Cardiovascular Morbidity and Mortality in the Losartan Intervention For Endpoint Reduction in Hypertension Study (LIFE)
2002 · paper · Clinical trials
A double-masked trial of 9,193 hypertensive patients with left ventricular hypertrophy, comparing losartan-based with atenolol-based treatment. Blood pressure fell similarly, but losartan gave fewer cardiovascular events, mainly strokes, and less new-onset diabetes.
4 findings
Substance Results p5: 'in 4017 (89%) and 4067 (89%) for diastolic pressure'. 4017/4605 is 87%, not 89%. The other five percentages in the sentence match the arm denominators.
- p. 5 Results, paragraph 2
4017 (89%) and 4067 (89%) for diastolic pressure
Only the authors can say what is right here.
Judge's note: The p5 image shows 4017 (89%). Every other percentage in the sentence works with the full arm sizes of 4605 and 4588 (49%, 46%, 89%, 48%, 45%). No other denominator for BP control is stated anywhere. Also, two different counts (4017 vs 4067) are both given as 89% with near-equal denominators. Only the authors can say whether the count or the percentage is wrong.
Second check: another model agreed
Report a problem with this finding
Substance Results p6: 'Discontinuation as a result of all adverse events, drug-related adverse events, and serious and serious drug-related adverse events were significantly less common in losartan than atenolol patients (figure 6)'. Figure 6 gives p=0·087 for the 'Serious' category.
- p. 6 Results, paragraph on Table 4 / Figure 6
and serious drug-related adverse events were significantly less common in losartan than atenolol patients (figure 6)
- p. 6 Figure 6, 'Serious' bar pair
p=0·087
- p. 6 Results, paragraph above Discussion
serious drug-related adverse events were significantly less common in losartan than atenolol patients (figure 6)
- p. 6 Results, paragraph after Table 4
and serious and serious drug-related adverse events were significantly less common in losartan than atenolol patients (figure 6)
Judge's note: The Figure 6 image shows: All p<0·0001, Drug-related p<0·0001, Serious p=0·087, Serious drug-related p=0·006. The caption says 'p is for between-group differences', and the Methods use a two-sided 5% level. The text lists 'serious' as a separate category alongside 'serious drug-related' and calls all of them significant, which the figure contradicts for 'Serious'.
Second check: another model agreed
Report a problem with this finding
Substance Table 5, alanine aminotransferase row: the changes are printed '1·2 (25·5)' (losartan, 28·2→27·0) and '0·8 (18·7)' (atenolol, 28·4→27·6). Both are positive although the means fell.
- p. 6 Table 5, Alanine aminotransferase row
28·2 (25·7) 27·0 (18·7) 1·2 (25·5)
- p. 6 Table 5, Alanine aminotransferase row, atenolol
28·4 (19·0) 27·6 (17·8) 0·8 (18·7)
- p. 6 Table 5, ALT row
1·2 (25·5)
Only the authors can say what is right here.
Judge's note: Image checked: there is no minus sign on either ALT change, while other rows show '–' (eg –3·7, –0·3). In the other rows the change equals Year 4 minus Baseline to within 0·1 (haemoglobin, HDL, uric acid). For ALT the magnitudes match exactly but the sign is reversed. A paired-subset calculation is unlikely to reverse the direction with identical magnitudes. Only the authors can confirm.
Second check: another model agreed
Report a problem with this finding
Reference or label Table 5 labels the creatinine row 'Creatinine (mmol/L)' with values 85·9–97·0. These values are in µmol/L, the unit the same table uses for uric acid.
- p. 6 Table 5, creatinine row label
Creatinine (mmol/L)
Judge's note: The image shows 'mmol/L' for creatinine and 'µmol/L' for uric acid, so this is not an extraction loss. The unit label is wrong by a factor of 1000.
Second check: another model agreed
Report a problem with this finding
10 minor (typos and the like; most checked by the judge only)
Wording The text gives the Table 4 inclusion rule as 'a difference of at least 1% between groups', but the Table 4 footnote says 'a difference between treatment groups >1%'.
- p. 6 Results text
a difference of at least 1% between groups
- p. 6 Table 4 footnote
a difference between treatment groups >1%
Judge's note: Both versions are visible on the p6 image. None of the listed additional events lies at exactly 1%, so the practical effect is nil. It is a minor inconsistency in how the rule is stated.
