Gastrointestinal Symptom Burden Research Articles

The Positive Effect of Mindfulness Rivals the Negative Effect of Neuroticism on Gastrointestinal Symptoms

The current study evaluated a theoretically-derived model of the relationships between psychological traits (neuroticism and mindfulness) and gastrointestinal (GI) symptom burden with indirect effects via general dispositional cognitions and health-related cognitions. A sample of women (N = 210, Mage = 22.83, SDage = 9.78) completed an online questionnaire battery consisting of self-reported GI symptom burden, neuroticism, mindfulness, general cognitions (emotional intelligence, reappraisal, suppression, rumination), and health-related cognitions (gastrointestinal-specific anxiety, pain catastrophizing). Our hypotheses were tested using multiple regression, latent variable, and structural equational modeling. Both mindfulness (Beta = − .220, p = .011) and neuroticism (Beta = .234, p = .001) significantly independently predicted GI symptom burden. Additionally, these relationships were completely accounted for via indirect effects of general cognitions and health-related cognitions, supporting our hypotheses: Indirect effect of neuroticism on GI symptom burden: Beta = .228, p = .007; Indirect effect of mindfulness on symptom burden: Beta = − .308, p = .011. The findings from the current study highlight the important role of both general and health-related cognitions in the experience of GI symptom burden and support theoretical models that posit mechanisms of mindfulness via adaptive coping strategies. Given the subjective nature of symptom experience, these findings may help to explain the efficacy of psychological therapies in reducing GI symptom burden.

Neither self-reported atopy nor IgE-mediated allergy are linked to gastrointestinal symptoms in patients with irritable bowel syndrome.

Among patients with irritable bowel syndrome (IBS), atopic disease has been proposed as a common comorbidity increasing the IBS symptom burden. We therefore assessed the prevalence of self-reported atopy among patients with IBS as compared to non-IBS controls, and whether atopy and higher serum IgE levels were associated with increased IBS symptom severity. Levels of total and specific IgE in serum were measured and questionnaires assessing the presence of atopic disease (ie, eczema, asthma, rhinoconjunctivitis, and pollen allergy), gastrointestinal symptom burden, food intolerance, somatic, and psychological symptoms were completed. In total, 223 patients with IBS and 47 controls participated. Presence of atopic disease was reported in 55% of patients with IBS compared to 40% of controls (P=.07). IBS patients with atopic manifestations (N=123) had higher total serum IgE levels (median 31 vs 16 kUA /L, P<.001) and higher prevalence of self-reported food intolerance (28% vs 9%, P=.002) than non-atopic IBS patients (N=100), respectively, but no major difference in gastrointestinal or psychological symptom burden was noted. However, severe somatic symptoms were more common among atopic than non-atopic patients with IBS (38% vs 27%, P=.028). We found no associations between self-reported atopy and IBS symptom severity using linear regression models. Atopic disease is common in patients with IBS, but that is also true for subjects without IBS. The presence of atopic disease in IBS is associated with self-reported food intolerance and somatic symptom severity, but unrelated to IBS symptom severity.

Short-term and family-reported long-term outcomes of simple versus complicated gastroschisis

BackgroundOur goal is to determine short- and long-term outcomes of simple gastroschisis (SG) and complicated gastroschisis (CG) patients including quality of life (QoL) measures, surgical reoperation rates, and residual gastrointestinal symptom burden. Materials and methodsRetrospective chart review of patients who underwent surgical repair of gastroschisis between January 1, 2009, and December 31, 2012, was performed at a quaternary children's hospital. Parent telephone surveys were conducted to collect information on subsequent operations and current health status as well as to assess QoL using two validated tools. ResultsOf 143 patients identified, 45 (31.5%) were reached and agreed to participate with a median follow-up age of 4.7 y. Although CG was associated with short-term outcomes such as longer length of stay, longer days to feeds, and higher complication rates, there were no major differences in long-term QoL outcomes when comparing SG and CG. Children with CG experienced abdominal pain/gas/diarrhea more often than those with SG and required more major abdominal procedures than those with SG (15% versus 0%, P = 0.009). ConclusionsDespite worse short-term outcomes, presence of certain gastrointestinal symptoms, and need for more surgical interventions for patients with CG, and overall QoL scores were reassuringly similar to those with SG.

