We all know how bad high cholesterol is for us, right? We know this because universities and drug companies throughout the world have carried out clinical trials over the years which have demonstrated decreased incidence of stroke and heart attack in people who have maintained their cholesterol under control. Several of these trials have compared people who are taking cholesterol-lowering statin drugs with people not taking statin drugs. In some cases, the results have been better than anticipated. A long term study of one of those trials produced some very surprising results, and was recently published in the European Heart Journal by Peter Sever and colleagues.
The ASCOT (Anglo-Scandinavian Cardiac Outcomes Trial) trials were started more than 11 years ago in the UK and was very successful. This part of the trial involved 10,297 patients with hypertension and high cholesterol levels. The objective of the ASCOT was to test whether those patients given the cholesterol-lowering drug atorvastatin (a.k.a. Lipitor) suffered significantly less heart attacks and strokes compared to those receiving the placebo treatment. The trial was terminated early (after 3 years) because there was a significantly higher incidence of non-fatal heart attack and stroke in the control group compared with the those treated with statins (36% relative risk reduction). Due to the clear benefit of statin treatment, the trial coordinators permitted any patient in either group to elect statin treatment, and continued to monitor them. 2 years later, even though most of the patients originally receiving placebo had switched to statins, the incidence of and the reasons for death remained relatively unchanged. In other words, statin treatment didn’t seem to provide any benefit for the patients who hadn’t taken them for the first 3 years. At this point, the majority of the trial participants were on statin cholesterol medication, and they were further monitored for another 6 years.
At the end of the study in 2010, a major analysis was conducted and the real surprise was discovered. Even though many of the patients initially in the placebo group had subsequently started taking statins and had been doing so for more than 7 years, deaths from any cause remained significantly lower in those originally assigned atorvastatin (520 patients that died who were initially on placebo vs. 460 patients that died who were on atorvastatin from the start). However, the real surprise was that the reason for those extra deaths in the group initially on placebo was not related to heart disease. Non-cardiovascular deaths were found to be significantly lower in those originally assigned atorvastatin during the initial 3 years of the trial. It wasn’t deaths from heart disease (though such deaths were fewer), and it wasn’t deaths from cancer that the statins prevented. Instead the cholesterol lowering statin drug atorvastatin prevented a significant number of deaths due to infection and respiratory illness.
This has given the drug company Pfizer (who sponsored the study) a pleasant surprise. Particularly in relation to people who have not suffered a previous heart attack or stroke, there has been a considerable amount of discussion in the newspapers and the scientific literature about whether these cholesterol-lowering statin drugs are as valuable as believed, whether their undesirable side-effects which some people experience (including muscle pain and weakness, memory loss, liver damage, and digestive problems, among others) are worth the benefit, and whether statins are value-for-money rather than an unjustifiable drain on public health systems. Pfizer might have anticipated some life saving benefit from years of treatment with Lipitor, but it was surely unexpected for the Pfizer-funded researchers to find significant life-saving effects, but only for those initially in the treatment group (not those who were on placebo for the first 3 years) and only for deaths associated with infection and respiratory illness.
The study has its skeptics, of course. Many people think that because the study was not initially designed to test for non-cardiovascular effects, it should not be trusted and a new trial should be designed. Others are highly suspicious of any study supported by a drug company. Still others insist that because there is not yet a scientific explanation for the unexpected findings, then the study results should be taken with a grain of salt. In any case, the results do appear to be valid and statistically significant. It is a promising outcome for millions of people worldwide, many of whom are either knowingly or unknowingly tolerating muscle pain, weakness, and digestive problems, in addition to risking other asymptomatic side-effects such as memory loss and liver damage, in the hopes that statin cholesterol medications will help them live longer.
Reversing The Already Done Cholesterol Damage to Arteries
Statins cholesterol drugs are well known to lower “bad” LDL cholesterol levels in the blood and thereby keep our arteries healthy by slowing the formation and build-up of cholesterol “plaque”. Though some may question the benefits of statin drugs vs. the side-effects of statin drugs (for example, muscle pain and weakness), there is no doubt that statins offer an important therapy for prevention of artery damage that may lead to heart attacks.
They say an ounce of prevention is worth a pound of cure, but what if your arteries are clogged up with cholesterol plaque already? Statins might help your condition not to get worse, but is there any way to get better? Can existing cholesterol plaques in your arteries actually be reversed? If one bold biotech company called AtheroNova has its way, there may soon be a new drug available that reverses artery damage caused by cholesterol plaques. And the best part is that the drug is based upon the fat-busting action of a natural substance called “bile” which is already in our bodies!
California-based and Russian-connected AtheroNova is poised to conduct clinical trials to show that its new bile-like drug can dissolve cholesterol build-up in the arteries. Bile is normally present in our digestive system (but not in the blood circulation), and its job is to help break down fats so they can be absorbed as nutrients into the body. The clever idea behind AtheroNova is to put a bile drug to work in the blood circulation, perhaps even via convenient skin-patch. Then the bile drug can do its fat-busting thing on cholesterol plaque which is a kind of fatty build-up. Once the bile drug breaks up the plaque, the dissolved cholesterol is to be carried away in the blood stream, and presumably converted to other useful substances (instead of just circulating in the blood and reforming new plaques). AtheroNova is basically aiming to wash out our greasy pipes with detergent!
Well, so much for the theory, it is now time for AtheroNova to show us the data that their new bile-based drug is both safe and effective in clinical trials. If it works, bile drug sales will dwarf those of the biggest sellers in history, including the statins and Viagra. AtheroNova may be on the brink of delivering a major new therapy to combat the number one killer of our time. This is cause for great hope and excitement, but let’s not all breathe a collective sigh of relief, forget about exercise, and eat pizza while sitting on the couch all day. Plaque purging patches won’t be available for a while, and when it comes to heart health an ounce of prevention will always be worth a pound of cure.
Statin Drugs Helps Against Prostate Cancer
Several lines of evidence in recent years have pointed toward the possibility that statin cholesterol drugs may reduce the risk of prostate cancer. Indeed, two new studies by researchers at the US National Cancer Institute and the Cleveland Clinic, respectively, in the Cancer Causes and Control journal and the Journal of Urology. The studies showed that high cholesterol is associated with not only increased incidence of prostate cancer, but also the increased incidence of the aggressive form of the disease. Furthermore, men taking statin drugs were less likely to be diagnosed with prostate cancer, less likely to to have the aggressive form, and less likely to have prostate enlargement.
Just a couple weeks ago we read in the European Heart Journal about the long term follow-up of the ASCOT study, and that statins significantly reduced the number of deaths by about 3%. Surprisingly the extra deaths in the placebo treated group were not due to heart disease, and they we not due to cancer. Instead the statins were protective against infection and respiratory illness. On the surface, these ASCOT results appear inconsistent with the idea that statins may protect against prostate cancer. It serves to illustrate how carefully these studies must be designed and interpreted. In any case, it is encouraging that statin drugs taken on a chronic basis by so many people (and not without potential side-effects including muscle pain, memory loss, digestive problems, and asymptomatic liver damage), are being shown to actually save lives one way or another.