Twirla contraceptive patch well tolerated in women with different BMIs
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A post-hoc analysis of the Twirla contraceptive patch showed that it was well tolerated among women with a BMI of 25 to 30 kg/m2 as well as those with a BMI less than 25 kg/m2, according to researchers.
Twirla (Agile Therapeutics) is a weekly patch that contains levonorgestrel (120 g/day) and ethinyl estradiol (30 g/day). It was approved in February 2020 for women of reproductive age with a BMI less than 30 kg/m2.
Anita L. Nelson, MD, medical director of the Research Center at Essential Access Health in California, said the Twirla patch helps address an “unmet need” for women who want a nondaily, noninvasive birth control option with lower hormone levels.
“There wasn’t a contraceptive out there that fit these criteria that many women were looking for, so I was excited to get involved in the Twirla study,” she told Healio Primary Care. “I believe that women should be able to choose the birth control option that works best for them, and it is our job as clinicians to find and test more options that will better suit their needs.”
According to the manufacturer, Twirla is less effective among women with a BMI of 25 kg/m2 or more to less than 30 kg/m2. Because of this, Nelson and colleagues conducted a post-hoc analysis to evaluate the safety and tolerability of Twirla in women with different BMIs.
The analysis included 800 women with a BMI less than 25 kg/m2 and 513 women with a BMI of 25 to 30 kg/m2. The researchers found that those in the lower BMI group were more likely than those in the higher BMI group to discontinue use due to treatment-emergent adverse events (12.6% vs. 10.5%), serious treatment-emergent adverse events (1.6% vs. 1%) and hormone-related treatment-emergent adverse events (24.4% vs. 20.5%). However, women in the lower BMI group also reported fewer application-site adverse events (5.3% vs. 6.4%). No cases of venous thromboembolism were reported.
The rate of inconsistent use was similar between both BMI groups at 0.8% or less over 13 cycles — or 1 year — according to Nelson.
Nelson and colleagues also reported efficacy data on 798 women with a BMI less than 25 kg/m2 and 511 women with a BMI of 25 to 30 kg/m2 and the Pearl Index of 684 women with a BMI less than 25 kg/m2 and 439 women with a BMI of 25 to 30 kg/m2 . They reported that the patch was 97% effective and associated with a Pearl Index of 3.46 (95% CI, 1.77-5.16) among participants in the lower BMI group. Meanwhile, it was 94.6% effective and associated with a Pearl Index of 5.69 (95% CI, 2.99-8.40) among those in the higher BMI group.
“When having birth control conversations with patients, providers can take comfort in knowing that they have data-driven support when discussing options relative to BMI categories,” Nelson said. “These data support the safety and tolerability of Twirla in women with BMI 25 to 30 kg/m2 as well as those with BMI less than 25 kg/m2.”