Prevalence, Duration, Severity, and Distress of Chemotherapy-Related Gastrointestinal Symptoms in Patients With a Hematologic Malignancy.

To describe prevalence, duration, severity, and distress of chemotherapy-related gastrointestinal (GI) symptoms, and evaluate inclusion of clinically relevant GI symptom items on cancer symptom questionnaires. . Longitudinal descriptive design. . Inpatient and outpatient hematology settings. . 105 adults with a hematologic malignancy receiving their third or subsequent cycle of chemotherapy. . Participants completed weekly assessments of 19 GI symptoms during a three-week period of chemotherapy. Descriptive statistics were calculated to summarize GI symptom prevalence, duration, severity, and distress ratings at each week. Findings were compared to item content of 12 cancer multisymptom questionnaires identified in the literature. . GI symptom prevalence, duration, severity, and distress. . Participants reported an average of three to five GI symptoms at each time point that were typically experienced as mild to moderate in duration, severity, and distress. Only 3 of 11 clinically relevant GI symptoms were included on more than half of the cancer symptom questionnaires. . Patients receiving chemotherapy experience a moderate GI symptom burden across a wide range of potential GI symptoms. . Future research should include measures of clinically relevant GI symptoms that may be emerging with new cancer therapies and toxicity prevention protocols.

PWE-160 Exploring Gastrointestinal Symptoms and Their Impact on Quality Of Life in Patients With Neuroendocrine Tumours

Introduction Treatments available to patients with neuroendocrine tumours(NETs) have been studied for their effect on tumour progression and carcinoid syndrome. However, there is minimal evidence on gastrointestinal (GI) symptom burden and its impact on quality of life (QoL). We aimed to determine whether patients with NETs receiving treatment experience GI symptoms, and to explore the impact that these symptoms have on QoL. Methods A prospective cohort of 46 patients with histologically confirmed NET visiting endocrine and oncology clinics completed GSRS (gastrointestinal symptom rating scale) and EORTC QLQ-GINET21 QoL questionnaires prior to establishment of a gastroenterology NET service. Results The majority of patients had a midgut(70%) or pancreatic(15%) primary with 96% having metastatic disease. Duration of diagnosis was 42 months (range 2–249), 91% having stable disease. The majority of patients reported GI symptoms including: abdominal cramps(80%), bloating(74%), excessive passing of wind(87%) and faecal urgency(87%). 50% had a stool frequency of more than 5 times a day and 71% of patients scored type 5 or higher on the Bristol Stool Chart. 54% of patients reported greasy/oily stool. 60% scored their QoL to be less than 7 out of 10. When asked how much bowel symptoms were affecting quality of life, 58% of patients scored more than 5 out of 10. 97% reported their illness to be distressing for those close to them. Conclusion This study represents the first systematic analysis of specifically defined GI symptoms experienced by NET patients. Despite having stable disease, many patients frequently experience GI symptoms which have a negative impact on QoL. Disclosure of Interest None Declared

Impact of switching from mycophenolate mofetil to enteric-coated mycophenolate sodium on gastrointestinal side effects in patients with autoimmune disease: a Phase III, open-label, single-arm, multicenter study.

BackgroundThe purpose of this study was to assess changes in gastrointestinal symptom severity in patients with autoimmune disease who were switched from mycophenolate mofetil to enteric-coated mycophenolate sodium (EC-MPS).MethodsIn this national, explorative, single-arm study, 111 patients were enrolled and switched to equimolar EC-MPS at baseline. The primary endpoint was change in the Gastrointestinal Symptom Rating Scale (GSRS) total score after 6–8 weeks of treatment (Visit 2). The optional follow-up visit was 6–12 weeks after completion of the study (Visit 2). Secondary endpoints were changes in GSRS subscale score; changes in gastrointestinal-related quality of life measured by the Gastrointestinal Quality of Life Index (GIQLI); and general health-related quality of life (HRQoL) measured by Psychological General Well-Being Index and assessment of overall treatment effect (OTE). Change was evaluated by paired t-tests.ResultsAt Visit 2, the mean ± standard deviation GSRS total score improved from 2.28±1.13 to 2.02±0.93 points. The change (−0.28±0.92 points, P=0.002) was statistically significant. The change at the follow-up visit (−0.36±0.94 points, P=0.001) was statistically significant and more than the minimal clinical important difference. GSRS subscores showed statistically significant and clinically relevant improvement for abdominal pain (−0.51±1.2 points, P<0.001) and indigestion (−0.42±1.33 points, P=0.002). Overall GIQLI score showed significant improvement from baseline to Visit 2 (−5.8±18.6 points, P=0.002). Per OTE, improvement was reported in 44.1% and 34.2% patients as rated by physicians and patients, respectively. The majority of patients (55%) reported OTE-HRQoL as unchanged. Diarrhea and nausea were the commonly reported adverse events.ConclusionPatients switched to EC-MPS experienced less gastrointestinal symptom burden and showed improvement in HRQoL.

