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No evidence given for claim that statins are beneficial for patients with chronic liver disease

Statins May Provide Treatment Alternative for Chronic Liver Disease

Our Review Summary

This release from the American Physiological Society summarizes a review of 50 studies on the effects of statins on liver function. The release suggests that statins may be a good treatment for chronic liver disease. However, the release doesn’t explain that the review article’s focus is on the basic biological effects of statins, not actual outcomes following statin treatment for people with advanced liver disease.

The potential benefits named in this release overshadow the very real and important harms statins have on the body, including the liver.

 

Why This Matters

Outside of transplantation, there are few treatments for end-stage liver disease so if a simple, inexpensive, well-tolerated and highly prescribed drug class such as statins can prevent progression towards liver failure, this would be a true medical advance.

The release suggests that statins, which have mostly been studied for their effects on prevention of cardiovascular diseases, may also reduce inflammation, fibrosis, and otherwise improve chronic liver diseases. There are ongoing concerns about the adverse effects of statins, however, including their potential risk for increasing liver failure, and so this review attempts to address, specifically that literature.

Even if there appear to be explanations for the physical effects of statins on liver disease, it remains an open question if all the other related adverse effects not mentioned in this article (including muscle-weakening and breakdown as well as cognitive difficulties) make them a worthwhile preventative treatment.

Most studies of statins and liver disease consider whether statins cause side effects rather than benefit. A large amount of data suggests that statins do cause liver inflammation but that the risks are relatively small. However, most doctors wouldn’t consider using statins to treat liver disease, especially those with advanced liver failure.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There is no information about the cost of statin therapy. This class of medicines includes a number of generic formulations that are relatively inexpensive. The release refers to statins as cost-effective. This reference to cost probably refers to their use for preventing heart disease. Whether these agents are cost-effective for treating liver disease is unknown.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Multiple benefits are mentioned, as well as what may take place biologically in the body when taking stains, but there are no numbers illustrating an advantage for such treatment. A measurement of the benefit would only come from high quality randomized trials. What may take place biologically in the body when taking statins is not an adequate substitute for trials that show an actual cause and effect.

If statins can reduce inflammation in chronic liver disease one has to ask:  Do the statin patients live any longer? If there is no observable benefit on quality or quantity of life, does statin therapy make any sense?

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The researchers acknowledge that statin drugs can contribute to liver damage in some people, but the statement that “statins are cost-effective, generally well-tolerated by patients and the benefits of statin treatment in most patients outweigh their potential hepatotoxic risk,” doesn’t seem to adequately address the potential harms.

People who are prescribed statins must undergo liver function tests since this class of drugs can cause rare but serious liver dysfunction. Deciding to give someone with advanced liver disease a statin as a means to help the patient’s liver is unproven and has the potential for real harm.

We aren’t provided any context on how significant the damage can be to those with advanced liver disease, or even in otherwise healthy people.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

Review articles involve an extensive literature search to identify pertinent studies on a specific topic. The collected research is then reviewed, assessed for quality, and the results summarized according to question the review hopes to answer. Many review articles are of very high quality but they are not the gold standard of evidence like randomized controlled trials. It would have been good if the release included this in a discussion of the limitations of the research.

The release focuses on underlying physiologic mechanisms or processes described in the articles reviewed that could be beneficial in patients with underlying liver disease due to inflammation from a variety of causes. However, the release doesn’t explain the transition from basic biology to clinical application. What data exists to support this basic biology? What types of studies were included in the review — were they randomized controlled trials, observational studies or case studies? Different types of studies yield different degrees of reliable evidence. Is the data sufficient to warrant treatment recommendations? If clinical studies are needed, what specifically will be tested? Answering these questions would help put the evidence into context that would be meaningful for readers.

Does the news release commit disease-mongering?

Not Applicable

Chronic liver disease is serious and there is no evidence of disease mongering here. Some context about the disease would have been useful for readers.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

Since this was based on a review article we don’t require a named funding source to rate this satisfactory. Nor do we have any evidence that the authors have any conflicts of interest. If there was, we would expect the news release to include them.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

Other than the mention of organ transplantation, there was no mention of other treatments or preventative measures to prevent liver failure.

For a number of liver conditions, there are specific treatments. Whether statins are effective and how they compare to existing treatments is an unanswered question.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Applicable

It’s pretty obvious that statins are everywhere in America.

Does the news release establish the true novelty of the approach?

Satisfactory

The concept of using statins to treat underlying liver disease as part of routine clinical care would be considered novel.  The study’s novelty (as well as its limitations) could have been described with more clarity.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

There are no notable examples of unjustifiable language here.

Total Score: 3 of 8 Satisfactory

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