Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial

Philip D Home, Stuart J Pocock, Henning Beck-Nielsen, Paula S Curtis, Ramon Gomis, Markolf Hanefeld, Nigel P Jones, Michel Komajda, John J V McMurray, RECORD Study Team

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Udgivelsesdato: 2009-Jun-20
OriginalsprogEngelsk
TidsskriftLancet
Vol/bind373
Udgave nummer9681
Sider (fra-til)2125-35
Antal sider10
ISSN0140-6736
DOI
StatusUdgivet - 20. jun. 2009

Fingeraftryk

rosiglitazone
Type 2 Diabetes Mellitus
Control Groups
Intention to Treat Analysis

Citer dette

Home, Philip D ; Pocock, Stuart J ; Beck-Nielsen, Henning ; Curtis, Paula S ; Gomis, Ramon ; Hanefeld, Markolf ; Jones, Nigel P ; Komajda, Michel ; McMurray, John J V ; Study Team, RECORD. / Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. I: Lancet. 2009 ; Bind 373, Nr. 9681. s. 2125-35.
@article{074c3dc0993f11de8598000ea68e967b,
title = "Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial",
abstract = "BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the combination of the two over 5-7 years of follow-up. We also assessed comparative safety. METHODS: In a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A(1c) (HbA(1c)) of 7.9{\%} were randomly assigned to addition of rosiglitazone (n=2220) or to a combination of metformin and sulfonylurea (active control group, n=2227). The primary endpoint was cardiovascular hospitalisation or cardiovascular death, with a hazard ratio (HR) non-inferiority margin of 1.20. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00379769. FINDINGS: 321 people in the rosiglitazone group and 323 in the active control group experienced the primary outcome during a mean 5.5-year follow-up, meeting the criterion of non-inferiority (HR 0.99, 95{\%} CI 0.85-1.16). HR was 0.84 (0.59-1.18) for cardiovascular death, 1.14 (0.80-1.63) for myocardial infarction, and 0.72 (0.49-1.06) for stroke. Heart failure causing admission to hospital or death occurred in 61 people in the rosiglitazone group and 29 in the active control group (HR 2.10, 1.35-3.27, risk difference per 1000 person-years 2.6, 1.1-4.1). Upper and distal lower limb fracture rates were increased mainly in women randomly assigned to rosiglitazone. Mean HbA(1c) was lower in the rosiglitazone group than in the control group at 5 years. INTERPRETATION: Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on myocardial infarction, rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs. FUNDING: GlaxoSmithKline plc, UK.",
keywords = "Administration, Oral, Angina, Unstable, Body Weight, Cholesterol, HDL, Cholesterol, LDL, Diabetes Mellitus, Type 2, Diuretics, Drug Therapy, Combination, Drug Utilization, Female, Fractures, Bone, Heart Failure, Hemoglobin A, Glycosylated, Hospitalization, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypoglycemic Agents, Male, Metformin, Middle Aged, Myocardial Infarction, Neoplasms, Prospective Studies, Sex Factors, Stroke, Sulfonylurea Compounds, Thiazolidinediones",
author = "Home, {Philip D} and Pocock, {Stuart J} and Henning Beck-Nielsen and Curtis, {Paula S} and Ramon Gomis and Markolf Hanefeld and Jones, {Nigel P} and Michel Komajda and McMurray, {John J V} and {Study Team}, RECORD",
year = "2009",
month = "6",
day = "20",
doi = "10.1016/S0140-6736(09)60953-3",
language = "English",
volume = "373",
pages = "2125--35",
journal = "Lancet",
issn = "0140-6736",
publisher = "TheLancet Publishing Group",
number = "9681",

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Home, PD, Pocock, SJ, Beck-Nielsen, H, Curtis, PS, Gomis, R, Hanefeld, M, Jones, NP, Komajda, M, McMurray, JJV & Study Team, RECORD 2009, 'Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial', Lancet, bind 373, nr. 9681, s. 2125-35. https://doi.org/10.1016/S0140-6736(09)60953-3

Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. / Home, Philip D; Pocock, Stuart J; Beck-Nielsen, Henning; Curtis, Paula S; Gomis, Ramon; Hanefeld, Markolf; Jones, Nigel P; Komajda, Michel; McMurray, John J V; Study Team, RECORD.

