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ForumsSide Effects & ManagementFAERS pharmacovigilance data for semaglutide — anyone have experience?

FAERS pharmacovigilance data for semaglutide — anyone have experience?

bri_stats Thu, Mar 21, 2024 at 2:29 PM 36 replies 2,800 viewsPage 1 of 8
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bri_stats
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Mar 21, 2024 at 2:29 PM#1

Read the primary source rather than the write-up and the two do not agree, so here is what is actually in it.

The dose-response is real but shallow at the top. Across STEP 1 and STEP 4 the gap between 1.7mg and 2.4mg is a couple of percentage points of body weight on average, and the average is carrying a wide spread — plenty of people at 1.7mg sit above the 2.4mg mean. If a dose is working and tolerable, "working" is the relevant variable, not "maximal".

Where I think it is weakest: the subgroup findings are the part I trust least — with enough subgroups something is always significant, and these were not all pre-registered.

So the question, as narrowly as I can put it: what the dose-response curve actually looks like above 1.7mg, because the trial means hide how few people account for the extra loss. Numbers rather than impressions, if you have them.

Note on sourcing:
Figures above are from the primary publication rather than the press summary. If a number here disagrees with one you have, post yours and we will work out which of us is reading a secondary source.
42 12sarah_nash92, FitDadDave, RunnerRach and 39 others
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HPLC_Greg
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Mar 21, 2024 at 4:38 PM#2
bri_stats said:
The dose-response is real but shallow at the top.

That holds for the injectable. The oral formulation has different absorption behaviour and the dose numbers are not interchangeable, which is worth saying out loud because people quote them as if they were.

I would rather be corrected than agreed with, if it comes to it.

Last edited: Mar 21, 2024 at 10:38 PM
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Dr.KarenChen
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Mar 21, 2024 at 6:47 PM#3
bri_stats said:
The dose-response is real but shallow at the top.

I will push back on the "any working dose is fine" framing. The maintenance evidence sits overwhelmingly at the top studied dose, and the extension data shows regain tracking dose reduction rather than tracking stopping. Holding low is reasonable; pretending it is evidentially equivalent is not.

Last edited: Mar 22, 2024 at 12:47 AM
40 10TomFromTexas, mike.trainer_LA, sarah_nash92 and 37 others
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BariatricNurseD
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Mar 21, 2024 at 8:56 PM#4

Answering the narrow version, because the broad one does not have a single answer. Steady state is the thing most people miss. The terminal half-life is about a week, so every dose step takes four to five weeks to fully express itself. Judging a step at day ten is judging the ascent, not the plateau, and it is the single commonest reason people escalate before they needed to.

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fiona_VT
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Mar 22, 2024 at 9:43 AM#5
HPLC_Greg said:
The oral formulation has different absorption behaviour and the dose numbers are not interchangeable, which is worth saying out loud because people…

Agreed, though "tolerable" needs defining. A dose you tolerate by eating almost nothing is not tolerated, it is being paid for somewhere else — usually in lean mass, sometimes in adherence three months later.

Last edited: Mar 22, 2024 at 10:43 AM
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