UPDATED CLINICAL DATA:
Sandostatin LAR® (octreotide acetate for injectable suspension) Is the Only Somatostatin Analogue Proven to Reduce Tumor Volume (1)
In 2 open-label clinical trials, Sandostatin LAR® reduced tumor volume in previously untreated acromegalic patients (1)
The evidence is clear - study results demonstrate patient benefit
- 36% median tumor shrinkage achieved in previously untreated acromegalic patients at Week 48 (n=94)* (1)
- Greater than 20% median tumor shrinkage at Week 24 (n=143) (1)
- No patient experienced an increase in tumor volume while on treatment with Sandostatin LAR® (n=49) (2)
Long-term tolerability (1) and over 600,000 patient-years of experience (3) provide clinical confidence †‡
Based on the results of a postmarketing randomized Phase 4 study. 104 treatment naive ('de novo') acromegalic patients were randomized to either pituitary surgery or 20 mg of Sandostatin LAR®. Crossover was allowed according to treatment response and a total of 76 patients were exposed to Sandostatin LAR®. Approximately half of the patients initially randomized to Sandostatin LAR® were exposed to Sandostatin LAR® up to 1 year. The majority of these patients were exposed to 30 mg every 4 weeks. (1) WHO=World Health Organization.
* Data on file, Novartis Pharmaceuticals.
† Combined experience with immediate release Sandostatin® Injection and Sandostatin LAR®.
‡ Includes both ongoing and completed trials in acromegaly and carcinoid syndrome.
References
- Sandostatin LAR® Depot [prescribing information].
East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 2008. - Mercado M, Borges F, Bouterfa H. A prospective, multicentre study to investigate the efficacy, safety and tolerability of octreotide LAR® (long-acting repeatable octreotide) in the primary therapy of patients with acromegaly. Clin Endocrinol. In press.
- Data on file, Novartis Pharmaceuticals.
