MEDMONITOR - Pearls from Recent Medical Journals and Conferences 25/2/02
THE NEW ENGLAND JOURNAL OF MEDICINE, February 14, 2002; 346:466-468,476-483:
Individuals with elevated blood levels of homocysteine are at increased risk
for the development of dementia, including Alzheimer disease (AD).
Cross-sectional studies demonstrate an inverse relationship between the amino acid homocysteine levels and dementia risk, but the mechanism behind
this correlation remains unknown. Boston University School of Medicine researchers, led by Dr. Philip A. Wolf, studied dementia development in 1092
adults who participated in the famed Framingham Study. These study subjects
did not have dementia at study entry. Homocysteine levels were measured 8
years before study entry and again at the time of study entry. The median
follow-up period was 8 years. During the study period, 111 individuals developed dementia, 83 of whom were diagnosed AD. The investigators found
that each 5 micromol/L increase in homocysteine level was associated with an
AD risk increase of approximately 40%. Homocysteine levels greater than 14
micromol/L were associated with virtually doubling of AD risk.
Controlled, prospective clinical trials will seek to confirm these retrospective observations, and bench research will attempt to elucidate the
role of homocysteine in dementia development. Elevated blood homocysteine
levels have also been linked to increases in the risk for neural tube defects such as spina bifida, coronary artery events, stroke, poor
obstetrical outcomes, deep vein thrombosis (DVT), and pulmonary embolism
(PE). The link between increasing levels of homocysteine and these clinical
outcomes is an increased propensity to form blood clots, a so-called
"hypercoagulable state" or "thrombophilia." Individuals with homocysteine
mediated thrombophilia can often lower their clinical risk by increasing
their consumption of the vitamins folate, B12, B6, and betaine. Though these
low-tech interventions are likely to play a vital protective role in disease
prevention, they are unlikely to obviate the need for therapeutics that impact fundamental disease targets such as amyloid plaques and
neurofibrillary tangles in AD, platelet gp IIb/IIIa in acute coronary syndromes, and thrombin in DVT/PE.
--
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, February 6, 2002; 39:377-386:
Integrilin plus tPA is good for some heart attack patients.
For patients with acute myocardial infarction (AMI, heart attack), Millennium's (NASDAQ: MLNM) Integrilin (eptifibatide) plus low-dose tissue
plasminogen activator (tPA, Genentech's [NYSE: DNA] Activase and TNKase)
improves reperfusion quality and speed compared with standard tPA
monotherapy. A well-conceived study by leading cardiologists from The Cleveland Clinic was able to demonstrate a significant advantage for
combination therapy in re-establishing the nourishing blood flow to the heart that is lost after blood clot occlusion of coronary arteries during a
heart attack. The re-established flow nourishes the heart muscle, the cornerstone of therapeutic success in AMI care. Integrilin plus tPA was not
associated with a significant increase in major bleeding events.
The investigators note that, "The clinical utility of this (combination)
strategy hinges on the tradeoff between safety and efficacy, and awaits confirmation in larger clinical trials designed to detect differences in
mortality and other key outcomes of AMI." These investigations are ongoing,
and are likely to continue to demonstrate these improved outcomes.
--
ARCHIVES OF NEUROLOGY, February, 2002;59:213-216,223-227: Two studies
strengthen the link between cholesterol and Alzheimer disease.
The first paper showed that older individuals taking lipid-lowering medications have a lower risk of dementia, including Alzheimer disease (AD),
than their counterparts that do not take these medications. The publication
is a Canadian population-based study from the Canadian Study of Health and
Aging.
The second investigation demonstrated that 24-week treatment with Merck's
(NYSE: MRK Zocor (simvastatin) favorably affects cholesterol metabolism in
the brain, a mechanism by which long-term statin use could help lower incidence of AD.
Together, the papers further strengthen the need for prospective study of
statins for the treatment of AD. Investigations of statins in dementia, especially AD and vascular dementia, are ongoing. Prospective trial
recruitment has been underway since July 2001 for the most prominent investigation, a phase II study funded by The Institute for the Study of
Aging (ISOA) for use of Pfizer's (NYSE: PFE) Lipitor in mild AD. Final results are expected in 2003.
Statins are marketed by Pfizer, Merck, Novartis (NYSE: NVS), and Bristol-Myers Squibb (NYSE: BMY). AstraZeneca (NYSE: AZN) will soon market a
powerful statin. Although statins are not yet confirmed to address molecular
targets known to play a fundamental role in the development or maintenance
of AD, they may be approved to treat AD sooner than novel therapeutics. If
so, companies selling statins will derive significant revenue from increased
sales until more effective therapeutics are approved. More detail on AD therapeutics can be found in Btech Investor Report: Progress in Alzheimer
Disease Therapeutics (September 28, 2001).
--
THE 60TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF DERMATOLOGY
(AAD): Remicade promising for the treatment of psoriasis.
Johnson & Johnson's (NYSE: JNJ) Remicade (infliximab) provides a rapid,
durable clinical response and a high level of sustained efficacy for at least six months in patients with moderate-to-severe psoriasis. Clinical
trial and biological evidence is mounting to suggest that Remicade may treat
underlying disease pathology in addition to favorably affecting skin symptoms. In this open-label extension trial, investigators set out to
determine whether or not those who had a favorable response to Remicade in
the initial randomized study (The Lancet, June 9, 2001) could maintain the
benefits of a Psoriasis Area Severity Index (PASI) improvement of at least
50%. The magnitude of Remicade treatment effect was clinically acceptable,
the agent was generally well tolerated, and the adverse event profile was
reassuring and in line with that seen with Remicade use in rheumatoid arthritis and Crohn disease trials. The study adds to the growing body of
data supporting Remicade's expansion into psoriasis care.
BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
February 25, 2002
RETURN
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BTECH NEWS, published by Btech Investor, Inc., highlights selected events in
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combines scientific, clinical, and business experience to perform comprehensive analysis of the biotechnology industry and to identify future
industry leaders.
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