Search results for "Tolerability"
showing 10 items of 372 documents
RANDOMIZED PHASE II STUDY OF FIRST-LINE EVEROLIMUS (EVE) + BEVACIZUMAB (BEV) VERSUS INTERFERON ALFA-2A (IFN) + BEV IN PATIENTS (PTS) WITH METASTATIC …
2012
ABSTRACT Background Study results demonstrated that IFN augments BEV activity and improves median PFS in pts with mRCC. Thus, combination BEV + IFN is a standard first-line treatment option for mRCC. Combining BEV with the mTOR inhibitor EVE may be an efficacious and well-tolerated treatment option. The open-label, phase II RECORD-2 trial compared first-line EVE + BEV and IFN + BEV in mRCC. Patients and methods: Therapy-naive pts with clear cell mRCC and prior nephrectomy were randomized 1:1 to BEV 10 mg/kg IV every 2 weeks with either EVE 10 mg oral daily or IFN (9 MIU SC 3 times/week, if tolerated). Tumour assessments were every 12 weeks. Primary objective was treatment effect on progress…
Pharmacotherapy of Borderline Personality Disorder: A Metaanalysis of Randomised Controlled Trials
2009
Background:In Borderline Personality Disorder (BPD), pharmacotherapy is used for the treatment of specific BPD pathology facets, such as cognitive-perceptual, affective, or impulsivity symptoms. Due to the polymorphic phenomenology of the disorder, different classes of drugs are used, e.g., antipsychotics, antidepressants, or mood stabilizers.Aims:To evaluate the up-to-date evidence of drug treatment efficacy for BPD.Method:A systematic review and metaanalysis of randomised controlled trials was done. All randomised comparisons of drug vs. placebo, drug vs. drug, or drug vs. a combination of drugs in adult BPD patients were eligible for inclusion. Outcomes comprised BPD core pathology as de…
Palliative splenic irradiation in primary and post PV/ET myelofibrosis: outcomes and toxicity of three radiation schedules
2009
Splenectomy and splenic irradiation (SI) are the sole treatment modalities to control drug resistant splenomegaly in patients with myelofibrosis (MF). SI has been used in poor surgical candidates but optimal total dose and fractionation are unclear. We retrospectively reviewed 14 MF patients with symptomatic splenomegaly. Patients received a median of 10 fractions in two weeks. Fraction size ranged from 0.2–1.4 Gy, and total dose varied from 2–10.8 Gy per RT course. Overall results indicate that 81.8% of radiation courses achieved a significant spleen reduction. Splenic pain relief and gastrointestinal symptoms reduction were obtained in 94% and 91% of courses, respectively. Severe cytopeni…
EMG, Rate of Perceived Exertion, Pain, Tolerability and Possible Adverse Effects of a Knee Extensor Exercise with Progressive Elastic Resistance in P…
2020
In people with haemophilia (PWH), elastic band training is considered an optimal option, even though the literature is scarce. The aim was to evaluate normalized electromyographic amplitude (nEMG), rate of perceived exertion (RPE), pain, tolerability, and possible adverse effects during the knee extension exercise using multiple elastic resistance intensities in PWH. During a single session, 14 severe PWH undergoing prophylactic treatment performed knee extensions without resistance and with different intensity levels of elastic resistance. nEMG was measured for the knee extensors and participants rated their RPE, tolerability and pain intensity after each condition. Patients had to report …
Bone marrow evaluation according to the PVSG and WHO criteria in 90 essential thrombocythemia (ET) patients treated with PEG interferon alpha-2b. Pre…
2005
Abstract Ninety ET patients diagnosed according to the PVSG criteria were enrolled in a phase II study (sponsored by the Schering-Plough Company) designed to evaluate the efficacy, safety and tolerability of a two years treatment with PEG Interferon alpha-2 b (PEG Intron). The patients, observed in 16 Italian Centres belonging to the GIMEMA Cooperative Group and judged at high risk, had been previously treated with cytoreductive (97%) and antiplatelet (91%) drugs. At the study start the patients, 60 F and 30 M, mean age 45 years, showed splenomegaly in 22% of cases. The Hematological Response (HR: PLT<500 x109/L) was observed in 64/81 (79%) and 48/55 (87%) of the patients on PEG Intr…
Reaction of the bone structure to methotrexate-Palacos flow y. Experimental investigations in animals.
