The August 10, 2006 New England Journal of Medicineâ€™s lead article, High Dose Atorvastatin after Stroke or Transient Ischemic Attack reports the results of the Stroke Reduction by Aggressive reduction in Cholesterol Levels (SPARCL) trial. The study is sponsored by the drug manufacturer (Pfizer) and all of the authors are Pfizer employees, consultants and grant recipients.
The study found â€œThe atorvastatin group had 218 ischemic strokes and 55 hemorrhagic strokes, whereas the placebo group had 274 ischemic strokes and 33 hemorrhagic strokes. The five-year absolute reduction in the risk of major cardiovascular events was 3.5 percent (hazard ratio, 0.80; 95 percent confidence interval, 0.69 to 0.92; P=0.002). The overall mortality rate was similar, with 216 deaths in the atorvastatin group and 211 deaths in the placebo group (P=0.98), as were the rates of serious adverse events.
Elevated liver enzyme values were more common in patients taking atorvastatin.â€
It was also reported â€ A total of 136 patients in the placebo group and 154 patients in the atorvastatin group died from causes other than stroke before they could have a nonfatal stroke.â€ And â€œOn the basis of our data, 46 patients (95 percent confidence interval, 24 to 243) would need to be treated for five years to prevent one stroke, 29 patients (95 percent confidence interval, 18 to 75) to prevent one major cardiovascular event, and 32 patients (95 percent confidence interval, 22 to 59) to avoid one revascularization procedure.â€
What is not reported is an estimate of the cost of preventing one stroke using high dose atorvastatin (Lipitor). Medicynicâ€™s estimate is as follows: Additional expenses for the use of the drug in post stroke patients include the drug ($1200/year), additional laboratory costs (liver function tests 2 times a year $150), 1 additional physician visit because of the medication ($75) giving a total of $1425/year/patient for this intervention.
Figuring, as the article suggests, that 46 patients need to be treated for five years to prevent one stroke the cost to prevent one stroke ($1425X46X5) is $327,750 to prevent one stroke. Given the limited benefit of this treatment, no improvement in survival but a small decrease in new strokes, can our system afford such an intervention?
Medicynic realizes this cost estimate is not scientific (i.e. not the actual costs experienced) but rather a seat of the pants estimate based on current costs of care. The estimate is, however, indicative of the price of this intervention. Should the NEJM require all such studies include an accurate cost estimate and include this information in the debate about the intervention’s utility?