Good News for INSPIRE Study
The INSPIRE trial compared 2 different treatments for severe
and very severe chronic obstructive pulmonary disease (COPD):
salmeterol/fluticasone propionate (SFC) and tiotropium bromide.
Researchers found both treatments to be similar in their effect on
symptom exacerbation, but they differed when it came to the
nature of the exacerbations—which indicates that the treatments
work in different ways. Further, the type of exacerbations will differ,
depending on the therapy. The study also found that over 2
years, SFC had a sustained improvement in quality of life, compared
with tiotropium; however, in adverse side effects, SFC fared
worse than tiotropium—the most common adverse event being
exacerbation of symptoms.
Warning for New Anticlotting Drug
While clinical trials have
shown the new anticlotting drug
idraparinix to be effective for the
treatment of deep vein thrombosis
(DVT) and for the longterm
prevention of blood clots,
new trials indicate that it is not
as effective for treating potentially
life-threatening pulmonary
embolisms. In fact, long-term
use indicates that, compared
with standard treatment, idraparinix
may have a higher rate of
serious bleeding complications.
Three studies by the drug's
manufacturer, sanofi-aventis, support
these findings, and all appeared
in the New England
Journal of Medicine. Edward
Amorosi, MD, of the New York
University Medical Center noted,
"The long duration of action for
idraparinix is a benefit, but it is
also a hazard because there is
no antidote. It appears to be a
more effective antithrombotic
for DVT, but it is not safe enough
to make it standard treatment."
Vitamin E Claims May Be False
A recent study in Free Radical
Biology and Medicine suggests
that years of data from clinical
trials on vitamin E may be
flawed. Researchers say that the
levels of vitamin E being used in
those studies were not high
enough. The level of vitamin E
needed to reduce oxidative
stress is about 1600 to 3200 IU
daily, 4 to 8 times higher than
what was being studied. Scientists
say that this fact could
account for the inconsistency in
vitamin E study results over the
years, researched mostly for its
use in preventing or treating cardiovascular
disease.
Update on HIV Drug Trial
A new phase 3 trial comparing HIV drugs darunavir (Prezista) with ritonavir and lopinavir/ritonavir (Kaletra) in treatment-naïve patients yielded the following conclusions:
- 84% of darunavir/ritonavir patients reached an undetectable viral load vs 78% of patients in the lopinavir/ritonavir group
- Both groups had a low incidence of discontinuation
- Incidence of lipid-related adverse events were 1.7% in the darunavir/ritonavir group and 5.2% in the lopinavir/ritonavir group
- The average change in CD4-1 cells from baseline was similar in both groups
It is important to note that the once-daily, 800-mg dose of Prezista is not yet FDA-approved.
Gardasil Even More Effective
A Merck-sponsored study on its human
papillomavirus (HPV) drug Gardasil has determined
the drug's efficacy in preventing strains
that cause 90% of all cervical cancers. The study,
which included 11,000 women aged 15 to 26,
showed Gardasil to be 38% effective against 10
additional types of HPV that are believed to cause
20% of all cervical cancer.
Gardasil study results so far have shown:
Strain | % Effectiveness |
HPV 16 | ~100% |
HPV 18 | ~100% |
HPV 45 | 45% |
HPV 31 | 45% |
HPV remains the most common sexually transmitted
disease in America—6.2 million Americans
are infected with genital HPV each year, and half
of all sexually active women and men will get it at
some point in their lives, according to the Centers
for Disease Control and Prevention.
BLOOM Trial Continues as Planned
An independent Echocardiographic Data Safety
Monitoring Board has reviewed the phase 3 Behavioral
Modification and Lorcaserin for Overweight
and Obesity Management (BLOOM) trial and declared
no reason to discontinue the study. In an effort to
ensure patient safety, the monitoring board reviewed
the unblended echocardiograms of patients performed
after 6 months of the trial. Rates of FDAdefined
valvulopathy in the study group did not constitute
stopping the trial. BLOOM is a double-blind,
randomized, placebo-controlled trial of 3200 patients
to evaluate 10-mg bid doses of lorcaserin versus
placebo over a 2-year treatment period.
MS Drug Improves Quality of Life
According to a recent phase 3 clinical trial,
natalizumab (Tysabri), by Biogen Idec and Elan
Corp, offers significant improvements in healthrelated
quality of life for patients with multiple
sclerosis. When compared with placebo, results
from the trial indicated that patients sustained
their improved quality of life rather than just a
slowing down of quality of life deterioration. Study
details appeared in the August 20, 2007, issue of
Annals of Neurology.
