TABLE 2.
Original 12-mo trial Treatment |
Patients, No. | Annualized rate (%/y), mean ± SD | |||
---|---|---|---|---|---|
Baseline to year 1 | Year 1 to year 2 (on drug) |
Year 2 to OLEbaseline (off drug) |
OLEbaseline to OLEend (on drug) |
||
Octreotide | 13 | −6.5±4.9 (on drug) | −3.9±5.9 | 4.0±10.2 | −5.7±6.7 |
Placebo | 8 | −1.7±8.9 (off drug) | −8.3±12.3 | 2.4±4.7 | −3.2±5.1 |
Total | 21 | NA | −5.6±9.0b | 3.4±8.2 | −4.7±6.1c |
P value (total rate=0) | NA | .01 | .11 | .002 |
NA = not available; OLEbaseline = reenrollment in a 2-year open-label extension study; OLEend = open-label extension study completion.
P<.001 for total group rate of change on drug from year 1 to year 2 (−5.6%) vs year 2 to OLEbaseline, off drug (3.4%).
P=.001 for total group rate of change on drug from OLEbaseline to OLEend (−4.7%) vs year 2 to OLEbaseline, off drug (3.4%).