Arimidex Depression News

The U.S. Food and Drug Administration today approved Zulresso (brexanolone)=
 injection for intravenous (IV) use for the treatment of postpartum depress=
ion (PPD) in adult women. This is the first drug approved by the FDA specif=
ically for PPD.

PPD is a major depressive episode that occurs following childbirth, althoug=
h symptoms can start during pregnancy. As with other forms of depression, i=
t is characterized by sadness and/or loss of interest in activities that on=
e used to enjoy and a decreased ability to feel pleasure (anhedonia) and ma=
y present with symptoms such as cognitive impairment, feelings of worthless=
ness or guilt, or suicidal ideation.

arimidex depression news
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The efficacy of Zulresso was shown in two clinical studies in participants =
who received a 60-hour continuous intravenous infusion of Zulresso or place=
bo and were then followed for four weeks. One study included patients with =
severe PPD and the other included patients with moderate PPD. The primary m=
easure in the study was the mean change from baseline in depressive symptom=
s as measured by a depression rating scale. In both placebo controlled stud=
ies, Zulresso demonstrated superiority to placebo in improvement of depress=
ive symptoms at the end of the first infusion. The improvement in depressio=
n was also observed at the end of the 30-day follow-up period.

The possibility that SSRIs might, by inhibiting CYP2D6, slow the metabolism=
 of tamoxifen and reduce its effectiveness is a concern given that as many =
as one-fourth of breast cancer patients experience clinical depression and =
may be treated with SSRIs. In addition, SSRIs are sometimes used to treat h=
ot flashes caused by hormone therapy.

Fann, who is also a professor of psychiatry and behavioral sciences at the =
University of Washington, called the new mandate a good first step, but he =
pointed out that screening once is not enough because depression can develo=
p at so many different points. He recommends that doctors treating cancer p=
atients be proactive about screening for depression throughout cancer treat=
ment.

But like many others suffering from depression, cancer patients often have =
to be coaxed to seek that treatment. Despite some gains made over the last =
few decades to destigmatize depression, many still see it as a sign of pers=
onal weakness that can be overcome by sheer will or as a shameful character=
 defect.

While some articles have advocated the avoidance of all SSRI antidepressant=
s, depression is common among women being treated for breast cancer and may=
 be more common in those receiving tamoxifen. Depression should not be igno=
red in this situation; a conservative approach to its management would emph=
asize the careful section of co-administered to avoid significant interacti=
ons.

Because estrogen is known to have a positive effect on mood, it is reasonab=
le to assume that these hormonal therapies that suppress estrogen activity =
might have the opposite effect. A recent article reviews the side effects c=
ommonly reported in women treated with these hormonal treatments, including=
 hot flashes and mood changes. This article discusses a case of a 56-year-o=
ld woman with no prior psychiatric history who develops severe mood changes=
 after treatment with anastrozole. The symptoms of depression resolve after=
 discontinuation of treatment.

Exactly how frequently depression occurs in women treated with these hormon=
al therapies has not been well-studied. Clinically depression is observed i=
n some breast cancer patients receiving hormonal therapies. Large clinical =
trials have yielded generally positive results regarding the risk of depres=
sion in women treated with tamoxifen. In the Study of Tamoxifen and Raloxif=
ene (STAR), women at high risk for breast cancer received tamoxifen (n =3D =
973) or raloxifene (n =3D 1010). Depressive symptoms initially increased af=
ter the start of therapy, followed by a partial return to baseline levels. =
The change was small (e.g., about 1.5 points in CES-D scores).

The data suggest that mood changes are not commonly associated with hormona=
l therapies for breast cancer. This is reassuring; however, we do know that=
 depression is relatively common in women diagnosed with breast cancer. Whe=
ther the depression stems from the effects of hormonal modulation or other =
factors, for instance, the burden of having a life-threatening illness, we =
must recognize that this population of women is at high risk for psychologi=
cal distress and depression and should be routinely assessed.



Depression and anxiety are listed as side effects of anastrozole, but clini=
cal trials showed that the incidence was about the same for women taking th=
e drug as for women given an inert placebo. However, it is normal for peopl=
e diagnosed with cancer and undergoing cancer treatment to feel depressed, =
anxious, or both. No matter what the cause, depression, anxiety, and other =
mood disturbances can be helped, so talk to a healthcare professional about=
 treatment options.

