Trial reportCardiovascular diabetology2008

Effect of the addition of rosiglitazone to metformin or sulfonylureas versus metformin/sulfonylurea combination therapy on ambulatory blood pressure in people with type 2 diabetes: a randomized controlled trial (the RECORD study).

Michel Komajda, Paula Curtis, Markolf Hanefeld, Henning Beck-Nielsen, Stuart J Pocock, Andrew Zambanini, Nigel P Jones, Ramon Gomis, Philip D Home, RECORD Study Group

Registry-linked trialOpen access · goldFull text readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular diabetology, 2008. The graph read 8 numbers from its abstract, feeding 1 cell of the map: it favours the comparator in 1. It reports registered trial NCT00379769. Cited by 21 papers, 3 of them syntheses that pooled it.

8numbers the graph read from it
1cell of the map it votes in
21citing papers in PubMed, 3 pooled it
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

← favours the treatmentfavours the comparator →
-0.604.900 · no effect
24-hour ambulatory systolic BP (sBP)rosiglitazone vs sulfonylureasfavours the comparator · hypertension, t2dfeeds one cell of the map
Δ 2.700.50 to 4.900.016
Similar differences were observed for rosiglitazone versus sulfonylureas at 12 months (sBP 2.7 [95% CI 0.5-4.9] mmHg, p = 0.016; dBP 2.1 [95% CI 0.7-3.4] mmHg, p = 0.003), but differences were smaller and/or not statistically significant at 6 months (sBP 1.5 [95% CI -0.6 to 3.6] mmHg, p = NS; dBP 1.3 [95% CI 0.0-2.5] mmHg, p = 0.049).
Ambulatory diastolic BP (dBP)rosiglitazone vs metforminfavours the comparator · hypertension, t2dfeeds one cell of the map
Δ 2.701.40 to 4.00< 0.001
Corresponding changes for ambulatory diastolic BP (dBP) were comparable (6 months 2.7 [95% CI 1.4-4.0] mmHg, p < 0.001; 12 months 3.1 [95% CI 1.8-4.5] mmHg, p < 0.001).
24-hour ambulatory diastolic BP (dBP)rosiglitazone vs sulfonylureasfavours the comparator · hypertension, t2dfeeds one cell of the map
Δ 2.100.70 to 3.400.003
Similar differences were observed for rosiglitazone versus sulfonylureas at 12 months (sBP 2.7 [95% CI 0.5-4.9] mmHg, p = 0.016; dBP 2.1 [95% CI 0.7-3.4] mmHg, p = 0.003), but differences were smaller and/or not statistically significant at 6 months (sBP 1.5 [95% CI -0.6 to 3.6] mmHg, p = NS; dBP 1.3 [95% CI 0.0-2.5] mmHg, p = 0.049).
24-hour ambulatory systolic BP (sBP)rosiglitazone vs sulfonylureasno clear difference · hypertension, t2dfeeds one cell of the map
Δ 1.50-0.60 to 3.60NS
Similar differences were observed for rosiglitazone versus sulfonylureas at 12 months (sBP 2.7 [95% CI 0.5-4.9] mmHg, p = 0.016; dBP 2.1 [95% CI 0.7-3.4] mmHg, p = 0.003), but differences were smaller and/or not statistically significant at 6 months (sBP 1.5 [95% CI -0.6 to 3.6] mmHg, p = NS; dBP 1.3 [95% CI 0.0-2.5] mmHg, p = 0.049).
24-hour ambulatory diastolic BP (dBP)rosiglitazone vs sulfonylureasno clear difference · hypertension, t2dfeeds one cell of the map
Δ 1.300.00 to 2.500.049
Similar differences were observed for rosiglitazone versus sulfonylureas at 12 months (sBP 2.7 [95% CI 0.5-4.9] mmHg, p = 0.016; dBP 2.1 [95% CI 0.7-3.4] mmHg, p = 0.003), but differences were smaller and/or not statistically significant at 6 months (sBP 1.5 [95% CI -0.6 to 3.6] mmHg, p = NS; dBP 1.3 [95% CI 0.0-2.5] mmHg, p = 0.049).
24-hour ambulatory systolic BP (sBP)rosiglitazone vs metforminfavours the comparator · hypertension, t2dfeeds one cell of the map
Δ 2.500.20 to 4.800.031
At 6 and 12 months, reductions in 24-hour ambulatory systolic BP (sBP) were greater with rosiglitazone versus metformin (difference at 6 months 2.7 [95% CI 0.5-4.9] mmHg, p = 0.015; 12 months 2.5 [95% CI 0.2-4.8] mmHg, p = 0.031).
24-hour ambulatory systolic BP (sBP)rosiglitazone vs metforminfavours the comparator · hypertension, t2dfeeds one cell of the map
Δ 2.700.50 to 4.90p = 0.015
At 6 and 12 months, reductions in 24-hour ambulatory systolic BP (sBP) were greater with rosiglitazone versus metformin (difference at 6 months 2.7 [95% CI 0.5-4.9] mmHg, p = 0.015; 12 months 2.5 [95% CI 0.2-4.8] mmHg, p = 0.031).
Ambulatory diastolic BP (dBP)rosiglitazone vs metforminfavours the comparator · hypertension, t2dfeeds one cell of the map
Δ 3.101.80 to 4.50< 0.001
Corresponding changes for ambulatory diastolic BP (dBP) were comparable (6 months 2.7 [95% CI 1.4-4.0] mmHg, p < 0.001; 12 months 3.1 [95% CI 1.8-4.5] mmHg, p < 0.001).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Thiazolidinediones×blood pressure

