Nitromed’s BiDil Combination Therapy for Congestive Heart Failure

On November 8, 2004 Nitromed reported that the data from its Phase 3 A-HeFT trial would be published in the New England Journal of Medicine and presented at the American Heart Association’s Late Breaking Scientific Sessions. This randomized, placebo-controlled, double blind clinical trial enlisted 1050 African American patients with New York Heart Association class III [...]

Eli Lilly and Sankyo’s CS-747 / Prasugrel for Acute Coronary Syndrome

On October 25, 2004 Eli Lilly and Company and Sankyo Company announced that a Phase 3 clinical trial comparing the antiplatelet agents prasugrel and Plavix™ is scheduled to begin later this year. The study, known as TRITON-TIMI 38, will include a reported 13,000 patients who are suffering acute coronary syndromes (heart attacks or unstable angina) [...]

Vytorin for the Treatment of Hyperlipidemia

Vytorin is a combination therapy comprised of two drugs already separately approved for the treatment of hyperlipidemia. Zocor (simvistatin) and Zetia (ezetimibe) are combined in this oral medication currently awaiting an FDA decision on approval. Results released by Merck and Schering-Plough in March 2004 from Phase III clinical trials demonstrated that patients taking Zocor and [...]

Cordis Carotid System for Carotid Artery Disease

On April 21, 2004 Cordis Corporation announced that the FDA’s Circulatory System Devices Panel had recommended approval of the Cordis Carotid System. Cordis’ pre-market approval application drew upon results of the SAPPHIRE Study, which included 334 high-risk surgical patients randomized to receive the stent with embolic protection vs. the traditional carotid endarterectomy. According to [...]

CV Therapeutics’ Ranexa for Chronic Angina

On April 20, 2004 CV Therapeutics released data from its Monotherapy Assessment of Ranolazine In Stable Angina (MARISA) trial. The company reported that patients with chronic angina taking Ranexa™ (ranolazine) had a statistically significant increase in symptom-limited exercise duration at trough drug concentrations. The MARISA clinical trial is a double blind, placebo controlled study involving [...]

Torcetrapib for increasing HDL cholesterol

On April 7, 2004 Pfizer announced preliminary results of a Phase I trial with torcetrapib, its experimental therapy for increasing HDL cholesterol. A study was published in the April 8, 2004 issue of the New England Journal of Medicine, involving 19 patients. The results showed that torcetrapib significantly increased the level of high-density lipoprotein (HDL) [...]

FM-VP4 for the treatment of hyperlipidemia

On April 5, 2004 Forbes Medi-Tech Inc. announced preliminary results of its Phase II clinical trial of FM-VP4 for the treatment of hyperlipidemia. The company reported that statistical significance was achieved at the trial’s primary endpoint of lowering low density lipoprotein (LDL) cholesterol. An 11% reduction in LDL cholesterol, as compared to placebo, was [...]

Enoximone

On March 25, 2004 Myogen Inc. announced preliminary results from its Phase III clinical trial of enoximone capsules. The 201 participants were patients with the most advanced stages of chronic heart failure who were dependent on intravenous (IV) inotrope therapy. The study was designed to evaluate enoximone capsules as an effective treatment to wean patients [...]

Taxus Express

On March 4, 2004, Boston Scientific announced that Taxus Express, its paclitaxel-eluting stent system for the treatment of coronary artery disease, had received FDA approval. The company indicated that it planned to launch Taxus Express in the United States immediately. Cordis Corporation’s Cypher™ stent (see Week and the newly approved Taxus stent are currently [...]

CYPHER Sirolimus-eluting Stent

On February 18, 2004, Cordis Corporation announced completion of patient enrollment in the first randomized head-to-head coronary stent trial comparing its new CYPHER sirolimus-eluting coronary stent with the Taxus Express (2) paclitaxel-eluting coronary stent. This trial is expressly designed to compare performance differences between the two drug-eluting stents, particularly in high-risk patient group subsets such [...]