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ROSIGLIATAZONE EVALUATED FOR CARDIOVSCULAR OUTCOMES IN ORAL AGENT COMBINATION THERAPY FOR TYPE 2 DIABETES (RECORD): A MULTICENTRE, RANDOMISED, OPEN –LABEL TRIAL. PHILIP D HOME DM, STUART J POCOCK PHD. AND COLLEAGUES. ROSIGLITAZONE IS AN INSULIN SENSITISER USED IN COMBINATION WITH MEFORMIN, A SULFONYLUREA, OR BOTH, FOR LOWERING BLOOD GLUCOSE IN PEOPLE WITH TYPE 2 DIABETES. WE ASSESSEDCARDIOVASCULAR OUTCOMES AFTER ADDITION OF ROSIGLITAZONE TO EITHER METFORMIN OR SULFONYLUREA COMPARED WITH THE COMBINATION OF THE 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 A1C (HB A1C) 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 GOVERNMENT CLINICAL TRIALS NUMBER NCT00379769. FINDINGS. 321 PEOPLE IN THE ROSIGLITAZONE GROUP AND 323 INTHE ACTIVE CONTROL GROUP EXPERIENCED THE PRIMARY OUTCOME DURING A MEAN 5-5 YEAR FOLLOW UP, MEETING THE CRITERION ON NON-INFERIORITY (HR 0.99, 95% CL 0.85-1.16). HR WAS 0-84 (0-59) FOR CARDOVASCULAR 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 THEACTIVE CONTROL GROUP (HR2.10, 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 RSIGLITAZONE. MEAN HBA1C WAS LOWER IN THE ROSIGLITAZONE GROUP THAN IN THE CONTROL GROUP AT 5 YEARS. INTERPRETATION. ADDITION ROSIGLITAZONE TO GLUCOSE LOWERING THERAPY IN PEOPLE WITH TYPE 2 DIABETES IS CONFIRMEDTO 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 CARDIVASCULAR MORBIDITY OR MORTALITY COMPARED WITH STANDARD GLUCOSE –LOWERING DRUGS. 

PREGUNTA 1

WHAT WAS THE MAIN PURPOSE OF THE STUDY?
A) TO TREAT PATIENTS WITH TYPE 2DIABETES.
B) TO DETERMINE THE INCIDENCE OF HOSPITALIZATION IN PATIENTS TAKING ROSIGLITAZONE.
C) TO DISCOVER THE EFFECTS THAT ROSIGLITAZONE HAS ON HEART FAILURE IN PATIENTS WITH TYPE 2 DIABETES.
D) TO GET GOVERNMENT APPROVAL FOR ROSIGLITAZONE.

PREGUNTA 2
 
ROSIGLITAZONE IS AN INSULIN SENSITISER USED TO:
A) LOWER INSULINE IN PEOPLE WITH TYPE 2 DIABETES
B) LOWER BLOOD GLUCOSEIN PEOPLE WITH TYPE 2 DIABETES.
C) INCREASE BLOOD GLUCOSE IN PEOPLE WITH TYPE 2 DIABETES.
D) DIMINISH INSULINE IN PEOPLE WITH TYPE 1 DIABETES.

PREGUNTA 3
 
WHAT DID THE TWO GROUPS HAVE IN COMMON?
A) PARTICIPANTS WERE GIVEN SULFONYLUREA.
B) PARTICIPANTS WERE GIVEN ROSIGLITAZONE.
C) PARTICIPANTS HAD NEARLY SIMILAR LEVELS OF HBA1C.
D) PARTICIPANTS WERE ALL FROM THE SAMECENTRE.

PREGUNTA 4
 
WHAT DOES THE AUTHOR CONCLUDE REGARDING THE SAFETY OF ROSIGLITAZONE IN GLUCOSE-LOWERING THERAPY FOR PATIENTS WITH TYPE-2 DIABETES?
A) THE PERCENTAGE OF PATIENTS RESULTING IN HEART FAILURE WAS VERY HIGH FOR BOTH GROUPS.
B) ROSIGLITAZONE, IN GENERAL, CAUSES HEART FAILURE.
C) ROSIGLITAZONE IS GENERALLY SAFE, BUT NOT FOR WOMEN.
D) ROSIGLATAZONE SHOULD BE USEDONLY FOR MALE PATIENTS.
 
PREGUNTA 5

ADDITION ROSIGLITAZONE TO GLUCOSE LOWERING THERAPY IN PEOPLE WITH TYPE 2 DIABETES IS CONFIRMED TO:
A) INCREASE THE RISK OF HEART FAILURE AND OF SOME FRACTURES, MAINLY IN MEN.
B) INCREASE THE RISK OF HEART FAILURE AND OF SOME FRACTURES, MAINLY IN WOMEN.
C) THE DATA ARE CONCLUSIVE ABOUT ANY POSSIBLE EFFECT ON MYOCARDIAL INFARCTION,
D)...