Wednesday, August 04, 2004

Treatment of Heart Failure with Spironolactone — Trial and Tribulations                       John J.V. McMurray, M.D., and Eileen O'Meara, M.D. The application of evidence based on the results of clinical trials is a key aim of modern medical practice. Viewed from that perspective, the findings of Juurlink and colleagues in this issue of the Journal (pages 543–551) could be considered encouraging. The Randomized Aldactone Evaluation Study (RALES) showed that, when added to standard treatment (including an angiotensin-converting–enzyme [ACE] inhibitor), a low dose of the aldosterone antagonist spironolactone reduced the risk of death by 30 percent over an average follow-up period of two years among carefully selected patients with current or recent heart failure. But before you start celebrating, read on.....   Rates of Hyperkalemia after Publication of the Randomized Aldactone Evaluation Study David N. Juurlink, M.D., Ph.D., Muhammad M. Mamdani, Pharm.D., M.P.H., Douglas S. Lee, M.D., Alexander Kopp, B.A., Peter C. Austin, Ph.D., Andreas Laupacis, M.D., and Donald A. Redelmeier, M.D. Background : The Randomized Aldactone Evaluation Study (RALES) demonstrated that spironolactone significantly improves outcomes in patients with severe heart failure. Use of angiotensin-converting–enzyme (ACE) inhibitors is also indicated in these patients. However, life-threatening hyperkalemia can occur when these drugs are used together. Methods We conducted a population-based time-series analysis to examine trends in the rate of spironolactone prescriptions and the rate of hospitalization for hyperkalemia in ambulatory patients before and after the publication of RALES. We linked prescription-claims data and hospital-admission records for more than 1.3 million adults 66 years of age or older in Ontario, Canada, for the period from 1994 through 2001. Results Among patients treated with ACE inhibitors who had recently been hospitalized for heart failure, the spironolactone-prescription rate was 34 per 1000 patients in 1994, and it increased immediately after the publication of RALES, to 149 per 1000 patients by late 2001 (P<0.001). The rate of hospitalization for hyperkalemia rose from 2.4 per 1000 patients in 1994 to 11.0 per 1000 patients in 2001 (P<0.001), and the associated mortality rose from 0.3 per 1000 to 2.0 per 1000 patients (P<0.001). As compared with expected numbers of events, there were 560 (95 percent confidence interval, 285 to 754) additional hyperkalemia-related hospitalizations and 73 (95 percent confidence interval, 27 to 120) additional hospital deaths during 2001 among older patients with heart failure who were treated with ACE inhibitors in Ontario. Publication of RALES was not associated with significant decreases in the rates of readmission for heart failure or death from all causes. Conclusions The publication of RALES was associated with abrupt increases in the rate of prescriptions for spironolactone and in hyperkalemia-associated morbidity and mortality. Closer laboratory monitoring and more judicious use of spironolactone may reduce the occurrence of this complication. Source Information From the Departments of Medicine (D.N.J., D.S.L., A.L., D.A.R.), Pharmacy (M.M.M.), Health Policy, Management, and Evaluation (D.N.J., M.M.M., D.S.L., P.C.A., A.L., D.A.R.), and Public Health Sciences (P.C.A.), University of Toronto; and the Institute for Clinical Evaluative Sciences (D.N.J., M.M.M., D.S.L., A.K., P.C.A., A.L., D.A.R.) — both in Toronto. Address reprint requests to Dr. Juurlink at Sunnybrook and Women's College Health Sciences Centre, G Wing 106, 2075 Bayview Ave., Toronto, ON M4N 3M5, Canada, or at dnj@ices.on.ca 10:22:04 PM    comment [] Think Enron was bad? Now come the drug company scandals - they're worse! How Schering Manipulated Drug Prices and Medicaid By REED ABELSON $345.5 million settlement by Schering-Plough yesterday to resolve a government Medicaid investigation provides a detailed glimpse into how drug companies can manipulate prices to overcharge state and federal programs. Government officials have taken a keen interest in how drug makers price and market their drugs in recent years, and the settlement is the latest in a series reached with large drug makers over accusations that they have overcharged Medicaid. Last year, Bayer paid $257 million and GlaxoSmithKline paid $86.7 million to settle similar allegations. During the late 1990's, Claritin, a popular allergy medicine, generated billions of dollars in sales for Schering-Plough, and the company poured tens of millions of dollars into consumer advertising, using the celebrity Joan Lunden to endorse it. http://www.nytimes.com/2004/07/31/business/31drug.html?ex=1249099200&;en=110f5c17e479a3b8&ei=5090&partner=rssuserland 9:51:47 PM    comment [] ANOTHER DRUG FAILURE - NOT WELL ADVERTISED, OF COURSE. Arthritis drugs fail after weeks OA affects joints like the hips and knees Pain relief creams containing drugs similar to aspirin stop working in patients with osteoarthritis (OA) within weeks, research shows. Current OA guidelines recommending lotions containing non-steroidal anti-inflammatory drugs should be revised, say the authors. The Nottingham University scientists found the treatment was no better than a dummy cream after two weeks. Their findings are reported in the British Medical Journal. http://news.bbc.co.uk/1/hi/health/3935785.stm 9:43:14 PM    comment []

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