“If as a hypothetical, the drug is inactive itself, but blocks an enzyme responsible for metabolizing donepezil, and donepezil levels rise and cause improvement, then one can’t say that the drug in question is effective. One can’t even say that the ‘combination’ is effective. Would you take a drug that may have side effects such as liver toxicity and others, just so it can block an enzyme to raise the level of another drug, and especially when several marketed drugs may do the same? What would likely happen if the drug group showed advantageous effects in these STAR trials is that sensitivity analyses would be done to help assess whether the drug also had an effect or what the contribution of donepezil levels was to the effect.”
Dr. Atri is on advisory board for several pharmaceutical companies, but has no financial ties with Lundbeck or Otsuka. Dr. Schneider has financial relationships with a number of pharmaceutical companies.
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