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Center for Global Research Data

Effect of treatment on lipid profiles in patients with inflammatory bowel disease a systematic review and meta-analysis

Lead Investigator: Janneke van der Woude, Erasmus Medical Center
Title of Proposed Research: Effect of treatment on lipid profiles in patients with inflammatory bowel disease a systematic review and meta-analysis
Vivli Data Request: 4043
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract with a complex, multifactorial etiology. IBD consists of two separate diagnoses: ulcerative colitis (UC) and Crohn’s disease (CD), who differ in extent due to differences in the affected segment, extend, fashion, histology, complications and extra-intestinal manifestations. UC is characterized by superficial mucosal inflammation of the rectum and to a variable extent the colon in a continuous fashion, usually without granulomas in the biopsies. CD is characterized by skip lesions of, most frequently, the ileum and colon. Potentially, also the proximal gastrointestinal tract is affected in CD. The inflammation is transmural leading to structuring disease with ileus-like symptoms due to stenosis and penetrating disease characterized by fistula, micro perforations and abscesses. Also, extra-intestinal manifestations can occur in patients with inflammatory bowel disease, including arthritis, dermatological (erythema nodosum, pyoderma gangrenosum), oral (aphthous ulcera) and ocular (uveitis) lesions.

Chronic systemic inflammation is an independent risk factor for atherosclerosis due to stimulation of plaque formation, leading to endothelial dysfunction and platelet activation and aggregation. IBD is associated with venous thromboembolism, particularly during disease flares (Grainge et al. 2010). A meta-analysis of 9 cohort and case control studies, suggested that IBD is associated with a higher risk on cerebrovascular accidents (CVA, OR 1.18) and ischemic heart disease (IHD, OR 1.19). Predictive factors were the female gender and a younger age (<40-50 years), with no difference between UC and CD. There was no association with peripheral arterial disease (Singh et al. 2014). In addition, conflicting results were reported with regard to cardiovascular disease (CVD) mortality. Moreover, patients with IBD show an increase in intima thickness as measurement of atherosclerotic disease burden (Papa et al. 2005). Most interestingly, studies conclude that IBD is one of the disorders where changes in lipid profiles are observed, namely a hypercholesterolemia without evident increase in traditional cardiovascular risk factors including obesity, diabetes, hypertension or familiar hypercholesterolemia. IBD patients tend to have lower levels of total cholesterol and low density lipoprotein cholesterol (LDL-C) during disease activity whereas decrease in inflammation due to medical therapy increases those variables (Aris et al. 2011). Previous studies have found that treatment with infliximab (Koutroubakis et al. 2009) and tofacitinib (Sands et al. 2018) alter the lipid profile comparably. Although this increase in ‘bad’ cholesterol is unwanted, the increase in high density lipoprotein cholesterol (HDL-C) can be beneficial due to cardioprotective functioning. Therefore, we will conduct a literature review and meta-analysis to assess the metabolic actions of IBD treatment on the lipid profile.

Requested Studies

A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis
Data Contributor: Pfizer Inc.
Study ID: NCT00787202
Sponsor ID: NCT00787202

Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Data Contributor: Pfizer Inc.
Study ID: NCT01465763
Sponsor ID: NCT01465763

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Data Contributor: Pfizer Inc.
Study ID: NCT01458951
Sponsor ID: NCT01458951

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Data Contributor: Pfizer Inc.
Study ID: NCT01458574
Sponsor ID: NCT01458574