Denufasol vs VX potentiator (VX-770?)

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Jeana</b></i>

Okay, it appears to me by looking at other studies that 20 mL is about 1%. So, it appears that those on Denufosol had an FEV1 increase of about 6% after 48 weeks. The only thing that worries me is that if I get the placebo, since you aren't allowed to be on hypertonic that my lung function may decrease in the first year without hypertonic or Denufosol. The second year I would get to be on Denufosol for sure though...</end quote></div>


First: it depends on what you're expected FEV1 is as to how you calculate the %, which is why this study doesn't quote improvement in %. Some very tall men have high expected FEV1's, where are shorter women have smaller expected FEV1. To make it apples to apples, you quote in absolute millileter improvement, not %.

You are right about having to stop HTS... it's a concern. The other concern is that you don't know all the side effects of any VX drug - whereas you do know side effects of Denufosol from Tiger I (300+ patients).

So there are benefits and drawbacks of both.

Again I think what's really important is that you're getting involved. You have a choice between 2 great meds which is very exciting and by enrolling you're helping the entire CF population. <img src="i/expressions/face-icon-small-smile.gif" border="0">

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Jeana</b></i>

Okay, it appears to me by looking at other studies that 20 mL is about 1%. So, it appears that those on Denufosol had an FEV1 increase of about 6% after 48 weeks. The only thing that worries me is that if I get the placebo, since you aren't allowed to be on hypertonic that my lung function may decrease in the first year without hypertonic or Denufosol. The second year I would get to be on Denufosol for sure though...</end quote></div>


First: it depends on what you're expected FEV1 is as to how you calculate the %, which is why this study doesn't quote improvement in %. Some very tall men have high expected FEV1's, where are shorter women have smaller expected FEV1. To make it apples to apples, you quote in absolute millileter improvement, not %.

You are right about having to stop HTS... it's a concern. The other concern is that you don't know all the side effects of any VX drug - whereas you do know side effects of Denufosol from Tiger I (300+ patients).

So there are benefits and drawbacks of both.

Again I think what's really important is that you're getting involved. You have a choice between 2 great meds which is very exciting and by enrolling you're helping the entire CF population. <img src="i/expressions/face-icon-small-smile.gif" border="0">

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Jeana</b></i>

Okay, it appears to me by looking at other studies that 20 mL is about 1%. So, it appears that those on Denufosol had an FEV1 increase of about 6% after 48 weeks. The only thing that worries me is that if I get the placebo, since you aren't allowed to be on hypertonic that my lung function may decrease in the first year without hypertonic or Denufosol. The second year I would get to be on Denufosol for sure though...</end quote></div>


First: it depends on what you're expected FEV1 is as to how you calculate the %, which is why this study doesn't quote improvement in %. Some very tall men have high expected FEV1's, where are shorter women have smaller expected FEV1. To make it apples to apples, you quote in absolute millileter improvement, not %.

You are right about having to stop HTS... it's a concern. The other concern is that you don't know all the side effects of any VX drug - whereas you do know side effects of Denufosol from Tiger I (300+ patients).

So there are benefits and drawbacks of both.

Again I think what's really important is that you're getting involved. You have a choice between 2 great meds which is very exciting and by enrolling you're helping the entire CF population. <img src="i/expressions/face-icon-small-smile.gif" border="0">

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Jeana</b></i>

Okay, it appears to me by looking at other studies that 20 mL is about 1%. So, it appears that those on Denufosol had an FEV1 increase of about 6% after 48 weeks. The only thing that worries me is that if I get the placebo, since you aren't allowed to be on hypertonic that my lung function may decrease in the first year without hypertonic or Denufosol. The second year I would get to be on Denufosol for sure though...</end quote>


First: it depends on what you're expected FEV1 is as to how you calculate the %, which is why this study doesn't quote improvement in %. Some very tall men have high expected FEV1's, where are shorter women have smaller expected FEV1. To make it apples to apples, you quote in absolute millileter improvement, not %.

