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Efficacy and safety of the long-term oral administration of carprofen in the treatment of osteoarthritis in dogs

Efficacy and safety of the long-term oral administration of carprofen in the treatment of osteoarthritis in dogs

The aim of this study conducted in France was to confirm the efficacy and safety of the oral administration of carprofen (Rimadyl®) at 4 mg/kg once a day during four months in the treatment of clinically chronic osteoarthritis in dogs. One hundred and ten dogs with chronic clinical signs of osteoarthritis were enrolled. The overall severity of the osteoarthritis condition and the cli- nical signs of osteoarthritis were assessed using visual analogue scales (VAS) on days 0, 5, 30, 60, 90 and 120. During the same visits, owners were asked to perform their own efficacy assessment through the grading of seven parameters using categorical scales. Hematological analyses were perfor- med on days 0 and 120. Clinical blood chemistry evaluations were perfor- med on days 0, 5, 60 and 120. The percentage of dogs showing a positive treatment effect increased from 12% on day 5 to 74% on day 120. The mean VAS scores significantly decreased throughout the study (P ≤ 0.05). Gastro- intestinal undesirable effects likely to be related to carprofen but with no harmful consequences were observed in 5% of treated dogs. No detrimental effects of the treatment on haematological, renal and hepatic parameters were observed. These results show that carprofen at 4 mg/kg once daily can be safely used over a 4 month period in the treatment of osteoarthritis in dogs and provides a steadily increasing improvement of the clinical signs.
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Efficacy and safety of hepatitis C direct-acting protease inhibitors (DAA-PI ) in real life in HIV-HCV coinfected patients

Efficacy and safety of hepatitis C direct-acting protease inhibitors (DAA-PI ) in real life in HIV-HCV coinfected patients

Cite this article as: Ménard et al.: Efficacy and safety of hepatitis C direct-acting protease inhibitors (DAA-PI ) in real life in HIV-HCV coinfected patients. BMC Infectious Diseases 2014 14(Suppl 2):P84. 1 SMIT, La Conception University Hospital, Marseille, France

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Do ethnobotanical and laboratory data predict clinical safety and efficacy of anti-malarial plants?

Do ethnobotanical and laboratory data predict clinical safety and efficacy of anti-malarial plants?

clinical outcomes of patients who have used specified remedies for treating an episode of malaria [8]. This approach has proved to work well in Mali [9]. There already exists a wealth of published ethnobotanical and pharmacological studies on anti-malarial plants. How- ever, this information has never been reviewed systemati- cally and there is no standard method for doing so. Standard scores and methods have been developed for meta-analysis of studies of medical interventions and diag- nostic tests [10]. There have been attempts at scoring plants according to basic ethnobotanical criteria (for exam- ple frequency of citation, or how widely a remedy is used [1,6] but these do not take into account all important fac- tors such as the quality of studies or pharmacological infor- mation on efficacy and safety. Others have prioritized plants according to the selectivity index in vitro, corre- sponding to the ratio between cytotoxicity and activity against Plasmodium falciparum [11]. The first aim of this study was to design a standard score that could be used to prioritize traditional herbal remedies for further research based on objective criteria and systematic literature reviews, combining all available information from both ethnobotanical and pharmacological studies. The second
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Real-world efficacy and safety of fluocinolone acetonide implant for diabetic macular edema: A systematic review

Real-world efficacy and safety of fluocinolone acetonide implant for diabetic macular edema: A systematic review

A search of PubMed was performed in March 2020 using the keywords (“Fluocinolone Acetonide” OR “Iluvien”) AND (“DME” OR “DMO” OR “Diabetic Macular Edema”) in order to identify publications assessing the efficacy and safety of the FAc implant on DME and retrieved 64 results. Only publications that were not solely evaluating the economic impact of the implant, which were also not case report studies, RCTs or subgroup analysis of RCTs, were selected. Of these, only articles published in English, those with a follow-up period of more than six months and a global population of more than 10 eyes with DME were selected. A total of 22 studies met all inclusion criteria and were included in the final analysis. When different patient subgroups were found for any given study, results were presented separately for each subgroup. Because of the nature of this work, no ethics committee approval was obtained.
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Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome: A randomized, double-blind study

Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome: A randomized, double-blind study