Previous studies have found magic mushroom-assisted therapy improved mental=
 health scores in people with end-of-life anxiety and depression. The study=
 done at Aquilino was different because it sought to measure clinically sig=
nificant depression on a specific scale -- MADRS -- and also because some o=
f the therapy took place in a group setting.

Psilocybin is the active ingredient in magic mushrooms, which, when combine=
d with therapy, has shown great promise for treatment of a variety of menta=
l health issues, including depression, anxiety, obsessive-compulsive disord=
er, alcoholism, and even smoking. Several universities, including Johns Hop=
kins, the University of California San Diego, and Imperial College in the U=
.K., are doing in-depth research on these emerging medications.

"When patients receive a diagnosis of advanced breast cancer, they learn th=
at their disease is treatable, but incurable. This is devastating news to t=
hose of us living with the disease, because we each have a lot more living =
to do with our loved ones and friends and goals we want to achieve. We pati=
ents want therapies that can result in longer life," said Shirley Mertz, pr=
esident of the Metastatic Breast Cancer Network. "Hearing that the results =
of MONARCH 2 showed significant improvement in overall survival for women l=
iving with HR+, HER2- advanced breast cancer is exciting and welcomed. Wome=
n with this type of breast cancer now have a treatment option that may allo=
w them more time to achieve their dreams."

About Eli Lilly and Company=20
Lilly is a global health care leader that unites caring with discovery to c=
reate medicines that make life better for people around the world. We were =
founded more than a century ago by a man committed to creating high-quality=
 medicines that meet real needs, and today we remain true to that mission i=
n all our work. Across the globe, Lilly employees work to discover and brin=
g life-changing medicines to those who need them, improve the understanding=
 and management of disease, and give back to communities through philanthro=
py and volunteerism. To learn more about Lilly, please visit us at lilly.co=
m and lilly.com/newsroom. (P-LLY)

Not surprisingly, many people who have been treated for breast cancer devel=
op depression. The combination of a life-threatening diagnosis, the side ef=
fects of treatment, and the changes to body image that go with treatment al=
l set the stage for a significant emotional impact.

Although her symptoms were caused by a drug-induced decrease in estrogen, t=
he effects of reduced levels of estrogen on mood, cognition and memory have=
 been studied in situations in which this occurs naturally. The premenstrua=
l phase of the menstrual cycle, the period immediately following childbirth=
 (the post-natal period) and also menopause are characterized by a reductio=
n in estrogen levels. And symptoms similar to those experienced by those on=
 estrogen-blocking drugs my friend is taking are common: mood swings, loss =
of attentiveness, fatigue, depression, anxiety and sleep disturbances. Stud=
ies many years ago found that estrogen increases the activity of serotonin =
in areas of the brain involved in mood, cognition and memory. The class of =
antidepressants that prolong serotonin activity, the SSRIs, have been used =
to relieve some of the more severe symptoms of PMS or postnatal depression,=
 for example, during periods of decreased estrogen availability.

Osteoporosis may limit mobility, which often leads to feelings of isolation=
 or depression. Additionally, twenty percent of seniors who break a hip die=
 within one year from either complications related to the broken bone itsel=
f or the surgery to repair it. Many patients require long-term nursing home=
 care.

Poor nutrition, lack of sleep, pain and psychological issues such as stress=
, anxiety and depression can also contribute to fatigue, leaving you feelin=
g exhausted and lacking in energy. This can then have a negative impact on =
your ability to cope, your quality of life and your independence. Many of t=
hese factors are treatable, so be sure to raise any issues with your doctor=
.

As for how long you'll take it - news at 11. At this point, all of us takin=
g AIs are guinea pigs. (Physician's Note: Doctors might interject here that=
 taking an FDA approved drug after an informed discussion with a licensed a=
nd treating physician does not meet their opinion of "guinea pig." Particip=
ating in important clinical trials can make a significant different in the =
way we treat breast cancer, so don't let fear of being a "guinea pig" dissu=
ade you from making an otherwise informed choice about clinical trials). Is=
 5 years best for aromatase inhibitor use? Is 7 years better? How about 10 =
years? There just hasn't been sufficient data collected (yet) to draw hard =
and fast conclusions. You'll probably be on your AI for 3 years minimum, if=
 you're switching over from tamoxifen; or for 5 years minimum, if you haven=
't taken tamoxifen. Beyond that, who knows? By 2 or 3 or 5 years from now, =
more studies will have been completed, and there'll be better data on which=
 your oncologist can base his recommendations. Good luck!
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