April 28th, 2015
Cardiovascular Outcomes with Sitagliptin: No Better or Worse Than Conventional Care
Larry Husten, PHD
Late Monday afternoon, Merck released the top line results of TECOS, the cardiovascular outcomes trial with its diabetes drug sitagliptin (Januvia). The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for heart […]
January 11th, 2013
Merck Starts to Suspend Worldwide Availability of Tredaptive
Larry Husten, PHD
In the wake of the negative HPS2-THRIVE study announced last month, Merck said today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant. Merck described its decision as being “aligned” with that of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which recommended on Thursday that drugs containing extended-release niacin and laropiprant should be suspended. The drug […]
January 3rd, 2013
Combination of Ezetimibe and Atorvastatin Back on FDA Approval Path
Larry Husten, PHD
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son […]