Crofelemer: A review of its use in the management of non-infectious diarrhoea in adult patients with HIV/AIDS on antiretroviral therapy

Drugs

Volumn 73, Issue 10, 2013, Pages 1121-1129

  Frampton, James E ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTIRETROVIRUS AGENT; ATROPINE PLUS DIPHENOXYLATE; CALCIUM ACTIVATED CHLORIDE CHANNEL; CHLORIDE CHANNEL; CHLORIDE ION; CROFELEMER; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; GREEN TEA EXTRACT; LOPINAVIR PLUS RITONAVIR; PLACEBO; POTASSIUM CHANNEL HERG; SODIUM ION;

ABDOMINAL PAIN; ACQUIRED IMMUNE DEFICIENCY SYNDROME; AIDS PATIENT; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; BARK; CD4 LYMPHOCYTE COUNT; CONDYLOMA ACUMINATUM; CONSTIPATION; CROTON; CROTON LECHLERI; DIARRHEA; DRUG ABSORPTION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG FATALITY; DRUG MECHANISM; DRUG METABOLISM; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ELECTROCARDIOGRAM; FLATULENCE; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL ABSORPTION; HEMORRHOID; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTESTINE CELL; INTESTINE FLUID; LABORATORY TEST; MULTICENTER STUDY (TOPIC); NAUSEA; OPEN STUDY; OPTIMAL DRUG DOSE; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLANT STEM; QT INTERVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; SIDE EFFECT; STOMACH ACID SECRETION; THROMBOCYTOPENIA; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VIRUS LOAD; VITAL SIGN;

ANTI-RETROVIRAL AGENTS; ANTIDIARRHEALS; DIARRHEA; HIV INFECTIONS; HUMANS; PLANT EXTRACTS; PROANTHOCYANIDINS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

CROTON LECHLERI;

EID: 84879897892     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-013-0083-6     Document Type: Article

References (18)

1. Siddiqui U, Bini EJ, Chandarana K, et al. Prevalence and impact of diarrhea on health-related quality of life in HIV-infected patients in the era of highly active antiretroviral therapy. J Clin Gastroenterol. 2007;41(5):484-90.
2. Knox TA, Spiegelman D, Skinner SC, et al. Diarrhea and abnormalities of gastrointestinal function in a cohort of men and women with HIV infection. Am J Gastroenterol. 2000;95:3482-9.
3. MacArthur RD, Dupont HL. Etiology and pharmacologic management of noninfectious diarrhoea in HIV-infected individuals in the highly active antiretroviral therapy era. Clin Infect Dis. 2012;55:860-7.
4. Hill A, Balkin A. Risk factors for gastrointestinal adverse events in HIV treated and untreated patients. AIDS Rev. 2009;11(1):30-8.
5. Tramarin A, Parise N, Campostrini S, et al. Association between diarrhea and quality of life in HIV-infected patients receiving highly active antiretroviral therapy. Qual Life Res. 2004;13:243-50.
6. Crutchley RD, Miller J, Garey KW. Crofelemer, a novel agent for treatment of secretory diarrhea. Ann Pharmacother. 2010;44(5):878-84.
7. Cottreau J, Tucker A, Crutchley R, et al. Crofelemer for the treatment of secretory diarrhea. Expert Rev Gastroenterol Hepatol. 2012;6(1):17-23.
8. Jones K. Review of Sangre de Drago (Croton lechleri) - A South American tree sap in the treatment of diarrhea, inflammation, insect bites, viral infections, and wounds: traditional uses to clinical research. J Altern Complement Med. 2003;9(6):877-96.
9. Salix Pharmaceuticals Ltd. FDA approves FULYZAQ (Crofelemer) 125 mg delayed-release tablets for the symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART) [media release]. 2 Jan 2013. http://www.salix.com.
10. Salix Pharmaceuticals Ltd. FULYZAQ (crofelemer) delayed-release tablets for oral use: US prescribing information. 2013. http://www.salix.com/assets/pdf/ prescribe-info/fulyzaq-pi.pdf. Accessed 28 Feb 2013.
11. Tradtrantip L, Namkung W, Verkman AS. Crofelemer, an antisecretory antidiarrheal proanthocyanidin oligomer extracted from Croton lechleri, targets two distinct intestinal chloride channels. Mol Pharmacol. 2010;77(1):69-78.
12. Fischer H, Machen TE, Widdicombe JH, et al. A novel extract SB-300 from the stem bark latex of Croton lechleri inhibits CFTR-mediated chloride secretion in human colonic epithelial cells. J Ethnopharmacol. 2004;93(2-3):351-7.
13. Gabriel SE, Davenport SE, Steagall RJ, et al. A novel plant-derived inhibitor of cAMP-mediated fluid and chloride secretion. Am J Physiol. 1999;276(1 Pt 1):G58-63.
14. Holodniy M, Koch J, Mistal M, et al. A double blind, randomized, placebo-controlled phase II study to assess the safety and efficacy of orally administered SP-303 for the symptomatic treatment of diarrhea in patients with AIDS. Am J Gastroenterol. 1999;94(11):3267-73.
15. Gao W-Y. Application number: 202292Orig1s000. Medical review(s). 2012. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2012/202292Orig1s000MedR.pdf. Accessed 21 Mar 2013.
16. MacArthur RD, Hawkins T, Brown SJ, et al. Safety and tolerability of crofelemer 125 mg for treating non-infectious diarrhea in HIV + individuals: results from double-blind and open-label studies [poster 787]. Conference on Retroviruses and Opportunistic Infections; 3-6 Mar 2013; Atlanta (GA).
17. MacArthur RD, Hawkins T, Brown SJ, et al. ADVENT trial: crofelemer for the treatment of secretory diarrhea in HIV + individuals [poster 889]. Conference on Retroviruses and Opportunistic Infections; 5-8 Mar 2012; Seattle (WA).
18. Fougera Pharmaceuticals Inc. VEREGEN® (sinecatchins) ointment, 15% for topical dermatologic use only: US prescribing information. Initial US approval 2006. http://www.veregen.com/pdf/Veregen-Promotional-4page-PI.pdf. Accessed 2 Apr 2013.