Outlook: Clinical Trials

APRIL 01, 2008
Susan Farley

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


10.9 mL

23.9 mL


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)

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-na?ve 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-na?ve patients, have not yet been approved by the FDA.