Outlook: Clinical Trials

DECEMBER 01, 2008

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, recently released new data that showed that rosuvastatin calcium (Crestor) 20 mg significantly reduced major cardiovascular (CV) events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by 44%, compared with placebo (P <.001) among individuals with elevated high-sensitivity C-reactive protein but low-to-normal cholesterol levels. Results of the trial also showed, 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 lowdensity lipoprotein cholesterol of 50% (P <.001). The results were presented recently at the American Heart Association Scientific Sessions and published concurrently online by the New England Journal of Medicine.

Trials Produce Positive Long-Term Results for RA Drug

The results of several phase 3 clinical trials evaluating certolizumab pegol (Cimzia) have shown long-term benefits for patients with rheumatoid arthritis (RA). Presented at the American College of Rheumatology (ACR) Annual Scientific Meeting, the results from several phase 3 clinical trials involving certolizumab pegol showed that the drug provides rapid and sustained relief from signs and symptoms of RA for 2 years. Results from an open-label extension study to the double-blind, placebo-controlled RAPID (RA PreventIon of structural Damage) 1 met both coprimary end points (ACR 20 response scores at week 24 and change from baseline in modified total Sharp scores at week 52) and showed that certolizumab pegol together with methotrexate provided ACR 20 response as early as week 1 with sustained long-term benefit in relieving RA symptoms through 100 weeks.

Teduglutide Lessens Parenteral Nutrition Dependence for Patients with SBS

Positive 1-year data from a phase 3 extension study of teduglutide (Gattex) were recently presented at the American College of Gastroenterology Annual Scientific Meeting in Orlando, Florida. The 28-week, blinded, placebo-controlled phase 3 trial included 65 of the 71 patients who had completed a 24-week randomized phase 3 study that evaluated low-dose teduglutide (0.05 mg/kg/day) and high-dose teduglutide (0.10 mg/kg/day) versus placebo. Patients who were already receiving teduglutide in the initial phase 3 study continued their dose for an additional 28 weeks, for a total of 52 weeks of treatment. Patients who received placebo in the original study were randomized to receive either the low- or high-dose teduglutide, for a total of 28 weeks of treatment. Teduglutide is an investigational product for patients dependent on parenteral nutrition (PN) due to short bowel syndrome (SBS). The results of the study showed that teduglutide demonstrated an excellent safety and tolerability profile for up to 1 year (which was the primary end point of the study) and provided the ability to safely reduce PN dependence.

Cholesterol Compound Shows Promise in Lowering LDL Cholesterol

Three separate phase 2 trials evaluating the cholesterol management compound AEGR-733, a microsomal triglyceride transfer protein inhibitor, recently produced promising data. All 3 trials were designed to evaluate the efficacy, safety, and tolerability of low doses of AEGR-733 alone and in combination with other lipid-lowering agents such as atorvastatin calcium (Lipitor), ezetimibe (Zetia), and fenofibrate. The preliminary data from the trials indicated statistically significant reductions in patients' low-density lipoprotein (LDL) cholesterol versus baseline and also suggested a promising safety and tolerability profile. In the 3 trials, researchers collected data on more than 460 patients who suffer from dyslipidemia and were given AEGR-733 alone in doses ranging from 2.5 to 10 mg and also in combination with other lipid-lowering agents over 8 to 12 weeks. Patients experienced a reduction in their triglyceride levels by up to 50% and weight loss of up to 3% after 12 weeks on therapy. In addition, an ongoing, openlabel phase 3 study of AEGR-733 is focusing on patients with homozygous familial hypercholesterolemia. Preliminary data from this study show LDL cholesterol reductions of >50% in the majority of patients who have reached high dosages in the study.

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