Research frontiers Studies have observed altered intestinal microflora in IBS patients and an in- crease in symptoms after enteric infections, suggesting that restoration of the intestinal microflora may be a useful therapeutic goal. One strategy to restore normal flora is the use of probiotics. Probiotics are beneficial bacteria or yeasts that are ingested to improve health. Probiotics are also known to modulate the immune response and reduce cytokine production. This pilot study investigated the efficacy and safety of Lactobacillus casei rhamnosus LCR35, a probiotic used for its antidiarrhoeal properties for more than 50 years and shown in vitro to adhere to intestinal cells and to display antibacterial activity against a large variety of pathogens. Major problems in clinical research on IBS are the multiple presentations of this disease, the high placebo response and the absence of any consensus on the main outcome measure.
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Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)

Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)

Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin (IL)- 17A, a pro-inflammatory cytokine that mediates joint damage [ 11 ]. Ixekizumab is approved for use in active PsA, moderate-to-severe psoriasis, pedi- atric psoriasis (C 6 years with body weight C 25 kg), ankylosing spondylitis, and non-radiographic axial spondyloarthritis [ 12 , 13 ]. Persistent efficacy over 3 years was observed in the SPIRIT-P1 trial, a phase 3 trial investi- gating ixekizumab treatment in patients with active PsA who had not previously received biologic therapy for PsA or psoriasis [ 14 ]. SPIRIT-P2 is a phase 3 trial of 363 patients with active PsA who had an inadequate response or an intolerance to one or two TNF inhibitors. In this study, ixekizumab improved the signs and symptoms of PsA with superiority to placebo (PBO) at 24 weeks [ 15 ]. Furthermore, clinical improvements persisted up to 1 year during the extension period [ 16 ]. In this article, the authors report their evaluation of the long-term efficacy and safety profile of ixekizumab in patients with prior inadequate response or intolerance to TNF inhibitors through 3 years of treatment in SPIRIT-P2.
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Efficacy and Safety of Sofosbuvir plus Daclatasvir for Treatment of HCV-associated Cryoglobulinemia Vasculitis.

Efficacy and Safety of Sofosbuvir plus Daclatasvir for Treatment of HCV-associated Cryoglobulinemia Vasculitis.

Accepted Manuscript Efficacy and Safety of Sofosbuvir plus Daclatasvir for Treatment of HCV-associated Cryoglobulinemia Vasculitis David Saadoun, Stanislas Pol, Yasmina Ferfar, Laurent Alric, Christophe Hezode, Si Nafa Si Ahmed, Luc de Saint Martin, Cloé Comarmond, Anne Sophie Bouyer, Lucile Musset, Thierry Poynard, Matthieu Resche Rigon, Patrice Cacoub PII: S0016-5085(17)30269-X

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Efficacy and Safety of Everolimus and Mycophenolic Acid With Early Tacrolimus Withdrawal After Liver Transplantation: A Multicenter Randomized Trial

Efficacy and Safety of Everolimus and Mycophenolic Acid With Early Tacrolimus Withdrawal After Liver Transplantation: A Multicenter Randomized Trial

Efficacy and safety of everolimus and mycophenolic acid with early tacrolimus withdrawal after liver transplantation: A multicenter, randomized trial Faouzi Saliba 1 , Christophe Duvoux 2 , Jean Gugenheim 3 , Nassim Kamar 4 , Sébastien Dharancy 5 , Ephrem Salamé 6 , Martine Neau-Cransac 7 , François Durand 8 , Pauline Houssel- Debry 9 , Claire Vanlemmens 10 , Georges Pageaux 11 , Jean Hardwigsen 12 , Daniel Eyraud 13 , Yvon Calmus 14 , Fabienne Di Giambattista 15 , Jérôme Dumortier 16 , Filomena Conti 14

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Efficacy and safety of autologous stem cell transplantation after induction therapy with lenalidomide, bortezomib, and dexamethasone

