By Bill Berkrot and Ransdell Pierson
WASHINGTON Sun Mar 30, 2014 11:34am EDT
The GlaxoSmithKline logo is seen at the entrance of a building in Luxembourg, September 10, 2013. Picture taken September 10, 2013
Credit: Reuters/Yves Herman
<span id="articleText"><span id="midArticle_start"/> WASHINGTON (Reuters) - A new type of heart drug being developed by GlaxoSmithKline, which failed the main goal of a Phase III study of patients with chronic but well-treated heart disease, showed signs of potential benefit, the trial's co-leader said.
<span id="midArticle_1"/> The results presented at the American College of Cardiology scientific meeting in Washington on Sunday provided a glimmer of hope that the medicine, darapladib, may have value.
<span id="midArticle_2"/> "I'm convinced there is a signal here of efficacy and the drug is safe," said Dr. Harvey White, co-chair of the large, Glaxo-sponsored international study, who presented the findings.
<span id="midArticle_3"/> The real test of darapladib is likely to come from a second, late-stage study in far less stable patients who received the medicine within 30 days of a heart attack.
<span id="midArticle_4"/> A positive result in that study could put the drug back on track, after it was largely discounted by analysts and investors following the first Phase III failure.
<span id="midArticle_5"/> The stakes are high for the British drugmaker as gaining full control of darapladib was one of the reasons behind its $3.6 billion acquisition of Human Genome Sciences in 2012.
<span id="midArticle_6"/> Human Genome had rejected an earlier $2.6 billion offer, claiming that Glaxo was underestimating the blockbuster sales potential of darapladib.
<span id="midArticle_7"/> Glaxo had previously said darapladib did no better than a placebo in decreasing the risk of a combination of cardiovascular death, heart attack and stroke in the trial called Stability.
<span id="midArticle_8"/> The trial involved 15,828 patients followed for a median of 3.7 years.
<span id="midArticle_9"/> For those taking the Glaxo pill, 9.7 percent had one of the major adverse events compared with 10.4 percent for the placebo, which was not a statistically significant difference.
<span id="midArticle_10"/> A lack of any impact on stroke prevention appears to have contributed to the failure of the study, researchers surmised.
<span id="midArticle_11"/> In addition, the effect of the Glaxo drug may have been muted by the high level of care the patients were receiving.
<span id="midArticle_12"/> Almost all were taking statins and aspirin and nearly 80 percent were on blood pressure drugs - all known to decrease the risk of heart attacks, strokes and death.
<span id="midArticle_13"/> "We're setting a very high bar and we may have affected our ability to (determine) a treatment effect," said White, director of the coronary care unit at Auckland City Hospital in New Zealand.
<span id="midArticle_14"/> SECONDARY GOALS IMPORTANT
<span id="midArticle_15"/> The drug's impact on the secondary goals of the study was deemed "nominally significant" by researchers, meaning they saw the potential of a clinically meaningful effect despite falling short of statistical significance.
<span id="midArticle_0"/> One of the secondary goals looked at the combined number of people who died from heart disease, had a heart attack, or needed urgent artery clearing procedures.
<span id="midArticle_1"/> The other secondary goal studied the combined number of people who died from heart disease, had a heart attack, were hospitalized for unstable angina or required any artery clearing procedure.
<span id="midArticle_2"/> "These are all things that are very important for patients," White explained.
<span id="midArticle_3"/> When isolated from the composite goals, darapladib did numerically better at delaying heart attacks.
<span id="midArticle_4"/> There were 361 heart attacks in the drug group and 405 in the placebo group, although the percentage difference missed statistical significance. There were also fewer deaths among darapladib patients.
<span id="midArticle_5"/> The stroke numbers by comparison were nearly identical - 154 versus 152 for placebo.
<span id="midArticle_6"/> Darapladib blocks an enzyme known as Lp-PLA2, high levels of which are considered a risk factor for heart disease.
<span id="midArticle_7"/> It is believed the drug changes the composition of plaque on artery walls, making it less likely to rupture and cause clogs and serious heart problems.
<span id="midArticle_8"/> One sub group of darapladib patients that fared better than the overall population was smokers, who had a greater decrease in major adverse events than non-smokers.
<span id="midArticle_9"/> "Previous studies showed that smokers have higher Lp-PLA2 levels, and it's plausible that smokers may be more responsive to Lp-PLA2 inhibition," White said.
<span id="midArticle_10"/> The most common side effects with darapladib were diarrhea, and unpleasant odor in feces, urine and skin.
<span id="midArticle_11"/> There was a higher rate of kidney failure reported in patients who took the Glaxo drug, but White said most researchers did not believe that was related to darapladib.
<span id="midArticle_12"/> White said he was disappointed the drug failed to meet the main goal of the study, the results of which were also published in the New England Journal of Medicine.
<span id="midArticle_13"/> "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 said.
<span id="midArticle_14"/> Glaxo, meanwhile, is pinning its hopes on the next large study in sicker patients that should have results available in two or three months.
<span id="midArticle_15"/> "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, said in a telephone interview.
<span id="midArticle_0"/> "The main thing will be the next study."
