INTERCEPT CONTROL TRIAL, WHAT ELSE !

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Intercept Pharma released its first data’s on their CONTROL Trial results


So, ICPT explain us that statins is lowering LDL levels  and that their CONTROL trial demonstrated it, good news known for years!  it is a success !

But Intercept dont sell statins ! they are promoting OCA and their study show that OCA :

  • is increasing serioulsly LDL levels in a short time 
  • is inducing pruritus for more than 50% of the patients.


So they confirmed in one study the known adverse effects of OCA, LDL increase and prurit.

Regarding the induced LDL level increase ,  ICPT explain that it can be reversed using statins and that a majority of NASH patients ar eligible to statins because of their high cholesterol levels.

it is true , but what is not said is : future NASH patients are mainly, not diagnosed for NASH yet but their physician easely diagnosed high LDL levels and they are already treated with statins.  

Curiously this configuration was totally forgotten in CONTROL design, no data on patients with statins treatment at baseline ?

Thoses patients will increase their LDL levels under OCA and oblige their physicians to increase statin's doses to balance. 

The argued tiny statin dose needed to compense OCA effect presented as an argument by ICPT is definitively not a good argument. 

Regarding the prurit , the rate of patients with prurit at 25 mg is the double as prevously noticed in FLINT,  ( 55% rate is the highest noticed in all studies, the previous highest was 50% noticed for a 40 mg dose in the Japan study)

ICPT announce that the prurit was mild or moderate and that only 2 patients discontinued  because of it,  thereford one can notice that only 67 of the 84 patients completed the study, and that all the discontinuations were in OCA arms, none in the placebo arm ! so, what was the other causes of the discontinuations if not prurit ?

To complete, ICPT announce a death during the trial. 

The annonced cause was a liver and kidney failure. DSMB and physicians do not  link this death to the treatment.

INTERCEPT  say that nothing is sure, to my opinion it only mean that the death was a patient in one of the OCA arms, not placebo.

It is always difficult to comment a death in a study, some patients have advanced disease and multiple pathologies, linking a death to a treatment is not obvious !

Nevertheless one can notice that liver failure under OCA was one of the main risk noticed by FDA in the PBC study and that’s why they limited the dose to 10 mg to reduce the risk. They will surely monitor the causes of this death closely.




NASHBIOTECH COMMENT


CONTROL trial presented as a succes mainly prove the benefit of statins on LDL levels, all physician noticed it for years ! 

It was a study designed to make investors and scientists  at ease on a possible use of statins with OCA to compense OCA main adverse effect.

But the trial was not designed to comply with real world, where patient diagnosed with NASH are already under statins for months when starting a potential OCA treatment.

The trial also confirmed a fast effect of OCA on LDL level increase and an induced pruritus higher than previously noticed. It is a problem for a supposed long term treatment.

To complete, as initiated during the PBC trial, liver failure under OCA should be monitored seriously.

It is not sure that investors will be at ease as ICPT imagine.




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