You are right about having to stop HTS... it's a concern. The other concern is that you don't know all the side effects of any VX drug - whereas you do know side effects of Denufosol from Tiger I (300+ patients).

So there are benefits and drawbacks of both.

Again I think what's really important is that you're getting involved. You have a choice between 2 great meds which is very exciting and by enrolling you're helping the entire CF population. <img src="i/expressions/face-icon-small-smile.gif" border="0">

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Jeana</b></i>
<br />
<br />Okay, it appears to me by looking at other studies that 20 mL is about 1%. So, it appears that those on Denufosol had an FEV1 increase of about 6% after 48 weeks. The only thing that worries me is that if I get the placebo, since you aren't allowed to be on hypertonic that my lung function may decrease in the first year without hypertonic or Denufosol. The second year I would get to be on Denufosol for sure though...</end quote>
<br />
<br />
<br />First: it depends on what you're expected FEV1 is as to how you calculate the %, which is why this study doesn't quote improvement in %. Some very tall men have high expected FEV1's, where are shorter women have smaller expected FEV1. To make it apples to apples, you quote in absolute millileter improvement, not %.
<br />
<br />You are right about having to stop HTS... it's a concern. The other concern is that you don't know all the side effects of any VX drug - whereas you do know side effects of Denufosol from Tiger I (300+ patients).
<br />
<br />So there are benefits and drawbacks of both.
<br />
<br />Again I think what's really important is that you're getting involved. You have a choice between 2 great meds which is very exciting and by enrolling you're helping the entire CF population. <img src="i/expressions/face-icon-small-smile.gif" border="0">

 

[Jeana]

My clinic has been offered the opportunity to do the VX-770 but not the VX-809. I'm leaning towards the Denufosol study, with the my biggest hesitation being that I don't want to lose any of my FEV1 that I worked so hard to gain since pregnancy, since I won't be able to do hypertonic. Although I have not been as compliant with the hypertonic any. It's the one I haven't always been making time for.

On a different note, I just received a thing for jury duty. If they call me while I am on a drug study and would have to miss my required appointment to do jury duty could I get a doctor's note to excuse me? I would be willing to serve jury duty, but not at the expense of being kicked off of a drug study.

 

[Jeana]

My clinic has been offered the opportunity to do the VX-770 but not the VX-809. I'm leaning towards the Denufosol study, with the my biggest hesitation being that I don't want to lose any of my FEV1 that I worked so hard to gain since pregnancy, since I won't be able to do hypertonic. Although I have not been as compliant with the hypertonic any. It's the one I haven't always been making time for.

On a different note, I just received a thing for jury duty. If they call me while I am on a drug study and would have to miss my required appointment to do jury duty could I get a doctor's note to excuse me? I would be willing to serve jury duty, but not at the expense of being kicked off of a drug study.

 

[Jeana]

My clinic has been offered the opportunity to do the VX-770 but not the VX-809. I'm leaning towards the Denufosol study, with the my biggest hesitation being that I don't want to lose any of my FEV1 that I worked so hard to gain since pregnancy, since I won't be able to do hypertonic. Although I have not been as compliant with the hypertonic any. It's the one I haven't always been making time for.

On a different note, I just received a thing for jury duty. If they call me while I am on a drug study and would have to miss my required appointment to do jury duty could I get a doctor's note to excuse me? I would be willing to serve jury duty, but not at the expense of being kicked off of a drug study.

 

[Jeana]

My clinic has been offered the opportunity to do the VX-770 but not the VX-809. I'm leaning towards the Denufosol study, with the my biggest hesitation being that I don't want to lose any of my FEV1 that I worked so hard to gain since pregnancy, since I won't be able to do hypertonic. Although I have not been as compliant with the hypertonic any. It's the one I haven't always been making time for.

On a different note, I just received a thing for jury duty. If they call me while I am on a drug study and would have to miss my required appointment to do jury duty could I get a doctor's note to excuse me? I would be willing to serve jury duty, but not at the expense of being kicked off of a drug study.

