Merck and Co at a Crossroads with the Next Warfarin Heart Drug

Merck & Co put huge amounts of resources into sponsoring a study of 26,000 heart patients in 32 countries. These people have already had heart attacks or strokes or are in a high-risk category for having heart trouble due to poor blood flow in their lower limbs. Vorapaxar is meant to significantly reduce the occurrence of these repeat heart attacks. Unfortunately, it also raised the potential for serious internal bleeding, particularly in the head. The risks of this drug may actually outweigh the rewards. This is the conclusion from the American College of Cardiology and published in the New England Journal of Medicine.

Vorapaxar, an Alernative to Warfarin?

Vorapaxar for the makers was envisaged as the great (profit-making) alternative to Warfarin. This is the generic version of a drug called Coumadin, the unquestionable market leader cardiologists’ heart drug of choice the World over. Warfarin is a complex and difficult drug to use because getting the dosage quantities just right vital. Overdose and internal bleeding, in the gut or even elsewhere in the body is a possible side effect. Underdose and blood clotting become even more likely. Blood clots of course cause heart attacks.

Vorapaxar and Bleeding Risk

13,000, half of all patients in this latest study continued on their traditional heart medication such as Aspirin plus Warfarin. The other half was treated with tablets of Vorapaxar each day. However, the Merck funded tests were halted for the Vorapaxar patients after abnormally higher numbers of people reported with internal head bleeding. These sufferers had previously had strokes. The control half of the study population continued on as normal.

Vorapaxar and Heart Problems

Three years into the study around 1 in 10 of the Vorapaxar patients had suffered heart problems, either a stroke or a heart attack, or had even died from coronary disease. This result was only marginally better than those in the control group and certainly not a statistically significant result. On the negative side 1 in 25 of patients under the new drug regime suffered moderate or severe internal bleeding, which compared with 1 in 50 for the control group.

The good news for Merck and the patients involved was that 2 out of every three patients gained some measurable benefits from the new drug. So now the company faces the dilemma of whether to request FDA approval for commercial release or to abandon the sunken costs, which are considerable.