In a study with patients inadequately controlled with a first-generation SSA... PATIENTS WHO SWITCHED TO SIGNIFOR LAR WERE MORE LIKELY TO REACH BIOCHEMICAL CONTROL³

SIGNIFOR LAR was directly compared with octreotide LAR and lanreotide autogel²³

A prospective, multicenter, randomized, parallel-group, phase 3 study in patients who were inadequately controlled* with and switched from a first-generation SSA²³

Study Design: A multicenter, randomized, three-arm study conducted in patients with acromegaly inadequately controlled on a first-generation SSA. Patients were randomized to double-blind SIGNIFOR LAR 40 mg (n=65) or SIGNIFOR LAR 60 mg (n=65) or to continued open-label pretrial SSA therapies at maximal or near maximal doses (n=68). A total of 181 patients completed the 6-month trial.²³

*Inadequately controlled acromegaly defined as GH >2.5 μg/L; IGF-1 >1.3 ULN.

Patients inadequately controlled on another SSA who switched to SIGNIFOR LAR treatment were more likely to experience biochemical control than those who remained on their previous SSA³

†Defined as mean GH concentration <2.5 μg/L and normalized IGF-1 concentration (between the upper and the lower limits of normal).
‡Primary endpoint (patients with IGF-1 < lower limit of normal [LLN] were not considered as “responders”).
§For one active comparator, the maximum approved US dose was not used, but most patients received the most common US dose for acromegaly.

IGF-1 and GH Reduction

SIGNIFOR LAR reduced IGF-1 and GH in patients previously inadequately controlled on a first-generation SSA^23,II

Individualizing Treatment for the Patient with Acromegaly

Presented by Michael H. Shanik, MD, FACP, FACE

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Tumor Reduction

Additional reductions in tumor volume were seen in some patients who switched to SIGNIFOR LAR^23,¶

The proportion of patients with >25% reduction in tumor volume was assessed at 6 months (N=198)

¶In a prospective, multicenter, randomized, parallel-group, phase 3 study in patients who were inadequately controlled with and switched from a first-generation SSA.²³

Adverse events documented in patients inadequately controlled on a first-generation SSA

#Diabetes mellitus includes the terms diabetes mellitus and type 2 diabetes mellitus.
SEE SECTION 6.1 IN FULL PRESCRIBING INFORMATION FOR COMPLETE ADVERSE REACTION TABLE.