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Glaxo - Loading Dose and Maintenance Dose?
As an interesting new viewpoint on the possible recommended dosing schedule, GourmetStyleWellness has recently learned that Glaxo made a slight modification to its Phase III trials as far as dosing goes. It seems the plan, were they to continue, was to administer 2.5mg daily to the trial participants only for the first six months, and then reduce dosage to 0.5mg for the following six months.*
This method is worthy of note for several reasons. First off it implies that Glaxo was apparently planning on giving their subjects six months of a full "loading dose" of 2.5 mg/day, followed by six months of a "maintenance dose" of the standard 0.5 mg/day. This is clearly in contrast to what most of us had assumed would be their protocol: a 2.5 mg/day dose from the start, without later modification.
Any number of reasons could be given for this modified dosing schedule. Some feel that Glaxo saw the best results in the Phase II trials at 2.5mg, but felt a lower dose might maintain the results with fewer side effects after 6 months. Some simply feel that including 2.5 as one of the main doses in the final trials demonstrates Glaxo's comfort with a higher dose, dispelling the concerns related to side effects many people have. Others feel that this shows there is something unique about the drug in that its dose can be reduced over time without losing effectiveness... and still others think that this not only verifies the safety of 2.5, it implies that without that first "kick", 0.5 daily may not be sufficient, or would make results take much longer to appear.
A Key statement from the Phase II trials was:"significant suppression of both serum and scalp DHT was observed with 0.5mg (90% and 50-60% respectively) and 2.5mg (95% and 82% respectively) dutasteride. No drug related serious adverse events were observed in the study, nor were there differences in the incidence of adverse events of special interest relative to placebo at the 0.5mg dose."
They didn't mention what side effects, if any, there were at the 2.5mg dose. Quite likely then 0.5mg is enough to do the job better than finasteride - which depletes serum DHT by around 70%. We recommend that the consumer errs on the side of caution and sticks with 0.5mg from the start. It's probably going to be enough for most men and given the cost of taking 5x the amount, the return is small.
Whatever the case may be, the absence of the final clinical data forbids us from coming to any solid conclusions on the issue. As a result, the question remains: How much should you take? There is no data to answer that question yet, but it is important that the consumer is aware of the potential health risks of taking a drug that does not currently have a published safety, dose, and effectiveness profile for younger hair loss sufferers. Since this drug must be prescribed and used for "off label" purposes, legal recourse in the case of adverse events would not be easy, and in fact may be impossible. On a positive note, many of our users are storming forward with Avodart anyway, and it will be beneficial for the rest of us to see how they respond to it.
http://www.regrowshair.com/non-...-dosing-charts/
So whats you opinion?
As an interesting new viewpoint on the possible recommended dosing schedule, GourmetStyleWellness has recently learned that Glaxo made a slight modification to its Phase III trials as far as dosing goes. It seems the plan, were they to continue, was to administer 2.5mg daily to the trial participants only for the first six months, and then reduce dosage to 0.5mg for the following six months.*
This method is worthy of note for several reasons. First off it implies that Glaxo was apparently planning on giving their subjects six months of a full "loading dose" of 2.5 mg/day, followed by six months of a "maintenance dose" of the standard 0.5 mg/day. This is clearly in contrast to what most of us had assumed would be their protocol: a 2.5 mg/day dose from the start, without later modification.
Any number of reasons could be given for this modified dosing schedule. Some feel that Glaxo saw the best results in the Phase II trials at 2.5mg, but felt a lower dose might maintain the results with fewer side effects after 6 months. Some simply feel that including 2.5 as one of the main doses in the final trials demonstrates Glaxo's comfort with a higher dose, dispelling the concerns related to side effects many people have. Others feel that this shows there is something unique about the drug in that its dose can be reduced over time without losing effectiveness... and still others think that this not only verifies the safety of 2.5, it implies that without that first "kick", 0.5 daily may not be sufficient, or would make results take much longer to appear.
A Key statement from the Phase II trials was:"significant suppression of both serum and scalp DHT was observed with 0.5mg (90% and 50-60% respectively) and 2.5mg (95% and 82% respectively) dutasteride. No drug related serious adverse events were observed in the study, nor were there differences in the incidence of adverse events of special interest relative to placebo at the 0.5mg dose."
They didn't mention what side effects, if any, there were at the 2.5mg dose. Quite likely then 0.5mg is enough to do the job better than finasteride - which depletes serum DHT by around 70%. We recommend that the consumer errs on the side of caution and sticks with 0.5mg from the start. It's probably going to be enough for most men and given the cost of taking 5x the amount, the return is small.
Whatever the case may be, the absence of the final clinical data forbids us from coming to any solid conclusions on the issue. As a result, the question remains: How much should you take? There is no data to answer that question yet, but it is important that the consumer is aware of the potential health risks of taking a drug that does not currently have a published safety, dose, and effectiveness profile for younger hair loss sufferers. Since this drug must be prescribed and used for "off label" purposes, legal recourse in the case of adverse events would not be easy, and in fact may be impossible. On a positive note, many of our users are storming forward with Avodart anyway, and it will be beneficial for the rest of us to see how they respond to it.
http://www.regrowshair.com/non-...-dosing-charts/
So whats you opinion?