Efficacy and safety of autologous stem cell transplantation after induction therapy with lenalidomide, bortezomib, and dexamethasone

neutropenia led to a lenalidomide discontinuation. Thus, neuropathy risk appeared to be significantly lower with lenalidomide than with thalidomide. The incidence of thalidomide- related neuropathy (all grades) varies between 10 and 83% (21–23,35–37). With TVD combination, the risk of peripheral neuropathy ≥ grade 3 is about 10 to 31% (26–29,38), in comparison to our 5% rate with RVD combination. This rate of peripheral neuropathy ≥ grade 3 related to RVD was similar to the rate found by Rosiñol et al comparing RVD and TVD (5% versus 15.4%) (31). In our cohort, only one thromboembolic event underwent, but in a patient who had discontinued his thromboprophylaxis, while no herpes zoster infection occurred. Surprisingly, we did not find secondary malignant event as in previous studies (18,20). This could be due to the small effective of our cohort. But this confirms the low risk of second malignancy. The safety data are consistent with those collected in other studies with RVD combination (18-20). Overall, we found lower grade 3 or 4 AE with RVD (22.5%) than reported with TVD (57% in a recent meta-analysis) (26). Furthermore, a recent study showed superiority of RVD versus RD in patients non-candidates to ASCT (39). These results confirm the efficacy and the safety of this regimen, even in older patients thanks to a good profile of tolerance. So, we could apply the RVD regimen in patients non-candidates to ASCT, too. Even though our study suffers from its small size, it confirms the previous results about this strategy of MM treatment in transplantation-eligible patients. Moreover, we have led this study on patients from the real life, comparatively to the patients from controlled- study, which they usually are younger, with fewer comorbidities and a stronger follow-up to avoid compliance issues than in real conditions of practice.
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Pilot evaluation of the efficacy and safety of topical methotrexate meddrop administration for early mycosis fungoides

Pilot evaluation of the efficacy and safety of topical methotrexate meddrop administration for early mycosis fungoides

Introduction Mycosis fungoides (MF) is the most frequent form of primary cutaneous lymphoma. The main treatment strategies for early MF are skin-directed therapies including very potent corticosteroids, topical chemotherapies (carmustine, nitrogen mustard), topical retinoids, TLR-agonists (imiquimod, resiquimod), PUVA, UVB and total body electron beam therapy (TBEBT). Photodynamic therapy, excimer laser, topical methotrexate/laurocapram, calcineurin inhibitors and ingenol mebutate have been evaluated in small series. Oral or intramuscular methotrexate (MTX) is the usual next-in-line systemic agent if skin-directed therapies fail, but is associated with potential systemic adverse effects (myelosuppression, hepatotoxicity, renal toxicity and pulmonary restrictive syndrome). The MEDDROP device increases the epidermal permeability using a pulsed flow of pure oxygen together with a MTX cartridge. The efficacy and safety of the MEDDROP-MTX system was assessed in a pilot study involving 13 patients with early MF.
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PROMPT : A prospective study to assess efficacy and safety of metyrapone in endogenous Cushing's syndrome

PROMPT : A prospective study to assess efficacy and safety of metyrapone in endogenous Cushing's syndrome

• Based on observational retrospective studies published over more than 50 years, metyrapone is approved for the treatment of endogenous Cushing’s syndrome (CS) in 15 European countries. 2 • PROMPT is the first prospective study to document the safety and efficacy of metyrapone using modern assay techniques.

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Efficacy and safety of a third anti-TNF monoclonal antibody in Crohn's disease after failure of two other anti-TNF.

Efficacy and safety of a third anti-TNF monoclonal antibody in Crohn's disease after failure of two other anti-TNF.

For Peer Review Abstract: Adalimumab (ADA) and certolizumab pegol (CZP) have demonstrated efficacy in Crohn’s disease (CD) patients previously treated with infliximab (IFX). Aim: To assess the efficacy and tolerability of a third anti-TNF in CD after failure of and/or intolerance to two different anti-TNF. Methods: CD patients who received ADA or CZP after loss of response and/or intolerance to two anti-TNF were included in this retrospective study. Data were collected using a standardized questionnaire. Clinical response, duration, safety and reasons for discontinuation were assessed. Results: Sixty-seven patients treated with CZP (n=40) or ADA (n=27) were included. A clinical response was observed in 41 (61%) at week 6 and 34 patients (51%) at week 20. The probability of remaining under treatment at 3 months, 6 months and 9 months was 68%, 60% and 45%, respectively. At the end of follow-up, the third anti-TNF had been stopped in 36 patients for intolerance (n=13), or failure (n=23). Two deaths were observed . Conclusion: Treatment, with a third anti-TNF (CZP or ADA) agent, of CD patients who have experienced loss of response and/or intolerance to two anti-TNF antibodies, has favorable short- and long-term efficacy and is an option to be considered in patients with no other therapeutic options.
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Efficacy and safety of Jentadueto(R) (linagliptin plus metformin).

