Abstract

A pharmacodynamic and pharmacokinetic study to determine the clinical significance of drug interactions between azathioprine and sulfasalazine, Balsalazide or Pentasa in patients with inflammatory bowel disease.
The specific aims of the study are to estimate the proportion of clinically important leukopenia, defined as a total white blood cell (WBC) count <3,000 X 10 9/L, when SAS 4 g/day, Balsalazide 6.75 g/day, or Pentasa 4 g/day is combined with maintenance of remission treatment with a stable dose of 6MP or AZA in patients with one of the inflammatory bowel diseases (IBD), either ulcerative colitis (UC) or Crohn's disease. These estimates (and 95% CIs) will be computed at weeks 2, 4, 6, and 8 after adding SAS, Balsalazide, or Pentasa to AZA or 6MP therapy. The secondary aim is to estimate the change (and 95% CI) in total WBC count for each treatment group at weeks 2, 4, 6, and 8 after adding SAS, Balsalazide, or Pentasa to AZA or 6MP therapy.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000585-30
Application #
6415479
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
30
Fiscal Year
2001
Total Cost
Indirect Cost

  Institution

Name
Mayo Clinic, Rochester
Department
Type
DUNS #
City
Rochester
State
MN
Country
United States
Zip Code
55905

  Publications

Yu, Alan S L; Shen, Chengli; Landsittel, Douglas P et al. (2018) Baseline total kidney volume and the rate of kidney growth are associated with chronic kidney disease progression in Autosomal Dominant Polycystic Kidney Disease. Kidney Int 93:691-699
Kamimura, Daisuke; Suzuki, Takeki; Wang, Wanmei et al. (2018) Higher plasma leptin levels are associated with reduced left ventricular mass and left ventricular diastolic stiffness in black women: insights from the Genetic Epidemiology Network of Arteriopathy (GENOA) study. Hypertens Res 41:629-638
Nowak, Kristen L; You, Zhiying; Gitomer, Berenice et al. (2018) Overweight and Obesity Are Predictors of Progression in Early Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol 29:571-578
Tirumanisetty, P; Prichard, D; Fletcher, J G et al. (2018) Normal values for assessment of anal sphincter morphology, anorectal motion, and pelvic organ prolapse with MRI in healthy women. Neurogastroenterol Motil 30:e13314
McKenzie, Katelyn A; El Ters, Mirelle; Torres, Vicente E et al. (2018) Relationship between caffeine intake and autosomal dominant polycystic kidney disease progression: a retrospective analysis using the CRISP cohort. BMC Nephrol 19:378
Dad, Taimur; Abebe, Kaleab Z; Bae, K Ty et al. (2018) Longitudinal Assessment of Left Ventricular Mass in Autosomal Dominant Polycystic Kidney Disease. Kidney Int Rep 3:619-624
Brosnahan, Godela M; Abebe, Kaleab Z; Rahbari-Oskoui, Frederic F et al. (2017) Effect of Statin Therapy on the Progression of Autosomal Dominant Polycystic Kidney Disease. A Secondary Analysis of the HALT PKD Trials. Curr Hypertens Rev 13:109-120
Kamimura, Daisuke; Suzuki, Takeki; Furniss, Anna L et al. (2017) Elevated serum osteoprotegerin is associated with increased left ventricular mass index and myocardial stiffness. J Cardiovasc Med (Hagerstown) 18:954-961
Chung, Jin Ook; Koutsari, Christina; Blachnio-Zabielska, Agnieszka U et al. (2017) Intramyocellular Ceramides: Subcellular Concentrations and Fractional De Novo Synthesis in Postabsorptive Humans. Diabetes 66:2082-2091
West, Nancy A; Lirette, Seth T; Cannon, Victoria A et al. (2017) Adiposity, Change in Adiposity, and Cognitive Decline in Mid- and Late Life. J Am Geriatr Soc 65:1282-1288

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