ABSTRACT
Objective To explore the effects of short-term application of rosuvastatin on LDL-C concentration and the incidence of cardiovascular events after percutaneous coronary intervention (PCI) in patients with diabetes mellitus associated with mild-moderate renal insufficiency (MMRI). Methods From Dec. 2008 to Oct. 2011, 2998 patients were enrolled from 53 centers in China for a TRACK-D project. Of them, 1590 patients to receive PCI were selected for this trial and assigned to rosuvastatin group (n=808) and control group (n=782). Patients in rosuvastatin group were treated with 10mg rosuvastatin every evening for 2 days before and 3 days after intervention. Control patients did not receive statin treatment in the 2 days before and 3 days after the procedure. The levels of LDL-C in the serum were measured before and after 72 hours of interventional treatment. The cardiovascular event rate was recorded during hospitalization and follow-up of 30 days. Results The baseline data were not significantly different (2.56±0.81mmol/L vs 2.52±0.81mmol/L, P>0.05) between the two groups. At 72 hours after PCI, the LDL-C concentration was lower in rosuvastatin group than in control group (2.12±0.67mmol/L vs 2.61±0.67mmol/L, P<0.01). The difference in LDL-C between post- and pre-operation were -0.42±0.59mmol/L vs 0.09±0.54mmol/L in rosuvastatin group and control group respectively and statistically significant (P<0.01). During the hospitalization and follow-up period of 30 days, the incidence of cardiovascular events was lower in rosuvastatin group than in control group (3.3% vs 4.9%, P=0.127), without significant difference. Conclusion The short-term application of rosuvastatin during the perioperative period in the patients with diabetes mellitus associated with MMRI (stages 2-3) can reduce LDL-C concentration and the incidence of cardiovascular events.
ABSTRACT
<p><b>BACKGROUND</b>Tumor necrosis factor-α is a key mediator in the pathogenesis of psoriasis. Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-α. The purpose of this study was to validate the efficacy and safety of 5 mg/kg infliximab therapy in Chinese patients with moderate to severe plaque psoriasis.</p><p><b>METHODS</b>In this multicenter, double-blind, placebo-controlled trial, 129 patients with moderate-to-severe psoriasis were randomized to the induction therapy (weeks 0, 2 and 6) with infliximab 5 mg/kg (n = 84) or placebo (n = 45), followed with infliximab 5 mg/kg scheduled at week 14 and week 22 in the infliximab group, and infliximab 5 mg/kg scheduled at weeks 10, 12 and 16 in the placebo group. The primary end point was the proportion of patients who achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI 75 response rate) from baseline at week 10.</p><p><b>RESULTS</b>At week 10, 81.0% of patients treated with infliximab (5 mg/kg) achieved a 75% or greater improvement compared with 2.2% of patients treated with placebo (P < 0.001). A significant improvement in PASI, Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), was seen from week 6 through week 14 in the infliximab group compared with the placebo group. Through week 22, PASI, PGA, DLQI were well maintained. The incidence of adverse events for the infliximab treatment group was slightly higher in comparison to the placebo treatment group during the first 10 weeks without statistical significance. However, there were 3 cases of tuberculosis that developed during the 26 weeks treatment with infliximal.</p><p><b>CONCLUSIONS</b>Infliximab treatment was effective as induction and maintenance treatments for Chinese patients with moderate to severe plaque psoriasis. Most drug-induced adverse events were mild to moderate, and well tolerated. Screening for tuberculosis is essential and prophylactic treatment should be given if necessary.</p>