Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon

Raynaud's phenomenon is a disorder characterized by spasm of digital arteries leading to blanching, coldness and discomfort of the affected digit, affecting up to 3-5% of the population at some time in their lives. Raynaud's is roughly classified into primary and secondary forms. The primary form may occur without apparent cause or following such things as acute trauma, repetitive vibrating trauma or frostbite. Secondary Raynaud's occurs in association with a variety of systemic immunological diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SS) and Sjogren's syndrome. Perhaps the most severe forms are associated with systemic sclerosis, less often in SLE where severe microvascular changes can lead to digital ulcerations which are difficult to heal and produce considerable functional impairment Treatment of Raynaud's has been a significant clinical challenge. The primary modality is to avoid cold exposure. Many drug classes have been shown to have some, but highly variable and potential toxicities. Diosmiplex is a prescription medical food product composed of the botanical based flavonoid molecule, diosmin, and a proprietary systemic blood alkalinizing agent, Alka4-complex. Diosmin has been used successfully in Europe as a drug for chronic venous insufficiency and its complications, including venous ulcers for more than 35 years. There is a large body of published literature regarding the molecular activity, clinical efficacy and safety of the active molecule in diosmin as well as its effects on the microvasculature where it has been shown to reduce inflammation, improve structural integrity, reduce capillary damage and improve capillary flow but no prospective clinical studies have been published regarding its effect in Raynaud's phenomenon. This will be the first prospective study to examine the efficacy and safety of diosmin, as diosmiplex, in both primary and secondary Raynaud's. The study will intentionally seek to enroll a subset of subjects with scleroderma with Raynaud's complicated by digital ulcers. This will be a two (2) month randomized, double blind, placebo controlled study. Patients with either primary or secondary Raynaud's phenomenon present for at least 12 months and either untreated or inadequately controlled on therapy, defined as having at least four (4) vasospastic episodes/week, will be eligible for enrollment