phytosterols and Rheumatic-Diseases

To determine the post-marketing safety profile of avocado-soybean unsaponifiables since their commercialization in France until 2008.. We used data provided by French spontaneous reporting system via the network of National Pharmacovigilance centres. We analysed all suspected adverse drug reactions (ADRs) concerning avocado-soybean unsaponifiables (ASU) reported between 1978 and 2008 and notified in the French Pharmacovigilance Database.. We kept 117 ADRs concerning 117 patients (mean age 65.5 years, 72% female). ADRs (35.9%) were "serious" (resulted in hospitalisation or prolonged it). No death was reported. In most of cases, causality of ASU was "possible" and others drugs were also suspected. The most frequently reported ADRs were cutaneous (32.5% of all ADRs, with eczemas or urticaria), hepatic (16.2%, mostly hepatocellular injuries) and gastrointestinal (12%, with 9 cases of colitis and/or diarrhea) ADRs. In these cases, dechallenge of ASU allowed rapid regression of symptoms. Others significant ADRs were coagulation and platelet (6.8%), neurological (6%) and metabolic or nutritional (4.3%) disorders.. This Pharmacovigilance analysis of ASU notified since their commercialisation in France highlights the diversity of ADRs with several class-organ involved. Cutaneous, hepatic and gastro-intestinal disorders were the most frequently reported ADRs. Since ASU is largely prescribed in France, incidence of their ADRs seems to be "very rare" (although we did not take into account the part of under-notification). These safety data should be discussed in the light of the poor expected clinical benefit of ASU in rheumatology (low "Service Medical Rendu") or in stomatology (insufficient "Service Medical Rendu").

Topics: Adult; Aged; Aged, 80 and over; Blood Coagulation Disorders; Chemical and Drug Induced Liver Injury; Databases, Factual; Drug Combinations; Drug Eruptions; Female; France; Gastrointestinal Diseases; Glycine max; Hospitalization; Humans; Male; Middle Aged; Nervous System Diseases; Persea; Phytosterols; Phytotherapy; Plant Extracts; Product Surveillance, Postmarketing; Rheumatic Diseases; Safety; Vitamin E

In this work, the authors have studied the effect of advocate/soya-bean extracts (Piasclédine) on the collagenolytic activity of cultured rabbit articular chondrocytes and human rheumatoid synovial cells. Incubation of these cells for 48 h with 10 micrograms/ml of Piasclédine show that this drug slightly increases collagenase production. As expected, incubation of these cells with interleukin-1 (100 pg/ml) induces an important release of collagenase. Piasclédine partially reverses the effect of interleukin-1 on synovial cells and totally abolishes its action on chondrocytes. Moreover, incubation of the two cell types for 5 days with Piasclédine prior to a 48 h-exposure to interleukin-1 prevents partially the effect of interleukin-1. These data suggest a potential role for Piasclédine to limit the deleterious effects of interleukin-1 in osteoarticular diseases by reducing the capacity of this cytokine to stimulate collagenase production by synoviocytes and chondrocytes.

Topics: Animals; Cartilage, Articular; Cells, Cultured; Collagen; Drug Combinations; Drug Evaluation; Humans; Interleukin-1; Microbial Collagenase; Peptide Hydrolases; Phytosterols; Plant Extracts; Rabbits; Rheumatic Diseases; Synovial Membrane; Time Factors; Vitamin E

Topics: Coffee; Myocarditis; Phytosterols; Rheumatic Diseases; Rheumatic Heart Disease; Steroids