Published: April 17, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

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Giving statins before cardiac surgery may improve outcomes, a systematic review showed.

In pooled results from 11 randomized trials, patients who received preoperative statins had a significantly lower rate of postoperative atrial fibrillation (19% versus 35.6%, OR 0.40, P<0.01), according to Oliver Liakopoulos, MD, of the University of Cologne in Germany, and colleagues.

In addition, statin-treated patients had significantly shorter stays in the intensive care unit and in the hospital. There also were nonsignificant trends toward reduced rates of myocardial infarction (MI) and renal failure, the researchers reported in a Cochrane review.

No statin-related side effects were reported.

"Thus, the beneficial effects of statins presumably overbalance the inherent risks that are associated with ... statin pre-treatment," the authors wrote.

Use of preoperative statins for all patients "seems premature," they wrote, but "it appears reasonable and in compliance with existing guidelines to advocate an intensified preoperative statin treatment, followed by a rigorous postoperative re-initiation regimen, in all hyperlipidemic patients with multiple cardiac risks and coronary heart disease scheduled for cardiac surgery."

Evidence from randomized controlled trials, including a recent systematic review, has shown that preoperative statins reduce periprocedural cardiovascular events after percutaneous coronary interventions and noncardiac surgery. Results are conflicting, however, for patients undergoing cardiac surgery, with some studies showing a benefit and others showing no effect.

To explore the issue, Liakopoulos and colleagues collected information from 11 randomized trials that compared any statin treatment before cardiac surgery with either no preoperative statin therapy or placebo. The analysis included a total of 984 patients (71.5% male, mean age 65), who mostly underwent on-pump coronary artery bypass grafting (CABG).

Six trials used atorvastatin (Lipitor), two used simvastatin (Zocor), and one each used fluvastatin (Lescol), rosuvastatin (Crestor), and pravastatin (Pravachol).

Statin treatment before surgery was associated with a reduction in postoperative atrial fibrillation -- with a number needed to treat of seven -- but no effect on mortality through an average follow-up of 16.4 days (0.6% in each group) or postoperative stroke (1.1% versus 1.6%, P=0.67).

Statin therapy was associated with less time spent in the intensive care unit (by an average of 3.39 hours, P=0.005) and in the hospital (by an average of 0.48 days, P=0.013).

"Both findings might be driven by the higher incidence of atrial fibrillation in statin-untreated patients, which is known to be associated to postoperative complications and prolonged duration of hospital stay," the authors noted.

Patients who received preoperative statins had lower rates of MI (1.3% versus 2.7%) and renal failure (3.2% versus 7.1%), although neither difference reached statistical significance (P>0.05 for both).

The authors noted that the results may not be generalizable to patients undergoing cardiac surgery other than CABG.

Future studies, they added, should examine preoperative statin use in high-risk patients, the use of newer statins, compliance to statin therapy, quality of life effects, and the cost-effectiveness of using statins before cardiac surgery.

The authors reported no conflicts of interest.

Primary source:The Cochrane Library
Source reference:
Liakopoulos O, et al "Preoperative statin therapy for patients undergoing cardiac surgery" Cochrane Database of Syst Rev 2012; DOI: 10.1002/14651858.CD008493.pub2.

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WINSTON-SALEM, N.C., April 17, 2012 /PRNewswire via COMTEX/ -- Tengion, Inc. /quotes/zigman/116156/quotes/nls/tngn TNGN -4.17% , a leader in regenerative medicine, today announced that it recently completed a successful Pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its lead preclinical program, the Neo-Kidney Augment(TM). The FDA and the Company have agreed on a good laboratory practice (GLP) animal study program required to support an Investigational New Drug (IND) filing and initiation of a Phase 1 clinical trial in chronic kidney disease (CKD) patients. The Company anticipates that it will submit an IND filing for the product candidate during the first half of 2013 and that its Phase 1 trial will provide initial human proof-of-concept data in 2014.

"We are very pleased with the progress of the Neo-Kidney Augment program. Our successful interactions with the FDA are a testament to the high quality of work done by our scientific team and have led to plans for an IND filing followed by a Phase 1 clinical trial to be conducted in CKD patients that could lead to human proof-of-concept data," said John L. Miclot, Tengion's President and Chief Executive Officer. "We are focused on realizing the key milestones for both of our lead programs in order to help patients as well as create value for all of our stakeholders."

In addition to the Neo-Kidney Augment, the Company is developing the Neo-Urinary Conduit(TM), which is in a Phase 1 trial in bladder cancer patients and is intended to regenerate native-like urinary tissue for patients requiring a urinary diversion following bladder removal (cystectomy).

About the Neo-Kidney Augment(TM)The Neo-Kidney Augment(TM) is intended to prevent or delay the need for dialysis or kidney transplantation by catalyzing the regeneration of functional kidney tissue in patients with advanced chronic kidney disease (CKD). This increase in functional kidney mass could thereby delay or prevent the need for dialysis or kidney transplant in patients with end stage renal disease (ESRD). According to the United States Renal Data System, more than $27 billion in Medicare costs each year are attributable to patients with ESRD and ESRD is associated with an approximate 20% mortality rate per year, with the average life expectancy of a patient initiating dialysis of approximately four years. Tengion scientists have published and presented positive data on the effect of the Company's Neo-Kidney Augment in four different preclinical models of CKD. Two of these preclinical models have been conducted for a sufficiently long period of time to demonstrate durability and an impact on survival. Tengion anticipates submitting an IND filing for the Neo-Kidney Augment to FDA during the first half of 2013. Tengion is also exploring moving forward using the Advanced Therapy Medicinal Products (ATMP) pathway, an established regulatory route in Europe for advanced cell-based therapies.

