Outlook: Clinical Trials

Pharmacy Times
Volume 0

Ms. Farley is a freelance medical writerbased in Wakefield, Rhode Island.

Wyeth Drug Combo The Many Benefits of StatinsEasing Hot Flashes

Data from Wyeth's phase 3 trialsof bazedoxifene/conjugated estrogensshow the drug combinationreduced both the number andseverity of hot flashes in postmenopausalwomen by as muchas 80%, compared with placebo.The combo also improved symptomsof vulvar and vaginal atrophy.Secondary data show that sleepdisturbances were reduced andmenopause-related quality of lifewas improved. If further analysisand clinical studies are successful,Wyeth plans to submit its newdrug application to the FDA in thesecond quarter of 2008. Data werepresented recently at the NorthAmerican Menopause SocietyAnnual Meeting.

New SSRI ImprovesSense of Well-being

A data analysis indicated thatthe selective serotonin reuptakeinhibitor escitalopram (Lexapro)effectively improves the lives ofpatients with major depressive disorder(MDD) and those with generalizedanxiety disorder (GAD).Researchers used the Quality ofLife Enjoyment and SatisfactionQuestionnaire to analyze 1140MDD patients and 1045 GAD patients.Compared with placebo, patientstaking 10 mg to 20 mg of escitalopramfor 8 weeks experiencedsignificant improvements intheir quality of life, including theirability to function and go to workand their sense of well-being. Theresults were reported at the EuropeanCollege of NeuropsychopharmacologyCongress in October 2007.

The Many Benefits of Statins

Harvard School of Public Health researchers suggestthat the anti-inflammatory and antioxidant propertiesof statins also may be slowing the decline oflung function in the elderly, even among formersmokers. The researchers analyzed data from theongoing Veterans Affairs Normative Aging Study andtargeted 803 patients who had their lung functionmeasured at least twice between January 1995 andJune 2005. Forced expiratory volume in 1 second(FEV1) and forced vital capacity (FVC) were measured,and the participants completed questionnaireson 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 resultssuggest that those who quit smoking recently or whohave quit for a long time will benefit from takingstatins. Findings appear in the late October issue ofthe American Journal of Respiratory and Critical CareMedicine.

New Therapy Improves Psoriasis

According to an international phase 3 study, morethan two thirds of patients with moderate-to-severepsoriasis had a 75% reduction in their symptomsafter 2 doses of ustekinumab. In fact, >1200 participantsexperienced significant improvements in theirpsoriasis-related quality of life within 4 weeks oftreatment, compared with placebo. Ustekinumab isa novel monoclonal antibody that targets cytokinesinterleukin (IL)-23 and IL-23. According to the drug'smanufacturer, Centocor Inc, "[Centocor] may be ableto offer dermatologists and patients a new, promisingbiologic therapy with an infrequent dosing regimenfor 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 thanwithout the drug. This 30% improvement in mortality is the firstimprovement in the treatment of head and neck cancer in almost 25years, according to the study leaders. This outcome affects patientswith tumors in the mouth, larynx, and pharynx, which account for 5%of newly diagnosed cancers in the United States. Each year, 11,000Americans die from head and neck cancer. The study results showeda 3-year survival rate in 48% of patients taking cisplatin and fluorouracil(the standard treatment), compared with 62% of patients takingdocetaxel—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-mgtablets)—with 100 mg ritonavir once daily with emtricitabineand tenofovir disoproxil fumarate (Truvada) andlopinavir/ritonavir (Kaletra) 800 mg/200 mg once daily withTruvada in treatment-na?ve patients yielded the followingconclusions:

  • 84% of darunavir/ritonavir patients reached an undetectableviral 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% inthe 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-mgdose of Prezista, as well as the use of Prezista in treatment-na?ve patients, have not yet been approved by theFDA.

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