Hormonal Contraceptives’ Safety Profile Comparison for Women with Sickle Cell Disease

Natasha Bala, MD

Research suggests that combined hormonal contraceptives (CHC) have a similar safety profile to progestin-only contraceptives (POC) with regard to women with sickle cell disease and their risk of thromboembolism (TE).

The study made use of population-level administrative claims data from publicly-insured US women with sickle cell disease. It was presented at the American Society of Hematology (ASH) Annual Meeting.

The study was led by Natasha Bala, MD, from the Nationwide Children's Hospital in Columbus, Ohio. The investigators set out to explore hormonal contraception use patterns, as well as to evaluate risk of thromboembolism (TE), during the first year of contraception use.

“We hypothesized that TE rates are higher in women prescribed combined hormonal contraceptives (CHC) as compared to women prescribed progestin-only contraceptives (POC),” Bala and colleagues wrote.

Background

The investigators utilized data from female patients ages 12 to 44 with information consistent with sickle cell disease, drawn from the Centers for Medicare and Medicaid Services Analytic eXtract (CMS MAX) from the period of 2006 to 2018.

They identified new prescriptions for contraception through the use of ICD-9 or 10 procedure codes or national drug codes. The descriptor ‘CHC’ covered three types of contraception: the transdermal patch, the combined oral contraceptive pill (OCP), and the vaginal ring. ‘POC’ covered depot medroxyprogesterone acetate (DMPA) injection, intrauterine device (IUD), the progestin-only pill, and the subdermal implant.

The researchers defined TE as the observed existence of ≥2 ICD-9 or ICD-10 codes for one of the following categories:

• Arterial TE (stroke or myocardial infarction)
• Venous TE (deep vein thrombosis or pulmonary embolism)
• Arterial TE was also required to have an associated inpatient admission.

Findings

The research team identified a total of 141 new contraceptive users with sickle cell disease who, by their follow-up meeting, were found to have TE. When assessing the most common TE events, as well as their rates in the study population, they found them to be the following order:

• Pulmonary embolism (46.1%)
• Deep vein thrombosis (41.8%)
• Stroke (6.4%)
• Myocardial infarction (2.1%)

The study’s results indicated that there were no differences in TE rates between both of the most frequently used methods of each group, the combined DMPA (17.7 events per 1000 person-years) and OCP (15.5 events per 1000 person-years) (P=0.48).

They noted that the CHC user rate for TE were 16.4 events per 1000 person-years, and the rate for POC users was 17.0 events per 1000 person-years (P=0.84).

“We found that CHC was more frequently prescribed than POC, and identified low rates of long-acting reversible contraception use,” they wrote. “The most frequently prescribed agents were the combined OCP and the DMPA injection…Although limited by the retrospective study design and use of administrative claims data, this study suggests a similar safety profile for CHC and POC in women with (sickle cell disease) with respect to risk of TE.”

The study, “Hormonal Contraceptive Use and Association with Thromboembolism in Women with Sickle Cell Disease,” was presented at ASH 2022.