ADVERTISEMENT

A look at the long-term safety of an extended-regimen OC

The Journal of Family Practice. 2010 May;59(5):E9-E13
May 1, 2010|Family Medicine
Matthew G. Davis, MD;Kathleen Z. Reape, MD;Howard Hait, MS
Author and Disclosure Information

Matthew G. Davis, MD
Rochester Clinical Research, Inc., Rochester, NY

Kathleen Z. Reape, MD
Howard Hait, MS
Duramed Research, Inc., Horsham, Pa
kathleen.reape@barrlabs.com

The authors reported that this study was supported by Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, Inc.; that the study’s data were presented as a poster presentation at the Association for Reproductive Health Professionals Annual Meeting (Reproductive Health 2007), Minneapolis, Minn., on September 28, 2007; and that an abstract of the results appeared in Contraception. 2007;76:172.

The authors also acknowledge the editorial assistance of Marya Margolis of Duramed Research, Inc., and Irene Durham of Research Pharmaceutical Services, Inc.

This study reveals that adverse events after 4 years of continuous oral contraceptive use were similar to those observed during 1 year of use.

Discussion

This 3-year study increased our experience with a novel extended-regimen OC to 4 years of continuous use. The results should reassure clinicians who are prescribing extended-regimen OCs that their patients are unlikely to experience side effects that differ significantly from traditional 28-day OC regimens. In other long-term studies of 28-day regimens, the most common AEs were headache, back pain, nausea, pharyngitis, and upper respiratory infection.7,8

FAST TRACK

These results should reassure clinicians who are prescribing extended-regimen OCs that their patients are unlikely to experience side effects that differ significantly from traditional 28-day OC regimens.

Overall rates of study discontinuation and the incidence of AEs (including SAEs and AEs leading to discontinuation) were consistent with those observed in 1-year1,2,10,11 and 2-year6 studies of extended-regimen OCs.

There was no suggestion of increased risk of serious estrogen-related AEs. There were no reports of endometrial abnormalities or hyperplasia, which is consistent with the results of endometrial biopsies in a previous study that compared before- and after-treatment biopsy samples from 63 subjects in the 1-year Phase 3 trial.2

A pharmacokinetic analysis of a similar extended-regimen OC demonstrated that estrogen levels, measured on days 1, 21, 84, and 91 of a 91-day extended-regimen cycle, did not build up over the course of the regimen.12

The risk of thromboembolic disease associated with OCs is not related to the length of use, and a 5-year case-control study found significantly decreasing odds ratios for reports of VTE in OC users over time.13 In this extension study, there were no reported thromboembolic AEs and there was no suggestion of an increased risk of thrombosis with the long-term use of this regimen, although such findings are not unexpected for a small-scale study.

Acknowledgements
The principal investigators and their locations are as follows: Angeli Adamczyk, Paige Brainard (Tucson, Ariz), Ted Anderson, Robert Rosenfeld, Shali Scott (Nashville, Tenn), Matthew Davis (Rochester, NY), William Gibbons, Laurel Stadtmauer (Norfolk, Va), James Lackey (Oklahoma City, Okla), Sooji Lee-Rugh (Arlington, Va), Thomas Littlejohn (Winston-Salem, NC), James Maly (Lincoln, Neb), David Portman (Columbus, Ohio), George Raad (Charlotte, NC), and Mark Shepard (Washington, DC).

CORRESPONDENCE Kathleen Reape, MD, Teva Branded Pharmaceutical Products R&D, Inc., 425 Privet Road, Horsham, PA 19044; Kathleen. Reape@barrlabs.com

ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT