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A NTIEPILEPTICS TO C ARRY S UICIDALITY WARNING , PAGE 6

THE LEADER

Internal Medicine News


IN NEWS
AND
MEETING
COVERAGE

www.inter nalmedicinenews.com
VO L . 4 2 , N O. 3 T he Leading Inde p endent Ne wspaper for the Inter nist—Since 1968 F E B R UA RY 1 , 2 0 0 9

INSIDE
Breast Cancer
Decline Linked to
M EDICINE
OF
A GAPITO S ANCHEZ J R ./B AYLOR C OLLEGE
HT Cessation
New WHI data affirm hormonal link.
Self-Harm BY BRUCE JANCIN breast cancer risk imparted by
Some abused teens may Denver Bureau hormone therapy rises sooner
deliberately embed foreign and more steeply than previ-
objects into soft tissues. S A N A N T O N I O — Two new ously recognized, and it swiftly
Dr. Rachelle Doody says the phase II trial of bapineuzumab ‘at statistical analyses of Women’s declines after HT is discontin-
PAGE 10
least had some signal’ that the agent is safe and effective. Health Initiative data persua- ued, Dr. Rowan T. Chlebowski
sively indicate that the recent said at the San Antonio Breast
abrupt decline in breast cancer Cancer Symposium.
Amyloid Theory Genetics in Your
Practice
incidence in the United States is
attributable to a dramatic drop
in the use of estrogen-plus-prog-
“The good news for women
here is that the risk rapidly dis-
sipated in just a year or year and
Sputters for AD Dr. Matthew R.G. Taylor
looks at genome-wide
association studies.
estin menopausal hormone
therapy, and not—as skeptics
have argued—to less utilization
a half,” said Dr. Chlebowski, a
medical oncologist at the Los
Angeles Biomedical Research
B Y M I C H E L E G. caused early-onset Alzheimer’s, PAGE 28 of mammography. Institute in Torrance, Calif.
S U L L I VA N coupled with the association of Academic fencing over causal- The WHI was a very large
Mid-Atlantic Bureau plaque deposition and early ity aside, the practical take- National Institutes of Health–
Alzheimer’s in Down syndrome home message from the latest sponsored study on the preven-
he amyloid hypothesis patients, added weight to the Women’s Health Initiative tion of cardiovascular disease

T isn’t dead, but it seems to


be limping a bit in the
race for an Alzheimer’s cure.
theory (Trends Pharmicol. Sci.
1991;12:383-8). A new research
boom was born.
(WHI) data analyses is that the See Breast Ca page 2

Some researchers who pre-


dicted 5 years ago that an anti-
But the first phase III trials of
antiamyloid agents have brought Myelodysplastic Syndrome
amyloid disease-modifying ther- no good news.
apy was imminent are now
reevaluating that optimism—in-
Tramiprosate, a E-amyloid an-
tagonist, was the disappointment
‘Severely Underestimated’
cluding the geneticist who first of 2007; tarenflurbil, a gamma- Tea Time BY ROBERT FINN Medicare patients. This is about
suggested the pathologic link secretase modulator, this year’s Regular consumption of San Francisco Bureau eightfold greater than previous
between amyloid plaque depo- downer. And positive findings in hibiscus tea may help estimates based on the Nation-
sition and Alzheimer’s disease. bapineuzumab’s phase II trial S A N F R A N C I S C O — Myelo- al Cancer Institute’s Surveil-
control blood pressure.
“Everything is taking a lot were slim. A post hoc analysis dysplastic syndrome is far more lance, Epidemiology, and End
longer than I thought it would; showed that some patients with PAGE 30 common than previous estimat- Results (SEER) Program, Dr.
there’s no question about that,” mild to moderate Alzheimer’s, ed, and patients with this blood Stuart L. Goldberg said at the
John Hardy, Ph.D., said in an with no genetic risk factors, had disorder tend to be older and annual meeting of the Ameri-
interview. cognitive improvement after get- Projected sicker than the general Medicare can Society of Hematology.
In 1991, Dr. Hardy, a professor ting the vaccine. Apparently, the population, based on an analysis The current analysis also
of neuroscience at University finding was enough for Elan Payments of claims by more than 1.7 mil- showed that during a 3-year fol-
College London, postulated that Pharmaceuticals Inc. and Wyeth Medicare panel suggests lion Medicare enrollees. low-up, newly diagnosed MDS
E-amyloid deposition was the Pharmaceuticals, but maybe not boosting physician fees Each year, there are about patients were more likely than
root of a pathologic cascade that for Dr. Hardy. by 1.1% in 2010. 76,000 new cases of myelo- the general Medicare popula-
resulted in Alzheimer’s disease. “The data right now are nei- dysplastic syndrome (MDS), ac- tion to have cardiac complica-
The concurrent discovery that a ther positive nor negative. At PAGE 33 cording to the study of the tions, dyspnea, diabetes, and
mutation in the amyloid pre- this point, the only thing we can Medicare Standard Analytic File, kidney complications. These
cursor protein (APP) gene See Amyloid page 20 a random sampling of 5% of See Syndrome page 6
6 NEWS FEBRUARY 1, 2009 • INTERNAL MEDICINE NEWS

Epilepsy Drug Warnings to Add Suicidal Ideation


B Y B E T S Y B AT E S The relative risk for suicidality was highest among pa- Drug Evaluation and Research, in a statement.
Los Angeles Bureau tients receiving drugs for epilepsy (3.5), compared with “Symptoms such as anxiety, agitation, aggression,
psychiatric (1.5) and other indications (1.9). hostility, mania, and insomnia may be precursors to
he Food and Drug Administration has directed However, the absolute rate of events was highest in emerging suicidality,” the alert stated.

T physicians to inform patients taking anticon- psychiatric patients (8.5 suicidality reports per 1,000 pa-
vulsant medications that the drugs have the po- tients receiving antiepileptic medications, compared with
tential to increase suicidal thoughts and behavior. 5.7 per 1,000 for psychiatric patients taking placebo).
Although physicians were encouraged to discuss the
risks and benefits of continuing treatment, they were
also urged to warn patients and families against stop-
Families and caregivers should also be notified of this Among epilepsy patients, 3.4 events per 1,000 were re- ping medications abruptly. ■
risk so that they can be attuned to changes in behavior ported for those receiving antiepileptic medications,
in patients receiving antiepileptic medications, accord- compared with 1.0 for those assigned to receive placebo. The FDA’s health care alert is available at www.fda.gov/
ing to the FDA’s alert for health care professionals. Four patients randomized to receive antiepileptic cder/drug/InfoSheets/HCP/antiepileptics200812.htm.
Based on an agency review of nearly 200 clinical tri- drugs committed suicide during the trials that were ex-
als of 11 antiepileptic drugs, the directive coincided with amined by the FDA, while no patient assigned to place-
an FDA announcement that manufacturers of any bo took his or her own life. However, those numbers
medication in the class will be required to add warn- were not high enough to justify a warning of suicide
Drugs to Receive New
ings about suicidal thoughts or behavior in on drug labeling, the press release stated. Suicidality Labeling
prescribing information or labeling and to “The biological reasons for the increase in
develop medication guides for patients.
See related the risk for suicidal thoughts and behavior ob- he Food and Drug Administration called for
Revised labeling or an explanation “why
they do not believe such labeling changes are
commentary served in patients being treated with
on page 9. antiepileptic drugs are unknown,” according
T new labeling for these drugs, some of which
also are available in generic form:
necessary” must be submitted to the agency to the FDA. Carbamazepine (marketed as Cabatrol, Equetro,
within 30 days. A review article about suicidality and Tegretol, Tegretol XR)
Jack Cox, a spokesman for Pfizer Inc., said in a tele- antiepileptic drugs noted that the baseline suicide rate Clonazepam (marketed as Klonopin)
phone interview his firm will comply with the order. among patients with epilepsy is 5 times higher than that Clorazepate (marketed as Tranxene)
“Pfizer will work closely with the FDA to update the la- seen in the general population, and higher still (25-fold) Divalproex sodium (marketed as Depakote,
beling of our antiepileptic medications Lyrica [prega- in patients with temporal lobe epilepsy and complex Depakote ER, Depakene)
balin] and Neurontin [gabapentin], in a timely manner.” partial seizures (Drug Saf. 2007;30:123-42). Ethosuximide (marketed as Zarontin)
“We have not heard directly from the FDA, but we Although that article commented on antiepileptic Ethotoin (marketed as Peganone)
will work to address any of the agency’s concerns,” said medications’ disparate mechanisms of action and vary- Felbamate (marketed as Felbatol)
Tricia Geoghegan, a spokesperson for Ortho-McNeil ing effects on serotonin metabolism (a hypothesized Gabapentin (marketed as Neurontin)
Neurologics, makers of topiramate. Ms. Geoghegan link to suicidality), the FDA report found that the risk Lamotrigine (marketed as Lamictal)
noted that the label for Topamax (topiramate) has al- for suicidal thought or behavior was “generally consis- Lacosamide (marketed as Vimpat)
ways included “content about this topic,” but added that tent” among the 11 drugs studied. Levetiracetam (marketed as Keppra)
revisions will be made should the FDA request them. As the name implies, antiepileptic drugs were intro- Mephenytoin (marketed as Mesantoin)
The agency’s decision drew on data from placebo- duced and approved for the treatment of seizures. Methosuximide (marketed as Celontin)
controlled clinical trials that enrolled a total of 43,892 However, they are prescribed for conditions, including Oxcarbazepine (marketed as Trileptal)
patients aged 5 and older taking the medications for bipolar disorder, depression, anxiety, neuropathic and Phenytoin (marketed as Dilantin Suspension)
epilepsy, psychiatric disorders, and other conditions. chronic pain, and migraine, among others. Pregabalin (marketed as Lyrica)
The FDA meta-analytic review of 199 trials deter- “Patients being treated with antiepileptic drugs for Primidone (marketed as Mysoline)
mined that patients receiving antiepileptic drugs were at any indication should be monitored for the emer- Tiagabine (marketed as Gabitril)
a twofold risk of suicidal behavior or thoughts (0.43%), gence of worsening of depression, suicidal thoughts, Topiramate (marketed as Topamax)
compared with patients receiving placebo (0.24%). The or behavior, or any unusual changes in mood or be- Trimethadione (marketed as Tridione)
difference translates to 1 additional case of suicidality per havior,” said Dr. Russell Katz, director of the division Zonisamide (marketed as Zonegran)
530 patients treated with antiepileptic drugs. of neurology products in the FDA’s Center for

High Incidence dromes may be severely underestimated.”


The study focused on the Medicare
“These data give support to the use of
chelation therapy to remove the iron [re-
payments in 2003, compared with $6,739
in the general Medicare population.
Syndrome from page 1 Standard Analytic File for 2003. Of more sulting from transfusions] so we don’t Dr. Goldberg acknowledged serving
than 1.7 million Medicare patients in see the secondary comorbid problems,” on the speakers bureau of Novartis.
comorbidities (see box) contribute to the sample, 5,594 had the diagnostic Dr. Goldberg said. The research was supported by Novar-
high mortality: Over a 3-year period, code for MDS, of which 3,078 were new The average newly diagnosed case of tis and by Quorum Consulting Inc. in
39% of MDS patients died. This rate is cases. That translated to an age-adjusted MDS resulted in $28,023 in Medicare San Francisco. ■
even higher among patients whose MDS incidence of 181 per 100,000 patients, or
was caused by chemotherapy—63% about 76,600 patients in the entire
over 3 years. Medicare system. Comorbidities in MDS Patients at 3-Year Follow-Up
Previous SEER estimates put the an- Of those patients, only 53% actually
nual incidence of MDS at about 10,000 underwent diagnostic bone marrow MDS patients General Medicare population
cases. But there is reason to believe that studies. “Therefore, even if we exclude
this is an underestimate, said Dr. Gold- the clinical cases, we still have an inci- 74%
berg, a hematologist/oncologist in dence four times what the SEER project Cardiac complications
group practice in Hackensack, N.J. has suggested,” Dr. Goldberg said. 42%
“Until recently myelodysplasia was Compared with the general Medicare
51%
not considered to be a form of cancer, population, patients with MDS were sig- Dyspnea
and therefore [was] not tracked by our nificantly older, with 72% of them aged 28%
registries,” Dr. Goldberg said. “The ma- 70 years or above compared with 57% of
jority of patients with myelodysplasia the general population. And they were 43%
Diabetes
are elderly, if not very old. And many of more likely to be male (49% vs. 42%) and
E LSEVIER G LOBAL M EDICAL N EWS

33%
these patients may not be referred for white (90% vs. 86%).
evaluation of their cytopenias. Further- Among patients with MDS, comor- 1.8%
more, if referred, they may not undergo bidities were more common in patients re- Kidney complications
diagnostic bone marrows, or if they un- ceiving blood transfusions. Of patients 0.4%
dergo a diagnostic bone marrow, it may receiving transfusions, 80% had cardiac Note: Based on an analysis of data from a random sample of 1.7 million
be done in primary care, and not re- complications, vs. 69% of the others. This Medicare patients.
ferred to the tumor registry. Thus, we was also true of new cases of diabetes Source: Dr. Goldberg
think that the myelodysplastic syn- (48% vs. 32%) and dyspnea (62% vs. 41%).

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