Victoza Medical Letter Questions

Question 1

Weight loss with Victoza in six phase 3 studies? How long was it sustained?

Comparison to Byetta?

Answer 1

2.2-7.1 lbs (~1-3 kg) for up to 2-3 years in LEAD 2 and 3 respectively.

~1 kg when switched from Byetta to Victoza in LEAD 6

Question 2

LEADER

TRIAL DESIGN OF LEADER?

NUMBER OF PATIENTS?

DURATION OF FOLLOW UP?

Answer 2

DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED

9K

FOLLOWED FOR AT LEAST 3.5 BUT UP TO 5 YEARS

Question 3

LEADER

DIFFERENCE BETWEEN VICTOZA AND PLACEBO STANDARD OF CARE ARM:

A1C?

WITHDRAWAL PERCENTAGE AND REASON?

Answer 3

• 0.4% AT PREDEFINED 3 YEAR FOLLOWUP
  1. 6% WITH VICTOZA AND 0.4% WITH PLACEBO D/T NAUSEA

Question 4

LEADER

WHAT WERE ENROLLING CRITERIA FOR LEADER:

PRIOR DIABETES DRUGS?

A1C?

Answer 4

drug-naïve or treated with oral antidiabetic drugs (OADs), NPH long-acting analog or premixed

(A1C) of >=7%

Question 5

LEADER

WHAT WERE ENROLLING CRITERIA FOR LEADER:

CV DISEASE?

Answer 5

≥50 years with at least one coexisting CV condition

• coronary heart disease,
• cerebrovascular disease,
• peripheral vascular disease,
• chronic kidney stage 3 or greater, or
• New York Heart Association class II or III heart chronic heart failure

≥60 years with at least one cardiovascular risk factor determined by investigators.

• microalbuminuria or proteinuria,
• hypertension and left ventricular hypertrophy,
• left ventricular systolic or diastolic dysfunction, or
• an ankle-brachial index of

Question 6

LEADER

Primary endpoint for LEADER?

Answer 6

time from randomization to first occurrence of a composite cardiovascular outcome comprised of

• CV death,
• non-fatal myocardial infarction (MI) or
• non-fatal stroke.

Question 7

LEADER

median follow up for LEADER

Answer 7

3.8 years

Question 8

LEADER

MACE OUTCOME REDUCTION?

P VALUES FOR INFERIORITY AND SUPERIORITY?

HOW DOES THIS COMPARE TO PREVIOUS CVOT STUDIES (NOT IN LETTER)

Answer 8

13%

<0.001 FOR NON INFERIORITY AND <0.01 FOR SUPERIORITY

Question 9

LEADER

EXPANDED MACE OUTCOME REDUCTION? P VALUE?

WHAT IS EXPANDED MACE?

Answer 9

12% (P=0.005)

EXPANDED MACE INCLUDES:

• coronary revascularization, or
• hospitalization for unstable angina pectoris or heart failure
• hospitalization heart failure

Question 10

LEADER

BESIDES MACE AND EXPANDED, WHAT CV OUTCOMES HAD SIGNIFICANT DECREASES?

Answer 10

DEATH FROM CV CAUSE (MACE): -12%

DEATH FROM ANY CAUSE: -15%

MYOCARDIAL INFARCTION (COMPOSITE OF SILENT AND FATAL): -14%

Question 11

LEADER

BESIDES MACE AND EXPANDED, WHAT MICROVASCULAR OUTCOMES HAD SIGNIFICANT DECREASES?

Answer 11

COMPOSITE OF NEPHROPATHY AND RETINOPATHY: -16%

Question 12

LEADER

BESIDES MACE AND EXPANDED, WHAT CV RISK FACTOR OUTCOMES HAD SIGNIFICANT DECREASES?

Answer 12

WEIGHT DECREASE: -5.1 LBS (2-3KG)

BLOOD PRESSURE: -1.2MMHG

MYOCARDIAL INFARCTION (COMPOSITE OF SILENT AND FATAL): -14%

Question 13

LEADER

HOW MANY CASES OF MTC?

Answer 13

1 PATIENT IN THE PLACEBO GROUP

Question 14

LEADER

HOW MANY CASES OF ACUTE AND CHRONIC PANCREATITIS?

PANCREATIC CANCER? PANCREATIC CANCER CASES IN THE PHASE 3 CLINICAL TRIAL PROGRAM?

Answer 14

ACUTE: LESS WITH VICTOZA (18) THAN PLACEBO (23)

CHRONIC: LESS WITH VICTOZA (0) THAN PLACEBO (2)

PANCREATIC CANCER: MORE WITH VICTOZA (13) THAN WITH PLACEBO (9; INCLUDES DEATHS DUE TO MALIGNANCY)

Question 15

LEADER

RATE OF HYPOGLYCEMIA? SEVERE HYPOGLYCEMIA

Answer 15

SIMILAR RATES OF HYPOGLYCEMIA

SIGNIFICANTLY LESS SEVERE HYPO WITH VICTOZA: 2.4% VS 3.3% (P=0.02)

Question 16

LEADER

PERCENT OF GALLBLADDER DISEASE?

Answer 16

GALLBLADDER DISEASE: MORE WITH VICTOZA (3.1%) VS PLACEBO (1.9%) WITH P<001

Question 17

LEADER

PERCENT OF GALLBLADDER DISEASE?

Answer 17

GALLBLADDER DISEASE: MORE WITH VICTOZA (3.1%) VS PLACEBO (1.9%) WITH P