About the Neo-Urinary Conduit(TM)The Neo-Urinary Conduit(TM) is a combination of a patient's own cells and bioabsorbable scaffold that is intended to catalyze regeneration of a native-like urinary tissue conduit, passively transporting urine from the ureters through a stoma, or hole in the abdomen, into a standard ostomy bag. Standard of care for patients requiring a non-continent urinary diversion uses bowel tissue to construct a conduit for urine to exit from the body. There are over 20,000 urinary diversions performed annually in the United States and Europe. These patients are at risk for complications associated with the use of bowel tissue, as well as for those associated with the surgery to harvest the bowel tissue. The Neo-Urinary Conduit is the only product candidate currently in development that aims to avoid the use of bowel tissue. The Neo-Urinary Conduit is being evaluated in an ongoing Phase 1 clinical trial in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients. Four patients have been enrolled to date in the trial at the University of Chicago Medical Center and at The Johns Hopkins Hospital in Baltimore, Maryland. The Company expects to complete implantation of the remaining patients in the trial by the end of 2012.

About TengionTengion, a clinical-stage regenerative medicine company, is focused on developing its Organ Regeneration Platform(TM), to harness the intrinsic regenerative pathways of the body to regenerate a range of native-like organs and tissues and delay or eliminate the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications. An initial clinical trial is ongoing for the Company's lead product candidate, the Neo-Urinary Conduit(TM), an autologous implant that is intended to catalyze regeneration of native-like urinary tissue for bladder cancer patients requiring a urinary diversion following bladder removal. The Company's lead preclinical candidate is the Neo-Kidney Augment(TM), which is designed to prevent or delay dialysis kidney transplantation by increasing renal function in patients with advanced chronic kidney disease. Tengion has worldwide rights to its product candidates.

Forward-Looking StatementsCertain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to the Company's: (i) plans to develop and commercialize its product candidates, including the Neo-Kidney Augment and the Neo-Urinary Conduit; and (ii) expectations regarding ongoing and planned preclinical studies and clinical trials. Although Tengion believes that these statements are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there are a number of factors that may cause actual results to differ from these statements. For instance there can be no assurance that: (i) the Company will be able to successfully enroll patients in its clinical trials, including its Phase 1 clinical trial for the Neo-Urinary Conduit; (ii) patients enrolled in the Company's clinical trials will not experience adverse events related to the Company's product candidates, which could delay clinical trials or cause the Company to terminate the development of a product candidate; (iii) the results of the clinical trial for the Neo-Urinary Conduit will support further development of that product candidate; (iv) data from the Company's ongoing preclinical studies, including its proposed GLP program for the Neo-Kidney Augment, will continue to be supportive of advancing such preclinical product candidates; and (v) the Company will be able to progress its product candidates that are undergoing preclinical testing, including the Neo-Kidney Augment, into clinical trials and that the Company will be successful in designing such clinical trials in a manner that supports the development of such product candidate; and (vi) the Company will be able enter into strategic partnerships on favorable terms, if at all, or obtain the capital it needs to develop its product candidates and continue its operations. For additional factors which could cause actual results to differ from expectations, reference is made to the reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward looking statements in this release are made only as of the date hereof and the Company disclaims any intention or responsibility for updating predictions or expectations in this release.

SOURCE Tengion, Inc.

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The $20 billion kidney dialysis business, the nation’s first foray into universal health care, keeps growing exponentially with mixed results across the country, but here in Connecticut the news is mainly good on the ultimate measure of success — survival — with only one of the 40 clinics showing worse-than-expected mortality rates.

That’s not to say that issues of infection control, medication mistakes and a less-than-acceptable physical environment don’t crop up and find their way into clinic reports authored by personnel at the state Department of Health following surprise visits to the facilities.

The New London Dialysis Center, which is part of the private DaVita, Inc,. corporate chain, holds the distinction of having the highest mortality rates, according to data collected by the Centers for Medicare and Medicaid Services and made user-friendly by ProPublica, the Pulitizer-prize-winning investigative website.

The state and national death rate for dialysis patients is 20 percent, but at the New London center it was 30 percent from 2007-2010, 22 percent worse than expected when the patient mix is adjusted for age, sex, race, ethnicity and diabetes, CMS data shows.

The first-year mortality rate at the New London Center was 40 percent from 2007-2010, also higher than expected, where the average for the state and nation is 27 percent.

Congress, in a bipartisan move, approved full federal coverage for end stage renal disease in July 1973, the only such public health ailment in this category. Robin Fields at ProPublica said as CMS started monitoring the death rates for these dialysis patients over time, it found the rate continued to climb until 2002 where there was some improvement. First-year survival rates however, didn’t budge.

Fields, one of the main authors on ProPublica’s 2010 examination of kidney dialysis centers, said first-year death rates are more a reflection of the potential lack of health care for patients without insurance before they face kidney failure.

Fields said that “clinics with good records in this regard are important models and clinics with bad records should surely be pushed to make improvements.”

CMS also tracks the percentage of patients who have never seen a specialist before going on dialysis, something that adds to complications.

ProPublica first put data on mortality, hospitalizations, infections, clinical benchmarks and the physical conditions of clinics in the public purview two years ago after waiting since 2008 for the government to release the information under a Freedom of Information Act request. Continued...

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