The association of personality, appraisal, catastrophising and vigilance with gastrointestinal symptom-specific anxiety

This study investigates the relationship between psychosocial factors and functional gastrointestinal disorder symptomatology by testing a more comprehensive and integrated model than found in prior research. A total of 233 respondents completed an online battery to assess factors such as personality, dysfunctional cognitions and gastrointestinal anxiety. Results based on path modelling provided support for the majority of the hypothesised pathways. This study implicates a number of personality factors and dysfunctional cognitive processes as relevant to functional gastrointestinal disorder symptom burden. These findings have implications for future research, including which dysfunctional cognitive processes should be targeted therapeutically.

Symptom Burden Clusters: A Challenge for Targeted Symptom Management. A Longitudinal Study Examining Symptom Burden Clusters in Breast Cancer

ContextAlthough there has been a growing interest in cancer symptom clusters, less is known about symptom burden clusters. ObjectivesTo explore clusters of burdensome symptoms over time, the impact on health status and quality of life, and coping capacity in patients with breast cancer. MethodsIn this longitudinal study, a sample of 206 patients completed the Memorial Symptom Assessment Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, and the Sense of Coherence scale, at diagnosis of primary or recurrent breast cancer, and at one-, three-, and six-month follow-ups. ResultsThree clusters of burdensome symptoms were identified: emotional symptom burden, gastrointestinal symptom burden, and unwellness symptom burden. Most burdensome were emotional symptoms, with worrying, feeling sad, and feeling nervous as the core or defining symptoms. Over time, additional symptoms escalated the emotional symptom burden. The gastrointestinal symptom burden, with “change in the way food tastes” as a core symptom, was more often associated with chemotherapy. Less stable over time, the unwellness symptom burden could be interpreted as short- and long-term side effects of hormonal therapy. Of these clusters, only the emotional symptom burden cluster significantly diminished health status and quality of life. Patients reporting lower coping capacity experienced higher levels of symptom burden. ConclusionThis study provides insights into symptom burden clusters over time. A challenging approach toward symptom management in clinical oncology is to target the burden of a symptom cluster and to recognize the need for individually designed interventions to ameliorate symptom burden in cancer patients.

Clinical and psychosocial functioning in adolescents and young adults with anorectal malformations and chronic idiopathic constipation

Faecal incontinence (FI) and constipation occur following corrective surgery for anorectal malformations (ARMs) and in children or adults with chronic constipation without a structural birth anomaly (chronic idiopathic constipation, CIC). Such symptoms may have profound effects on quality of life (QoL). This study systematically determined the burden of FI and constipation in these patients in adolescence and early adulthood, and their effect on QoL and psychosocial functioning in comparison with controls. Patients with ARMs or CIC were compared with age- and sex-matched controls who had undergone appendicectomy more than 1 year previously and had no ongoing gastrointestinal symptoms. Constipation and FI were evaluated using validated Knowles-Eccersley-Scott Symptom (KESS) and Vaizey scores respectively. Standardized QoL and psychometric tests were performed in all groups. The study included 49 patients with ARMs (30 male, aged 11-28 years), 45 with CIC (32 male, aged 11-30 years) and 39 controls (21 male, aged 11-30 years). The frequency of severe constipation among patients with ARMs was approximately half that seen in the CIC group (19 of 49 versus 31 of 45); however, frequencies of incontinence were similar (22 of 49 versus 21 of 45) (P < 0·001 versus controls for both symptoms). Physical and mental well-being were significantly reduced in both ARM and CIC groups compared with controls (P = 0·001 and P = 0·015 respectively), with generally worse scores among patients with CIC. Both were predicted by gastrointestinal symptom burden (P < 0·001). There were no statistically significant differences in state or trait psychiatric morbidity between groups. FI and constipation are major determinants of poor QoL in adolescents and young adults with ARMs and in those with CIC.

