Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly.

Lombardi G, Minuto F, Tamburrano G, Ambrosio MR, Arnaldi G, Arosio M, Chiarini V, Cozzi R, Grottoli S, Mantero F, Bogazzi F, Terzolo M, Tita P, Boscani PF, Colao A

Journal of endocrinological investigation1 Mar 2009Cited by 36 (Europe PMC)

PMID19542735DOI10.1007/bf03346453PepBankPUB-19542735

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Summary

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Results from this study22

22 results from studies that gave the peptide. 22 results from people.

01HumanNon-randomized trialEfficacy outcome
In somatostatin analogue-naive acromegaly, lanreotide normalized GH in 32 patients (63%).
In plain wordsIn acromegaly without prior somatostatin analogue treatment, lanreotide normalized growth hormone in 63%.
Peptide
Lanreotide
Outcome
Not applicableGH normalization overall
Study
n = 51
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Patients with normalized GH
32 patients
overall
Patients with normalized GH
63%
overall
Source sentences
Summary
GH levels normalized in 32 patients (63%), similarly in de novo and post-op patients (72% vs 50%, p=0.48); in 100% of group A, in 73% of group B and in 21% of group C (p<0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273501
02HumanNon-randomized trialEfficacy outcome
In somatostatin analogue-naive acromegaly, lanreotide normalized IGF-I in 19 patients (37%).
In plain wordsIn acromegaly without prior somatostatin analogue treatment, lanreotide normalized IGF-I in 37%.
Peptide
Lanreotide
Outcome
Not applicableIGF-I normalization overall
Study
n = 51
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
IGF-I normalization
19 patients
all patients, somatostatin analogue-naive
IGF-I normalization
37%
all patients, somatostatin analogue-naive
Source sentences
Summary
IGF-I levels normalized in 19 patients (37%), similarly in the de novo and post-op patients (33% vs 50%, p=0.48): in 65% of group A, 33% of group B, and in 16% of group C.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273506
03HumanNon-randomized trialEfficacy outcome
In acromegaly, lanreotide reduced circulating GH by 80+/-17%.
In plain wordsIn acromegaly, lanreotide reduced growth hormone by 80+/-17%.
Peptide
Lanreotide
Outcome
DecreaseCirculating GH decrease
Study
n = 51
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Circulating GH decrease
80%
mean decrease, reported as 80+/-17%
Circulating GH decrease, +/- value
17%
spread reported after +/-; type of spread not stated
Source sentences
Summary
Circulating GH levels decreased by 80+/-17%, IGF-I levels by 44+/-27%, and ALS by 30+/-17%.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273511
04HumanNon-randomized trialEfficacy outcome
In acromegaly, lanreotide reduced circulating IGF-I by 44+/-27%.
In plain wordsIn acromegaly, lanreotide reduced IGF-I by 44+/-27%.
Peptide
Lanreotide
Outcome
DecreaseCirculating IGF-I decrease
Study
n = 51
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Circulating IGF-I decrease
44%
mean decrease, reported as 44+/-27%
Circulating IGF-I decrease, +/- value
27%
spread reported after +/-; type of spread not stated
Source sentences
Summary
Circulating GH levels decreased by 80+/-17%, IGF-I levels by 44+/-27%, and ALS by 30+/-17%.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273512
05HumanNon-randomized trialEfficacy outcome
In acromegaly, lanreotide reduced acid-labile subunit by 30+/-17%.
In plain wordsIn acromegaly, lanreotide reduced acid-labile subunit by 30+/-17%.
Peptide
Lanreotide
Outcome
DecreaseAcid-labile subunit decrease
Study
n = 51
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Acid-labile subunit decrease
30%
mean decrease, reported as 30+/-17%
Acid-labile subunit decrease, +/- value
17%
spread reported after +/-; type of spread not stated
Source sentences
Summary
Circulating GH levels decreased by 80+/-17%, IGF-I levels by 44+/-27%, and ALS by 30+/-17%.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273513
06HumanNon-randomized trialEfficacy outcome
In acromegaly, hyperhidrosis significantly improved during lanreotide treatment; the abstract reports 68.6%, p<0.001.
In plain wordsIn acromegaly, excessive sweating significantly improved during lanreotide treatment.
Peptide
Lanreotide
Outcome
Direction not reportedHyperhidrosis improvement
Study
n = 51
Analysis
Secondary
Outcome group
Clinical Symptoms · Whole body
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Hyperhidrosis percentage as reported
68.6%
listed among symptoms that significantly improved; basis of percentage not stated
P
< 0.001
listed symptoms and QoL together
Source sentences
Summary
