Real world utilization of 91 day extended levonorgestrel-containing combined oral contraceptives in Europe: a multinational database study

Abstract

Objective

As part of the risk management plan in Europe, this study was conducted to characterize drug utilization patterns of Seasonique, a 91 day extended levonorgestrel-containing combined oral contraceptive (COC_LNG).

Methods

A retrospective observational study was conducted in France, Italy and Belgium using electronic medical record databases obtained from general practitioners (GPs) in all participating countries and gynecologists in France from 2015 to 2018. The study population included women receiving ≥1 prescription of 91 day COC_LNG during the study period. Prescribing patterns of 91 day COC_LNG were examined including: (1) treatment duration; (2) indication; (3) use of combined oral contraceptive (COC) before 91 day COC_LNG initiation; and (4) switch from and to combined hormonal contraceptives (CHCs) or other contraceptives.

Results

Totals of 235, 220, 207 and 659 women using 91 day COC_LNG were identified in French, Italian and Belgian GP, and French gynecologist databases, respectively. Across databases, 46–76% of women were prescribed a single 91 day COC_LNG prescription and median treatment duration ranged from 3 to 6 months. The most common indication was contraception (42–81%), followed by menstrual migraines (2–14%). Use of COC during the 6 months prior to 91 day COC_LNG initiation was 14% across GP databases, but was lower (8%) in the French gynecologist database. The frequency of switching from 91 day COC_LNG to CHCs or other contraceptives was generally low (5–12%), with the highest proportion being among patients of French gynecologists.

Conclusions

Findings indicate that 91 day COC_LNG was prescribed for relatively short durations and predominantly as indicated for contraception. Most results were comparable across all participating countries.

KEY POINTS

• Findings from this drug utilization study in European databases across general practitioners and French gynecologists confirmed that 91 day extended levonorgestrel-containing combined oral contraceptive (COC_LNG) was prescribed for relatively short durations (median 3–6 months); predominantly for the intended indication of contraception.

• Combined oral contraceptive use during the 6 months prior to 91 day COC_LNG initiation, and switching from 91 day COC_LNG to combined hormonal contraceptives or other contraceptives, were generally low (14% or less).

• These findings were mostly consistent across participating countries.

Keywords:

• Levonorgestrel
• ethinyl estradiol
• combined oral contraceptives
• extended contraceptives
• drug utilization
• real world data

Transparency

Declaration of funding

This study was funded by Theramex Ltd. and Teva Pharmaceutical Industries Ltd. (or its affiliates). The sponsors had a role in study design, scientific oversight, management, data interpretation, manuscript writing and decision to submit manuscript for publication.

Author contributions: S.K.: study design and scientific oversight, interpretation of results, manuscript writing. M.T.: study design, acquisition of data, analysis and interpretation of results. A.E., S.D., D.R.: interpretation of results. A.L.: interpretation of results. All authors critically reviewed and approved the final manuscript.

Declaration of financial/other relationships

S.K. has disclosed that she is an employee of Teva Pharmaceuticals Industries Ltd. M.T. has disclosed that he is an employee of IQVIA which received financial support to conduct the study. A.E., S.D. and D.R. have disclosed that they are employees of the Drug Safety Research Unit; the Drug Safety Research Unit is an independent, academic research institution and has received funds from Theramex for consulting on the study; A.E., S.D. and D.R. have no other conflicts of interest to declare. A.L. has disclosed that he is an advisor to Theramex.

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect those of Theramex or Teva Pharmaceuticals Industries Ltd. and/or its affiliates.

Acknowledgements

The authors acknowledge Rukki Mirotznik (Teva) for providing writing support.

Data availability statement

The original contributions presented in the study are included in the article/supplementary material.

Notes

i Seasonique is a registered trademark of Theramex, London, UK.