Mycophenolic acid in kidney transplant patients with diabetes mellitus: does the formulation matter?

Diabetes mellitus is frequent in kidney transplant recipients and is commonly associated with gastrointestinal (GI) complications. Delayed gastric emptying affects 30% to 50% of patients with type 1 or 2 diabetes and can influence oral drug absorption. Time-to-peak concentration of mycophenolic acid (MPA) from mycophenolate mofetil (MMF) is longer in diabetic kidney transplant patients than patients without diabetes. By retaining gut contents in the stomach for longer, this could increase local GI toxicity in diabetic recipients due to an extended duration of exposure to MPA in the stomach. The enteric-coated mycophenolate sodium (EC-MPS) formulation delays the release of MPA until pH is higher than 5.5, such that absorption takes place more distally compared with MMF. Patient-reported outcomes data have been used to assess the effect of conversion to EC-MPS in maintenance kidney transplant patients with diabetes who were experiencing MMF-related GI symptoms. Results indicated that conversion leads to improved GI symptom burden despite higher MPA exposure under the EC-MPS regimen. Improved GI tolerance using EC-MPS has permitted maintenance of optimal MPA exposure in nondiabetic populations. Comparative trials to evaluate the GI symptom burden and maximum achieved MPA dosing using the EC-MPS and MMF formulations in de novo and maintenance diabetic kidney transplant recipients are merited.

Gastrointestinal Symptom Burden, Psychiatric Comorbidity, and Health Related Quality of Life (HRQoL) Among Patients With Esophageal- and Anorectal Spastic Motor Disorders (SMD)

Gastrointestinal Symptom Burden, Psychiatric Comorbidity, and Health Related Quality of Life (HRQoL) Among Patients With Esophageal- and Anorectal Spastic Motor Disorders (SMD)

Improvement of gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric‐coated mycophenolate sodium in liver transplant patients

As many as 50% of liver transplant patients suffer gastrointestinal (GI) disturbances post-transplant. Conversion from mycophenolate mofetil (MMF) to mycophenolate sodium (EC-MPS) alleviates GI symptom burden in renal transplant recipients. We employed a validated patient and physician-reported assessment to evaluate the impact of conversion to EC-MPS in liver transplant patients. This is a prospective, longitudinal, single-center, open-label pilot study. Thirty-one MMF-treated liver transplant patients with GI symptoms were converted to equimolar EC-MPS. Gastrointestinal Symptom Rating Scale (GSRS), GI Quality of Life, SF-12v2 and physician-reported assessments were used to evaluate GI symptom burden and severity. A significant improvement in overall GSRS score was noted from baseline (2.57; 95% CI 2.12-3.10) to one month (1.90; 1.68-2.12; p = 0.0007) and three months (1.82; 1.60-2.04; p = 0.0002) post-conversion with significant reductions in all subgroups except Reflux. The overall Gastrointestinal Quality of Life Index (GIQLI) score also showed significant increase in health-related quality of life between one month (90.89; 84.04-97.75) and three months (100.04; 94.57-105.51; p = 0.0009), with all subgroups except social functioning (p = 0.0861) and medical treatment (p = 0.3156) demonstrating significant improvements. This pilot study demonstrates improvement in GI symptom burden when converting from equimolar doses of MMF to EC-MPS. This benefit persisted for three months without evidence of rejection.

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

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. 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. 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. Conversion from MMF to 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.

