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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (6039)	3/27/2002 9:22:21 AM
From: Biomaven	Read Replies (2) \| Respond to of 52153

<SCIO> I should comment a little more on the Milrinone trial reported in the same issue of the JAMA. This is a very expensive (nearly $2k per use) Sanofi drug that is pretty widely used in heart failure. Here's what the editorial had to say: In the Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) study, Cuffe and colleagues3 randomly assigned 951 patients with an exacerbation of chronic heart failure and for whom inotropic therapy was "indicated but not . . . required" to 48-hour intravenous treatment with milrinone or placebo. The primary end point was hospitalization for a cardiovascular cause within 60 days. Milrinone was associated with a higher rate of early treatment failure, more sustained hypotension and new atrial arrhythmias, and a nonsignificant higher number of deaths in hospital (3.8% vs 2.3%; P = .19) and after 60 days (10.3% vs 8.9%; P = .41). The authors rightly conclude that milrinone should not be used as an adjunct to standard treatment of patients with an exacerbation of heart failure. The patients in this trial had a lower in-hospital mortality than for all patients admitted to a hospital with heart failure, confirming that patients with severe acute heart failure were probably excluded from the study. Milrinone is a phosphodiesterase inhibitor and has been shown to have short-term advantageous effects on hemodynamics but to cause death in the long term in patients with chronic heart failure.5 The report by Cuffe et al is an example of a clinical trial with an important neutral (possibly negative) result that should affect clinical care. Only a cavalier investigator would now embark on a trial in acute heart failure, and even the use of milrinone for circulatory support in other similar conditions will be questioned. And talking also about dobutamine and dopamine: The most commonly used drugs for the maintenance of circulation are dopamine and dobutamine.12, 13 Their use in acute heart failure will need to be reconsidered in the light of the findings with milrinone because of the similarity of these drugs' mechanism of action.14 Some trials with dobutamine have suggested harm.8, 9 The key here is that Nesiritide is somewhat better (and perhaps more importantly, much easier to use) than intravenous nitroglycerine, and if the standard inotropes are now being further called into question, there is a real possibility of Nesiritide eventually (over many years) becoming the standard of care for much acute heart failure, as well as for the outpatient/in-home treatment of incipient heart failure. One caution: a very savvy physician friend I know has in the past been pretty cautious about the value of Nesiritide given the entrenched and mostly cheap drugs it competes with. Peter