Reviewer's report
Title:A randomized, double-blind, placebo-controlled, multiple-dose
parallel-group clinical trial to assess the effects of teduglutide on gastric emptying
of liquids in healthy subjects
Version: 2Date:18 July 2013
Reviewer: Chris K Rayner
Reviewer's report:
Data are presented for healthy volunteers given the GLP-2 agonist teduglutide or
placebo for 10 days. The authors report that teduglutide was not associated with
slowing of gastric emptying of a liquid high fat drink as evaluated by the
paracetamol absorption test.
Major issues:
1. The authors present the rationale of the study as a desire to show whether
teduglutide could slow gastric emptying in short bowel syndrome patients, who
are on multiple medications, the absorption of which could be affected by
changes in gastric emptying. It is unclear, therefore, why they studied healthy
volunteers, in whom two previous studies, using better methods of assessing
gastric emptying, had previously shown no effect (refs 21 and 25). They indicate
that the study reported in ref 27 did show slowing of gastric emptying in short
bowel patients – which is exactly the population they are concerned about. Their
concluding statement that their findings are of relevance in SBS patients is
therefore unjustified.
2. The method of assessing gastric emptying is suboptimal. We are given scant
details about the nutrient liquid, which we are told has a high fat content. Can the
fat and aqueous phases of the liquid separate in the stomach and empty at
different rates? If so, the acetaminophen, which will presumably empty with the
aqueous phase, will not provide information about emptying of the fat phase.
Minor issues:
1. When referring to previous studies in this area, the authors should compare
the doses given to those used in the current study
2. Is there any evidence of tachyphylaxis for the effects of GLP-2 agonists on
gastric emptying, as is the case for GLP-1 (see Diabetes 2011;60(5):1561-5). If
so, an important feature of study design would be the duration of treatment.
3. The manuscript could be edited considerably to reduce the length. There are
many details not directly relevant are given in the introduction (eg. page 6
paragraph 1).
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Not suitable for publication unless extensively edited
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Reviewer's report
Title:A randomized, double-blind, placebo-controlled, multiple-dose
parallel-group clinical trial to assess the effects of teduglutide on gastric emptying
of liquids in healthy subjects
Version: 2Date:18 July 2013
Reviewer: Chris K Rayner
Reviewer's report:
Data are presented for healthy volunteers given the GLP-2 agonist teduglutide or
placebo for 10 days. The authors report that teduglutide was not associated with
slowing of gastric emptying of a liquid high fat drink as evaluated by the
paracetamol absorption test.
Major issues:
1. The authors present the rationale of the study as a desire to show whether
teduglutide could slow gastric emptying in short bowel syndrome patients, who
are on multiple medications, the absorption of which could be affected by
changes in gastric emptying. It is unclear, therefore, why they studied healthy
volunteers, in whom two previous studies, using better methods of assessing
gastric emptying, had previously shown no effect (refs 21 and 25). They indicate
that the study reported in ref 27 did show slowing of gastric emptying in short
bowel patients – which is exactly the population they are concerned about. Their
concluding statement that their findings are of relevance in SBS patients is
therefore unjustified.
2. The method of assessing gastric emptying is suboptimal. We are given scant
details about the nutrient liquid, which we are told has a high fat content. Can the
fat and aqueous phases of the liquid separate in the stomach and empty at
different rates? If so, the acetaminophen, which will presumably empty with the
aqueous phase, will not provide information about emptying of the fat phase.
Minor issues:
1. When referring to previous studies in this area, the authors should compare
the doses given to those used in the current study
2. Is there any evidence of tachyphylaxis for the effects of GLP-2 agonists on
gastric emptying, as is the case for GLP-1 (see Diabetes 2011;60(5):1561-5). If
so, an important feature of study design would be the duration of treatment.
3. The manuscript could be edited considerably to reduce the length. There are
many details not directly relevant are given in the introduction (eg. page 6
paragraph 1).
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Not suitable for publication unless extensively edited
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Please review this paper.
user
Reviewer's report
Title:A randomized, double-blind, placebo-controlled, multiple-dose
parallel-group clinical trial to assess the effects of teduglutide on gastric emptying
of liquids in healthy subjects
Version: 2Date:18 July 2013
Reviewer: Chris K Rayner
Reviewer's report:
Data are presented for healthy volunteers given the GLP-2 agonist teduglutide or
placebo for 10 days. The authors report that teduglutide was not associated with
slowing of gastric emptying of a liquid high fat drink as evaluated by the
paracetamol absorption test.
Major issues:
1. The authors present the rationale of the study as a desire to show whether
teduglutide could slow gastric emptying in short bowel syndrome patients, who
are on multiple medications, the absorption of which could be affected by
changes in gastric emptying. It is unclear, therefore, why they studied healthy
volunteers, in whom two previous studies, using better methods of assessing
gastric emptying, had previously shown no effect (refs 21 and 25). They indicate
that the study reported in ref 27 did show slowing of gastric emptying in short
bowel patients – which is exactly the population they are concerned about. Their
concluding statement that their findings are of relevance in SBS patients is
therefore unjustified.
2. The method of assessing gastric emptying is suboptimal. We are given scant
details about the nutrient liquid, which we are told has a high fat content. Can the
fat and aqueous phases of the liquid separate in the stomach and empty at
different rates? If so, the acetaminophen, which will presumably empty with the
aqueous phase, will not provide information about emptying of the fat phase.
Minor issues:
1. When referring to previous studies in this area, the authors should compare
the doses given to those used in the current study
2. Is there any evidence of tachyphylaxis for the effects of GLP-2 agonists on
gastric emptying, as is the case for GLP-1 (see Diabetes 2011;60(5):1561-5). If
so, an important feature of study design would be the duration of treatment.
3. The manuscript could be edited considerably to reduce the length. There are
many details not directly relevant are given in the introduction (eg. page 6
paragraph 1).
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Not suitable for publication unless extensively edited
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
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