Improved gastrointestinal symptoms and quality of life after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients receiving tacrolimus

Hyeon Seok Hwang, Bok Jin Hyoung, Sol Kim, Ha Young Oh, Yon Su Kim, Jung Kyung Kim, Yeong Hoon Kim, Yong Lim Kim, Chan Duck Kim, Gyu Tae Shin, Chul Woo Yang, Hyeon Seok Hwang, Bok Jin Hyoung, Sol Kim, Ha Young Oh, Yon Su Kim, Jung Kyung Kim, Yeong Hoon Kim, Yong Lim Kim, Chan Duck Kim, Gyu Tae Shin, Chul Woo Yang

Abstract

It is reported that a conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) relieves gastrointestinal (GI) symptom burden and improves health-related quality of life (HRQoL). However, it is unclear whether renal transplant recipients using tacrolimus receive the same benefit from the conversion. In this prospective, multi-center, open-label trial, patients were categorized into two groups by their GI symptom screening. Equimolar EC-MPS (n=175) was prescribed for patients with GI burdens; those with no complaints remained on MMF (n=83). Gastrointestinal Symptom Rating Scale (GSRS) and Gastrointestinal Quality of Life Index (GIQLI) were evaluated at baseline and after one month. Patients and physicians completed Overall Treatment Effect (OTE) at one month. EC-MPS-converted patients had worse GSRS and GIQLI scores at baseline than MMF-continued patients (all P<0.001). Significant improvements in GSRS and GIQLI scores were observed for EC-MPS-converted patients at one month, but MMF-continued patients showed worsened GSRS scores (all P<0.05). OTE scale indicated that EC-MPS patients improved in overall GI symptoms and HRQoL more than MMF patients did (P<0.001). In tacrolimus-treated renal transplant recipients with GI burdens, a conversion from MMF to EC-MPS improves GI-related symptoms and HRQoL.

Keywords: Enteric-coated mycophenolate sodium; Gastrointestinal Symptom; Kidney Transplantation; Mycophenolate mofetil; Quality of Life; Tacrolimus.

Figures

Fig. 1
Fig. 1
Schematic diagram of study design and conduct. EC-MPS, enteric-coated mycophenolate sodium; MMF, mycophenolate mofetil; GSRS, Gastrointestinal Symptom Rating Scale; GIQLI, Gastrointestinal Quality of Life Index.
Fig. 2
Fig. 2
Simple questionnaire screening for GI symptoms. *denotes P values <0.001. EC-MPS, enteric-coated mycophenolate sodium; MMF, mycophenolate mofetil.
Fig. 3
Fig. 3
Patient-reported outcomes at baseline in EC-MPS converted and MMF continued group. (A) GSRS subscale scores (B) GIQLI subscale scores. *denotes P values <0.001. Note the significantly impaired GSRS and GIQLI all subscale scores in EC-MPS converted group. EC-MPS, enteric-coated mycophenolate sodium; MMF, mycophenolate mofetil; GSRS, Gastrointestinal Symptom Rating Scale; GIQLI, Gastrointestinal Quality of Life Index.
Fig. 4
Fig. 4
Changes in patient-reported outcomes after one month in EC-MPS converted and MMF continued group. (A) changes in GSRS subscale (B) changes in GIQLI subscale scores. *denotes P values <0.05. EC-MPS converted group significantly improved in GSRS and GIQLI all subscale scores compared to MMF continued group. EC-MPS, enteric-coated mycophenolate sodium; MMF, mycophenolate mofetil; GSRS, Gastrointestinal Symptom Rating Scale; GIQLI, Gastrointestinal Quality of Life Index.
Fig. 5
Fig. 5
Overall Treatment Effect (OTE) rating for (A) patient-rated general health-related quality of life (HRQoL) and (B) physician-rated GI symptoms after conversion to EC-MPS compared to baseline. EC-MPS converted group significantly improved in patient- and physician-rated OTE compared to MMF continued group (all P<0.001). EC-MPS, enteric-coated mycophenolate sodium; MMF, mycophenolate mofetil.

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