Outlook: Clinical Trials

Pharmacy Times, Volume 0, 0

Statin Reduces Risk of Cardiovascular Events in Large Outcomes Study

The JUPITER study (Justification for the Use of statins in Primary prevention:an Intervention Trial Evaluating Rosuvastatin), a long-term, randomized,double-blind, placebo-controlled, large-scale study of 17,802 patients, recentlyreleased new data that showed that rosuvastatin calcium (Crestor) 20 mgsignificantly reduced major cardiovascular (CV) events (defined in this study asthe combined risk of myocardial infarction, stroke, arterial revascularization,hospitalization for unstable angina, or death from CV causes) by 44%, comparedwith placebo (P <.001) among individuals with elevated high-sensitivityC-reactive protein but low-to-normal cholesterol levels. Results of the trial alsoshowed, for patients taking rosuvastatin:

  • The combined risk of heart attack, stroke, or CV death was cut by nearly half (47%; P <.001).
  • The risk of heart attack was decreased by more than half (54%; P <.001).
  • The risk of stroke was reduced by nearly half (48%; P = .002).
  • Total mortality was significantly decreased by 20% (P = .02).

In addition, the results of the study showed a reduction in the median lowdensitylipoprotein cholesterol of 50% (P <.001). The results were presentedrecently at the American Heart Association Scientific Sessions and publishedconcurrently online by the New England Journal of Medicine.

Trials Produce Positive Long-Term Results for RA Drug

The results of several phase 3 clinical trialsevaluating certolizumab pegol (Cimzia) haveshown long-term benefits for patients withrheumatoid arthritis (RA). Presented at theAmerican College of Rheumatology (ACR)Annual Scientific Meeting, the results fromseveral phase 3 clinical trials involving certolizumabpegol showed that the drug providesrapid and sustained relief from signsand symptoms of RA for 2 years. Resultsfrom an open-label extension study tothe double-blind, placebo-controlled RAPID(RA PreventIon of structural Damage) 1met both coprimary end points (ACR 20response scores at week 24 and changefrom baseline in modified total Sharp scoresat week 52) and showed that certolizumabpegol together with methotrexate providedACR 20 response as early as week 1 withsustained long-term benefit in relieving RAsymptoms through 100 weeks.

Teduglutide Lessens Parenteral Nutrition Dependence for Patients with SBS

Positive 1-year data from a phase 3extension study of teduglutide (Gattex)were recently presented at theAmerican College of GastroenterologyAnnual Scientific Meeting in Orlando,Florida. The 28-week, blinded, placebo-controlledphase 3 trial included 65 ofthe 71 patients who had completeda 24-week randomized phase 3 studythat evaluated low-dose teduglutide(0.05 mg/kg/day) and high-dose teduglutide(0.10 mg/kg/day) versus placebo.Patients who were already receivingteduglutide in the initial phase 3 studycontinued their dose for an additional 28weeks, for a total of 52 weeks of treatment.Patients who received placeboin the original study were randomizedto receive either the low- or high-doseteduglutide, for a total of 28 weeks oftreatment. Teduglutide is an investigationalproduct for patients dependenton parenteral nutrition (PN) due to shortbowel syndrome (SBS). The results ofthe study showed that teduglutide demonstratedan excellent safety and tolerabilityprofile for up to 1 year (which wasthe primary end point of the study) andprovided the ability to safely reduce PNdependence.

Cholesterol Compound Shows Promise in Lowering LDL Cholesterol

Three separate phase 2 trials evaluatingthe cholesterol management compoundAEGR-733, a microsomal triglyceridetransfer protein inhibitor, recentlyproduced promising data. All 3 trialswere designed to evaluate the efficacy,safety, and tolerability of low dosesof AEGR-733 alone and in combinationwith other lipid-lowering agents such asatorvastatin calcium (Lipitor), ezetimibe(Zetia), and fenofibrate. The preliminarydata from the trials indicated statisticallysignificant reductions in patients'low-density lipoprotein (LDL) cholesterolversus baseline and also suggested apromising safety and tolerability profile.In the 3 trials, researchers collected dataon more than 460 patients who sufferfrom dyslipidemia and were given AEGR-733 alone in doses ranging from 2.5 to 10mg and also in combination with otherlipid-lowering agents over 8 to 12 weeks.Patients experienced a reduction in theirtriglyceride levels by up to 50% andweight loss of up to 3% after 12 weekson therapy. In addition, an ongoing, openlabelphase 3 study of AEGR-733 is focusingon patients with homozygous familialhypercholesterolemia. Preliminary datafrom this study show LDL cholesterolreductions of >50% in the majority ofpatients who have reached high dosagesin the study.