Eli Lilly (NEO:LLY)
Historical Stock Chart
From Jul 2019 to Jul 2024
![Click Here for more Eli Lilly Charts. Click Here for more Eli Lilly Charts.](/p.php?pid=staticchart&s=NEO%5ELLY&p=8&t=15)
'Adequate' Treatment Isn't Enough to Make Most Depressed Patients
Become Symptom Free
Study calls for early and aggressive monitoring of patient response to
antidepressants
INDIANAPOLIS, June 14 /PRNewswire-FirstCall/ -- Despite following their
primary care doctor's orders, only 23 percent of depressed patients taking
therapeutically adequate doses of three common antidepressants in a large study
became symptom free, suggesting physicians need more help recognizing
depression, evaluating patient response to treatment and following published
guidelines, according to a paper published in the June 14 issue of the Archives
of Internal Medicine.
The ARTIST (A Randomized Trial Investigating SSRI Treatment) study compared the
effectiveness of three serotonin reuptake inhibitors (SSRIs) in patients being
treated by primary care physicians in a real-world setting. Although 64 percent
of patients completing the trial received "adequate" treatment, three out of
four still reported significant symptoms of depression, such as depressed mood,
loss of interest in things or low energy.
Patients were deemed adequately treated if they continued on medication at
therapeutic levels for six months, the time required to meet minimum practice
guidelines. According to current treatment guidelines, most of these patients
needed a more aggressive treatment approach, such as an increase in dose or a
switch in therapy, than they received. Even with more rigorous treatment
strategies than are generally reported in primary care studies, there continues
to be less-than-optimal remission and partial-response rates, according to the
study.
"To give patients their best chance at getting completely well, all of their
symptoms need to be addressed, emotional and physical," said Ralph Swindle,
Ph.D., Research Clinical Psychologist at Eli Lilly and Company. "Depression can
make every day seem like a nightmare. For that reason, physicians should
monitor patient progress early and often, preferably with brief outcome
measures. The findings suggest they need to make adjustments in treatment when
a patient fails to improve or only partially responds to initial treatment."
According to practice guidelines,(1) if a patient does not feel better after
two months of treatment, their physician should increase the dose, switch
medications or augment with a second medication or psychotherapy to help
patients achieve success. Complete resolution of all depression symptoms is
the goal of treatment. When symptoms don't go away completely, patients can
have difficulty getting well and staying that way.(2)
"Patients need to know they should expect more from depression treatment. They
need to be encouraged to continue treatment until all depression symptoms
(physical and emotional) are gone," Swindle said. "Patients and their loved
ones need to be encouraged to be an active and vocal participant in treatment.
If their treatment isn't making a difference after two months, it is time for a
discussion with your physician that the treatment needs to change."
Additional Study Highlights
* Among all patients, 46 percent were classified as non-responders after six
months, and 32 percent were classified as partial responders.
* Among all patients, 53 percent received therapy classified a priori as
"adequate," but did not achieve remission by six months.
* Thirteen percent of patients in this naturalistic study received therapy
defined as "aggressive" therapy. This was defined as being on medication for
each evaluation period in the study; having at least one medication switch and
one medication increase, or more than one switch in therapy; or having
later-stage therapies for at least one evaluation. These treatment patterns
are consistent with recommended treatments for more treatment-resistant
depressions. Patients who achieved remission at six months continued to have
the best average scores on each of the depression and psychological measures at
nine months.
* Conducting such a study in a "real world setting" provides an evaluation of
effectiveness of therapy in clinical practice. Scientifically, however, the
findings of such studies may be less reliable because of the lack of rigorous
controls found in randomized clinical trials.
Methods
Participants in the nine-month study were males and females, 18 years of age
and older, who were screened for depression by their primary care physician and
deemed appropriate for SSRI therapy. A total of 573 patients were followed
through structured telephone interviews conducted at baseline, one, three, six
and nine months post enrollment. Patients were randomized to receive
fluoxetine (20mg/day), paroxetine (20mg/day) or sertraline (50mg/day). After
the initial randomization, the study was entirely naturalistic and
observational, with treatment changes determined by the decisions of physicians
and patients.
Remission was defined as an SCL-20 score of 6 or less, with a minimum required
change of 12.3 to be considered clinically meaningful. Partial response was
defined as not meeting remission criteria but experiencing a 50 percent
decrease in the Symptom Checklist-20 items (SCL-20) from baseline. Patients who
were either off medication or were intermittently on medication after six
months were considered inadequately treated.
The primary outcome measure was the SCL-20. Secondary outcome measures
included the Short Form 36 and subscales, the mental and physical component
summary scores and subscales, a positive well-being scale from the RAND Medical
Outcomes Study, self-reported disability days, and the number of symptoms
reported on the Primary Care Evaluation of Mental Disorders (PRIME- MD)
Depression Scale.
Limitations
The study was a naturalistic, open-label study designed to compare outcomes
associated with SSRI therapy in usual primary care practices. Overall outcomes
might have improved if there were designated strategies for dealing with
less-than-adequate clinical response.
Also, the outcomes evaluations were obtained independent of clinical care, and
were not shared with physicians. If physicians had received those evaluations,
they might have made different treatment decisions.
Lastly, data on medication status comes from the patient, which can be
inaccurate. The self-report mechanism was very thorough, however, in eliciting
information about continuation, dose of medication, number of times per day
medication was taken, and changes in medication. In addition, medication
information was collected by telephone interview, by a trained interviewer not
connected with the treating physician, to minimize the risk that patients would
report "socially acceptable" adherence to treatment.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and information
-- for some of the world's most urgent medical needs. Additional information
about Lilly is available at http://www.lilly.com/ .
(1) Practice Guideline for the Treatment of Patients With Major Depression, 2nd
edition. (April, 2000):
http://www.psych.org/psych_pract/treatg/pg/Depression2e.book-7.cfm - figure3
(2) Paykel ES, et al. Psychol Med. 1995;25(6):1171-1180.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
DATASOURCE: Eli Lilly and Company
CONTACT: David Shaffer (US), +1-317-651-3710, cell: +1-317-997-0632, or
Jennifer Yoder (OUS), +1-317-433-3445, cell: +1-317-652-0912, both of Eli
Lilly and Company