Network and cable TV, as well as print media, are being flooded by commercials for the prescription drug Victoza (liraglutide) based on the results from this clinical trial. On the ads, paid actors say “Can one medicine help treat both blood sugar and cardiovascular risk?”
Let’s take a closer look at the basis for these claims.
The LEADER Trial followed people at high-risk for heart disease events (prior history heart disease, kidney disease, type 2 diabetes), 4668 participants prescribed the drug, 4672 given placebo. After 3.8 years:
4.7% of participants given drug died of cardiovascular causes
6.0% of participants given placebo died of cardiovascular causes
This means that there was a 1.3% reduction in death from cardiovascular causes. No significant reduction was seen in non-fatal cardiovascular events, non-fatal stroke, or hospitalization from heart failure. Put another way, there were 1.6 cardiovascular deaths per year per 100 participants on placebo, 1.2 cardiovascular deaths per year per 100 participants on Victoza, or a reduction of 0.4 cardiovascular deaths per year per 100 high-risk participants. Fatal heart attacks were reduced from 0.2 per year per 100 participants to 0.1.
Here is the associated graph:
Based on these data that were double-blind and placebo-controlled, you could conclude that Victoza reduces cardiovascular death in type 2 diabetics at high-risk for cardiovascular events . . . by a teensy-teensy bit.
But, as always when Big Pharma is part of the picture, there are some problems:
- The study was funded in part by Victoza’s manufacturer, Novo Nordisk. It is well established that, when the manufacture sponsors a trial, it virtually always comes out in favor of the drug. Researchers supported by Big Pharma vehemently deny any bias, but the evidence is clear: bias nearly always gets through.
- There was a concerning rise in pancreatic cancer in participants given Victoza, though it fell just below statistical significance
- The incidence of cholecystitis (gallstone attacks) doubled in participants given Victoza.
- The drug costs around $850 per month, or $10,200 per year. Even if your costs are largely covered by your health insurance or Medicare, we all as a society bear this added extraordinary cost burden.
One thing the researchers and the marketing people for the manufacturer did not do this time, despite Big Pharma having done this many times in past, particularly with statin cholesterol drugs, is trumpet the “relative risk” reduction. The reduction in fatal heart attacks from 0.2 per 100 participants per year to 0.1 would, in past, have been advertised as 50% reduction in heart attack. This time they just make marketing claims without specifying the actual value. Imagine you hired an investment advisor who boasts, because he made 8% on his investors’ money last year compared to another’s 4%, claims that he makes 100% more money for you. Incomprehensible, but the status quo for much of the pharmaceutical literature.
So $10,000 per person per year to reduce heart attack risk by 0.1 in a study paid for by the manufacturer. Sounds like a huge ripoff to me.
Of course, health strategies that dramatically reduce cardiovascular events such as dietary elimination of small, oxidation-prone LDL particles; vitamin D restoration; fish oil supplementation to achieve a RBC omega-3 index of 10%; magnesium supplementation; iodine supplementation with thyroid optimization; and efforts to cultivate bowel flora and thereby reduce inflammation, serum lipopolysaccharide levels, small LDL particles and triglycerides, among other effects, aren’t part of the equation.