WASHINGTON, March 30 Sun Mar 30, 2014 8:56am EDT
<span id="articleText"/> WASHINGTON, March 30 (Reuters) - An experimental 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 Sunday.
<span id="midArticle_0"/> The results presented at the American College of Cardiology scientific meeting in Washington provided a glimmer of hope that the medicine may have value.
<span id="midArticle_1"/> "I'm convinced there is a signal here of efficacy," said Dr. Harvey White, co-chair of the Glaxo-sponsored international study.
<span id="midArticle_2"/> The real test of the drug, 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_3"/> 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_4"/> 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_5"/> Human Genome had rejected an earlier $2.6 billion offer, on the grounds that Glaxo was underestimating the blockbuster sales potential of darapladib.
<span id="midArticle_6"/> 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_7"/> That trial involved 15,828 patients followed for a median of 3.7 years.
<span id="midArticle_8"/> For those taking the Glaxo pill, 9.7 percent had one of the major adverse events compared with 10.4 percent for placebo, which was not a statistically significant difference.
<span id="midArticle_9"/> A lack of any impact on stroke prevention appears to have contributed to the failure of the study, researchers surmised.
<span id="midArticle_10"/> 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_11"/> 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_12"/> The drug's impact on a pair of composite 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. (Reporting by Bill Berkrot; Editing by Sophie Hares)
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<span id="articleText"/> WASHINGTON, March 30 (Reuters) - An experimental 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 Sunday.
<span id="midArticle_0"/> The results presented at the American College of Cardiology scientific meeting in Washington provided a glimmer of hope that the medicine may have value.
<span id="midArticle_1"/> "I'm convinced there is a signal here of efficacy," said Dr. Harvey White, co-chair of the Glaxo-sponsored international study.
<span id="midArticle_2"/> The real test of the drug, 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_3"/> 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_4"/> 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_5"/> Human Genome had rejected an earlier $2.6 billion offer, on the grounds that Glaxo was underestimating the blockbuster sales potential of darapladib.
<span id="midArticle_6"/> 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_7"/> That trial involved 15,828 patients followed for a median of 3.7 years.
<span id="midArticle_8"/> For those taking the Glaxo pill, 9.7 percent had one of the major adverse events compared with 10.4 percent for placebo, which was not a statistically significant difference.
<span id="midArticle_9"/> A lack of any impact on stroke prevention appears to have contributed to the failure of the study, researchers surmised.
<span id="midArticle_10"/> 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_11"/> 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_12"/> The drug's impact on a pair of composite 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. (Reporting by Bill Berkrot; Editing by Sophie Hares)
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