Enteric-coated mycophenolate sodium

Importance of the field: Mycophenolic acid (MPA) therapy is a fundamental component of most post-transplant immunosuppressive regimens. Side effects, however, are common and frequently necessitate dose reductions or discontinuations.Areas covered in this review: Enteric-coated mycophenolate sodium (EC-MPS) is designed to improve the gastrointestinal (GI) tolerability of MPA. This review assesses the pharmacology, efficacy and safety of EC-MPS.What the reader will gain: An understanding of the use of EC-MPS in solid organ transplantation and the key trials examining the GI impact of EC-MPS versus the immediate-release mycophenolate mofetil (MMF) formulation. The article also addresses the possible impact of proton pump inhibitor therapy, and the optimal MPA dose with different concomitant immunosuppressants.Take home message: Evidence from blinded trials using standard reporting measures or patient-reported outcomes has not confirmed a significant improvement in the GI symptom burden using EC-MPS. Several open-label studies, however, have consistently shown an improvement in GI tolerability with EC-MPS, which can permit restoration of the optimal MPA dose. EC-MPS has equal efficacy and possibly a different tolerability profile to MMF, thus offering a choice to physicians and their patients, particularly those experiencing MMF-related GI symptoms, diabetic patients or those in whom an MPA dose reduction is required.

Improved Gastrointestinal Symptoms and Quality of Life after Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients Receiving Tacrolimus

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.

EC‐MPS permits lower gastrointestinal symptom burden despite higher MPA exposure in patients with severe MMF‐related gastrointestinal side‐effects

Gastrointestinal (GI) adverse events in renal transplant patients are a common cause of mycophenolate mofetil (MMF) dose reductions, which result in an increased risk of graft rejection because of a low immunosuppression. This study investigated whether conversion from MMF to enteric-coated mycophenolate sodium (EC-MPS) in renal transplant patients with serious GI side-effects, alleviated these symptoms and allowed administration of higher doses of EC-MPS. Nineteen renal transplant patients with severe MMF-related GI side-effects underwent a progressive reduction in MMF dose until symptoms disappeared. At this point, 12-h AUC(MMF) was evaluated and patients were shifted to an equimolar dose of EC-MPS. The EC-MPS dose was then progressively increased until the highest recommended dose was reached or GI symptoms re-appeared. Four weeks post-conversion, AUC(EC-MPS) was determined. Conversion led to a mean increase in EC-MPS dose of 68% (P < 0.0001), with a corresponding rise in AUC(0-12) (60.5%, P < 0.0006) associated with significant benefits in terms of both quality of life (Kidney Transplant Questionnaire, P < 0.01) and GI symptoms (Gastrointestinal Symptom Rating Scale, P < 0.0001), using validated questionnaires. In five of 19 patients, the EC-MPS dose could not be increased because of the prompt insurgence of GI symptoms. Renal function and biochemical parameters remained stable post-conversion and no rejection episodes occurred. These findings suggest that, in selected patients, EC-MPS may be better tolerated than MMF when GI symptoms are particularly important and permits higher mycophenolic acid exposure, when required.

Improved gastrointestinal symptom burden after conversion from mycophenolate mofetil to enteric‐coated mycophenolate sodium in kidney transplanted children

It has been shown in adult kidney transplant recipients that a conversion from MMF to EC-MPS significantly reduced the GI related symptom burden. No such study exists on children with GI problems while receiving MMF therapy. Ten paediatric kidney transplant recipients (mean age 14.5 yr, s.d. 4.5) receiving triple immunosuppression (Cyclosporin A or Tacrolimus + MMF + Prednisolone) with severe GI symptoms were converted to an equimolar dose of EC-MPS. The GSRS was completed before and at four wk after the switch, and GFR was determined for a mean period of six months. Values were compared by the paired t-test. Mean GSRS improved significantly after the switch to EC-MPS in all but one patient, from 2.1 (s.d. 0.9) to 1.1 (s.d. 0.6). The differences could be found in all four subscales. Graft function did not change after conversion to EC-MPS. In children with moderate or severe GI symptoms while receiving MMF, conversion to EC-MPS led to significantly reduced GI symptoms.