Efficacy and safety of Jentadueto(R) (linagliptin plus metformin).

The present paper provides a PK/PD evaluation of linagliptin plus metformin and an updated review of the randomized clinical trials and of the bioequivalence studies that have assessed both the efficacy and tolerability/safety of this linagliptin-metformin combination. We will particularly focus our analysis on the safety profile of the combination and what might be its potential use in patients with mild to moderate CKD and in elderly subjects despite the classical limitations of use of metformin in such clinical conditions. To identify relevant studies, an extensive literature search of MEDLINE was performed from January 2008 to December 2012, with the two key-words “metformin” and “linagliptin”. No language restrictions were imposed. Reference lists of original studies, narrative reviews, previous systematic reviews, the European Public Assessment Report (EPAR) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of the linagliptin plus metformin FDC 33 and the approval document of this FDC by the Food and Drug Administration (FDA) 34 have been also carefully examined.
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Repeated Artemisinin-Based Combination Therapies in a Malaria Hyperendemic Area of Mali: Efficacy, Safety, and Public Health Impact

Repeated Artemisinin-Based Combination Therapies in a Malaria Hyperendemic Area of Mali: Efficacy, Safety, and Public Health Impact

Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Odonto-Stomatology, University of Bamako, Bamako, Mali; Aix-Marseille University, Marseille, France Abstract. Artemisinin-based combination therapies (ACTs) are the first-line treatment of uncomplicated malaria. The public health benefit and safety of repeated administration of a given ACT are poorly studied. We conducted a randomized trial comparing artemether-lumefantrine, artesunate plus amodiaquine (AS+AQ) and artesunate plus sulfadoxine-pyrimethamine (AS+SP) in patients 6 months of age and older with uncomplicated malaria in Mali from July 2005 to July 2007. The patient received the same initial treatment of each subsequent uncomplicated malaria episode except for treatment failures where quinine was used. Overall, 780 patients were included. Patients in the AS+AQ and AS+SP arms had significantly less risk of having malaria episodes; risk ratio (RR) = 0.84 (P = 0.002) and RR = 0.80 (P = 0.001), respectively. The treatment efficacy was similar and above 95% in all arms. Although all drugs were highly efficacious and well tolerated, AS+AQ and AS+SP were associated with less episodes of malaria.
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SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results

SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results

Figure 1 Flow chart of included patients and populations analysed: (A) full analysis set (FAS) for safety endpoint: all subjects who underwent treatment or attempted treatment with at least one FRED device; (B) population of efficacy: all subjects treated with FRED or FRED Jr device. Five patients were not implanted with the study device. Two patients died during the follow-up (perforation of the parent artery during intracranial catheterization 2 days after the procedure for the first patient, and lung cancer 10 months after the procedure for the second one). At 6 months, one patient did not complete the follow-up visit and one patient in a coma did not have control imaging performed. Five patients were withdrawn before 12 months: three were lost to follow-up, one withdrew consent, and one did not undergo the 12-month visit owing to non-implantation of the FRED device.
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Intact skin and not stripped skin is crucial for the safety and efficacy of peanut epicutaneous immunotherapy (EPIT).

Intact skin and not stripped skin is crucial for the safety and efficacy of peanut epicutaneous immunotherapy (EPIT).