Second check: another model agreed
Report a problem with this finding
Typo Author surname printed as 'Kristiansson' in the byline ('Krister Kristiansson') and in the conflict-of-interest statement, but as '(K Kristianson PhD)' in the p1 affiliation list.
- p. 1 Affiliations
(K Kristianson PhD)
- p. 1 Author byline
Krister Kristiansson
- p. 9 Conflict of interest statement
K Kristiansson is a Merck employee
- p. 1 Affiliations
K Kristianson PhD
Judge's note: Images show 'Krister Kristiansson' in the byline, 'K Kristiansson is a Merck employee' on p9, and '(K Kristianson PhD)' under Merck Research Laboratories Scandinavia on p1. It is the same author: same initial, and the Merck affiliation matches the COI statement. The field monitor 'Johan Kristianson' is a different person.
Second check: none (judge only)
Report a problem with this finding
Typo Affiliation reads 'University of Alabama, Birmingham, Alabama, AL, USA', so the state is given twice.
- p. 1 Affiliations
Alabama, AL, USA
Judge's note: Confirmed in the p1 image. This is a cosmetic redundancy.
Second check: none (judge only)
Report a problem with this finding
Typo The Methods say 'independent data and safety monitoring board', while the LIFE committees list says 'Data safety and monitoring board'.
- p. 7 LIFE committees
Data safety and monitoring board
- p. 2 Methods
independent data and safety monitoring board
Judge's note: Both forms are visible in the p2 text and the p7 image. This is a cosmetic naming inconsistency.
Second check: none (judge only)
Report a problem with this finding
Typo Figure 2 trial profile reads '29 excluded for irregularites' instead of 'irregularities'.
- p. 3 Figure 2
29 excluded for irregularites
Judge's note: The misspelling is visible in the Figure 2 image on p3.
Second check: none (judge only)
Report a problem with this finding
Typo Misspellings: "steering committe" (conflict of interest statement, p9) and "29 excluded for irregularites" (Figure 2, p3)
- p. 9 Conflict of interest statement
steering committe.
- p. 9 Conflict of interest statement
steering committe
- p. 3 Figure 2
irregularites
Judge's note: Both are visible in the page crops: "committe" on p9 under Conflict of interest statement, and "irregularites" in the Figure 2 flow-chart box on p3. Spelling only.
Second check: none (judge only)
Report a problem with this finding
Typo The Figure 4 title reads 'Kaplan Meier curves for primary composite endpoint', without the hyphen used in Figure 5 ('Kaplan-Meier') and in the text.
- p. 5 Figure 4 caption
Kaplan Meier curves for primary composite endpoint
- p. 5 Figure 5 caption
Kaplan-Meier curves for individual endpoints
- p. 5 Figure 4 title
Figure 4: Kaplan Meier curves for primary composite endpoint
Judge's note: Both captions checked on the p5 images. This is a cosmetic inconsistency.
Second check: none (judge only)
Report a problem with this finding
Typo Clinical data management: 'Lotta Jonssson (Sweden)' has three s's; it is probably 'Jonsson'.
- p. 7 Clinical data management
Lotta Jonssson (Sweden)
Judge's note: The triple 's' is visible on the p7 image. Elsewhere the paper uses 'Jonsson' (eg 'P Jonsson').
Second check: none (judge only)
Report a problem with this finding
Typo Monitoring office list uses a full stop where a comma is expected: "Jonathan Edelman (USA). Michael Busch-Sørensen (Denmark/Iceland),"
- p. 7 Monitoring office
Jonathan Edelman (USA). Michael Busch-Sørensen
Judge's note: Crop of p7 right column (Monitoring office) shows the full stop after "(USA)" inside a comma-separated list of names; the other entries are separated by commas. Punctuation only.
Second check: none (judge only)
Report a problem with this finding
Typo UK investigator list repeats names out of alphabetical order: "P Peverley, J Pittard, R Pool, K Premawardhana, I Ramsay, S Patel, R Paton, M Peverley, J Pittard, R Pool, K Premawardhana, R Purdy, M Pye, I Ramsay"
- p. 8 LIFE investigators, UK
K Premawardhana, I Ramsay, S Patel, R Paton, M Peverley, J Pittard,
Judge's note: Crop of p8 right column shows J Pittard, R Pool, K Premawardhana and I Ramsay each listed twice. The sequence also falls out of alphabetical order ("I Ramsay, S Patel"), which points to a copy-paste duplication rather than different people with the same names. Cosmetic.
Second check: none (judge only)