Inadequate use of proton-pump inhibitors in patients with liver cirrhosis

Patients with liver cirrhosis have a high prevalence of gastrointestinal symptoms. The use of antiacid therapy (AAT) in these patients is unexplored. We aimed to assess the use of AAT in cirrhotic patients. A total of 128 consecutive cirrhotic patients were evaluated for the use of and indications for acid-suppressive agents. Upper endoscopy findings and concomitant medications were registered. A validated questionnaire was used to measure the gastrointestinal symptom burden. Adequate indications for AAT were those strongly supported by the medical literature. Forty percent (n=51) of patients with cirrhosis were on AAT. Thirty-seven percent (n=19) of these had adequate and 63% (n=32) inadequate indications for AAT. The major inadequate indication was previous variceal bleeding (34%). Patients with inadequate indications for AAT had increased severity of symptoms of indigestion compared with patients without AAT (P<0.05). Multivariate analysis revealed that inadequate use of AAT was independently related only to previous variceal bleeding and the number of concomitant medications. AAT is used by a large proportion of patients with cirrhosis. In the majority, therapy is based on inadequate indications, mainly continuous long-term therapy after previous variceal bleeding. Patients with an inadequate indication for acid-suppressive medications have increased severity of symptoms of indigestion, indicating that gastrointestinal symptoms might be a factor contributing to proton-pump inhibitor consumption in these patients.

Improvement in 3-Month Patient-Reported Gastrointestinal Symptoms After Conversion From Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients

The benefit of conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) in terms of gastrointestinal symptom burden has been evaluated previously using patient-reported outcomes. However, data are lacking concerning the sustained effect of conversion over time, and the potential impact of concomitant calcineurin inhibitor. In this 3-month, prospective, multicenter, longitudinal, open-label trial, MMF-treated renal transplant patients with gastrointestinal symptoms receiving cyclosporine or tacrolimus were converted to equimolar doses of EC-MPS. Change in gastrointestinal symptom burden was evaluated using a validated Gastrointestinal Symptom Rating Scale (GSRS). A significant improvement in GSRS score was observed from baseline (2.61, 95% CI 2.54-2.68) to month 1 (1.87, 95% CI 1.81-1.93) after conversion to EC-MPS and was sustained to month 3 (1.81, 95% CI 1.74-188; both P<0.0001 versus baseline). The mean change in overall GSRS score from baseline to month 1 was -0.74 overall (cyclosporine: -0.73 and tacrolimus: -0.74; all P<0.0001 versus baseline), with a slight further improvement (-0.79) at month 3 (cyclosporine: -0.82 and tacrolimus: -0.78; all P<0.0001 versus baseline). A significant improvement in GSRS subscale scores was also observed in the total population regardless of calcineurin inhibitor at month 1, sustained to month 3 (all P<0.0001 versus baseline). The improvement in GSRS score postconversion was similar in African-American and non-African-American patients, and in diabetic and nondiabetic patients. This exploratory study in 728 patients demonstrates that following conversion from MMF to EC-MPS, regardless of concomitant calcineurin inhibitor, GSRS is improved and sustained over 3 months.

Patient-Reported Gastrointestinal Symptom Burden and Health-Related Quality of Life following Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium

The benefit of converting renal transplant recipients with gastrointestinal (GI) complaints from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) has not been evaluated using patient-reported outcomes. A multicenter, open-label, prospective study was undertaken in MMF-treated renal transplant patients. Patients experiencing GI complaints were converted to equimolar EC-MPS (Cohort A). Patients without GI complaints remained on MMF (Cohort B). At baseline and Visit 2 (4-6 weeks postbaseline), patients completed the Gastrointestinal Symptom Rating Scale (GSRS), Gastrointestinal Quality of Life Index (GIQLI) and Psychological General Well-being Index (PGWBI). At Visit 2, patients and physicians completed the Overall Treatment Effect (OTE) scale for GI symptoms. Additionally, patients completed the OTE for health-related quality of life (HRQoL). Minimal important difference (MID) was calculated for GSRS and GIQLI based on patients' and physicians' OTE evaluation. Of 328 patients enrolled (i.e. the intent-to-treat and safety populations), 278 formed the per-protocol population (Cohort A, n=177; Cohort B, n=101). At baseline, Cohort A had significantly worse scores on all GSRS, GIQLI and PGWBI subscales compared to Cohort B (all P<0.0001). All GSRS, GIQLI and PGWBI subscale scores improved significantly in Cohort A between baseline and Visit 2 (all P<0.0001). Mean improvements in all GSRS subscales and most GIQLI subscores exceeded the calculated MID. GSRS, GIQLI and PGWBI subscales remained stable in Cohort B. This first exploratory study indicates that converting patients with mild, moderate or severe GI complaints from MMF to EC-MPS significantly reduces GI-related symptom burden and improves patient functioning and well-being.