 

[Jeana]

My clinic has been offered the opportunity to do the VX-770 but not the VX-809. I'm leaning towards the Denufosol study, with the my biggest hesitation being that I don't want to lose any of my FEV1 that I worked so hard to gain since pregnancy, since I won't be able to do hypertonic. Although I have not been as compliant with the hypertonic any. It's the one I haven't always been making time for.
<br />
<br />On a different note, I just received a thing for jury duty. If they call me while I am on a drug study and would have to miss my required appointment to do jury duty could I get a doctor's note to excuse me? I would be willing to serve jury duty, but not at the expense of being kicked off of a drug study.

 

[Jeana]

Saveferris,
I know that saying 20 mL is about 1% isn't going to be completely accurate. I was looking at a women's study (on smokers) to kind of help me know the comparison. So, I guess it's a little more accurate than looking at a men's study.

I would think that the company could easily quote average percent increase based on the actual participants in the study, since they know their pre, during and post FEV1s. Most drug studies seem to quote the percent.

 

[Jeana]

Saveferris,
I know that saying 20 mL is about 1% isn't going to be completely accurate. I was looking at a women's study (on smokers) to kind of help me know the comparison. So, I guess it's a little more accurate than looking at a men's study.

I would think that the company could easily quote average percent increase based on the actual participants in the study, since they know their pre, during and post FEV1s. Most drug studies seem to quote the percent.

 

[Jeana]

Saveferris,
I know that saying 20 mL is about 1% isn't going to be completely accurate. I was looking at a women's study (on smokers) to kind of help me know the comparison. So, I guess it's a little more accurate than looking at a men's study.

I would think that the company could easily quote average percent increase based on the actual participants in the study, since they know their pre, during and post FEV1s. Most drug studies seem to quote the percent.

 

[Jeana]

Saveferris,
I know that saying 20 mL is about 1% isn't going to be completely accurate. I was looking at a women's study (on smokers) to kind of help me know the comparison. So, I guess it's a little more accurate than looking at a men's study.

I would think that the company could easily quote average percent increase based on the actual participants in the study, since they know their pre, during and post FEV1s. Most drug studies seem to quote the percent.

 

[Jeana]

Saveferris,
<br />I know that saying 20 mL is about 1% isn't going to be completely accurate. I was looking at a women's study (on smokers) to kind of help me know the comparison. So, I guess it's a little more accurate than looking at a men's study.
<br />
<br />I would think that the company could easily quote average percent increase based on the actual participants in the study, since they know their pre, during and post FEV1s. Most drug studies seem to quote the percent.

 

[SEANP]

I would do the Denufosol. My son did it about a year ago. The only draw back is that it is 3x a day (at least it was when he did it) and like was mentioned above, it is much closer to approval. The VX trial does sound promising though and I think in the end if it pans out, more beneficial, but much less is known about side effects at this point.

 

[SEANP]

I would do the Denufosol. My son did it about a year ago. The only draw back is that it is 3x a day (at least it was when he did it) and like was mentioned above, it is much closer to approval. The VX trial does sound promising though and I think in the end if it pans out, more beneficial, but much less is known about side effects at this point.

 

[SEANP]

I would do the Denufosol. My son did it about a year ago. The only draw back is that it is 3x a day (at least it was when he did it) and like was mentioned above, it is much closer to approval. The VX trial does sound promising though and I think in the end if it pans out, more beneficial, but much less is known about side effects at this point.

 

[SEANP]

I would do the Denufosol. My son did it about a year ago. The only draw back is that it is 3x a day (at least it was when he did it) and like was mentioned above, it is much closer to approval. The VX trial does sound promising though and I think in the end if it pans out, more beneficial, but much less is known about side effects at this point.

 

[SEANP]

I would do the Denufosol. My son did it about a year ago. The only draw back is that it is 3x a day (at least it was when he did it) and like was mentioned above, it is much closer to approval. The VX trial does sound promising though and I think in the end if it pans out, more beneficial, but much less is known about side effects at this point.