Piascledine 30 Capsules is a daily supplement made with selected ingredients to help tackle the symptoms of osteoarthritis, including aches and pains, and mobility difficulties.
Piascledine® (300 mg capsules). Composition: Each capsule contains: Unsaponifiable extract (ASU 300) corresponding to: Persea gratissima oil unsaponifiable - 100 mg. Glycine max. (L) oil unsaponifiable - 200 mg. Excipients: Colloidal anhydrous silica. Butylhydroxytoluene. Pharmacological classification: A 34 other/complementary/western herbal medicines. Pharmacological action: Piascledine® belongs to the class of "SYSADOA" (symptomatic slow-acting drugs in osteoarthritis). The mechanism of action of the active substances in Piascledine® has been assessed through in-vitro and in-vivo studies in osteoarthritis, and showed the following: 1) Direct and indirect effects to promote the synthesis of cartilage extracellular matrix macromolecules (anabolic pathway): Increase in the proteoglycans synthesis by normal as well as osteoarthritis articular chondrocytes, especially those of high molecular weight, with a quality similar to physiological proteoglycans. Inhibition of proteoglycans degradation. Stimulation of the synthesis and accumulation of aggrecans (major proteoglycans in cartilage) in osteoarthritis chondrocytes. Stimulation of the type II collagen production by synoviocytes and articular chondrocytes. Prevention of the inhibitory effect of osteoarthritic subchondral osteoblasts on aggrecan and type II collagen synthesis by chondrocytes, in a co-culture model. Stimulation of the expression of factors such as TGF- β1 and TGF-β2. 2) Effects to limit the degradation of cartilage extracellular matrix components (catabolic pathway): Inhibition of the negative effects of IL-1β on collagen and aggrecan production. Inhibition of the stimulatory effect of IL-1β at increasing the collagenolytic activity in synovial cells and chondrocytes. Inhibition of the IL-1β-induced synthesis and activity of the collagenase (MMP-13) and stromelysin (MMP3) in chondrocytes. Reduction of IL-6 and IL-8 proinflammatory cytokine production as well as IL-1β-induced overproduction of PGE2. Stimulation of the plasminogen activator inhibitor 1 (PAI-1). All these effects account for a potential beneficial effect of Piascledine® on the repair and protection of the cartilage extracellular matrix components. 3) Structure-modifying effect and reduction of joint cartilage deterioration: In a randomized, double-blind, placebo-controlled, 3-year study (ERADIAS, 2010) was designed to assess the potential structure-modifying effects of Piascledine® once daily in patients with hip osteoarthritis, using repeated X-ray measures of the hip joint space width (JSW) as the main efficacy criterion. In accordance with oarsiomeract recommendations, the assessment of efficacy was also made by calculating the proportion of patients with osteoarthritis progression, i.e. patients with a JSW loss ≥ 0.5 mm over 3 years.
This study showed a significant reduction (p = 0.04) of joint cartilage deterioration, through a relative risk reduction of 20%, for patients to experience osteoarthritis progression when treated with Piascledine®, compared with placebo. 4) Sparing effects of Piascledine® on nonsteroidal anti-inflammatory drugs (NSAIDs): In clinical studies where the potential NSAIDs-sparing effect of Piascledine® was assessed, it was shown that, in patients with hip or knee osteoarthritis, the mean dosage of NSAIDs (standardized as diclofenac mg-equivalent) was reduced by about 60 tablets of diclofenac 25 mg monthly. The reduction or discontinuation of NSAIDs was decided upon patient's will, according to his/her symptom improvement during the treatment. Indications: Piascledine® is used in adults for the relief of symptoms of osteoarthritis, such as pain and difficulties when moving. Also refer to pharmacological action; points 3 and 4. Identification: Piascledine® is available as capsules with an orange cap and opaque grey body marked 'P300'. Presentation: Heat-formed PVC blister and aluminium foil containing 15 capsules. Cardboard box containing: 1 blister of 15 capsules or 2 blisters of 15 capsules each (30 capsules). Not all pack sizes may be marketed
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