Ms. Farley is a freelance medical writer
based in Wakefield, Rhode Island.
Wyeth Drug Combo The Many Benefits of Statins
Easing Hot Flashes
Data from Wyeth's phase 3 trials
of bazedoxifene/conjugated estrogens
show the drug combination
reduced both the number and
severity of hot flashes in postmenopausal
women by as much
as 80%, compared with placebo.
The combo also improved symptoms
of vulvar and vaginal atrophy.
Secondary data show that sleep
disturbances were reduced and
menopause-related quality of life
was improved. If further analysis
and clinical studies are successful,
Wyeth plans to submit its new
drug application to the FDA in the
second quarter of 2008. Data were
presented recently at the North
American Menopause Society
Annual Meeting.
New SSRI Improves
Sense of Well-being
A data analysis indicated that
the selective serotonin reuptake
inhibitor escitalopram (Lexapro)
effectively improves the lives of
patients with major depressive disorder
(MDD) and those with generalized
anxiety disorder (GAD).
Researchers used the Quality of
Life Enjoyment and Satisfaction
Questionnaire to analyze 1140
MDD patients and 1045 GAD patients.
Compared with placebo, patients
taking 10 mg to 20 mg of escitalopram
for 8 weeks experienced
significant improvements in
their quality of life, including their
ability to function and go to work
and their sense of well-being. The
results were reported at the European
College of Neuropsychopharmacology
Congress in October 2007.
The Many Benefits of Statins
Harvard School of Public Health researchers suggest
that the anti-inflammatory and antioxidant properties
of statins also may be slowing the decline of
lung function in the elderly, even among former
smokers. The researchers analyzed data from the
ongoing Veterans Affairs Normative Aging Study and
targeted 803 patients who had their lung function
measured at least twice between January 1995 and
June 2005. Forced expiratory volume in 1 second
(FEV1) and forced vital capacity (FVC) were measured,
and the participants completed questionnaires
on medication, pulmonary problems, and smoking.
|
Loss of Respiratory Function
|
| Statin Users | Non-statin Users |
FEV1 | 10.9 mL | 23.9 mL |
FVC | 14 mL | 36.2 mL |
Although further data are needed, these results
suggest that those who quit smoking recently or who
have quit for a long time will benefit from taking
statins. Findings appear in the late October issue of
the
American Journal of Respiratory and Critical Care
Medicine.
New Therapy Improves Psoriasis
According to an international phase 3 study, more
than two thirds of patients with moderate-to-severe
psoriasis had a 75% reduction in their symptoms
after 2 doses of ustekinumab. In fact, >1200 participants
experienced significant improvements in their
psoriasis-related quality of life within 4 weeks of
treatment, compared with placebo. Ustekinumab is
a novel monoclonal antibody that targets cytokines
interleukin (IL)-23 and IL-23. According to the drug's
manufacturer, Centocor Inc, "[Centocor] may be able
to offer dermatologists and patients a new, promising
biologic therapy with an infrequent dosing regimen
for the treatment of psoriasis."
Cancer Drug Adds Life to Standard Chemotherapy
A sanofi-aventis–sponsored trial of the cancer drug docetaxel
(Taxotere) showed that by adding the drug to standard chemotherapy,
patients with head and neck cancer may live >3 years longer than
without the drug. This 30% improvement in mortality is the first
improvement in the treatment of head and neck cancer in almost 25
years, according to the study leaders. This outcome affects patients
with tumors in the mouth, larynx, and pharynx, which account for 5%
of newly diagnosed cancers in the United States. Each year, 11,000
Americans die from head and neck cancer. The study results showed
a 3-year survival rate in 48% of patients taking cisplatin and fluorouracil
(the standard treatment), compared with 62% of patients taking
docetaxel—now considered "state of the art."
Update on HIV Drug Trial (February 2008 column corrected)
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A new phase 3 trial comparing HIV drugs darunavir
(Prezista)—at an investigational 800-mg dose (two 400-mg
tablets)—with 100 mg ritonavir once daily with emtricitabine
and tenofovir disoproxil fumarate (Truvada) and
lopinavir/ritonavir (Kaletra) 800 mg/200 mg once daily with
Truvada 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 median change in CD4+ cells from baseline was similar in both groups
It is important to note that the once-daily, 800-mg
dose of Prezista, as well as the use of Prezista in treatment-naïve patients, have not yet been approved by the
FDA.
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