Anonymous
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Anonymous
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I've been an advocate of Novartis products when reasonable in practice. Price it so plans cover it, as I don't see enough here to justify a premium.
(Reference, Medscape) Among the top reservations about PARADIGM-HF is the extent to which it should replace ACE inhibitors in patients with systolic heart failure, for whom the agents are a mainstay. The trial randomized only patients who successfully completed a single-blind run-in phase consisting of enalapril for two weeks and then LCZ699 for twice that long—all after being stable for at least a month on either an ACE inhibitor or angiotensin-receptor blocker (ARB). Of the 10 521 entering the run-in phase, >2000 dropped out, mostly because they couldn't tolerate one of the two agents, often because of hypotension; ultimately 8442 were randomized.
"How do we know what will happen in the real world?" Konstam asked. The study doesn't show how many patients never before exposed to the drug would become hypotensive. In clinical practice, he said, "You don't get a run-in period."
(Reference, Medscape) Among the top reservations about PARADIGM-HF is the extent to which it should replace ACE inhibitors in patients with systolic heart failure, for whom the agents are a mainstay. The trial randomized only patients who successfully completed a single-blind run-in phase consisting of enalapril for two weeks and then LCZ699 for twice that long—all after being stable for at least a month on either an ACE inhibitor or angiotensin-receptor blocker (ARB). Of the 10 521 entering the run-in phase, >2000 dropped out, mostly because they couldn't tolerate one of the two agents, often because of hypotension; ultimately 8442 were randomized.
"How do we know what will happen in the real world?" Konstam asked. The study doesn't show how many patients never before exposed to the drug would become hypotensive. In clinical practice, he said, "You don't get a run-in period."