Daliresp (roflumilast)

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spacecowgirl

spacecowgirl

in the bee-loud glade
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Since we apparently we don't have enough clinical discussions here. I haven't seen any of this yet (I work very PRN retail) but it did see it discussed in a d/c plan for a hospitalized patient with multiple respiratory-related hospitalizations (but no spirometry, not sure she even has COPD). There was a rep at a COPD conference I went to earlier this year, that was the first I had even heard of it. I wasn't too impressed by the clinical outcomes data - mishmash of COPD severities, mishmash of concomitant meds (some not even the standard of practice).

Have you seen it? If you have, do you know the monthly cost? What do you think of it clinically?
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spacecowgirl said:
Since we apparently we don't have enough clinical discussions here. I haven't seen any of this yet (I work very PRN retail) but it did see it discussed in a d/c plan for a hospitalized patient with multiple respiratory-related hospitalizations (but no spirometry, not sure she even has COPD). There was a rep at a COPD conference I went to earlier this year, that was the first I had even heard of it. I wasn't too impressed by the clinical outcomes data - mishmash of COPD severities, mishmash of concomitant meds (some not even the standard of practice).

Have you seen it? If you have, do you know the monthly cost? What do you think of it clinically?
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I've seen it only once in retail. I'm not sure what the cost was since it was just going on the shelf and the patient was not there yet
 
it's ungodly expensive, with a very limited utility, and the whole approval process was hinky as well. this isn't a drug that shouldnt be used much at all at this point.

out of my COPD pts, the only one I've got on it came to me already on it.
 
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crazybob said:
I've seen it only once in retail. I'm not sure what the cost was since it was just going on the shelf and the patient was not there yet
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Student! What do the trials say? We're having a clinical discussion. :meanie:
 
We had one patient on it, they needed a PA, and it was expensive. They took it for 2 days and developed "terrible, screaming headaches." Pure anecdotal evidence here, so don't read much into it, but 0/1 doesn't look good for now.

Additionally, nearly 10% of pts get diarrhea, and about 8% have weight loss which are both interesting. Clearly we're getting a load of systemic effect, when we'd much rather target only the lungs. I guess in the grand scheme these aren't terrible side effects (QT a mile long, agranulocytosis, TTP), but they're probably bothersome enough that pts wouldn't take it. Weight loss might be a good thing in some patients, although a lot of my COPDers are frail little old ladies.
 
I don't know anything about it but it has a sweet name!

Roflcopter.gif
 
Roflumilast is new drug, only reserved for severe COPD. Common sxms are diarrea, nausea. But depression, suicidal idea side effect is more of a concern.
 
This is why we don't have these threads. 🙄
 
All4MyDaughter said:
RAWR!!!!!!!!!! 😀 hehe
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Hormones.

Seriously though. I hear people complaining how we don't have any meaningful clinical discussions and then npage comes in here and draws a helicopter. Apparently the job shortage threads and the PharmD vs MD/DO/PA/NP/PHD/STD are the only ones people will post in.
 
spacecowgirl said:
Hormones.

Seriously though. I hear people complaining how we don't have any meaningful clinical discussions and then npage comes in here and draws a helicopter. Apparently the job shortage threads and the PharmD vs MD/DO/PA/NP/PHD/STD are the only ones people will post in.
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Cool thread. I have never seen this drug and what info I found on it does not excite me to look further into it.

On the other hand, it is also a very cool rotfcopter, so I am torn about wither or not it means we can't have clinical discussions. :laugh:
 
I just got back from the ACCP conference which had a few abstracts presented on this drug. There was a cost-benefit analysis showing that it was slightly more cost-effective globally than tiotropium, however, this did not include an analysis of the main quality-of-life measures, just (slight) reduction in number of exacerbations.

What is lacking for this drug, however, is information on its benefit in patients already optimized on therapy with anticholinergics, LABAs and ICS. We have add-on trials showing a slight reduction in frequency of COPD exacerbations in patients with chronic-bronchitis predominant COPD. I don't think anyone would think of using this drug in a patient without medically optimized treatment, due to significant wallet toxicity and lack of substantial objective benefits (i.e., improvement in SGRQ or FEV1).

I've seen it used a few times in patients with end-stage COPD awaiting lung transplantation. I would preferentially use it over theophylline due to a much more favorable side-effect/tolerability profile, but these patients are few and far between depending on where you practice. The theory behind the drug is great, but needs to be borne out through a lot more basic science research before it will enjoy widespread use.
 
Praziquantel86 said:
What is lacking for this drug, however, is information on its benefit in patients already optimized on therapy with anticholinergics, LABAs and ICS. We have add-on trials showing a slight reduction in frequency of COPD exacerbations in patients with chronic-bronchitis predominant COPD. I don't think anyone would think of using this drug in a patient without medically optimized treatment, due to significant wallet toxicity and lack of substantial objective benefits (i.e., improvement in SGRQ or FEV1).
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That's exactly it. The people I would want to use it for - those maxed out on all therapy - it hasn't been tested for that use.

I agree that the theory is great, it would be nice to have a new MOA for treatment but this doesn't really seem to add much value.

Someone needs to invent a better delivery mechanism for inhaled meds. My pulm rehab people get so confused by all the different inhalers and if you only get 18% of the dose with optimal technique, most people are getting a lot less than that.
 
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