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Lanreotide Autogel in the Treatment of Persistent Diarrhea following a Total Colectomy.

ABSTRACT: Diarrhea is one of the most common complications following colectomy in patients with slow transit constipation (STC). Early postoperative diarrhea is usually treated with opioid agonists; however, to date, published data on the management of persistent diarrhea after colectomy for STC are scarce. Here, we report a case of severe diarrhea after a total colectomy with ileorectal anastomosis. One year after the surgery, the patient presented with persistent diarrhea. Treatment with a long-acting somatostatin analogue, lanreotide Autogel, was initiated. One month after the first injection of lanreotide Autogel the diarrhea was resolved. The patient's stool transit was markedly improved (type 4 or type 5 according to the Bristol Stool Chart compared to type 7 before the treatment), positively affecting the patient's quality of life (mean score of 2.1 on the Irritable Bowel Syndrome Quality of Life questionnaire compared to 3.9 before the treatment). This case report describes a successful use of lanreotide Autogel in a patient with persistent diarrhea after a total colectomy.

SUBMITTER: Schoeters P

PROVIDER: S-EPMC4684851 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Lanreotide Autogel in the Treatment of Persistent Diarrhea following a Total Colectomy.

Schoeters Patrick P De Pooter Karl K

Case reports in gastrointestinal medicine 20151206

Diarrhea is one of the most common complications following colectomy in patients with slow transit constipation (STC). Early postoperative diarrhea is usually treated with opioid agonists; however, to date, published data on the management of persistent diarrhea after colectomy for STC are scarce. Here, we report a case of severe diarrhea after a total colectomy with ileorectal anastomosis. One year after the surgery, the patient presented with persistent diarrhea. Treatment with a long-acting s ...[more]

PMID: 26770844

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Project description:INTRODUCTION:Although the previous lanreotide autogel/depot syringe had been well received, feedback indicated that improvements could be made to make it more user-friendly. Additionally, the view that patients should have greater involvement in the research and development process is echoed by the International Neuroendocrine Cancer Alliance. A series of studies aimed to develop and validate a new syringe that works better for patients, caregivers and healthcare professionals (HCPs) by involving these groups at key stages in the development and testing process. METHODS:The multicentre, international, human factor studies, consisted of four formative studies and one validation study. The formative studies collected patient, caregiver and HCP feedback on the lanreotide autogel/depot syringe on the market at the time, and on newly designed prototypes. The validation study was conducted to evaluate the final syringe to confirm that it can be used effectively and safely in the intended environment, by the intended user, for the intended purpose. RESULTS:Overall, 213 individuals participated in the studies; 145 contributed to the formative studies and 68 to the validation study. The validated new-generation syringe included several important updates compared with the lanreotide autogel/depot syringe currently on the market, including the flanges, which are now larger and have a better grip; the overcap, which is white, ridged, opaque and bigger; the plunger supports and the thermoformed tray. No participant hurt themselves or others during the validation study (although several misuses were reported), and all participants succeeded in delivering a complete dose and activating the safety system. CONCLUSION:With collaboration, a new syringe was developed to meet the needs of patients, caregivers and HCPs, whilst ensuring lanreotide was delivered effectively and safely. These studies highlight the importance of involving patients, caregivers and HCPs in clinical evaluation studies to develop medical products that address their concerns and meet their needs. FUNDING:Ipsen. Plain language summary available for this article.

Project description:BACKGROUND:In the double-blind (DB) ELECT study, lanreotide depot/autogel significantly reduced versus placebo the need for short-acting octreotide for symptomatic carcinoid syndrome (CS) control in neuroendocrine tumor (NET) patients. Here we present patient-reported symptom data during DB and initial open-label (IOL) treatment. MATERIALS AND METHODS:Adults with NETs and CS history, with/without prior somatostatin analog use, were randomized to 16 weeks' DB lanreotide 120 mg subcutaneous or placebo every 4 weeks, followed by 32 weeks' IOL lanreotide. Patients recorded diarrhea and/or flushing frequency and severity daily by Interactive Voice (Web) Response System for 1 month prior to randomization and throughout the study. RESULTS:Of 115 patients randomized (n?=?59 lanreotide, n?=?56 placebo), 56 lanreotide and 45 placebo patients enrolled in the IOL phase. During DB treatment, least square (LS) mean percentages of days with moderate/severe diarrhea and/or flushing were significantly lower for lanreotide (23.4%) versus placebo (35.8%; LS mean difference [95% confidence interval]: -12.4 [-20.73 to -4.07]; p?=?.004). For DB lanreotide patients, average daily composite (frequency × severity) diarrhea scores improved significantly between DB and IOL treatment (mean difference: -0.71 [-1.20 to -0.22]; p?=?.005), and remained stable for diarrhea and/or flushing. For DB placebo patients, composite scores for diarrhea, flushing, and diarrhea and/or flushing improved significantly between DB and IOL treatment (mean differences: -1.07 [-1.65 to -0.49]; -1.06 [-1.93 to -0.19]; and -2.13 [-3.35 to -0.91]; all p???.018). CONCLUSION:Improved diarrhea and flushing control in CS patients during 16-week lanreotide treatment was sustained during maintenance of lanreotide treatment for the 32-week IOL phase (48 weeks total). IMPLICATIONS FOR PRACTICE:This study prospectively collected daily patient-reported data on diarrhea and flushing from the ELECT trial to evaluate the direct impact of lanreotide depot on patients' relief of carcinoid syndrome symptoms. Treatment with lanreotide depot was associated with significant reductions in the percentages of days patients reported symptoms of diarrhea and flushing, as well as reductions in the frequency and severity of daily symptoms compared with placebo during 16 weeks of double-blind treatment. These improvements were sustained for 32 additional weeks of open-label lanreotide treatment (i.e., through week 48 of treatment), resulting in clinically meaningful, long-term symptom reduction.

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Lanreotide Autogel in the Treatment of Persistent Diarrhea following a Total Colectomy.

Publications

Lanreotide Autogel in the Treatment of Persistent Diarrhea following a Total Colectomy.

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