Search results for "Adverse effect"

Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, eva…

2011

Summary Background  Hyaluronic acid (HA) fillers are frequently used for the correction of facial soft tissue defects. Aim  To compare the efficacy and safety of a novel HA filler, HAE (Emervel Deep), with those of HAP (Restylane Perlane) in the treatment of severe nasolabial folds (NLF). Patients/Methods  A split-face, randomized and evaluator-blinded comparison study. Subjects were randomized to receive injection of HAE or HAP on their left or right NLF. Efficacy was evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Local tolerability was assessed based on subject diary during the first 3 weeks after injection. Adverse events were also evaluated. Results…

Efficacy and Safety of IQYMUNE®, a Ten Percent Intravenous Immunoglobulin in Adult Patients With Chronic, Primary Immune Thrombocytopenia

2018

Background: Intravenous immunoglobulin (IVIG) IQYMUNE® is a highly purified 10% IVIG that was assessed using the new stringent definition of response described in the revised guideline on the clinical investigation of IVIG. The efficacy and the safety of IQYMUNE® were investigated in adult patients with chronic primary immune thrombocytopenia (ITP). Methods: In this phase III multinational, multicentre, prospective, uncontrolled, open-label, single-arm study, adult patients with a baseline platelet count < 30 × 10 9 /L were treated with IVIG 10% at a dose of 2 g/kg body weight administered over 2 consecutive days. The primary endpoint was Response over the study period and was defined accor…

Treatment of Newly Diagnosed Moderate or Severe Chronic Graft-Versus-Host Disease with Prednisone and Everolimus (PredEver first): A Prospective Mult…

2019

Background Chronic graft-versus-host disease (cGVHD) is the major cause of treatment related morbidity and mortality after allogeneic stem cell transplantation (allo-HSCT). Recently Paul Martin et al. reported that treatment success at 1 year (defined as a patient being in partial (PR) or complete remission (CR) of cGVHD, in ongoing remission of underlying disease and not requiring any secondary treatment for cGVHD) was the only endpoint associated with clinical benefit. Strikingly this robust endpoint was only achieved in less than 20% of patients undergoing primary treatment for cGVHD. Therefore, although most patients show initial response to first-line therapy, long-term clinically mean…

Cyclophosphamide Pulse Therapy after Natalizumab Discontinuation for Multiple Sclerosis: a multicenter study.

2015

Importance: Natalizumab discontinuation induces the recurrence of Multiple Sclerosis (MS) disease activity: Currently no therapeutic approach has been found able to abolish disease reactivation. Objective: To collect data from patients with MS switching from natalizumab to cyclophosphamide. Design: Retrospective multicentre study. Setting: Nine Multiple Sclerosis Centers in Italy. Participants: A total of 47 patients with clinically definite RR-MS switched to cyclophosphamide after natalizumab discontinuation. Two patients were excluded from the analysis because received less than 12 natalizumab infusions. The remaining 45 patients were subdivided into two main groups: Early Treatment (peri…

2021

ObjectiveTo assess the safety and efficacy of epigallocatechin-3-gallate (EGCG) add-on to glatiramer acetate (GA) in patients with relapsing-remitting multiple sclerosis (RRMS).MethodsWe enrolled patients with RRMS (aged 18–60 years, Expanded Disability Status Scale [EDSS] score 0–6.5), receiving stable GA treatment in a multicenter, prospective, double-blind, phase II, randomized controlled trial. Participants received up to 800 mg oral EGCG daily over a period of 18 months. The primary outcome was the proportion of patients without new hyperintense lesions on T2-weighted (T2w) brain MRI within 18 months. Secondary end points included additional MRI and clinical parameters. Immunologic eff…

Complications of Botulinum toxin A: An update review.

2021

Cosmetic surgery procedures have increased manifolds all over the world owing to the ever-increasing demand of people to look beautiful and young. Injectable treatments like botulinum toxin are becoming more popular owing to their rapid, well-defined, and lasting results for the reduction of facial fine lines, wrinkles, and facial rejuvenation. These emerging treatments are quite safe but can have certain adverse effects. In this article, we have highlighted the complications and side effects of botulinum toxin based on the anatomical location. The possible causes and precautions to prevent these complications are also discussed. The search of literature included peer-reviewed articles incl…

Efficacy, safety and tolerability of combined low-dose simvastatin-fenofibrate treatment in primary mixed hyperlipidaemia.

2007

In order to assess the long-term (12 months) efficacy and safety of fenofibrate administered with simvastatin in the treatment of primary mixed hyperlipidaemia, we conducted a study that compared increasing dosages of these drugs in subgroups of men and women belonging to a clinical sample of outpatients. This was an open study carried out in patients with primary mixed hyperlipidaemia (lipoprotein phenotype IIb) who needed a combined therapeutic approach because of their poor response to a single-drug regimen with an HMG-CoA reductase inhibitor (simvastatin). Thus, a fibrate (fenofibrate) was added to the therapy. The study lasted 12 months. Forty-five patients (mean age: 58.9 ± 11.3 years…

2021

AIMS/INTRODUCTION In patients with pulmonary embolism (PE), the impact of diabetes mellitus on patient profile and outcome is not well investigated. MATERIAL AND METHODS The German nationwide inpatient sample of the years 2005-2018 was analyzed. Hospitalized PE patients were stratified for diabetes, and the impact of diabetes on in-hospital events was investigated. RESULTS Overall, 1,174,196 PE patients (53.8% aged ≥70 years, 53.5% women) and, among these, 219,550 (18.7%) diabetes patients were included. In-hospital mortality rate amounted to 15.8%, and was higher in diabetes patients than in non-diabetes patients (19.8% vs 14.8%, P < 0.001). PE patients with diabetes had a higher prevalenc…

Arsenic Through the Gastrointestinal Tract

2015

Intestinal barrier function regulates (micro-)nutrient absorption and host defense mechanisms at the mucosal interface with the external environment. Maintaining gut homeostasis is essential for human health; however, many factors including food and water pollutants may affect the physiological balance at the intestinal level. One of the contaminants of highest health concern is arsenic, which affects more than 200 million people worldwide, causing cancer and cardiovascular and metabolic diseases. Arsenic affects intestinal health by disrupting barrier function and inducing inflammatory responses. Processes involved in the transiting of arsenic through the gastrointestinal tract can affect …

The Treatment of Medication-Related Osteonecrosis of the Jaw (MRONJ): A Systematic Review with a Pooled Analysis of Only Surgery versus Combined Prot…

2021

Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction of antiresorptive and antiangiogenic agents, and it is also a potentially painful and debilitating condition. To date, no specific studies have prospectively evaluated the efficacy of its treatment and no robust standard of care has been established. Therefore, a systematic review (2007–2020) with a pooled analysis was performed in order to compare MRONJ surgical techniques (conservative or aggressive) versus combined surgical procedures (surgery plus a non-invasive procedure), where 1137 patients were included in the pooled analysis. A statistically significant difference in the 6-month improvement rate, comp…