Use of teduglutide in adults with short bowel syndrome-associated intestinal failure.

Short bowel syndrome (SBS) is a rare gastrointestinal disorder associated with intestinal failure (SBS-IF) and poor health-related outcomes. Patients with SBS-IF are unable to absorb sufficient nutrients or fluids to maintain significantly metabolic homeostasis via oral or enteral intake alone and require long-term intravenous supplementation (IVS), consisting of partial or total parenteral nutrition, fluids, electrolytes, or a combination of these. The goal of medical and surgical treatment for patients with SBS-IF is to maximize intestinal remnant absorptive capacity so that the need for IVS support may eventually be reduced or eliminated. Daily subcutaneous administration of the glucagon-like peptide 2 analog, teduglutide, has been shown to be clinically effective in reducing IVS dependence and potentially improving the health-related quality of life of patients with SBS-IF. The management of patients with SBS-IF is complex and requires close monitoring. This narrative review discusses the use of teduglutide for patients with SBS-IF in clinical practice. The screening of patient eligibility for teduglutide treatment, initiation, monitoring of efficacy and safety of treatment, adapting or weaning off IVS, and the healthcare setting needed for SBS-IF management are described, taking into consideration data from clinical trials, observational studies, and clinical experience.

Malignancy rates in Crohn's disease patients with perianal fistula: A German retrospective cohort study.

BACKGROUND: Patients with inflammatory bowel disease are at increased risk of colorectal and extra-intestinal cancer. However, the overall cancer risk in patients with Crohn's disease (CD) with perianal fistulas (PF) (CPF) and those with CD without PF (non-PF CD) is unclear. OBJECTIVE: To describe the prevalence and incidence of cancer in patients with CPF and non-PF CD, and to estimate incidence rate ratio (IRR) of cancer between CPF and non-PF CD groups. METHODS: A retrospective cohort study was conducted using the German InGef (Institute for Applied Health Research Berlin) research database. Patients with a CD record and PF from 1 January 2013 to 31 December 2014 were identified and followed up from 1 January 2015 until the first occurrence of cancer, end of health insurance contributing data, death, or end of study period (31 December 2020). Prevalence of any type of cancer including patients with CD diagnosed with cancer in the selection period and incidence of cancer excluding patients with CD diagnosed with cancer in the selection period were calculated. RESULTS: In total, 10,208 patients with CD were identified. Of 824 patients with CPF (8.1%), 67 had had a malignancy (6-year period crude malignancy prevalence 8.13% [95% confidence interval (CI) 6.36%-10.21%]), which was lower than patients with non-PF CD (19.8% [95% CI 19%-20.6%]). Incidence (per 100,000 person-years) in patients with CPF was 1184 (95% CI 879-1561) and in non-PF CD was 2365 (95% CI 2219-2519). There was no significant difference in the adjusted IRR of cancer for the CPF group compared with the non-PF CD group (0.83 [95% CI 0.62-1.10]; p = 0.219). CONCLUSION: There was no significant difference in the incidence of any cancer in patients with CPF compared with non-PF CD. However, patients with CPF had a higher numerical risk of cancer than the general German population.

Impact of intestinal failure and parenteral support on adult patients with short-bowel syndrome: A multinational, noninterventional, cross-sectional survey.

BACKGROUND: Patients with short-bowel syndrome and intestinal failure (SBS-IF) require parenteral support (PS) and experience various symptoms and comorbidities. This survey assessed the impact of SBS-IF and PS on patients and their health-related quality of life (HRQoL). METHODS: An online survey of adult patients who had a self-reported clinician diagnosis of SBS-IF and were receiving PS was conducted in France, Germany, Italy, the UK, and the USA. Patients reported symptoms, comorbidities, and treatment satisfaction; the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) and the Home Parenteral Nutrition-Quality of Life (HPN-QoL) questionnaire assessed impact on work and HRQoL, respectively. RESULTS: Patients (N = 181; aged 52.0 ± 15.1 years; 56.9% women) experienced fatigue (75.1%), anemia (49.7%), and difficulty spending time with family (36.5%) and friends (30.4%). A total work productivity loss of 37.5% was calculated in patients reporting employment (29.3%). Patients typically (64.0%) reported some degree of satisfaction with their PS treatment. Almost two-thirds (59.7%) reported that their PS was either "not," "a little," or "moderately" convenient. The mean HPN-QoL scores were higher for patients who were satisfied with treatment (n = 116; 17.1 ± 21.0 [median, 16.7; interquartile range, 0.0-31.7]) than for patients who were dissatisfied/neither (n = 65; 1.7 ± 19.7 [median, 0.0; interquartile range, -13.3-13.3]). CONCLUSIONS: Patients with SBS-IF who are receiving PS experience burdensome symptoms and comorbidities and report impacts on work productivity and time spent with friends and family. This study can increase awareness of the impacts of SBS-IF and PS and how treatment satisfaction may influence patients' health and HRQoL.

A Pan-European and Canadian prospective survey to evaluate patient satisfaction with the SoloSTAR insulin injection device in type 1 and type 2 diabetes.

OBJECTIVE: This study evaluated patient satisfaction with SoloSTAR® (sanofi-aventis), a prefilled insulin pen device for injection of insulin glargine or insulin glulisine. METHODS: This was a 6-8-week multicenter (n = 652), observational, prospective Pan-European and Canadian registry study in patients with diabetes mellitus (n = 6542) who recently switched to or started treatment with insulin glargine and/or insulin glulisine using SoloSTAR or were insulin naïve. At the baseline visit, patients were asked to evaluate their satisfaction with their previous device, if applicable. After 6-8 weeks of SoloSTAR use, patients were asked to rate their satisfaction. RESULTS: Overall, 6481 patients (mean age 54 years, 48.7% male, 72% type 2 diabetes) were analyzed in this study. Of these, 4995 (77.1%) patients had used insulin before the study and 1641 (32.9%) and 3395 (68.0%) patients had previously used prefilled and/or reusable pens, respectively. During the study, SoloSTAR was used to administer insulin glargine and/or insulin glulisine by 97.3% and 36.0% of patients, respectively (both: 27.0%). Most patients rated SoloSTAR as "excellent/good" for ease of use (97.9%), learning to use (98.3%), selecting the dose (97.6%), and reading the dose (95.1%). Most patients rated ease of use (88.4%) and injecting a dose (84.5%) with SoloSTAR as "much easier/easier" versus their previous pen. Overall, 98% planned to continue using SoloSTAR. No safety concerns were reported. CONCLUSION: This European and Canadian survey shows that SoloSTAR was well accepted in this large patient population. Most patients preferred SoloSTAR to their previous pen and planned to continue SoloSTAR use.