Say goodbye to the Black Box Warning and Hello to HT

There is a renewed recognition of the benefits of hormone therapy. According to the recent press release on November 10th, the FDA is removing the boxed warnings following a comprehensive review of the scientific literature by an expert panel. The FDA is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.²  Of course, ongoing studies are needed to monitor long term safety and efficacy of hormone therapy.*

Of note, many menopause specialists are now using the term Hormone Therapy (HT) instead of HRT. The reason being that the goal is not to replace hormones to premenopausal levels – just to add back enough hormones to reduce symptoms and prevent other chronic conditions. HT is also a broader term that   includes replacement of hormones or using hormones to treat a disease.

Benefits of Hormone Therapy (HT)*

• Randomized studies show that individuals who initiate HT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures.
• FDA-approved HT containing estrogen and progesterone (or estrogen alone as indicated for postmenopausal individuals) can restore declining hormones, and relieve symptoms such as hot flashes, night sweats, sleep disturbances, and bone loss.²
• Estrogen is a key hormone for women and people with uteruses’ health. Every single part of the body depends on estrogen to operate at optimal levels—including the brain, bones, heart, and muscles.
• Women and people with uteruses who use HT reduce their risk of:
  • Cardiovascular diseases by as much as 50%,
  • Cognitive decline and Alzheimer’s disease by 35%.*
  • Bone fractures by 50 to 60%.
• Estrogen also helps collagen production, and collagen disappears from the vulva by up to 30% in the five years after menopause. ³
• Vaginal estrogen can be used by most breast cancer survivors, too, and it’s a win-win on the physical intimacy front.
• Vaginal estrogen can be used alongside HT.³
• Oral vs. Transdermal: Transdermal estrogen is associated with a lower risk of venous thromboembolism (blood clots) compared to oral HT because it avoids first-pass metabolism in the liver.

Cancer Considerations with Hormone Therapy

For individuals with a history of hormone-sensitive conditions like certain breast cancers, non-hormonal options are often recommended.   While the general recommendation is to avoid systemic HT for people with breast cancer history, some experts are calling for a more personalized approach, suggesting that for certain individuals with severe symptoms, a risk-benefit assessment might be considered, especially if non-hormonal treatments have failed. 

*Limitations & Uncertainties:

Due to the longstanding limited use of HRT, data from ongoing and future longitudinal studies will provide additional evidence about the risks/benefits of long term HT treatment. Careful consideration of individual factors need to go into making decisions to pursue HT (including, age, comorbidities, health history, current medication etc.) As with any therapy there can be potential risks associated with HT use.

Key Features

The iLet Bionic Pancreas is a continuous subcutaneous insulin infusion (CSII) system, also commonly referred to as an insulin pump. Like other tubed insulin pumps on the market, it features a small cartridge that holds insulin, an operating system that delivers the insulin, integration with a continuous glucose monitor (CGM), and is connected to the body via tubing with an insertion set.  

CGM compatibility includes:

☑️ Dexcom G6

☑️ Dexcom G7

☑️ Libre 3+

The Bionic Circle app enables iLet users to invite up to 10 friends or family members to view alerts, blood glucose trends, meal announcements, and insulin doses. Healthcare providers utilize the Healthcare Provider Bionic Portal to download iLet data for review during office visits or for remote patient monitoring.