Study: Controlling Risk factors doesn't change health

In recent decades, it has been treated as axiomatic by those doing medical research and those giving medical advice that reducing risk factors for a condition will reduce risk of having the condition, that is if there is a reduction in hypertension, there will be a similar reduction in the likelihood to have a heart attack.

A recent study, the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial was designed to demonstrate the effect of reducing certain risk factors for heart disease in diabetics. The risk factors were high blood sugar, high blood pressure, and high cholesterol levels. The arm of the study focusing on tight control of blood sugar was ended early due to people dying at a rate higher than expected.

The arm of the study which looked at cholesterol level control found that statins worked as expected in changing cholesterol levels, but did not reduce the odds for actually having heart disease. The arm of the study which looked at reducing hypertension found similar results.

Given that the results in this trial demonstrate that a reduction in what has been deemed a risk factor doesn’t translate in reduction in risk, do we need to require drug companies show that drugs influence actual morbidity from a condition and not simply twiddle risk factors before the FDA to approves them to treat a condition? Isn’t irresponsible for professionals to make broad statements based on studies which only demonstrate change to a risk factor, but do not actually demonstrate any change in actual morbidity?

Do you have links to the other “arms” of the study that you refer to, for cholesterol and high blood pressure? The study you link to appears to only be studying “intensive glucose lowering” vs. normal glucose lowering, i.e. to see whether lowering blood glucose (for those patients who already had bad effects from type II diabetes) to a lower level than ordinary therapy would do, would improve their morbidity rate. This intensively lowered blood glucose had unexpected bad effects. But I don’t see that this contradicts current practice, since this was more extreme than current practice. Nor does this seem to be about a new drug.

Without looking at the other studies that you referred to, it appears that you are over-generalizing about the results. I am sure there are lots of problems with the way that drug companies operate and get approvals for new drugs, but this study does not seem to speak to that issue at all.

Full disclosure: I did not read every word of the linked article, rather I skimmed it and read thoroughly the parts that discussed the treatment and its effects; nor do I have a background in medicine or medical research. So I am open to further persuasion or proof.
Roddy

Time has one story on it. Here is a link that covers all three arms.

A study to demonstrate mortality and morbidity would take at least 60 years, since we’re talking about altering the behavior of someone in their 20s and 30s who won’t die until they’re 80.

Roderick Femm is right, I think you’re misinterpreting these studies a bit. There was a standard treatment group and an intensive treatment group. The standard treatment group - in all arms - was receiving meds. The intense treatment group was getting more (and/or higher doses of) meds in addition to other treamtents to reduce their blood glucose, blood pressure, or lipids.

The purpose of the study was to see if lowering the above to the levels a non-diabetic would have would result in fewer CVD, stroke, and heart-related deaths when compared to the standard treatment.

The results of the blood pressure arm showed no difference in CVD events, but the intensive treatment group did have fewer strokes. The results of the cholesterol arm showed no difference between the two groups. The intensive treatment group of the blood glucose arm showed fewer CVD events, however those that did experience a heart attack were more likely to die as a result - much more likely.

It’s unclear what the reason is - could be coicidence, could be those patients who died had an unmeasured, underlying profile that made them more likely to experience a fatal heart attack, could be that lowering blood glucose to that level so quickly compromised their health.

Setting aside the increased risk of death in the blood glucose group, it was still an interesting study. It showed that perhaps reducing, for example, systolic blood pressure below 140 among diabetics (at least through medication), doesn’t provide much of a benefit. Maybe this will allow physicians to better provide treatment options for their patients.