Risk Of Local Adverse Events Research Articles

Efficacy of intra-articular hyaluronic acid in relief of pain in Kellgren and Lawrence grade 2 and 3 osteoarthritis knee

Introduction: Intra-Articular Hyaluronic Acid (IA-HA) supplementation not only improvises the synovial fluid flow dynamics and viscoelasticity but also potentially offers a positive effect on the arthritic disease process by promoting in vivo IAHA production and by providing an intra-articular anti-inflammatory effect. Objective: The primary objective of this study was to compare a single 6ml, intra-articular injection of hylan GF-20 with conservative treatment in patients with symptomatic mild to moderate knee Osteoarthritis (OA). Methodology: Patients with primary OA knee pain were randomly assigned to arthrocentesis plus a 6ml intra -articular injection of either hylan G-F 20 or conservative methods of treatment in a prospective, single-blinded (evaluator) randomised control study. Results were evaluated at Pre Injection, 3, 8, 16 and 24 weeks post-injection. The primary outcome criterion was change from baseline over 24 weeks in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and VAS Score. Results: A total of 70 patients (Kellgren–Lawrence grade II or III) was randomly assigned. Patients receiving hylan G-F 20 experienced statistically significantly greater improvements in WOMAC scores and VAS scores, than patients receiving conservative treatment. No increased risk of local adverse events was observed. Conclusions: This prospective randomised control study demonstrated that, in patients with knee osteoarthritis, a single 6 ml intra-articular injection of hylan G-F 20 is safe and effective in providing statistically significant, clinically relevant pain relief over 24 weeks, with a modest difference versus conservative treatment.

Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial

Objectives:The primary objective was to compare a single, 6 ml, intra-articular injection of hylan G-F 20 with placebo in patients with symptomatic knee osteoarthritis. The safety of a repeat injection...

Hylan versus hyaluronic acid for osteoarthritis of the knee: A systematic review and meta‐analysis

To compare the effectiveness and safety of intraarticular high-molecular hylan with standard preparations of hyaluronic acids in osteoarthritis of the knee. We performed a systematic review and meta-analysis of randomized controlled trials comparing hylan with a hyaluronic acid in patients with knee osteoarthritis. Trials were identified by systematic searches of Central, Medline, EMBase, Cinahl, the Food and Drug Administration, and Science Citation Index supplemented by hand searches of conference proceedings and reference lists (last update November 2006). Literature screening and data extraction were performed in duplicate. Effect sizes were calculated from differences in means of pain-related outcomes between treatment and control groups at the end of the trial, divided by the pooled standard deviation. Trials were combined using random-effects meta-analysis. Thirteen trials with a pooled total of 2,085 patients contributed to the meta-analysis. The pooled effect size was -0.27 (95% confidence interval [95% CI] -0.55, 0.01), favoring hylan, but between-trial heterogeneity was high (I(2) = 88%). Trials with blinded patients, adequate concealment of allocation, and an intent-to-treat analysis had pooled effect sizes near null. The meta-analyses on safety revealed an increased risk associated with hylan for any local adverse events (relative risk [RR] 1.91; 95% CI 1.04, 3.49; I(2) = 28%) and for flares (RR 2.04; 95% CI 1.18, 3.53; I(2) = 0%). Given the likely lack of a superior effectiveness of hylan over hyaluronic acids and the increased risk of local adverse events associated with hylan, we discourage the use of intraarticular hylan in patients with knee osteoarthritis in clinical research or practice.

Risk of local adverse events by gender following cardiac catheterization

To assess the reason for the relative high risk of local complications for women following cardiac catheterization by evaluating the associations between gender, sheath size, and local adverse outcomes following cardiac catheterization. The data used in this study were obtained from a portion of the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR), which included 13 878 patients who underwent cardiac catheterization at one of 59 participating cardiac catheterization institutions throughout the United States during late 2003. Rates of serious local vascular adverse events were calculated by gender following cardiac catheterization, by type of vascular hemostasis used, stratified by arterial sheath size. Serious local vascular events were reported in 3.54% of patients, most commonly hematoma (2.00%). The relative risk for women of any vascular complication was 1.40 [95%CI = 1.17, 1.67, p = 0.0002]. A statistically significant relative risk for woman was evident when collagen plug devices or manual compression alone were used as the first method for hemostasis. The rate of vascular complications increased progressively with increasing sheath size, more so in women than in men. High relative risk for women of local vascular complications following cardiac catheterization was demonstrated with use of manual compression, as well as with collagen plug devices to control femoral artery bleeding. Large sheath size is associated with both a relatively high absolute risk and a high relative risk for women. Knowledge of this information should be considered by interventional cardiologists in making decisions on how to achieve hemostasis following cardiac catheterization.

Risk of Local Adverse Events by Gender Following Cardiac Catheterization

Risk of Local Adverse Events by Gender Following Cardiac Catheterization

The tolerability of viscosupplementation: low incidence and clinical management of local adverse events

SUMMARYHylan G-F 20 (Synvisc®, Genzyme Biosurgery, Ridgefield, NJ) is aviscosupplement indicated for the treatment of pain due to osteoarthritis (OA) of the knee. Overall, the therapy is well tolerated with a low incidence of local and systemic adverse events (AEs). In our large clinical practice, our overall rate of local pain and swelling with treatment is consistent with that of previous reports and the product labeling. Local AEs that do occur with therapy are mostly mild to moderate in nature, transient, and resolve spontaneously or with symptomatic treatment. Local AEs thought tobe related to the treatment are clinically manageable and do not result in long-term sequelae, such that their occurrence should not preclude patients from the benefit of OA pain relief with therapy, including continued pain relief with repeat treatment. Based on previous published reports of hylan G-F 20 and our extensive clinical experience, relief of OA knee pain with hylan G-F 20 far outweighs the low risk of local AEs for patients who do not respond to other therapies indicated for the treatment of OAknee pain.