Effectiveness of self or partneradministration o

Authors: Roberto Salvatori Lisa B Nachtigall David M Cook Vivien Bonert Mark E Molitch Sandra Blethen Stephen Chang The SALSA Study Group

Publish Date: 2009/11/08

Volume: 13, Issue: 2, Pages: 115-122

PDF Link

Abstract

Surgical resection is often not curative in patients with acromegaly and longacting somatostatin analogues lanreotide or octreotide are often needed This study assessed the efficacy and safety of self or partneradministration of lanreotide in patients with acromegaly This was a sixmonth singlearm openlabel study conducted at 13 endocrinology clinics Fiftynine patients received deep subcutaneous lanreotide injections every 28 days Twelve patients started on 120 mg lanreotide and fortyseven started on 90 mg lanreotide At week 16 the dose was adjusted to 60 90 or 120 mg based on insulinlike growth factor1 IGF1 levels at week 12 Fiftynine patients with acromegaly either switched from longacting octreotide switch n = 33 or were somatostatin analogue treatmentnaïve or not currently taking longacting octreotide “other” n = 26 The key endpoints included the percentage of patients/partners able to self or partnerinject lanreotide and those with normal IGF1 or growth hormone GH levels at week 24/early termination 100 of patients/partners correctly self n = 41 or partnerinjected n = 18 lanreotide by week 4 By week 24/early termination IGF1 levels were controlled in 937 of switch and 462 of “other” patients while GH levels were controlled in 769 and 391 of patients respectively Both IGF1 and GH were controlled in 731 of switch and 304 of “other” patients Most switch patients 81 reported they preferred lanreotide over longacting octreotide for future use P = 00001 Self or partneradministration of lanreotide is generally well tolerated and associated with IGF1 and GH control in many lanreotidenaïve patients with acromegalyMost patients with acromegaly present with pituitary macroadenomas and are therefore often not cured by surgical resection even if the surgery is performed by an experienced neurosurgeon 1 Patients with persistent growth hormone GH excess after surgery require further treatment to reduce serum GH and insulinlike growth factor1 IGF1 and to attain normal life expectancy 2 Such treatment may include radiation or pharmacological therapy In many instances both treatments may be required because radiation effects are often delayed by years 3 Furthermore some studies suggest that primary medical therapy with longacting somatostatin analogues SSAs may be appropriate for patients who are at high surgical risk 4 or prior to surgery as this may improve the surgical cure rate 5 SSAs such as lanreotide Somatuline® Depot Ipsen Pharma Biotech Signes France and longacting octreotide octreotide acetate for injectable suspension LAR Sandostatin LAR® Depot Novatris East Hanover NJ inhibit both GH secretion and tumor growth and are the mainstay of pharmacological therapies for acromegaly 6 7Lanreotide comes in a longacting aqueousgel formulation that is administered via deep subcutaneous injection every 28 days and provides consistent drug release 8 It is provided in a readytouse prefilled syringe which obviates the need for drug reconstitution prior to administration The product is volume dependent and not concentration dependent with volumes ranging from 03–05 cc for delivery of the 60 90 and 120 mg doses A previous study reported that patients with acromegaly receiving a constant dose of lanreotide for ≥4 months before screening were able to successfully self or partneradminister lanreotide while maintaining GH and IGF1 control 9 We report the efficacy and safety of self or partneradministration of lanreotide in patients with acromegaly who were lanreotidenaïve and who switched from longacting octreotide LAR or who were SSA treatmentnaïve or not currently on octreotideThis was a 6month singlearm openlabel multicenter study evaluating the efficacy and safety of self or partneradministration of lanreotide in patients with acromegaly Patients either switched directly from octreotide LAR switch patients or were SSA treatment naïve or not currently on octreotide “other” patients they could have had octreotide 4 months prior to enrollment Patients receiving dopamine agonist DA treatment before the study were maintained on the same DA dosePatients were given the choice to self or partnerinject lanreotide A “partner” was defined as any person whom the patient trusted to administer the injection The local health care professional demonstrated the injection technique at week 0 to either the patient or the partner but the patient or partner administered all the injectionsHealth care professionals completed a questionnaire assessing the competency of each patient/partner at weeks 0 4 8 if needed and 24 The competency questionnaire included questions such as whether or not the patient/partner followed the instructions given administered the injection correctly administered the complete dose inserted the needle correctly and inserted the needle to the appropriate depth Patients completed a questionnaire inquiring about acromegaly symptoms at weeks 0 12 and 24 and an injection diary after each injection A total score for symptoms was calculated at each visit based on the patient’s sweating snoring joint pain headache and fatigue Each symptom was scored as −2 always −1 most of the time 0 sometimes 1 rarely or 2 never Switch patients also completed a convenience questionnaire at weeks 0 and 24 All questionnaires were made available in English and Spanish

Keywords: