Medline Abstract
LT United States Public Health Service, DHHS/FDA/CDER/OM/CACP, BLDG 22 Rm 3425, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. |
|||||||||||||||||||||||||||||
BACKGROUND: Mineralocorticoids are thought to play a role in tissue repair, including fibrous tissue formation. The antimineralocorticoid activity of spironolactone has been linked to an increased risk of gastrointestinal bleeding. Drospirenone is a synthetic progestin approved in combination with ethinyl-estradiol as an oral contraceptive (OC). It is a spironolactone-derivative, and its antimineralocorticoid effects could irritate the gastrointestinal tract leading to symptoms of irritable bowel syndrome (IBS). METHODS: A retrospective cohort study was conducted evaluating women 18-46 years of age in the IMS claims-database. New-users of progestin-based OCs were identified between 1997-2009. Ninety days of OC therapy and one year of prior enrollment with no prior diagnosis of IBS were required for inclusion. Cases were identified using a previously validated method for the diagnosis of IBS. Cox proportional hazards models were used to estimate the hazard ratio (HR) for developing IBS with the different OC formulations using levonorgestrel as a reference. RESULTS: The cohort included 939,281 women, averaging 29.1 years of age and 247 days of OC therapy. 3,050 incident cases of IBS were detected. The annualized incidence for IBS with drospirenone was 0.77% (1083 cases) while that for levonorgestrel was 0.46% (483 cases). The crude HR for development of IBS with drospirenone compared to levonorgestrel was 1.70 (95%CI 1.53-1.90), while the adjusted HR was 1.63 (95%CI 1.46-1.82). Multiple sensitivity analyses confirmed this association. Other OCs were unassociated with IBS. CONCLUSION: Our study found a positive association between drospirenone and a diagnosis of IBS that was not observed with other OCs. Publication Types:
MeSH Terms:
PMID: 22663950 |
This article has been cited by other articles:
|
RESEARCH: Risk of venous thromboembolism in women with polycystic ovary syndrome: a population-based matched cohort analysis Steven T. Bird, Abraham G. Hartzema, James M. Brophy, Mahyar Etminan, and Joseph A.C. Delaney CMAJ, February 5, 2013; 185: E115 - E120. |
|
||||||||||||||||||||||||
MEDLINE data is licensed by HighWire Press from the National Library of Medicine. Some material in the NLM databases is from copyrighted publications of the respective copyright claimants. Users of the NLM databases are solely responsible for compliance with any copyright restrictions and are referred to the publication data appearing in the bibliographic citations, as well as to the copyright notices appearing in the original publications, all of which are hereby incorporated by reference. |