Questions About Safety Of Natrecor Continue, With No Apparent Resolution Any Time Soon
(Posted by Tom Lamb at DrugInjuryWatch.com)
As reported previously, in June 2007 Scios, Inc. announced it had started enrolling patients in a 7,000-patient trial designed to "assess the long-term clinical outcomes and benefit/risk profile of Natrecor (nesiritide) in patients with acutely decompensated heart failure (ADHF)". At the time, Scios did not mention when this Natrecor safety trial would be completed nor when its results would be available.
As background, the safety profile of Natrecor has been a matter of much debate since a prominent heart doctor, Dr. Jonathan Sackner-Bernstein, published two reports in 2005 warning that Natrecor use was possibly linked to significantly increased rates of kidney problems and death.
Over time, we have monitored developments regarding the safety of Natrecor, including these two reports among other:
While we wait to learn the results of the large-scale Natrecor trial which started-up in June 2007 -- and finally find out whether or not Natrecor is associated with an increased risk of serious kidney problems which could be fatal -- we consider a couple more medical journal articles about the safety of Natrecor.
The first article, "Benefit-risk assessment of nesiritide in the treatment of acute decompensated heart failure", was published by Drug Safety in January 2007 but only recently came to our attention. Based on research done by the Baylor Heart and Vascular Institute, Baylor University Medical Center, in Dallas, Texas, we get the following information from the Medline Abstract for this January 2007 Natrecor article:
The effect of nesiritide on all-cause mortality is currently unresolved. Recent meta-analyses of existing databases have raised concerns regarding adverse effects of the drug on 30-day mortality. However, reviews of large, observational, registry databases do not suggest an adverse inpatient mortality effect compared with other vasodilator therapies. Further resolution of the mortality question awaits completion of pending randomised controlled clinical trials.When used for approved indications and according to recommended dosage and administration regimens, nesiritide represents a reasonable treatment adjunct for ADHF.
A more recent article, published online on September 5, 2007, from Nephrology Dialysis Transplantation, is "Predictors of mortality in adult patients with congestive heart failure receiving nesiritide—Retrospective analysis showing a potential adverse interaction between neseritide [sic] and acute renal dysfunction". Drawing from the Abstract for this the Abstract for this September 2007 Natrecor article:
- Univariate analysis revealed that Natrecor usage was associated with increased mortality
- However, Natrecor usage was not an independent predictor of mortality.
- When patients were stratified according to Natrecor usage, acute renal failure emerged as an independent risk factor for mortality only among patients who received Natrecor.
- Among congestive heart failure patients who developed acute renal failure, Natrecor usage emerged as the only independent predictor of mortality.
In turn, these findings led the authors to this Conclusion:
We conclude that, while [Natrecor] per se is not independently associated with an increased risk for mortality, the development of [acute renal failure] in association with [Natrecor] use may confer an increased risk of mortality.
We will continue to report on developments regarding this Natrecor drug-safety issue.