In a placebo-controlled, double-blind, randomized clinical trial, the tolerability of a proprietary larch arabinogalactan preparation (ResistAidTM) was investigated. METHODS: 199 healthy participants were randomly assigned to receive either placebo (n = 98) or an arabinogalactan preparation (n = 101) over a period of 12 weeks. As safety parameters the total number of adverse events, changes in ...

OBJECTIVE To examine safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of intrathecal nusinersen (previously ISIS-SMNRx), an antisense oligonucleotide designed to alter splicing of SMN2 mRNA, in patients with childhood spinal muscular atrophy (SMA). METHODS Nusinersen was delivered by intrathecal injection to medically stable patients with type 2 and type 3 SMA aged 2-...

Colorectal cancer is one of the most common cancers worldwide, and associated with high mortality rates in our country. The prognosis of patients diagnosed with metastatic colorectal cancer (mCRC) has improved markedly over the last 12 years, increasing from 5 months with best supportive care to almost 2 years with combination chemotherapy plus bevacizumab. Bevacizumab is well suited for use in...

OBJECTIVE To determine the efficacy and tolerability of citalopram when compared to other antidepressants for late-life depression (LLD). METHODS We searched electronic databases and trial registries to identify randomized controlled trials comparing citalopram to other antidepressants for LLD. Study quality was assessed using the Cochrane collaboration risk of bias tool. We summarized the ef...

OBJECTIVE Systemic sclerosis-associated interstitial lung disease (SSc-ILD) shares a number of clinical features and pathogenic mechanisms with idiopathic pulmonary fibrosis (IPF). This study was designed to evaluate the tolerability of the IPF treatment pirfenidone in SSc-ILD. The known gastrointestinal, skin, and liver adverse events (AE) of pirfenidone are of importance given the involvement...

Evidence-based medicine combines the best currently available evidence from systematic medical research, together with clinical expertise, in order to provide the best available care for patients. In conjunction with systematic reviews (meta-analyses), a critical review of evidence-based literature forms the basis for the development of clinical treatment guidelines. Current treatment guideline...

INTRODUCTION Aducanumab (BIIB037), a human monoclonal antibody selective for aggregated forms of amyloid beta, is being investigated as a disease-modifying treatment for Alzheimer's disease (AD). METHODS This randomized, double-blind, placebo-controlled single ascending-dose study investigated the safety, tolerability, and pharmacokinetics (PK) of aducanumab in patients with mild-to-moderate ...

BACKGROUND/AIMS In a post-marketing observational study, the efficacy and tolerability of memantine were examined in patients with moderate to severe Alzheimer's disease. METHODS The patients were treated with 20 mg/day of memantine for a 6-month period. The efficacy of memantine was evaluated using the Mini-Mental State Examination, the Nurses' Observation Scale for Geriatric Patients (NOSGE...

Despite promising reports of the use of omalizumab as add-on therapy in patients with systemic mastocytosis and recurrent anaphylaxis during specific venom immunotherapy (VIT), unpredicted adverse effects may lead to therapy failure. We present the case of a patient with systemic mastocytosis and Hymenoptera venom allergy who was administered omalizumab as add-on therapy to improve VIT tolerabi...