1989
With the combined osteosynthesis of pathological fractures in association with tumors and/or metastases in mind, E. Merck (Darmstadt, FRG) developed a bone cement containing a cytostatic agent, methotrexate-Palacos flow y (MTX-Pf). The animal-experimental study presented here investigates the tolerability of MTX-Pf in the femurs of rabbits with lateral comparison. In these investigations we used both the concentration of 0.63% MTX, as is currently used in standard clinical surgery, as well as a much higher concentration of 2.5% MTX. The histological sections were investigated using microradiographic methods and provided no indication of any significant differences between the femora with th…
Open-label ODYSSEY APPRISE study: Interim data from the first 843 participants
2018
Background PCSK9 inhibitors (PCSK9i) have been recommended by the ESC/EAS Task Force in very high risk subjects with ASCVD and those with heterozygous familial hypercholesterolemia (HeFH) with persistent high LDL-C levels despite maximally tolerated LLT. Purpose ODYSSEY APPRISE (NCT02476006) is the first study to assess efficacy and safety at Week (W) 12 of the PCSK9i alirocumab (ALI) in a real-life setting prior to commercial availability. Methods APPRISE was an open-label, single-arm study, conducted in 16 European countries and Canada. Subjects with inadequately controlled lipid levels despite maximally tolerated LLT were included. Based on physician's judgment, participants received eit…
NEO1 and NEO-EXT studies: Long-term safety of repeat avalglucosidase alfa dosing for 4.5 years in late-onset Pompe disease patients
2019
Safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of repeat avalglucosidase alfa dosing (5, 10, or 20 mg/kg qow) for 6 months were evaluated in NEO1 (NCT01898364) in late-onset Pompe disease patients either treatment-naive (Naive) or having received alglucosidase alfa for ≥9 months (Switch). In NEO-EXT (NCT02032524), an ongoing NEO1 extension, long-term safety and pharmacokinetics of repeat avalglucosidase alfa dosing will be monitored over 6 years. Interim safety results after 4.5 years of NEO-EXT are reported here. Mean ages at NEO1 enrollment were: Naive: 44.8 (SD:20.3, range:20-78) years and Switch: 46.7 (SD:14.1, range:21-68) years. Of the 24 NEO1 parti…
Drug Induced Liver Injury (DILI) due to variability in monacolin K content in Red Yeast Rice (RYR): An expert opinion
2020
Abstract Introduction Red yeast rice (RYR) is an effective cholesterol-lowering nutraceutical reversibly inhibiting 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase. As liver damage is a possible (albeit rare) side effect of HMG-CoA inhibitors, it make sense to focus on the tolerability of the liver to RYR extracts. The aim of this paper is to offer an expert opinion on the risk of liver damage by the use of RYR extract. Methods A review of the available literature has been carried out and critically reviewed by the authors. Results According to a large meta-analysis of 53 randomized clinical trials comprising 112 treatment arms, which included 8535 subjects with 4437 in the RYR arm and …
Systematic review and meta-analysis of the efficacy and safety of minocycline in schizophrenia
2017
ObjectiveOur aim was to perform an updated systematic review and meta-analysis on the efficacy and safety of adjunctive minocycline as a treatment of schizophrenia.MethodsWe conducted a PubMed/Scopus database search from inception to 3 February 2016 for randomized, placebo-controlled trials (RCTs), open non-randomized studies, and case reports/series evaluating minocycline in patients with schizophrenia. Random-effects meta-analysis of positive, negative, depressive, and cognitive symptom rating scales, discontinuation and adverse effects rates calculating standardized mean difference (SMD), and risk ratios±95% confidence intervals (CI95%) were calculated.ResultsSix RCTs were eligible (mino…