Search results for "Adverse effect"
showing 10 items of 1065 documents
COVID-19 Vaccine: A Survey of Hesitancy in Patients with Celiac Disease
2021
(1) Background: COVID-19 vaccination campaigns offer the best hope of controlling the pandemic. However, the fast production of COVID-19 vaccines has caused concern among the general public regarding their safety and efficacy. In particular, patients with chronic illnesses, such as celiac disease (CD), may be more fearful. Information on vaccine hesitancy plays a pivotal role in the development of an efficient vaccination campaign. In our study, we aimed to evaluate COVID-19 vaccine hesitancy among Italian CD patients. (2) Methods: an anonymous questionnaire was sent to CD patients followed at our tertiary referral center for CD in Milan, Italy. Patients were defined as willing, hesitant an…
Randomised trial of mycophenolate mofetil versus azathioprine for treatment of chronic active Crohn’s disease
1999
BACKGROUNDCrohn’s disease is a chronic inflammatory disease of the alimentary tract. Azathioprine is an effective agent in the management of chronic active Crohn’s disease leading to long term remission of disease activity. Such treatment leads to limited efficacy or side effects in a small subset of patients.AIMSTo compare efficacy and side effects of treatment with azathioprine plus corticosteroids versus mycophenolate mofetil (MMF) plus corticosteroids in patients with chronic active Crohn’s disease.METHODSSeventy patients with chronic active Crohn’s disease (Crohn’s disease activity index (CDAI) greater than 150) were randomised for treatment with azathioprine/cortisone or MMF/cortisone…
Safety of Topical Non-steroidal Anti-Inflammatory Drugs in Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis
2019
Objective We aimed to assess the safety of topical non-steroidal anti-inflammatory drugs (NSAIDs) in the management of osteoarthritis (OA) in a systematic review and meta-analysis of randomized, placebo-controlled trials. Methods A comprehensive literature search was undertaken in the MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Scopus electronic databases. Randomized, double-blind, placebo-controlled, parallel-group trials that assessed adverse events (AEs) with topical NSAIDs in patients with OA were eligible for inclusion. Authors and/or study sponsors were contacted to obtain the full report of AEs. The primary outcomes were overall severe and serious AEs, as w…
Effect of acetyl-l-carnitine in the treatment of diabetic peripheral neuropathy : A systematic review and meta-analysis
2017
Background/aim: Deficiency of acetyl-L-carnitine (ALC) and L-carnitine (LC) appears to play a role in peripheral diabetic neuropathy, although the evidence in humans is still limited. We conducted a systematic review and meta-analysis investigating the effect of ALC on pain and electromyographic parameters in people with diabetic neuropathy. Methods: A literature search in major databases, without language restriction, was undertaken. Eligible studies were randomized controlled trials (RCTs) or pre-and post-test studies. The effect of ALC supplementation on pain perception and electromyographic parameters in patients with diabetic neuropathy was compared vs. a control group (RCTs). The effe…
Neuro-Psychiatric Alterations in Patients with Diabetic Foot Syndrome
2019
Diabetic Foot Syndrome (DFS) is a common long-term complication of diabetes mellitus. DFS has recently been associated with adverse effects on brain function which could further impair the quality of life of these patients, as well as increase the social and economic burden, morbidity, and premature mortality of the disease. The current knowledge of neuropsychiatric alterations e.g. cognitive impairment, gait disorder, depression, and quality of life in patients with diabetic foot syndrome is summarized. The cognitive domains altered in DFS are executive function, memory, and psychomotor speed. Compared to diabetic patients without DFS, individuals with DFS present gait alterations caused …
Randomised Trial of Two Different Daily Doses of Interferon-α versus Classical Therapy in Treatment-Naïve Patients with Chronic Hepatitis C.
2018
To evaluate the efficacy and tolerability of two different daily doses of interferon-α (lymphoblastoid-IFNα-N1, Wellferon®) [IFNα] for 2 months, followed by the same dose on alternate days for up to 1 year, versus administration on alternate days for 1 year. A non-blind, randomised study of outpatients with chronic hepatitis C at five centres in Sicily, Italy. Ninety-seven consecutive treatment-naive patients [72 patients with hepatitis C virus (HCV) genotype 1b infection] with histological chronic hepatitis C were included in the study and randomised to receive IFNα subcutaneously: 5 million international units (MIU) daily for 2 months, followed by the same dose on alternate days for up to…
Diagnosis, monitoring and management of immune-related adverse drug reactions of anti-PD-1 antibody therapy.
2015
PD-1 checkpoint inhibitors are associated with a specific spectrum of immune-related adverse events. This spectrum is different from toxicities known for kinase inhibitors or cytotoxic drugs. Since PD-1 directed therapies show effectivity in an increasing number of malignant diseases, their clinical usage will increase rapidly. Therefore clinicians from different specialities such as medical oncology, internal medicine, family doctors and emergency unit staff should be aware of the adverse effects of PD-1 checkpoint inhibitors to avoid delays in diagnosis and treatment. Based on pooled data from pivotal trials as reported by the European Medicines Agency, the present paper reviews incidence…
Complications of botulinum toxin and fillers: A narrative review
2019
Background Cosmetic surgery and esthetic procedures have become a billion dollar industry owing to the ever-growing demand of the population to stay young. The injectable treatments including fillers and botulinum toxin have become highly popular because of their quick, predictable and lasting results in the management of facial wrinkles and rejuvenation. Although these treatment modalities are relatively safe, they are associated with certain side effects. Aims In this review, we will focus on the complications of fillers and botulinum toxin. Patients/methods The literature research considered published journal articles (clinical trials or scientific reviews). Studies were identified by se…
Treatment effect of alirocumab according to age group, smoking status, and hypertension: Pooled analysis from 10 randomized ODYSSEY studies
2019
Background: Age, smoking, hypercholesterolemia, and hypertension are major risk factors for atherosclerotic cardiovascular disease. Objective: We examined whether the effects of alirocumab on low-density lipoprotein cholesterol (LDL-C) differed according to age, hypertension, or smoking status. Methods: Data were pooled from 10 Phase 3 ODYSSEY randomized trials (24–104 weeks’ duration) in 4983 people with heterozygous familial hypercholesterolemia (FH) or non–familial hypercholesterolemia (3188 on alirocumab, 1795 on control [620 on ezetimibe and 1175 on placebo]). Most participants received concomitant maximum tolerated statin therapy. In 8 trials, the alirocumab dose was increased from 75…
The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract
2010
Aliment Pharmacol Ther 31, 548–552 Summary Background Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging. Fluorescent contrast agents are used to optimize imaging with CLE, and intravenous fluorescein is the most widely used contrast agent. Fluorescein is FDA-cleared for diagnostic angiography of the retina. For these indications, the safety profile of fluorescein has been well-documented; however, to date, fluorescein is not cleared for use with CLE. Aims To estimate the rate of serious and total adverse events attributable to intravenous fluorescein when used for gastrointestinal CLE. Methods We performed a cross sectional…