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To: Biomaven who wrote (1459)	2/7/2003 4:49:40 PM
From: Biomaven	Respond to of 1477

By the way, here's a recent publication of the earlier results showing potential safety benefits over dobutamine: Am Heart J 2002 Dec;144(6):1102-8 Related Articles, Links Effect of nesiritide (B-type natriuretic peptide) and dobutamine on ventricular arrhythmias in the treatment of patients with acutely decompensated congestive heart failure: the PRECEDENT study. Burger AJ, Horton DP, LeJemtel T, Ghali JK, Torre G, Dennish G, Koren M, Dinerman J, Silver M, Cheng ML, Elkayam U; Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or Natrecor Therapy. Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass 02215, USA. aburger@caregroup.harvard.edu BACKGROUND: Dobutamine is commonly used as a means of treating decompensated congestive heart failure (CHF). Although typically effective at improving short-term hemodynamics and symptomatology, the frequent occurrence of arrhythmias and tachycardia is undesirable. In this randomized, multicenter trial, we compared the safety and clinical effectiveness of the cardiac hormone nesiritide (human B-type natriuretic peptide) with dobutamine in hospitalized patients with decompensated CHF. METHODS: The study population consisted of 255 patients who were randomized to 1 of 2 doses of intravenous nesiritide (0.015 or 0.03 microg/kg/min) or dobutamine (> or =5 microg/kg/min) and stratified by means of an earlier history of ventricular tachycardia. Patients were also assessed with 24 hour Holter recordings immediately before and during study drug therapy and by means of signs and symptoms of CHF. RESULTS: Dobutamine significantly increased the mean (1) number of ventricular tachycardia events per 24 hours by 48 +/- 205 (P =.001), (2) repetitive ventricular beats per hour by 15 +/- 53 (P =.001), (3) premature ventricular beats per hour by 69 +/- 214 (P =.006), and (4) heart rate by 5.1 +/- 7.7 beats per minute (P <.001). These end points were significantly decreased or unchanged in the nesiritide groups. Nesiritide did not increase heart rate, despite a greater reduction of blood pressure. Both drugs were similarly effective means of improving signs and symptoms of CHF. CONCLUSIONS: Dobutamine is associated with substantial proarrhythmic and chronotropic effects in patients with decompensated CHF, whereas nesiritide actually reduces ventricular ectopy or has a neutral effect. Compared with dobutamine, nesiritide may be a safer, short-term treatment for patients with decompensated CHF. Peter

To: Biomaven who wrote (1459)	2/7/2003 4:50:23 PM
From: rkrw	Read Replies (1) \| Respond to of 1477

<<So it's not a breakthrough drug, but it doesn't have to be given the large size of the market and the absence of any branded competition at all. If it works marginally better and costs marginally less to use (because less monitoring needed), then that's all you need to sell a lot of drug.>> A lot of shortsellers lost a lot of money because they couldn't understand this simple concept.

To: Biomaven who wrote (1459)	2/7/2003 6:36:49 PM
From: Ausdauer	Read Replies (2) \| Respond to of 1477

Peter, no, I mean that the marketing has been fierce... ...not that you overexagerated drug efficacy. I see Natrecor as an interesting therapy, but not a blockbuster. Here is another big secret... NOBODY USES IV NITRO FOR ACUTE CHF DECOMPENSATIONS. JNJ's interest, IMHO, is something other than Natrecor, with Nesiritide being a cherry on top of the pie. I am not sure what the pie is. "Experts" in the industry tell me that Natrecor was priced incorrectly. They sell it too cheaply. Sure, that could change if volume sales increase with OP infusions, but I see that as a long way away. You either need a dedicated clinic or a portable infusion system. Oh, yes, and a clinical trial that would justify its use. JNJ is looking for an oral equivalent of Remicaide. I suspect that is the hook here. Start thinking of some cute names now. How about Rambocaide? Aus