during the dose-effect study [19]. In children severely al- lergic to cow’s milk treated by EPIT on intact skin, no se- vere adverse event was reported [21]. The application on stripped skin clearly allows the passive and massive passage of allergen through the skin into the lymphatics [2] completely modifying the biodis- tribution of allergen and the targeted cells, i.e. less acti- vated Langerhans cells. Tape-stripping also triggers mechanical injuries which activate keratinocytes and upregulate thymic stromal lymphopoietin (TSLP) expres- sion by keratinocytes and mRNA expression of inflamma- tory cytokines, all of them involved in the polarization of skin DCs to elicit a Th2 response seeing that a link between TSLP expression and the pathogenesis of AD has been shown in several mouse models [22-24]. By contrast, in a recent paper, Li et al. (2012) describe an epicutaneous treatment on intact skin to prevent oral food sensitization in a mouse model [25]. More specif- ically, the authors showed that high-dose PPE cutane- ous application on intact skin is capable of promoting skin local regulatory T-cell responses. At a systemic level, their results showed that the defined exposure of food allergens to intact skin suppresses the subsequent food allergy oral sensitization with suppression of multiple Ig isotypes (IgE, IgG1, IgG2a). Altogether, this greatly sug- gests that for treatment of Th2 disease, such as immuno- therapy of food allergy, avoiding tape-stripping could be of importance, leading to efficacy of EPIT and to maintain the safety of the treatment. The mechanisms involved with the epicutaneous allergen application for the treatment of food allergy are being explored (data submitted for publi- cation) and is likely due to a specific targeting to Langher- ans cells responsible to antigen presentation to T cells in lymph nodes and Treg expansion [26].
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Efficacy and safety of sodium zirconium cyclosilicate for hyperkalaemia: the randomized, placebo‐controlled HARMONIZE‐Global study

Efficacy and safety of sodium zirconium cyclosilicate for hyperkalaemia: the randomized, placebo‐controlled HARMONIZE‐Global study

A sequential closed testing procedure controlled the over- all type I error rate at 5%. A fixed hierarchical sequence was employed (see Supporting Information, Table S 3 for the vari- able test order); progression to the next test in the sequence continued until a two-sided P > 0.05 was encountered (P- values described as 1st, 2nd, 3rd controlled, etc.), at which point further inferential testing ceased and subsequent P- values (or P-values for variables not part of the closed proce- dure) were described as nominal. Detailed methods describing the statistical approaches are summarized in Sup- plementary Methods. All analyses were conducted using SAS, version 9.3.
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Efficacy and safety of vaginally administered lyophilized Lactobacillus crispatus IP 174178 in the prevention of bacterial vaginosis recurrence

Efficacy and safety of vaginally administered lyophilized Lactobacillus crispatus IP 174178 in the prevention of bacterial vaginosis recurrence

application and the scientific board approved the treatment period of 14 days for four cycles in women with a history of BV recurrence.  Certain BV risk factors, such as smoking and the use of vaginal douches, were only assessed at inclusion and not throughout the study and this may have contributed to the fact that we were unable to demonstrated long-term efficacy of treatment (i.e., at Visit 5). Likewise, data related to the patients’ sexuality, which is also a known risk factor of BV recurrence, were not collected [5– 7] . These risk factors may have resulted in vaginal dysbiosis once the probiotic treatment was stopped.
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Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial.

Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial.

Methods/Design: This study, called PEPTIDE (short for the French title “Etude Prospective sur l’Efficacité et la tolérance du PamidronaTe dans les dIscopathies Degeneratives Erosives”), will be a double-blind, randomized, placebo-controlled, parallel group, phase two clinical trial. A total of 48 patients will be recruited. These patients will be randomly assigned to one of the two groups, with 24 patients in each group: one group will be given pamidronate and the other a placebo. Pamidronate will be administered at a dose of 90 mg per day for two days consecutively, and every patient, irrespective of treatment group, will be given paracetamol to maintain blinding by preventing drug- induced fever. The primary outcome measure is a between-group difference of 30 points on a 100 mm Visual Analogue Scale (VAS) at three months. Secondary outcome measures are improvement in functional status and the drug’s safety. Primary and secondary outcome measures will be assessed at each visit (inclusion, at six weeks, three months, and six months). If the primary goal is not attained, the patient will be offered a rigid or semi-rigid back brace, irrespective of the treatment group.
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Efficacy and safety of laparoscopic fundoplication in lung transplant recipients

Efficacy and safety of laparoscopic fundoplication in lung transplant recipients

a lack of power, suggesting that the optimal time for fundoplication should be early. However we acknowledge that the improvement of FEV 1 could be due to natural improvement in the first 15 months post lung transplant and that the two main limitations of all these studies including ours are their retrospective and uncontrolled designs. Conduct a case-control study with a control group of lung transplant patients with non-operated reflux was not possible. Indeed we have a too small cohort of transplant patients. RCTs are needed for further evidences of the connection between GERD and CLAD and for the role anti reflux surgery as well (41).
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