DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

 

STATISTICAL REVIEW AND EVALUATION

(amendment of Clinical/Statistical Review of 12/04/02)

NDA #: 20-297

SERIAL #: SE8-009

DRUG NAME: Coreg (carvedilol)

INDICATION: to reduce mortality and the risk of infarction in clinically stable patients

who have survived the acute phase of a myocardial infarction

SPONSOR: Glaxo SmithKline

DOCUMENT REVIEWED:

  1. SAS data base in EDR

STATISTICAL REVIEWER: H.M. James Hung, Ph.D. (HFD-710)

MEDICAL REVIEWER: Norman Stockbridge, M.D. (HFD-110)

STATISTICAL KEY WORDS: Change of primary endpoint, alpha allocation

Distribution: NDA 20-297, SE8-009

HFD-110/Dr. Throckmorton

HFD-110/Dr. Stockbridge

HFD-700/Dr. Anello

HFD-710/Dr. Chi

HFD-710/Dr. Mahjoob

HFD-710/Dr. Hung

HFD-710/chron

JHung/301-594-5436/DB1/capricorn1.doc/12-9-2002

The following table is to replace Table 10 of the clinical/statistical review dated 12/4/02, as a result of some minor changes because a few patients (six in the placebo group and one in the carvedilol group) were hospitalized and died on the same dates. These minor changes did not affect the reviewers’ conclusions in the 12/4/02 review.

Table 10a. Time to event for death or cardiovascular hospitalization

Time (days)

CV hosp only

Death only

Death after hosp

Placebo

N=216

Carvedilol

N=224

Placebo

N=78

Carvedilol

N=65

Placebo

N=73

Carvedilol

N=51

Rand to hosp

Mean

Median

163

98

145

81

___

___

133

68

95

51

Rand to death

Mean

Median

___

___

187

148

195

93

276

233

223

185

Hosp to death

Mean

Median

___

___

___

___

142

66

128

48