Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Renal Transplant Recipients Experiencing Gastrointestinal Intolerance: A Multicenter, Double-Blind, Randomized Study

被引:44
作者
Langone, Anthony J. [1 ]
Chan, Laurence [2 ]
Bolin, Paul [3 ]
Cooper, Matthew [4 ]
机构
[1] Vanderbilt Univ, Sch Med, Div Nephrol, Med Ctr, Nashville, TN 37232 USA
[2] Univ Colorado, Hlth Sci Ctr, Div Nephrol, Denver, CO USA
[3] E Carolina Univ, Div Nephrol & Hypertens, Brody Sch Med, Greenville, NC USA
[4] Univ Maryland, Sch Med, Dept Surg, Baltimore, MD 21201 USA
关键词
Gastrointestinal; Quality of life; HRQoL; Mycophenolate mofetil; Mycophenolate sodium; QUALITY-OF-LIFE; ACUTE REJECTION; HEALTH-STATUS; COMPLICATIONS; RELIABILITY; CONVERSION; REDUCTION; SYMPTOMS; IMPACT; RISK;
D O I
10.1097/TP.0b013e318205568c
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background. Two open-label studies demonstrated that conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) significantly reduces gastrointestinal (GI) symptom burden and improves GI-specific health-related quality of life. Using a randomized design, this study evaluated changes in GI symptoms and health-related quality of life in patients converted from MMF to EC-MPS versus patients who continued with MMF-based treatment. Methods. In this 4-week, multicenter, randomized, prospective, double-blind, parallel-group trial, renal transplant recipients with GI symptoms receiving MMF plus a calcineurin inhibitor +/- corticosteroids were randomized to an equimolar dose of EC-MPS+MMF placebo or continue on their MMF-based regimen+EC-MPS placebo. The primary efficacy outcome was a change from baseline in total Gastrointestinal Symptom Rating Scale score of a minimally important difference of more than or equal to 0.3. Results. Three hundred ninety-six patients (EC-MPS group: n=199; MMF group: n=197) were included. A greater proportion of EC-MPS patients (62%) reached the primary efficacy outcome compared with MMF patients (55%); however, the difference was not statistically significant (P=0.15). EC-MPS patients had a significantly greater decrease in the Gastrointestinal Symptom Rating Scale indigestion syndrome dimension versus MMF patients. Within the subgroups of patients with diabetes, patients transplanted 6 to 12 months of study enrollment, and patients on steroids, a statistically significant greater proportion of EC-MPS versus MMF patients reached the primary efficacy outcome. Conclusions. Conversion fromMMFto EC-MPS may be associated with improvements in presence and severity of GI symptoms, particularly in patients with indigestion, diabetes, on steroids, and in patients converted between 6 and 12 months posttransplantation.
引用
收藏
页码:470 / 478
页数:9
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