ContradictsOpen on the map →What to test next →

3 readable studies in this cell: 1 favour the treatment, 1 find no difference, 1 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 1 contradict · head-to-head
Without it
0.25This paper moves it by −0.25. It would be no deciding trial.
← favours the treatmentfavours the comparator →
0 · no effect
This paper4,447 enrolled · 2001
Δ 3.101.80 to 4.50
NCT00676338820 enrolled · 2008
Δ 2.000.43 to 3.58
NCT00770653305 enrolled · 2007
Δ -2.49-5.40 to 0.42
4 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00379769 phase3completed

A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia

Ran2001Enrolled4,447Registered outcomes53Posted comparisons10ConditionsDiabetes Mellitus, Type 2ArmsMetformin, Rosiglitazone, Sulfonylurea
Open the trial in the graph
5 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2010 · on this map
    Pooled it
  4. Trial
  5. Renal function in type 2 diabetes with rosiglitazone, metformin, and glyburide monotherapy.Clinical journal of the American Society of Nephrology : CJASN · 2011
    Trial
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Sildenafil does not enhance but rather attenuates vasorelaxant effects of antidiabetic agents.Journal of smooth muscle research = Nihon Heikatsukin Gakkai kikanshi · 2015
    Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Rosiglitazone decreases blood pressure and renal injury in a female mouse model of systemic lupus erythematosus.American journal of physiology. Regulatory, integrative and comparative physiology · 2009
    Article
6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

10 authors at 6 institutions in 4 countries.

Michel KomajdaUniversité Pierre et Marie Curie Paris 6; Assistance Publique Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Paris, France. michel.komajda@psl.ap-hop-paris.fr
Paula Curtis
Markolf Hanefeld
Henning Beck-Nielsen
Stuart J Pocock
Andrew Zambanini
Nigel P Jones
Ramon Gomis
Philip D Home
RECORD Study Group
GlaxoSmithKline (United Kingdom) · GBEndokrinologikum · DEHospital Clínic de Barcelona · ESLondon School of Hygiene & Tropical Medicine · GBNewcastle University · GBSorbonne Université · FR

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundHypertension and type 2 diabetes are common co-morbidities. Preliminary studies suggest that thiazolidinediones reduce blood pressure (BP). We therefore used ambulatory BP to quantify BP lowering at 6-12 months with rosiglitazone used in combination with metformin or sulfonylureas compared to metformin and sulfonylureas in people with type 2 diabetes.

methodsParticipants (n = 759) in the multicentre RECORD study were studied. Those taking metformin were randomized (open label) to add-on rosiglitazone or sulfonylureas, and those on sulfonylurea to add-on rosiglitazone or metformin.

results24-Hour ambulatory BP was measured at baseline, 6 months and 12 months. At 6 and 12 months, reductions in 24-hour ambulatory systolic BP (sBP) were greater with rosiglitazone versus metformin (difference at 6 months 2.7 [95% CI 0.5-4.9] mmHg, p = 0.015; 12 months 2.5 [95% CI 0.2-4.8] mmHg, p = 0.031). Corresponding changes for ambulatory diastolic BP (dBP) were comparable (6 months 2.7 [95% CI 1.4-4.0] mmHg, p < 0.001; 12 months 3.1 [95% CI 1.8-4.5] mmHg, p < 0.001). Similar differences were observed for rosiglitazone versus sulfonylureas at 12 months (sBP 2.7 [95% CI 0.5-4.9] mmHg, p = 0.016; dBP 2.1 [95% CI 0.7-3.4] mmHg, p = 0.003), but differences were smaller and/or not statistically significant at 6 months (sBP 1.5 [95% CI -0.6 to 3.6] mmHg, p = NS; dBP 1.3 [95% CI 0.0-2.5] mmHg, p = 0.049). Changes in BP were not accompanied by compensatory increases in heart rate, did not correlate with basal insulin sensitivity estimates and were not explained by changes in antihypertensive therapy between the various strata.

conclusionWhen added to metformin or a sulfonylurea, 12-month treatment with rosiglitazone reduces ambulatory BP to a greater extent than when metformin and a sulfonylurea are combined.

trial registrationNCT00379769 http://clinicaltrials.gov/

Indexed as

AgedBlood PressureBlood Pressure Monitoring, AmbulatoryCircadian RhythmDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleFollow-Up StudiesHeart RateHumansHypertensionHypoglycemic AgentsMaleMetforminMiddle AgedRosiglitazoneHypoglycemic AgentsMetforminRosiglitazoneSulfonylurea CompoundsThiazolidinediones

Identifiers

PMID18435852
PMCPMC2390513
OpenAlexW2157095913

What Socratic holds

Textfull text, public
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.