g*e
2 楼
Correction: 明天我是指下周一。
【在 g****e 的大作中提到】
: 今天买今天出。个人建议不要玩这么刺激的，虽然我看好。
【在 g****e 的大作中提到】
: 今天买今天出。个人建议不要玩这么刺激的，虽然我看好。
i*y
3 楼
你到底明天买还是今天买?明天不会halt吗?
把句法改完了再发.
【在 g****e 的大作中提到】
: 今天买今天出。个人建议不要玩这么刺激的，虽然我看好。
把句法改完了再发.
【在 g****e 的大作中提到】
: 今天买今天出。个人建议不要玩这么刺激的，虽然我看好。
g*e
4 楼
我不玩它，就看热闹和灌水。
V*2
6 楼
You can and should read Blank's entire Northera review. Here are key,
summary excerpts:
In summary, in support of approval, there is one trial (Study 301) that is
strongly supportive of efficacy of droxidopa and contains many of the
attributes of a single trial that might stand alone to support efficacy:
large and multicenter trial, improvement on multiple ordered endpoints
including OHSA Item 1, OHQ and systolic blood pressure, and statistically
very persuasive findings. From a post-hoc analysis of the cumulative
distribution bin analysis of Study 301, there was a much larger group of
patients that had a greater level of improvement (improvement of ≥4 points
on the OHQ) on droxidopa than on placebo. Study 302, the OHQ hypothesis
generating study for Study 301, might be considered supportive of efficacy
if one considered OHQ to be a valid endpoint.
The primary reason to not recommend approval is the lack of sufficient
evidence of efficacy. There is only one successful trial and it is well
known that random factors can cause erroneous clinical trial outcomes.
Patients with symptomatic neurogenic orthostatic hypotension are vulnerable
and it is important to ensure their safety by protecting them from exposure
to drugs that may not be effective, particularly drugs that have a
theoretical basis for causing cardiovascular safety issues, as this drug has
. Additionally, the lack of evidence of durability is particularly
concerning. Patients should not be exposed to a drug chronically unless
benefit is established over a reasonable amount of time - at least three
months. It is possible that there is a down regulation of NE receptors in
the peripheral circulation after prolonged exposure to droxidopa. If this is
the case, one might consider approval but would need to label the product
differently than what is being currently proposed (long-term use).
Durability of effect should be studied further so that proper instructions
for use can be crafted. Finally, the safety of droxidopa is still poorly
characterized and another properly designed trial should be conducted to
evaluate it. This development program was not properly designed to evaluate
safety because of three factors: 1) the absence of a pure placebo group, 2)
most of the safety data were collected in open-label trials and 3) blood
pressure was collected with the head of the bed tilted at 30 degrees.
Vasoconstriction is the mechanism of action of droxidopa. Therefore, without
a control group, it is logical to assume that the cardiovascular adverse
events, and there were many, were caused by droxidopa. There is also the
concern of neuroleptic malignant syndrome. Since there were some Japanese
postmarketing cases that were not explicable on the basis of other drugs
known to cause the syndrome, one needs to be concerned that droxidopa may
cause this sometimes fatal condition.
summary excerpts:
In summary, in support of approval, there is one trial (Study 301) that is
strongly supportive of efficacy of droxidopa and contains many of the
attributes of a single trial that might stand alone to support efficacy:
large and multicenter trial, improvement on multiple ordered endpoints
including OHSA Item 1, OHQ and systolic blood pressure, and statistically
very persuasive findings. From a post-hoc analysis of the cumulative
distribution bin analysis of Study 301, there was a much larger group of
patients that had a greater level of improvement (improvement of ≥4 points
on the OHQ) on droxidopa than on placebo. Study 302, the OHQ hypothesis
generating study for Study 301, might be considered supportive of efficacy
if one considered OHQ to be a valid endpoint.
The primary reason to not recommend approval is the lack of sufficient
evidence of efficacy. There is only one successful trial and it is well
known that random factors can cause erroneous clinical trial outcomes.
Patients with symptomatic neurogenic orthostatic hypotension are vulnerable
and it is important to ensure their safety by protecting them from exposure
to drugs that may not be effective, particularly drugs that have a
theoretical basis for causing cardiovascular safety issues, as this drug has
. Additionally, the lack of evidence of durability is particularly
concerning. Patients should not be exposed to a drug chronically unless
benefit is established over a reasonable amount of time - at least three
months. It is possible that there is a down regulation of NE receptors in
the peripheral circulation after prolonged exposure to droxidopa. If this is
the case, one might consider approval but would need to label the product
differently than what is being currently proposed (long-term use).
Durability of effect should be studied further so that proper instructions
for use can be crafted. Finally, the safety of droxidopa is still poorly
characterized and another properly designed trial should be conducted to
evaluate it. This development program was not properly designed to evaluate
safety because of three factors: 1) the absence of a pure placebo group, 2)
most of the safety data were collected in open-label trials and 3) blood
pressure was collected with the head of the bed tilted at 30 degrees.
Vasoconstriction is the mechanism of action of droxidopa. Therefore, without
a control group, it is logical to assume that the cardiovascular adverse
events, and there were many, were caused by droxidopa. There is also the
concern of neuroleptic malignant syndrome. Since there were some Japanese
postmarketing cases that were not explicable on the basis of other drugs
known to cause the syndrome, one needs to be concerned that droxidopa may
cause this sometimes fatal condition.
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