A new heart drug made by GlaxoSmithKline failed the main goal of a phase III study, but that doesn't mean it wouldn't benefit patients.
"I'm convinced there is a signal here of efficacy and the drug is safe," Doctor. Harvey White, co-chair of the international study, told Reuters.
If the drug proves to be successful in a late-stage study in patients who suffered a heart attack within 30 days its credibility could be restored.
In the previous study the drug, dubbed darapladib, was no better than a placebo at " decreasing the risk of a combination of cardiovascular death, heart attack and stroke," Reuters reported.
The trial included 15,828 participants that were followed for a median time of 3.7 years. In the study 9.4 percent of the patients that were taking the Glaxo drug suffered a major adverse even compared with 10.4 percent of the control group taking placebos.
The researchers believe the high quality of care the study participants received may have contributed to the drug's failure by "muting" its effects.
"We're setting a very high bar and we may have affected our ability to (determine) a treatment effect," White told Reuters.
The most common side effects of the drug were diarrhea, and an unpleasant odor in the " feces, urine and skin," Reuters reported.
A high rate of kidney failure in the patients who took the Glaxo drug was also reported but this is not believed to be related to darapladib.
White said he was disappointed to see the drug fail the phase III trial.
"But there is a message here that something is going on. I wouldn't for one moment think that there's nothing going on here and it should be abandoned," he told Reuters.
The next step will be to see how the drug does in the new study including less-stable patients.
"If in the second study you see effects on the cardiovascular end points, this is still a potentially useful drug for patients with heart disease," Murray Stewart, Glaxo's head of Metabolic Pathways Cardiovascular Therapy Area, told Reuters. "The main thing will be the next study."
