Long Acting Somatostatin Analogs

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Sandostatin LAR depot is a sustained release intramuscular depot preparation of octreotide (93-96). A single, intramuscular, 10-, 20-, or 30-mg injection results

2 3 4 5 6 7 8 Time (hours)

Fig. 7. Effect of octreotide or placebo on hourly growth hormone (GH) levels in acromegaly. Mean percentage changes (± SE of basal values) of serum GH concentrations in patients with acromegaly treated with either 100 ¡¡g octreotide subcutaneously every 8 h (n = 52; a) or placebo (n = 47; b) subcutaneously every 8 h. Blood was sampled before an injection and every hour for 8 subsequent h before treatment (baseline), at the end of wk 2 and 4 of treatment, and 4 wk after discontinuation of treatment (washout). Octreotide or placebo was administered just after the 0-h sampling. (Reproduced from Ezzat S, Snyder PJ, Young WF, et al. Octreotide treatment of acromegaly: a randomized multicenter study. Ann Intern Med 1992;117:711-718.)

• Baseline A 2 weeks A 4 weeks O Washout

Fig. 7. Effect of octreotide or placebo on hourly growth hormone (GH) levels in acromegaly. Mean percentage changes (± SE of basal values) of serum GH concentrations in patients with acromegaly treated with either 100 ¡¡g octreotide subcutaneously every 8 h (n = 52; a) or placebo (n = 47; b) subcutaneously every 8 h. Blood was sampled before an injection and every hour for 8 subsequent h before treatment (baseline), at the end of wk 2 and 4 of treatment, and 4 wk after discontinuation of treatment (washout). Octreotide or placebo was administered just after the 0-h sampling. (Reproduced from Ezzat S, Snyder PJ, Young WF, et al. Octreotide treatment of acromegaly: a randomized multicenter study. Ann Intern Med 1992;117:711-718.)

in peak drug levels at 28 d with sustained suppression of integrated GH levels for up to 49 d (Fig. 8). GH is suppressed after monthly injections for up to 18 mo (97). IGF-1 levels are suppressed in 60-70% of patients receiving Sandostatin LAR depot.

Lanreotide, a 30-mg slow release intramuscular preparation injectable every 7, 10, or 14 d (98-100), suppresses integrated GH to less than 2.5 ng/mL in 60% of patients and normalizes IGF-1 in 60-70% of patients (100). It is not yet approved in the United States.

Clinical Response to Somatostatin Analogs

Octreotide reduces tumor size by 20-80% possibly in a dose-related fashion in about a third of patients (87,101,102), usually within the first 4 mo of initiating therapy. Preoperative octreotide for 3-6 mo may improve postoperative biochemical control (103,104).

Clinical features of acromegaly improve as GH/IGF-1 levels decrease during chronic administration of octreotide (103,105). Headache frequently resolves rapidly, within minutes of injection (106). Soft tissue swelling, caused by sodium and water retention in acromegaly, resolves rapidly with treatment in more than 70% of patients (87) and is accomplished by decreased swelling of face, feet, and hands, and reduced parasthesias and numbness caused by nerve entrapment.

Fig. 8. Long-term serum growth hormone (GH) responses to monthly LAR injections. Results are expressed as mean ( SE of either 12-h or 8-h daily GH profiles. The dose of Sandostatin LAR was 10 mg (n = 3), 20 mg (n = 2), or 30 mg (n = 3) every 60 d for injections 1 and 2 and 20 mg (n = 2), 30 mg (n = 5), or 40 mg (n = 1) every 28 (n = 4) or 42 d (n = 4) thereafter. GH profiles were taken at baseline (no treatment) and on the last day of each injection. (Adapted from ref. 95.)

Fig. 8. Long-term serum growth hormone (GH) responses to monthly LAR injections. Results are expressed as mean ( SE of either 12-h or 8-h daily GH profiles. The dose of Sandostatin LAR was 10 mg (n = 3), 20 mg (n = 2), or 30 mg (n = 3) every 60 d for injections 1 and 2 and 20 mg (n = 2), 30 mg (n = 5), or 40 mg (n = 1) every 28 (n = 4) or 42 d (n = 4) thereafter. GH profiles were taken at baseline (no treatment) and on the last day of each injection. (Adapted from ref. 95.)

Improved control is associated with decreased blood pressure, heart rate, and left-ventricular wall thickness (29,107) in patients without cardiac, renal, or liver disease. Octreotide improves left-ventricular ejection fraction and reduces systemic arterial resistance, oxygen consumption, and fluid volume in patients with cardiac failure. Joint function improves in those patients with bone and cartilage involvement, which can be reversed with chronic therapy (108). Sleep apnea improves after several months (109).

Side Effects

The side effects of somatostatin analogs, usually transient, are caused by the inhibitory effects of somatostatin on gastrointestinal hormones, motility, and secretion (84). Loose stools, flatulence, and nausea occur in approximately one-third of patients.

Patients with diabetes mellitus have lowered insulin requirements, although neither hypoglycemia nor hyperglyemia occur commonly. Reduced gallbladder contractility and delayed emptying occur in up to 25% of patients on octreotide, with subsequent development of gallbladder sludge (110,111). Clinically apparent cholelithiasis is uncommon. The incidence of gallbladder sludge or stones occurs most frequently in China (111), Australia (112), and the United Kingdom (104). In the United States, serial ultrasound suggests that one-third of patients experience echogenic gallbladder deposits, usually within 18 mo of initiating therapy (113), with no further episodes.

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