Premium
PII‐31
Author(s) -
Tian J.
Publication year - 2006
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.12.156
Subject(s) - placebo , medicine , concomitant , dementia , randomized controlled trial , clinical trial , cognitive impairment , vascular dementia , basal (medicine) , surgery , disease , pathology , insulin , alternative medicine
BACKGROUND The aim of this study is to evaluate the effect of hydroxysafflor yellow A (HSYA) on the progression of cognitive impairment in patients with VD. METHODS We selected outpatients, of both sexes, between 55 and 80 years old, with VD. Following a placebo wash‐out period (4 weeks), the patients received HSYA 100 mg t.i.d. or placebo for one year. The primary efficacy variable was the loss of over 10% of the basal score on the Mini‐Mental State Examination after one year. The time it took to reach this degree of impairment, the evolution of Pfeiffer score, the effect on functional disability and the drug safety were also evaluated. RESULTS 156 patients were included, 109 completed the study, and 142 underwent intent‐to‐treat analysis. At the end of the study, 34.6% of patients with placebo and 21.1% with HSYA had lost over 10% of their basal MMSE score. Favorable effects of HSYA were found on females (40.9% vs 10.5%, P =0.01876), patients without previous treatments (46.2% vs 13.3%, P =0.00748) and patients with concomitant antiplatelet treatment (35.0% vs 15.9; P =0.03836). Survival analysis showed that the patients with HSYA took longer to lose cognitive capacities ( P =0.031; RR=1.15–3.99). CONCLUSION HSYA did not reduce the cognitive decline at the stated period in the total group but it significantly delayed this decline and produces better evolution in females, in patients without previous treatments, and those with antiplatelet treatment. Clinical Pharmacology & Therapeutics (2005) 79 , P44–P44; doi: 10.1016/j.clpt.2005.12.156