Outlook: Clinical Trials

Pharmacy Times, Volume 0, 0

Good News for INSPIRE Study

The INSPIRE trial compared 2 different treatments for severeand very severe chronic obstructive pulmonary disease (COPD):salmeterol/fluticasone propionate (SFC) and tiotropium bromide.Researchers found both treatments to be similar in their effect onsymptom exacerbation, but they differed when it came to thenature of the exacerbations—which indicates that the treatmentswork in different ways. Further, the type of exacerbations will differ,depending on the therapy. The study also found that over 2years, SFC had a sustained improvement in quality of life, comparedwith tiotropium; however, in adverse side effects, SFC faredworse than tiotropium—the most common adverse event beingexacerbation of symptoms.

Warning for New Anticlotting Drug

While clinical trials haveshown the new anticlotting drugidraparinix to be effective for thetreatment of deep vein thrombosis(DVT) and for the longtermprevention of blood clots,new trials indicate that it is notas effective for treating potentiallylife-threatening pulmonaryembolisms. In fact, long-termuse indicates that, comparedwith standard treatment, idraparinixmay have a higher rate ofserious bleeding complications.

Three studies by the drug'smanufacturer, sanofi-aventis, supportthese findings, and all appearedin the New EnglandJournal of Medicine. EdwardAmorosi, MD, of the New YorkUniversity Medical Center noted,"The long duration of action foridraparinix is a benefit, but it isalso a hazard because there isno antidote. It appears to be amore effective antithromboticfor DVT, but it is not safe enoughto make it standard treatment."

Vitamin E Claims May Be False

A recent study in Free RadicalBiology and Medicine suggeststhat years of data from clinicaltrials on vitamin E may beflawed. Researchers say that thelevels of vitamin E being used inthose studies were not highenough. The level of vitamin Eneeded to reduce oxidativestress is about 1600 to 3200 IUdaily, 4 to 8 times higher thanwhat was being studied. Scientistssay that this fact couldaccount for the inconsistency invitamin E study results over theyears, researched mostly for itsuse in preventing or treating cardiovasculardisease.

Update on HIV Drug Trial

A new phase 3 trial comparing HIV drugs darunavir (Prezista) with ritonavir and lopinavir/ritonavir (Kaletra) 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 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 humanpapillomavirus (HPV) drug Gardasil has determinedthe drug's efficacy in preventing strainsthat cause 90% of all cervical cancers. The study,which included 11,000 women aged 15 to 26,showed Gardasil to be 38% effective against 10additional types of HPV that are believed to cause20% 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 transmitteddisease in America—6.2 million Americansare infected with genital HPV each year, and halfof all sexually active women and men will get it atsome point in their lives, according to the Centersfor Disease Control and Prevention.

BLOOM Trial Continues as Planned

An independent Echocardiographic Data SafetyMonitoring Board has reviewed the phase 3 BehavioralModification and Lorcaserin for Overweightand Obesity Management (BLOOM) trial and declaredno reason to discontinue the study. In an effort toensure patient safety, the monitoring board reviewedthe unblended echocardiograms of patients performedafter 6 months of the trial. Rates of FDAdefinedvalvulopathy in the study group did not constitutestopping the trial. BLOOM is a double-blind,randomized, placebo-controlled trial of 3200 patientsto evaluate 10-mg bid doses of lorcaserin versusplacebo 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 ElanCorp, offers significant improvements in healthrelatedquality of life for patients with multiplesclerosis. When compared with placebo, resultsfrom the trial indicated that patients sustainedtheir improved quality of life rather than just aslowing down of quality of life deterioration. Studydetails appeared in the August 20, 2007, issue ofAnnals of Neurology.