Polycystic ovary syndrome (PCOS) is a disease that causes imbalanced hormone levels, irregular periods, and cysts on the ovaries. It is one of the most common conditions among females, and many patients with PCOS have a wide range of other health problems. No medications exist specifically for PCOS, but medications for other diseases are used to manage PCOS. There is very little data describing medication use among those with PCOS. The purpose of this study is to indicate which drugs are used in the treatment of PCOS, how strongly they are used, and the types of patients they are used in. The findings of this study will help to provide a more complete understanding of how drugs are used to treat PCOS.
PCOS has a diverse range of symptoms that are often treated with a variety of pharmacological agents. A wide range of clinical practice guidelines for PCOS exist with significant heterogeneity in their recommendations. No medications have been approved by regulatory agencies specifically for the treatment of PCOS, and medication use in this population is therefore frequently off-label. Few studies describe medication use in this population, and the existing data is also rather macroscopic and provides little to no information on treatment patterns following diagnosis, differences in medication use by patient age or PCOS symptoms, or temporal trends in treatments.
To address this knowledge gap, we will assemble a cohort of patients newly diagnosed with PCOS and follow them from PCOS diagnosis until end of registration with the CPRD, end of the study period, or death. During the follow-up period, we will identify prescriptions for combined oral contraceptives, progestins, clomiphene, tamoxifen without an indication of breast cancer, aromatase inhibitors without an indication of breast cancer, androgen receptor antagonists, androgen synthesis inhibitors, gonadotropin modulators, spironolactone, retinoids, tetracycline or macrolide antibiotics with a concurrent acne diagnosis, and metformin, all considered separately. PCOS diagnoses and drug prescriptions will be identified using CPRD GOLD and Aurum. We will generate descriptive statistics to summarize characteristics of patients at the time of their PCOS diagnosis. Then, separately for each drug and by five-calendar year blocks in the study period, we will assess the prevalence, intensity, and persistence of medication use. We will also conduct additional analyses stratifying by age (≤50 vs. >50 years old, as a proxy for menopause) and by clinical manifestation of PCOS (hyperandrogenism, polycystic ovaries, menstrual dysfunction). This research will help to fill the knowledge gap regarding pharmacological treatment of PCOS.
Prescription prevalence; prescription rate; prescription duration.
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill University
Michael Dahan - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Samantha Shapiro - Collaborator - McGill University
Patient Level Index of Multiple Deprivation