The clinical trials of SANDOSTATIN LAR DEPOT were performed in patients who had been receiving Sandostatin Injection for a period of weeks to as long as 10 years. The acromegaly studies with SANDOSTATIN LAR DEPOT described below were performed in patients who achieved GH levels of < 10 ng/mL (and, in most cases < 5 ng/mL) while on subcutaneous Sandostatin Injection. However, some patients enrolled were partial responders to subcutaneous Sandostatin Injection, i.e., GH levels were reduced by > 50% on subcutaneous Sandostatin Injection compared to the untreated state, although not suppressed to < 5 ng/mL.

SANDOSTATIN LAR DEPOT was evaluated in three clinical trials in acromegalic patients.

In 2 of the clinical trials, a total of 101 patients were entered who had, in most cases, achieved a GH level < 5 ng/mL on Sandostatin Injection given in doses of 100 mcg or 200 mcg three times daily. Most patients were switched to 20 mg or 30 mg doses of SANDOSTATIN LAR DEPOT given once every 4 weeks for up to 27 to 28 injections. A few patients received doses of 10 mg and a few required doses of 40 mg. Growth hormone and IGF-1 levels were at least as well controlled with SANDOSTATIN LAR DEPOT as they had been on Sandostatin Injection and this level of control remained for the entire duration of the trials.

A third trial was a 12-month study that enrolled 151 patients who had a GH level < 10 ng/mL after treatment with Sandostatin Injection (most had levels < 5 ng/mL). The starting dose of SANDOSTATIN LAR DEPOT was 20 mg every 4 weeks for 3 doses. Thereafter, patients received 10 mg, 20 mg, or 30 mg every 4 weeks, depending upon the degree of GH suppression [see Dosage and Administration (2)]. Growth hormone and IGF-1 were at least as well controlled on SANDOSTATIN LAR DEPOT as they had been on Sandostatin Injection.

Table 5 summarizes the data on hormonal control (GH and IGF-1) for those patients in the first two clinical trials who received all 27 to 28 injections of SANDOSTATIN LAR DEPOT.

For the 88 patients in Table 5, a mean GH level of < 2.5 ng/mL was observed in 47% receiving SANDOSTATIN LAR DEPOT. Over the course of the trials, 42% of patients maintained mean growth hormone levels of < 2.5 ng/mL and mean normal IGF-1 levels.

Table 6 summarizes the data on hormonal control (GH and IGF-1) for those patients in the third clinical trial who received all 12 injections of SANDOSTATIN LAR DEPOT.

For the 122 patients in Table 6, who received all 12 injections in the third trial, a mean GH level of < 2.5 ng/mL was observed in 66% receiving SANDOSTATIN LAR DEPOT. Over the course of the trial, 57% of patients maintained mean growth hormone levels of < 2.5 ng/mL and mean normal IGF-1 levels. In comparing the hormonal response in these trials, note that a higher percentage of patients in the third trial suppressed their mean GH to < 5 ng/mL on subcutaneous Sandostatin Injection, 95%, compared to 78% across the 2 previous trials.

In all 3 trials, GH, IGF-1, and clinical symptoms were similarly controlled on SANDOSTATIN LAR DEPOT as they had been on Sandostatin Injection.

Of the 25 patients who completed the trials and were partial responders to Sandostatin Injection (GH > 5.0 ng/mL but reduced by > 50% relative to untreated levels), 1 patient (4%) responded to SANDOSTATIN LAR DEPOT with a reduction of GH to < 2.5 ng/mL and 8 patients (32%) responded with a reduction of GH to < 5.0 ng/mL.

Two open-label clinical studies investigated a 48-week treatment with SANDOSTATIN LAR DEPOT in 143 untreated (de novo) acromegalic patients. The median reduction in tumor volume was 20.6% in Study 1 (49 patients) at 24 weeks and 24.5% in Study 2 (94 patients) at 24 weeks and 36.2% at 48 weeks.