[Sarpogrelate hydrochloride for Raynaud's phenomenon of patients with collagen diseases]

To evaluate clinical efficacy of sarpogrelate hydrochloride (SPG), a novel 5HT2- serotonergic receptor antagonist, for Raynaud's phenomenon associated with collagen diseases.

Thirty two patients with collagen diseases such as scleroderma, mixed connective tissue disease, systemic lupus erythematosus, Sjögren's syndrome, and rheumatoid arthritis were enrolled. SPG (300mg/day) was administered for 8 weeks. Patients were asked to record the frequency of Raynaud's phenomenon and subjective symptoms in a diary, and evaluations were made in weeks 4 and 8 of treatment. Thermography and determination of whole blood serotonin levels were also conducted in some patients.

The frequency and duration of Raynaud's phenomenon and subjective symptoms such as coldness and pain significantly improved in weeks 4 and 8 compared to the pre-treatment baseline. Thermography showed significantly improvements of skin temperature recovery rate following cold water loading after treatment with SPG. Epigastric distress was reported by 3 patients, but no other adverse reaction or abnormal changes in laboratory tests were observed. Whole blood serotonin levels per platelet increased significantly after treatment with SPG, suggesting that administration of SPG might inhibit activation of the platelets.

A global improvement rate ("markedly improved" + " moderately improved") of 66% was obtained and SPG was regarded as safe in 85% of patients and useful or very useful in 82%. SPG is expected to be a useful new therapy for Raynaud's phenomenon in patients with collagen disease.