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UKPDS

  1. 1. UKPDS OVMC LANDMARK TRIALS SERIES UK Prospective Diabetes Study (UKPDS). “Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes.” Lancet. 1998; 352:837
  2. 2. UK Prospective Diabetes Study (UKPDS) Group Summarized by: Maria Morkos, MD; Laxmi Suthar, MD
  3. 3. BACKGROUND  In patients with T1DM, good blood glucose control can slow microvascular complications  However, the effect of intense blood glucose control on micro/macrovascular complications in T2DM is unknown
  4. 4. CLINICAL QUESTION What are the effects on microvascular and macrovascular complications in Type 2 diabetics when comparing intervention with a sulfonylurea or insulin vs. conventional treatment?
  5. 5. DESIGN  Randomized, multicenter: 23 hospitals in United Kingdom  Unblinded; computer-generated randomization  N= 3,867  Group 1: intensive treatment group  Group 2: conventional treatment group  Median follow-up: 10 years  Outcomes:  any diabetes-related endpoint (sudden death, death from hyperglycemia or hypoglycemia, fatal/nonfatal MI, CHF, CVA, renal failure, amputation, retinopathy requiring photocoagulation, cataract extraction, vitreous hemorrhage, or blindness)  diabetes-related death (death from MI, stroke, PVD, renal disease, hypo/hyperglycemia)  all cause mortality
  6. 6. POPULATION Inclusion Criteria  Newly diagnosed T2DM  25-65 years old  Fasting glucose of >108 Exclusion Criteria  Patients with significant ketonuria  MI within previous year  Cr > 1.98 mg/dL  Current angina or HF  >1 major vascular event  Significant retinopathy  Malignant HTN  Other severe illness
  7. 7. INTERVENTIONS  Intensive therapy  Sulfonylurea or insulin with goal fasting glucose <110 mg/dL  Conventional therapy  Goal “asymptomatic DM” <270 mg/dL with diet modification  If further hyperglycemia occurred, would be secondarily randomized to SU or insulin
  8. 8. RESULTS  No difference between intensive (SU or insulin) and conventional treatment groups in any of the endpoints  Diabetes-related mortality and all-cause mortality did not differ between the two arms  Median A1c was lower in the intensive vs conventional group (7% vs 7.9%)  Higher rates of hypoglycemic episodes were found in the intensive therapy arm (especially in insulin subgroup)
  9. 9. CRITICISMS  Multiple crossovers  Done in newly diagnosed diabetics  Excluded participants that had significant medical history  Looked at only three sulfonylureas (chlorpropamide, glibenclamide, and glipizide)  Insulin regimen unclear  Did not look at exercise as a lifestyle modification
  10. 10. BOTTOM LINE In T2DM, intensive blood glucose control (with SU or insulin) decreases the risk of microvascular complications but not macrovascular complications.
  11. 11. DISCUSSION QUESTIONS  What were the two arms of the UKPDS trial?  What were the inclusion criteria?  Did the two arms differ in any endpoints?  What was a major difference between the two arms?
  12. 12. DISCUSSION ANSWERS  What were the two arms of the UKPDS trial?  ANSWER: Intensive tx (SU or insulin) vs conventional tx (diet modification)  What were the inclusion criteria?  ANSWER: Newly diagnosed DM, age 25-65, fasting glucose of >108  Did the two arms differ in any endpoints/outlined outcomes?  ANSWER: No, there were no differences in macrovascular complications  What was a major difference between the two arms?  ANSWER: Hypoglycemia was increased in the intensive tx arm (also less microvascular complications in the intensive tx arm)
  13. 13. BOARD-LIKE QUESTION 64 yo M with T2DM, stage 4 CKD is evaluated for continued glycemic management. He is followed closely by Renal who is preparing him for HD, with initiation of erythropoietin therapy within the last 3 months. His average fasting and preprandial blood glucose values are 145-190. He does not have hypoglycemia. His insulin regimen consists of insulin detemir at bedtime and insulin glulisine before meals. His most recent A1c value decreased from 7.5% to 6.2%. (Adapted from MKSAP) QUESTION Which of the following is the most appropriate management for this patient’s diabetes? A. Continue current therapy B. Decrease insulin detemir dose C. Discontinue preprandial insulin glulisine D. Measure postprandial glucose level
  14. 14. BOARD-LIKE QUESTION Educational Objective: Manage the limitations of hemoglobin A1c measurements in a patient with diabetes mellitus and CKD. Key Point: - A1c is not always reliable in certain states - A1c an be falsely elevated in CKD b/c of carbamylated Hb 2/2 uremia interfering with some of the assays - A1c an be falsely decreased in setting of reduced erythrocyte span, iron deficiency, blood transfusions, and increased erythropoiesis with erythropoietin (like this patient) QUESTION Which of the following is the most appropriate management for this patient’s diabetes? A. Continue current therapy B. Decrease insulin detemir dose C. Discontinue preprandial insulin glulisine D. Measure postprandial glucose level
  15. 15. REFERENCES  Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (1998). Lancet, 352:837.

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