Not sure if this answers your question or addresses your concern - but what is known is that the trial excluded patients with a prior history of bleeding or on anticoagulant or other "blood thinning" treatment.
As listed on ANZCTR website....
![https://hotcopper.com.au/data/attachments/1502/1502494-a89ecc574421851c9452c286d584227d.jpg](https://hotcopper.com.au/data/attachments/1502/1502494-a89ecc574421851c9452c286d584227d.jpg)
Three things come to mind for me here.
1. Clinical trials often include much healthier patients than in the 'general' population. So these types of exclusion criteria are not of any particular concern to me at all. PPS is known to be an anticoagulant - and if you're trying to work out if it 'works' - you establish that in a population of patients where other factors such as safety issues don't "get in the way" of answering the primary question before you start working out how useful and safe it might be in some 'at risk' patient groups
2. This is only a Phase 2b trial - basically setting out to confirm clinical efficacy of a drug and determine the therapeutic dose range. As we know - PPS basically had a major win with the primary outcome - and while the market seemed to be, at times and in parts, a bit confused as to the 'significance' of the result - the passage of time has reinforced just how unambiguous the success was. But - it was never designed to determine which patients were best suited to being treated with PPS - that comes later.
3. While older patients are more prone to OA and bleeding events - it may well be that PPS is either contraindicated - or has to be used with caution - in these groups. Again - not a question that has been answered through decent research. But - in my opinion it wouldn't undermine the commercial opportunity in terms of market share - even if it does limit the unit sale potential. Basically NSAIDs - also used for OA - cannot or should only be used with caution (and for short periods) in elderly patients as.....they cause bleeding problems...apart from not working well and causing kidney issues. And the other option - opioid analgesics - are also to be used in elderly patients with great caution due to sedation / confusion etc - all of which can contribute to the risk of falls and the consequences thereof. So PPS is not going to be at a competitive disadvantage - and physicians will already be prone to considering bleeding risk in these patients regardless of the treatment they adopt.
So - in short - I'm not aware of any clear guidance on the suitability of PPS for elderly patients excluded. The current trial excluded these patients - so won't provide direction either. And my personal view is that this should not impact on the clinical 'value' of PPS as (potentially) a real breakthrough treatment for OA - and is unlikely to have a major 'headline' impact on commercial potential.
And finally...bear in mind PPS is a repurposed drug - so the safety profile has been very well established - and over a very long time. This puts it way ahead of much newer classes of treatment such as stem cell therapy, biologics and immunotherapy - even it may, at times, seem a little less 'leading edge'.
DYOR - my opinions only - etc etc...and let's hope for results tomorrow rather than Monday!