Statins – more bad news

The NEJM and the Great Statin Deception: Reductio ad absurdum

So now   the NEJM apparently (by it’s choice of words in the  29/11/2007   Extract)   wants to make omission to prescribe  statin a medical negligence  charge? …”clinical-performance measures for coronary artery disease..  indicatest  that  clinicians should be considered remiss if they do not prescribe these agents for all their eligible patients-

-despite the fact that no trials have shown that statins significantly  reduce all-cause mortality other than in rare malignant hypercholesterolemia, nor reduce the primary preventable pathogenesis of common vascular and malignant diseases- overweight and insulin-resistance -lipidemia;

-and despite the fact that the accompanying  CORONA trial result confirmed that, over a mean 32.8 months in over 5000 highrisk patients ie 13700 patient years, rosuvastatin failed to reduce deaths from cardiovascular or all causes;

-and despite the  overwhelming evidence that each of the following  separately – let alone when combined- do achieve these goals safely and at negligble cost:
– fish oil;  metformin;  appropriate HRT;  or combination of appropriate non-prescription vitamins, minerals, biologicals and herbs.
But then such low-cost, approriate safe natural supplements have no massive drug company sponsors precisely because they are long out of patent

The NEJM failed to publish with it’s Editorial extract Dr Masoudi’s conflict of interest: “is on the Speaker’s Bureau for Astra Zeneca (Rosuvastatin).

neil.burman@gmail.com

NEJM 2007:357:2301-2304 :2007
Statins for Ischemic Systolic Heart Failure   Frederick A. Masoudi, University of Colorado at Denver

Hydroxymethylglutaryl–coenzyme A reductase inhibitors (statins) represent one of the most important pharmacologic advances in the prevention of cardiovascular disease in decades. Since the publication of the Scandinavian Simvastatin Survival Study in 1994,1 several trials have demonstrated important benefits of statins in patients with established coronary disease. These findings have resulted in strong recommendations for the use of statins in clinical-practice guidelines.2 Statins are one of the few classes of drugs that are embedded in clinical-performance measures for coronary artery disease, which indicates that clinicians should be considered remiss if they do not prescribe these agents for all their eligible patients.3

NEJM  2007: 357:2248-2261
Rosuvastatin in Older Patients with Systolic Heart Failure

John Kjekshus, et al  for the CORONA Group University of Oslo, Rikshospitalet University Hospital, Oslo, Norway,

Background Patients with systolic heart failure have generally been excluded from statin trials. Acute coronary events are uncommon in this population, and statins have theoretical risks in these patients.

Methods A total of 5011 patients at least 60 years of age with New York Heart Association class II, III, or IV ischemic, systolic heart failure were randomly assigned to receive 10 mg of rosuvastatin or placebo per day. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included death from any cause, any coronary event, death from cardiovascular causes, and the number of hospitalizations.

Results

As compared with the placebo group, patients in the rosuvastatin group had decreased levels of low-density lipoprotein cholesterol (difference between groups, 45.0%; P<0.001) and of high-sensitivity C-reactive protein (difference between groups, 37.1%; P<0.001). During a median follow-up of 32.8 months, the primary outcome occurred in 692 patients in the rosuvastatin group and 732 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.83 to 1.02; P=0.12), and 728 patients and 759 patients, respectively, died (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.31). There were no significant differences between the two groups in the coronary outcome or death from cardiovascular causes. In a prespecified secondary analysis, there were fewer hospitalizations for cardiovascular causes in the rosuvastatin group (2193) than in the placebo group (2564) (P<0.001). No excessive episodes of muscle-related or other adverse events occurred in the rosuvastatin group.

Conclusions Rosuvastatin did not reduce the primary outcome or the number of deaths from any cause in older patients with systolic heart failure, although the drug did reduce the number of cardiovascular hospitalizations. The drug did not cause safety problems.

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