I: Lancet, Bind 373, Nr. 9681, 20.06.2009, s. 2125-35.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial

AU - Home, Philip D

AU - Pocock, Stuart J

AU - Beck-Nielsen, Henning

AU - Curtis, Paula S

AU - Gomis, Ramon

AU - Hanefeld, Markolf

AU - Jones, Nigel P

AU - Komajda, Michel

AU - McMurray, John J V

AU - Study Team, RECORD

PY - 2009/6/20

Y1 - 2009/6/20

N2 - BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the combination of the two over 5-7 years of follow-up. We also assessed comparative safety. METHODS: In a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A(1c) (HbA(1c)) of 7.9% were randomly assigned to addition of rosiglitazone (n=2220) or to a combination of metformin and sulfonylurea (active control group, n=2227). The primary endpoint was cardiovascular hospitalisation or cardiovascular death, with a hazard ratio (HR) non-inferiority margin of 1.20. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00379769. FINDINGS: 321 people in the rosiglitazone group and 323 in the active control group experienced the primary outcome during a mean 5.5-year follow-up, meeting the criterion of non-inferiority (HR 0.99, 95% CI 0.85-1.16). HR was 0.84 (0.59-1.18) for cardiovascular death, 1.14 (0.80-1.63) for myocardial infarction, and 0.72 (0.49-1.06) for stroke. Heart failure causing admission to hospital or death occurred in 61 people in the rosiglitazone group and 29 in the active control group (HR 2.10, 1.35-3.27, risk difference per 1000 person-years 2.6, 1.1-4.1). Upper and distal lower limb fracture rates were increased mainly in women randomly assigned to rosiglitazone. Mean HbA(1c) was lower in the rosiglitazone group than in the control group at 5 years. INTERPRETATION: Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on myocardial infarction, rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs. FUNDING: GlaxoSmithKline plc, UK.

AB - BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the combination of the two over 5-7 years of follow-up. We also assessed comparative safety. METHODS: In a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A(1c) (HbA(1c)) of 7.9% were randomly assigned to addition of rosiglitazone (n=2220) or to a combination of metformin and sulfonylurea (active control group, n=2227). The primary endpoint was cardiovascular hospitalisation or cardiovascular death, with a hazard ratio (HR) non-inferiority margin of 1.20. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00379769. FINDINGS: 321 people in the rosiglitazone group and 323 in the active control group experienced the primary outcome during a mean 5.5-year follow-up, meeting the criterion of non-inferiority (HR 0.99, 95% CI 0.85-1.16). HR was 0.84 (0.59-1.18) for cardiovascular death, 1.14 (0.80-1.63) for myocardial infarction, and 0.72 (0.49-1.06) for stroke. Heart failure causing admission to hospital or death occurred in 61 people in the rosiglitazone group and 29 in the active control group (HR 2.10, 1.35-3.27, risk difference per 1000 person-years 2.6, 1.1-4.1). Upper and distal lower limb fracture rates were increased mainly in women randomly assigned to rosiglitazone. Mean HbA(1c) was lower in the rosiglitazone group than in the control group at 5 years. INTERPRETATION: Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on myocardial infarction, rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs. FUNDING: GlaxoSmithKline plc, UK.

KW - Administration, Oral

KW - Angina, Unstable

KW - Body Weight

KW - Cholesterol, HDL

KW - Cholesterol, LDL

KW - Diabetes Mellitus, Type 2

KW - Diuretics

KW - Drug Therapy, Combination

KW - Drug Utilization

KW - Female

KW - Fractures, Bone

KW - Heart Failure

KW - Hemoglobin A, Glycosylated

KW - Hospitalization

KW - Humans

KW - Hydroxymethylglutaryl-CoA Reductase Inhibitors

KW - Hypoglycemic Agents

KW - Male

KW - Metformin

KW - Middle Aged

KW - Myocardial Infarction

KW - Neoplasms

KW - Prospective Studies

KW - Sex Factors

KW - Stroke

KW - Sulfonylurea Compounds

KW - Thiazolidinediones

U2 - 10.1016/S0140-6736(09)60953-3

DO - 10.1016/S0140-6736(09)60953-3

M3 - Journal article

C2 - 19501900

VL - 373

SP - 2125

EP - 2135

JO - Lancet

JF - Lancet

SN - 0140-6736

IS - 9681

ER -