SURMOUNT-1 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Clinical Trials
Page 24 of 26 of this archive, newest first.
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SURPASS-2 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Thiamine and the vomiting patient
Which markers are informative, which are confounded, and which move for reasons unrelated to nutrition.
SURPASS-3 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
What the upper limit of normal for ALT should be, and why it is not
Estimated glomerular filtration rate is a calculation with muscle mass in the denominator of its assumptions. In this population that matters.
SURMOUNT-OSA extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
SURPASS-2 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Grams per kilogram of what? The denominator problem in protein guidance
The practical difficulty is not knowing the target. It is meeting it on an appetite that has been pharmacologically reduced by half.
Micronutrient monitoring: which panel, how often, and on whose evidence
Micronutrient guidance for this drug class is borrowed almost entirely from post-bariatric surveillance, where the anatomy is different and the deficiency mechanisms are not…
LEADER misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
STEP 5 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
STEP 5 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The three-times-upper-limit convention, and where it came from
Asymptomatic pancreatic enzyme elevation is common on treatment and is not pancreatitis. The distinction is clinical, not biochemical.
TRIUMPH-3 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The dose that got you here and the dose that keeps you here
What the labels permit, what clinicians do, and the size of the gap between them.
Lean mass is a compartment, not a tissue
The instrument determines the answer more than the drug does, and the trade quotes the answer without naming the instrument.
Why "muscle-sparing" is a marketing term and not a measurement
The gap between a defensible recommendation and a confident one is where most of the harm in this subject lives.
SURMOUNT-1 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
SELECT misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The imaging substudy is an afterthought in the protocol and the centrepiece of the debate
The composition data comes from imaging substudies enrolling a few score participants at selected sites. It is the best evidence available and it is thin.