<span id="midArticle_1"/> (Reporting by Bill Berkrot; Editing by Sophie Hares)
<span id="midArticle_2"/>
WASHINGTON Sun Mar 30, 2014 11:34am EDT
Credit: Reuters/Yves Herman
<span id="articleText"><span id="midArticle_start"/> WASHINGTON (Reuters) - A new type of heart drug being developed by GlaxoSmithKline, which failed the main goal of a Phase III study of patients with chronic but well-treated heart disease, showed signs of potential benefit, the trial's co-leader said.
<span id="midArticle_1"/> The results presented at the American College of Cardiology scientific meeting in Washington on Sunday provided a glimmer of hope that the medicine, darapladib, may have value.
<span id="midArticle_2"/> "I'm convinced there is a signal here of efficacy and the drug is safe," said Dr. Harvey White, co-chair of the large, Glaxo-sponsored international study, who presented the findings.
<span id="midArticle_3"/> The real test of darapladib is likely to come from a second, late-stage study in far less stable patients who received the medicine within 30 days of a heart attack.
<span id="midArticle_4"/> A positive result in that study could put the drug back on track, after it was largely discounted by analysts and investors following the first Phase III failure.
<span id="midArticle_5"/> The stakes are high for the British drugmaker as gaining full control of darapladib was one of the reasons behind its $3.6 billion acquisition of Human Genome Sciences in 2012.
<span id="midArticle_6"/> Human Genome had rejected an earlier $2.6 billion offer, claiming that Glaxo was underestimating the blockbuster sales potential of darapladib.
<span id="midArticle_7"/> Glaxo had previously said darapladib did no better than a placebo in decreasing the risk of a combination of cardiovascular death, heart attack and stroke in the trial called Stability.
<span id="midArticle_8"/> The trial involved 15,828 patients followed for a median of 3.7 years.
<span id="midArticle_9"/> For those taking the Glaxo pill, 9.7 percent had one of the major adverse events compared with 10.4 percent for the placebo, which was not a statistically significant difference.
<span id="midArticle_10"/> A lack of any impact on stroke prevention appears to have contributed to the failure of the study, researchers surmised.
<span id="midArticle_11"/> In addition, the effect of the Glaxo drug may have been muted by the high level of care the patients were receiving.
<span id="midArticle_12"/> Almost all were taking statins and aspirin and nearly 80 percent were on blood pressure drugs - all known to decrease the risk of heart attacks, strokes and death.
<span id="midArticle_13"/> "We're setting a very high bar and we may have affected our ability to (determine) a treatment effect," said White, director of the coronary care unit at Auckland City Hospital in New Zealand.
<span id="midArticle_14"/> SECONDARY GOALS IMPORTANT
<span id="midArticle_15"/> The drug's impact on the secondary goals of the study was deemed "nominally significant" by researchers, meaning they saw the potential of a clinically meaningful effect despite falling short of statistical significance.
<span id="midArticle_0"/> One of the secondary goals looked at the combined number of people who died from heart disease, had a heart attack, or needed urgent artery clearing procedures.
<span id="midArticle_1"/> The other secondary goal studied the combined number of people who died from heart disease, had a heart attack, were hospitalized for unstable angina or required any artery clearing procedure.
<span id="midArticle_2"/> "These are all things that are very important for patients," White explained.
<span id="midArticle_3"/> When isolated from the composite goals, darapladib did numerically better at delaying heart attacks.
<span id="midArticle_4"/> There were 361 heart attacks in the drug group and 405 in the placebo group, although the percentage difference missed statistical significance. There were also fewer deaths among darapladib patients.
<span id="midArticle_5"/> The stroke numbers by comparison were nearly identical - 154 versus 152 for placebo.
<span id="midArticle_6"/> Darapladib blocks an enzyme known as Lp-PLA2, high levels of which are considered a risk factor for heart disease.
<span id="midArticle_7"/> It is believed the drug changes the composition of plaque on artery walls, making it less likely to rupture and cause clogs and serious heart problems.
<span id="midArticle_8"/> One sub group of darapladib patients that fared better than the overall population was smokers, who had a greater decrease in major adverse events than non-smokers.
<span id="midArticle_9"/> "Previous studies showed that smokers have higher Lp-PLA2 levels, and it's plausible that smokers may be more responsive to Lp-PLA2 inhibition," White said.
<span id="midArticle_10"/> The most common side effects with darapladib were diarrhea, and unpleasant odor in feces, urine and skin.
<span id="midArticle_11"/> There was a higher rate of kidney failure reported in patients who took the Glaxo drug, but White said most researchers did not believe that was related to darapladib.
<span id="midArticle_12"/> White said he was disappointed the drug failed to meet the main goal of the study, the results of which were also published in the New England Journal of Medicine.
<span id="midArticle_13"/> "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 said.
<span id="midArticle_14"/> Glaxo, meanwhile, is pinning its hopes on the next large study in sicker patients that should have results available in two or three months.
<span id="midArticle_15"/> "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, said in a telephone interview.
<span id="midArticle_0"/> "The main thing will be the next study."
<span id="midArticle_1"/> (Reporting by Bill Berkrot; Editing by Sophie Hares)
<span id="midArticle_2"/>
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