NOTE TO READERS: When this project lost substantial funding at the end of 2018, I lost the ability to continue publishing criteria-driven news story reviews and PR news release reviews - once the bread-and-butter of the site going back to 2006. The 3,200 archived reviews, while still educational, are getting old and difficult for me to technically maintain on the back end of the website. So I am announcing that I plan to remove these reviews from the site by April 1, 2021. The blog and the toolkit - two of the most popular features on the site - will remain. If you wish to peruse the reviews before they disappear, please do so by the end of March 2021. After that date you may still be able to access them via the Internet Archive Wayback Machine - https://archive.org/web/.

Niacin news provides another example of how surrogate outcomes don’t tell whole story

In his weekly journal review, Dr. Richard Lehman points out another classic example of how you can’t jump to conclusions just because a drug has an impact on a surrogate outcome.  It’s the big stuff we should focus on – not the surrogates.  He writes:

Niacin is an abundant natural B vitamin, which lowers bad cholesterol and raises good cholesterol. What’s not to like? Well, niacin, unfortunately. In doses that make any difference to lipid levels, it is very likely to make you feel sick, get flushes and/or rashes, and/or feel muscle pains. So Merck decided to market it in combination with laropripant, a prostaglandin antagonist that is meant to combat its unpleasant effects. Even so, a third of people who were recruited to the present trial could not continue past the run-in phase with the active combination. And now that the full results are out, we have confirmation that this dual agent definitely does not offer any cardioprotection despite its “favourable” effect on lipids. Worse still it causes bleeding, raises blood sugar, and shows a tendency to increase mortality in those who can tolerate taking it for three years. The Clinical Trials Support Unit (CTSU) at Oxford did a great job of running this trial with funding from Merck, following its usual rules of independence. In doing so, it provides a great illustration of the fact that lipid fractions are very unreliable surrogates for cardiovascular outcomes. But we knew that already, and it seems a great pity to me that many superb researchers were tied down for so long on a project that has made such a small contribution to clinical knowledge, whatever it may have contributed to the funds of CTSU.

More on the limitations of surrogate endpoints elsewhere on this website.

———————

Follow us on Twitter:

https://twitter.com/garyschwitzer

https://twitter.com/healthnewsrevu

and on Facebook.

 

You might also like

Comments

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.

Comments are closed.