Saturday, August 30, 2014

The PARADIGM-HF study; a new use for valsartan?

What does a drug company, facing a patent expiration, do? One option is the forced switch [see IPBiz post:
CBS News on August 28 covers "forced switch" related to drug Namenda ] Another option is to find a new use. In the post 3 Questions That Remain After Novartis' Blockbuster Trial Result , Forbes talks about a new use for the now-patent expired valsartan (Diovan):

The release of PARADIGM-HF trial, with its stunning results for Novartis’ combination drug, is good news for patients with heart failure and their doctors. The trial was ended early because the combination drug, which included sacubitril (an experimental drug) and valsartan (a current therapy), demonstrated superiority over enalapril (another current therapy).

The first issue/question raised by Forbes:

Heart failure is primarily a condition that affects the elderly. In PARADIGM-HF the average age was 64 years old, considerably younger than the typical patient with heart failure. The study also excluded patients with decreased kidney function. This situation is not unlike what we have seen in other trials of heart failure, including those that are the foundation for what is now considered standard therapy.

The actual question:

What will we do to ensure that once the drug is approved, that the learning about it does not stop?

The third issue related to data analysis:

The published article states that the sponsor, Novartis, collected, managed, and analyzed the data. The article states that the analysis followed a pre-specified plan and that an independent academic statistician replicated the analyses. However, it is not clear whether that person had access to all the raw data and forms and to what extent the statistician could assess what was done by the company.

The Forbes post did not mention the previous heart attack issue; from wikipedia:

Whether angiotensin receptor blockers may or may not increase the risk of myocardial infarction (heart attack) was announced in BMJ[6] and was debated in 2006 in the medical journal of the American Heart Association.[7][8] To date[when?], there is no consensus on whether ARBs have a tendency to increase MI, but there is also no substantive evidence to indicate that ARBs are able to reduce MI.


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