Search results for "Tolerability"
showing 10 items of 372 documents
Monitoring of Plasma Concentrations of Psychotropic Drugs in Pharmacovigilance
2015
The primary aims of pharmacovigilance are supervision and prevention of medication-related problems under everyday conditions. Pharmacovigilance is an indication for monitoring plasma concentrations, i.e. conducting therapeutic drug monitoring (TDM). Using TDM, it can be clarified if observed unwanted drug effects may be attributed to abnormally high or low drug concentrations. Utmost benefits from TDM are obtained for pharmacovigilance when the method is adequately integrated into the clinical treatment process. How to do this is described in consensus guidelines for TDM in psychiatry. During the last 20 years, TDM was very successful for detection of multiple pharmacokinetic drug-drug int…
A Prospective Open‐Label Observational Study of a Buffered Soluble 70 mg Alendronate Effervescent Tablet on Upper Gastrointestinal Safety and Medicat…
2021
Upper gastrointestinal (GI) side effects are a main reason for discontinuing bisphosphonate treatment, an important therapeutic option for osteoporosis patients. Consequently, the development of novel formulations with improved tolerability is warranted. In this multicenter prospective, observational, postauthorization safety study conducted in Italy and Spain, postmenopausal women (PMW) with osteoporosis (naïve to bisphosphonates) were treated weekly with a buffered soluble alendronate 70 mg effervescent (ALN-EFF) tablet (Binosto®) and followed for 12 ± 3 months. Information was collected on adverse events (AEs), medication errors, persistence, and compliance using the Morisky-Green questi…
Lurasidone in the Treatment of Bipolar Depression: Systematic Review of Systematic Reviews
2017
Introduction. A burgeoning number of systematic reviews considering lurasidone in the treatment of bipolar depression have occurred since its Food and Drug Administration extended approval in 2013. While a paucity of available quantitative evidence still precludes preliminary meta-analysis on the matter, the present quality assessment of systematic review of systematic reviews, nonetheless, aims at highlighting current essential information on the topic. Methods. Both published and unpublished systematic reviews about lurasidone mono- or adjunctive therapy in the treatment of bipolar depression were searched by two independent authors inquiring PubMed/Cochrane/Embase/Scopus from inception u…
Retreatment with interferon plus ribavirin of chronic hepatitis C non-responders to interferon monotherapy: a meta-analysis of individual patient dat…
2002
Background and aims: Retreatment with a combination of α interferon (IFN) plus ribavirin of patients with chronic hepatitis C who did not respond to IFN monotherapy has not been assessed in large controlled studies. Methods: To assess the effectiveness and tolerability of IFN/ribavirin retreatment of non-responders to IFN and to identify predictors of complete (biochemical and virological) sustained response, we performed a meta-analysis of individual data on 581 patients from 10 centres. Retreatment with various IFN schedules (mean total dose 544 mega units) and a fixed ribavirin dose (1000–1200 mg/daily depending on body weight) was given for 24–60 (mean 39.5) weeks. Results: Biochemical …
Awareness and understanding of cancer immunotherapy in Europe.
2014
3053 Background: Use of immunotherapies in the treatment of cancer is growing and a range of new immunotherapeutic strategies are being evaluated. It is important that healthcare providers (HCP) understand these treatments and how they compare with and may complement established therapies. As part of the activities of the POINT expert group, we commissioned a survey of current awareness, attitudes and perceptions of cancer immunotherapy in Europe. Methods: From August-September 2011, 426 healthcare professionals (HCPs: oncologists, surgeons and oncology nurses) from France, Germany, Italy, Spain and the UK (~85 respondents/country) completed online interviews. Representatives of patient ad…
Recent progress and new trends in the treatment of hepatitis B
2002
The annual rate of progression to cirrhosis in patients with chronic HBV is 0.4 to 14.2% and that of death 4 to 10%. HCC risk increases in parallel with the severity and duration of infection, with an annual incidence less than 0.5% in carriers and 6% in patients with cirrhosis. The main aim of antiviral therapy for chronic "wild-type" HBV infection is to suppress viral replication before cirrhosis and HCC develop. Two drugs are approved: IFN alpha and lamivudine. IFN alpha is costly, has a narrow range of efficacy, safety, and tolerability. Lamivudine is active, cheaper, and better tolerated but has limited efficacy, being associated with increasing resistance and loss of clinical response…
PEG IFN alfa-2a vs. alfa-2b: And the winner is …?
2009
Abstract Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team. N Engl J Med 2009 Aug 6;361(6):580–93. Background Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared. Methods At 118 sites, patients who had HCV genotype 1 infection and who had not …
Sodium zirconium cyclosilicate: a new potassium binder for the treatment of hyperkalemia
2018
Hyperkalemia is one of the most common electrolyte disturbances, especially among some groups of patients, such as in those with chronic kidney disease, diabetes or heart failure. Hyperkalemia has been associated with increased risks of mortality, arrhythmias, hospitalization and costs, as well as the need to down titrate/discontinue renin-angiotensin-aldosterone system inhibitors (RAASIs), despite their well-known cardiovascular and nephroprotective benefits. Current potassium binders have limitations (slow onset of action, limited selectivity for potassium binding, risk of drug interactions or gastrointestinal intolerance). Sodium zirconium cyclosilicate (SZC) is a new potassium binder re…
Microwave-induced thermoablation with Amica-probe is a safe and reproducible method to treat solid renal masses: results from a phase I study.
2012
Microwave thermal ablation (MWTA) could be considered in the future for treating small solid renal masses. The aim of the present study was to determine both the tolerability of the new Amica-probe applicator-induced MWTA used in vivo on patients with solid renal masses and the effects of heating on renal tumors and normal renal parenchyma. Fourteen patients with renal masses eligible for open radical nephrectomy were enrolled in this phase I study. All patients underwent MWTA of renal masses during the open surgery procedure before clamping of renal vascular pedicle. The effects of MWTA on patients' coagulation and tumor/renal vasculature were investigated. The histological effects of MWTA…
Efficacy and safety of tafluprost 0.0015% and timolol maleate 0.5% fixed combination in patients with ocular hypertension or open-angle glaucoma.
2014
Lowering intraocular pressure (IOP) is at present the only therapeutic approach to the treatment of glaucoma proven to be successful. The choice of therapy must take into account efficacy, tolerability, safety, quality of life, adherence and cost. Monotherapy fails to achieve a satisfactory IOP reduction in 40 - 75% of glaucoma patients after2 years of therapy. So far, three prostaglandin/timolol maleate 0.5% fixed combinations (FCs) are available.This review provides a background on the tafluprost-timolol FC (TTFC, Santen Oy) and its individual compounds. It summarizes the data on efficacy and safety, including comparative data with prostaglandin/timolol FCs already available.Tafluprost is…