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‘Significantly higher’ side effects with pellet vs. FDA-approved HT

Xiezhu Jiang
Xuezhi (Daniel) Jiang

PHILADELPHIA — Compared with postmenopausal women using FDA-approved hormone therapy, those treated with estradiol and/or testosterone pellet therapy experienced six times the number adverse side effects, including abnormal uterine bleeding and subsequent hysterectomy, according to findings from a retrospective cohort study.

“The menopausal provider should be cautious about prescribing pellet therapy as well as other forms of compounded bioidentical hormone therapy,” Xuezhi (Daniel) Jiang, MD, PhD, associate professor of obstetrics and gynecology at Sydney Kimmel Medical College of Thomas Jefferson University, told Endocrine Today. “The clinician should fully inform their patients when these medications are dispensed.”

Jiang and colleagues analyzed electronic medical records data from 154 postmenopausal women prescribed FDA-approved HT (mean age, 61 years; mean treatment duration, 2.37 years; 53.6% had hysterectomy prior to therapy) and 183 postmenopausal women treated with estradiol and/or testosterone pellet therapy (mean age, 51 years; mean treatment duration, 3.6 years; 41.2% had hysterectomy prior to therapy). Researchers assessed initial symptoms, such as hot flashes, vaginal dryness and decreased libido; side effects, including abnormal uterine bleeding, mood swings, anxiety, breast tenderness, acne and weight gain; and treatment duration through medical records. They applied Chi-square tests and logistic regression analyses to assess the difference in incidence of side effects between the two cohorts.

Researchers found the incidence of side effects was significantly higher in the pellet HT group vs. the FDA-approved HT group (63.9% vs. 10.6%), for an OR of 14.7 (95% CI, 7.93-27.25).

When assessing women with an intact uterus before initiating HT, 62.6% of women in the pellet HT group experienced at least one incident of abnormal uterine bleeding vs. 17.7% in the FDA-approved HT group (OR = 5.46; 95% CI, 2.49-11.98). Though the HT used in both cohorts included a variety of progestin agents, women in the pellet therapy group were more likely to undergo a hysterectomy after initiating therapy when compared with women prescribed FDA-approved HT (38.1% vs. 10%; OR = 3.2; 95% CI, 1.26-8.15).

The side effects disparity “raises a concern that the safety data is unclear on pellet treatment for menopausal symptoms,” Jiang said. “The patient may be happy with the efficacy, but there is no good safety data on this treatment, and there are no standardized safety monitoring procedures for the providers to follow.”

Jiang said the next steps should include a prospective study to evaluate endometrial pathology samples as well as other side effects for women treated with pellet therapy vs women treated with FDA-approved hormone therapy, to see if there are any potential differences that could help provide additional data on the comparative safety of the two approaches.by Regina Schaffer

For more information:

 

Xuezhi (Daniel) Jiang, MD, PhD, can be reached at the Sydney Kimmel Medical College of Thomas Jefferson University, 1025 Walnut St #100, Philadelphia, PA 19107; email: Daniel.Jiang@towerhealth.org.

 

Reference:

Jiang X, et al. P-50. Presented at: Annual Meeting of the North American Menopause Society; Oct. 11-14, 2017; Philadelphia.

Disclosures: The authors report no relevant financial disclosures.

 

Xiezhu Jiang
Xuezhi (Daniel) Jiang

PHILADELPHIA — Compared with postmenopausal women using FDA-approved hormone therapy, those treated with estradiol and/or testosterone pellet therapy experienced six times the number adverse side effects, including abnormal uterine bleeding and subsequent hysterectomy, according to findings from a retrospective cohort study.

“The menopausal provider should be cautious about prescribing pellet therapy as well as other forms of compounded bioidentical hormone therapy,” Xuezhi (Daniel) Jiang, MD, PhD, associate professor of obstetrics and gynecology at Sydney Kimmel Medical College of Thomas Jefferson University, told Endocrine Today. “The clinician should fully inform their patients when these medications are dispensed.”

Jiang and colleagues analyzed electronic medical records data from 154 postmenopausal women prescribed FDA-approved HT (mean age, 61 years; mean treatment duration, 2.37 years; 53.6% had hysterectomy prior to therapy) and 183 postmenopausal women treated with estradiol and/or testosterone pellet therapy (mean age, 51 years; mean treatment duration, 3.6 years; 41.2% had hysterectomy prior to therapy). Researchers assessed initial symptoms, such as hot flashes, vaginal dryness and decreased libido; side effects, including abnormal uterine bleeding, mood swings, anxiety, breast tenderness, acne and weight gain; and treatment duration through medical records. They applied Chi-square tests and logistic regression analyses to assess the difference in incidence of side effects between the two cohorts.

Researchers found the incidence of side effects was significantly higher in the pellet HT group vs. the FDA-approved HT group (63.9% vs. 10.6%), for an OR of 14.7 (95% CI, 7.93-27.25).

When assessing women with an intact uterus before initiating HT, 62.6% of women in the pellet HT group experienced at least one incident of abnormal uterine bleeding vs. 17.7% in the FDA-approved HT group (OR = 5.46; 95% CI, 2.49-11.98). Though the HT used in both cohorts included a variety of progestin agents, women in the pellet therapy group were more likely to undergo a hysterectomy after initiating therapy when compared with women prescribed FDA-approved HT (38.1% vs. 10%; OR = 3.2; 95% CI, 1.26-8.15).

The side effects disparity “raises a concern that the safety data is unclear on pellet treatment for menopausal symptoms,” Jiang said. “The patient may be happy with the efficacy, but there is no good safety data on this treatment, and there are no standardized safety monitoring procedures for the providers to follow.”

Jiang said the next steps should include a prospective study to evaluate endometrial pathology samples as well as other side effects for women treated with pellet therapy vs women treated with FDA-approved hormone therapy, to see if there are any potential differences that could help provide additional data on the comparative safety of the two approaches.by Regina Schaffer

For more information:

 

Xuezhi (Daniel) Jiang, MD, PhD, can be reached at the Sydney Kimmel Medical College of Thomas Jefferson University, 1025 Walnut St #100, Philadelphia, PA 19107; email: Daniel.Jiang@towerhealth.org.

 

Reference:

Jiang X, et al. P-50. Presented at: Annual Meeting of the North American Menopause Society; Oct. 11-14, 2017; Philadelphia.

Disclosures: The authors report no relevant financial disclosures.

 

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