Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes
2016 · paper · Clinical trials
Examines the effect of liraglutide on cardiovascular outcomes in people with type 2 diabetes in the LEADER trial. The available text gives only the author list and disclosures, not the methods or results.
1 finding
Reference or label Reference 11 reads 'JAMA Cardiol. 2016; 2: 126–35. DOI: 10.1001/jamacardio.2016.0103'; the volume is probably 1, with 2 being the issue number.
- p. 10 Reference 11
JAMA Cardiol. 2016; 2: 126–35. DOI: 10.1001/jamacardio.2016.0103
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: JAMA Cardiology began in 2016 as volume 1, and this article is in volume 1, issue 2. The crop confirms the reference prints '2016; 2: 126–35'.
Second check: another model agreed
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8 minor (typos and the like; most checked by the judge only)
Wording Discussion (p8): 'The prespecified primary microvascular outcome in our trial was a composite of nephropathy and retinopathy outcomes'. Methods (p4) list 'a composite renal and retinal microvascular outcome' among the 'Prespecified exploratory outcomes'.
- p. 8 Discussion, last paragraph
The prespecified primary microvascular outcome in our trial was a composite of
- p. 4 Methods, Outcomes
a composite renal and retinal microvascular outcome
Only the authors can say what is right here.
Judge's note: Checked both crops. The Methods define a single primary outcome (the MACE composite) and put the microvascular composite in the exploratory tier, with no multiplicity adjustment (text lines 74, 226). In the Discussion, 'primary' may mean 'main', but it reads as a tier label. The microvascular-wording part of C009 is covered here.
Second check: another model agreed
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Wording Table 1 (p14) is titled 'Primary and Secondary Outcomes.', but the paper defines no secondary outcomes: Methods (p4) say 'Prespecified exploratory outcomes', and Figure 1 (p12) is titled 'Primary and Exploratory Outcomes'.
- p. 14 Table 1 title
Primary and Secondary Outcomes.
- p. 4 Methods, Outcomes
Prespecified exploratory outcomes included an expanded composite
- p. 12 Figure 1 title
Figure 1. Primary and Exploratory Outcomes
- p. 8 Discussion, microvascular paragraph
The prespecified primary microvascular outcome in our trial was a composite of nephropathy and retinopathy outcomes.
Only the authors can say what is right here.
Judge's note: Checked the upright Table 1 page and the Figure 1 and Methods crops. Searching the text finds 'secondary' only in the Table 1 title and in a reference title. Every other mention calls the tier 'exploratory', with no multiplicity adjustment. Notes 2 to 4 (microvascular outcome called 'primary') are judged under C005.
Second check: another model agreed
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Wording Results (p7) give 'the rate ratio for confirmed hypoglycemia (plasma glucose level, <56 mg per deciliter ...) was 0.80'. Discussion (p9) gives 'a 20% lower rate of the combination of severe and confirmed hypoglycemia'. The Table 2 footnote defines confirmed hypoglycemia only by glucose <56 mg/dl.
- p. 7 Results, Safety and adverse events
the rate ratio for confirmed hypoglycemia (plasma glucose level, <56 mg per deciliter [3.1 mmol per liter]) was 0.80
- p. 9 Discussion, hypoglycemia paragraph
a 20% lower rate of the combination of severe and confirmed hypoglycemia
- p. 17 Table 2 footnote †
Confirmed hypoglycemia was defined a plasma glucose level of less than 56 mg per deciliter
Only the authors can say what is right here.
Judge's note: Checked all three crops. This is the only 0.80 estimate in the paper, so 1-0.80 matches the 20% figure. The paper never says whether 'confirmed' includes severe episodes, so the endpoint behind the 20% figure is labelled two ways. The authors should state which definition applies.
Second check: another model agreed
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Wording Table 2 (p16): 'Severe adverse event' (1502 vs 1533) is set flush-left like the 'Adverse event' heading, so the indented rows below it read as subsets of severe events. Yet 'Acute gallstone disease' 145 (3.1) vs 90 (1.9) is the total count; the Results (p7) give 'severe events (in 40 vs. 31)'.
- p. 16 Table 2, first block
Severe adverse event
- p. 16 Table 2, row indented under 'Severe adverse event'
Acute gallstone disease
- p. 7 Results, Safety and adverse events
(in 145 vs. 90 patients), including severe events (in 40 vs. 31)
Only the authors can say what is right here.
Judge's note: Checked the full page 16. 'Severe adverse event' has the same indentation as the section heading 'Adverse event', and Severe hypoglycemia, Acute gallstone disease, Hypothyroidism and the other rows are indented under it. The text shows the gallstone row is not limited to severe events, so the table's hierarchy is misleading even though the numbers are fine.
Second check: another model agreed
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Typo Disclosures (p1): 'lecture fees from ... Eli Lilly, Glaxo-SmithKline, Merck Sharp & Dohme' is hyphenated mid-line, while the rest of the paragraph has 'GlaxoSmithKline'.
- p. 1 Disclosures, Dr. Nauck lecture fees
Glaxo-SmithKline
Judge's note: Checked the crop: the hyphenated form is mid-line, so it is not a line-break hyphen. Lines 28, 31, 33 and 48 of the text all have 'GlaxoSmithKline'. This is a cosmetic inconsistency.
Second check: none (judge only)
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Typo Discussion (p8) has 'new-onset persistent macro-albuminuria' (hyphen mid-line); Methods (p4) have 'macroalbuminuria'.
- p. 8 Discussion
macro-albuminuria
- p. 4 Outcomes
macroalbuminuria
Judge's note: Checked the crops: the hyphen is mid-line, not a line break. This is a cosmetic spelling inconsistency.
Second check: none (judge only)
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Typo Results (p6): 'weight loss was 2.3 kg (95% CI, 2.5 to 2.0) higher' and 'systolic blood pressure was 1.2 mm Hg (95% CI, 1.9 to 0.5) lower' give the interval bounds in descending order. The diastolic and heart-rate intervals in the same sentence ('0.2 to 1.0', '2.5 to 3.4') are in ascending order.
- p. 6 Results, Cardiovascular risk factors
weight loss was 2.3 kg (95% CI, 2.5 to 2.0) higher
- p. 6 Results, Cardiovascular risk factors
1.2 mm Hg (95% CI, 1.9 to 0.5) lower
Judge's note: Confirmed on the page image. The point estimates lie inside the intervals, so the values can be recovered. The fault is the unconventional bound order, probably from dropping the minus signs.
Second check: none (judge only)
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Typo Table 2 footnote † (p17): 'Confirmed hypoglycemia was defined a plasma glucose level of less than 56 mg per deciliter' is missing the word 'as' ('defined as a').
- p. 17 Table 2 footnote †
Confirmed hypoglycemia was defined a plasma glucose level of less than 56 mg per deciliter
- p. 9 Discussion, hypoglycemia paragraph
a 20% lower rate of the combination of severe and confirmed hypoglycemia
- p. 7 Results, Safety and Adverse Events
the rate ratio for confirmed hypoglycemia (plasma glucose level, <56 mg per deciliter [3.1 mmol per liter]) was 0.80 (95% CI, 0.74 to 0.88)
Judge's note: The page image confirms 'as' is missing; the next sentence in the footnote reads 'was defined as'. The second point raised here (the 20% figure labelled 'severe and confirmed' vs 'confirmed') is judged under C004.
Second check: none (judge only)