placebo-controlled trial of the β3-adrenoceptor agonist solabegron for overactive bladder
2012
Abstract Background β-Adrenoceptor agonists are effective in animal models of bladder dysfunction, and the human bladder primarily expresses the β3 receptor subtype. Objective To evaluate the efficacy and tolerability of the highly selective and potent β3-adrenoceptor agonist solabegron in a clinical proof-of-concept study in incontinent women with overactive bladder (OAB). Design, setting, and participants This was a randomized, double-blind trial in adult women with OAB (one or more 24-h incontinence episodes and eight or more average 24-h micturitions). Interventions Solabegron 50mg ( n =88), solabegron 125mg ( n =85), or placebo ( n =85)—all twice daily—were administered. Outcome measur…