Symptoms (hyperhidrosis (68.6%), swelling (68.6%), asthenia (58.8%), spine arthralgia (54.9%), and paresthesias (52.9%) and QoL (from 9.1+/-7.9 to 6.1+/-6.6) significantly improved (p<0.001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273514
07HumanNon-randomized trialEfficacy outcome
In acromegaly, swelling significantly improved during lanreotide treatment; the abstract reports 68.6%, p<0.001.
In plain wordsIn acromegaly, swelling significantly improved during lanreotide treatment.
Peptide
Lanreotide
Outcome
Direction not reportedSwelling improvement
Study
n = 51
Analysis
Secondary
Outcome group
Clinical Symptoms · Whole body
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Swelling percentage as reported
68.6%
listed among symptoms that significantly improved; basis of percentage not stated
P
< 0.001
listed symptoms and QoL together
Source sentences
Summary
Symptoms (hyperhidrosis (68.6%), swelling (68.6%), asthenia (58.8%), spine arthralgia (54.9%), and paresthesias (52.9%) and QoL (from 9.1+/-7.9 to 6.1+/-6.6) significantly improved (p<0.001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273515
08HumanNon-randomized trialEfficacy outcome
In acromegaly, asthenia significantly improved during lanreotide treatment; the abstract reports 58.8%, p<0.001.
In plain wordsIn acromegaly, weakness significantly improved during lanreotide treatment.
Peptide
Lanreotide
Outcome
Direction not reportedAsthenia improvement
Study
n = 51
Analysis
Secondary
Outcome group
Clinical Symptoms · Whole body
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Asthenia percentage as reported
58.8%
listed among symptoms that significantly improved; basis of percentage not stated
P
< 0.001
listed symptoms and QoL together
Source sentences
Summary
Symptoms (hyperhidrosis (68.6%), swelling (68.6%), asthenia (58.8%), spine arthralgia (54.9%), and paresthesias (52.9%) and QoL (from 9.1+/-7.9 to 6.1+/-6.6) significantly improved (p<0.001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273516
09HumanNon-randomized trialEfficacy outcome
In acromegaly, spine arthralgia significantly improved during lanreotide treatment; the abstract reports 54.9%, p<0.001.
In plain wordsIn acromegaly, spinal joint pain significantly improved during lanreotide treatment.
Peptide
Lanreotide
Outcome
Direction not reportedSpine arthralgia improvement
Study
n = 51
Analysis
Secondary
Outcome group
Pain · Musculoskeletal
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Spine arthralgia percentage as reported
54.9%
listed among symptoms that significantly improved; basis of percentage not stated
P
< 0.001
listed symptoms and QoL together
Source sentences
Summary
Symptoms (hyperhidrosis (68.6%), swelling (68.6%), asthenia (58.8%), spine arthralgia (54.9%), and paresthesias (52.9%) and QoL (from 9.1+/-7.9 to 6.1+/-6.6) significantly improved (p<0.001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273517
10HumanNon-randomized trialEfficacy outcome
In acromegaly, paresthesias significantly improved during lanreotide treatment; the abstract reports 52.9%, p<0.001.
In plain wordsIn acromegaly, abnormal tingling sensations significantly improved during lanreotide treatment.
Peptide
Lanreotide
Outcome
Direction not reportedParesthesias improvement
Study
n = 51
Analysis
Secondary
Outcome group
Clinical Symptoms · Nervous system and cognition
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Paresthesias percentage as reported
52.9%
listed among symptoms that significantly improved; basis of percentage not stated
P
< 0.001
listed symptoms and QoL together
Source sentences
Summary
Symptoms (hyperhidrosis (68.6%), swelling (68.6%), asthenia (58.8%), spine arthralgia (54.9%), and paresthesias (52.9%) and QoL (from 9.1+/-7.9 to 6.1+/-6.6) significantly improved (p<0.001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273518
11HumanNon-randomized trialEfficacy outcome
In acromegaly, quality of life improved with lanreotide as the score decreased from 9.1+/-7.9 to 6.1+/-6.6, p<0.001.
In plain wordsIn acromegaly, quality of life improved during lanreotide treatment.
Peptide
Lanreotide
Outcome
DecreaseQuality of life score
Study
n = 51
Analysis
Secondary
Outcome group
Quality of life · Whole body
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
QoL score at start
9.1 QoL score
before treatment
QoL score at start, +/- value
7.9 QoL score
spread reported after +/-; type not stated
QoL score at end
6.1 QoL score
after treatment
QoL score at end, +/- value
6.6 QoL score
spread reported after +/-; type not stated
P
< 0.001
listed symptoms and QoL together
Source sentences
Summary
Symptoms (hyperhidrosis (68.6%), swelling (68.6%), asthenia (58.8%), spine arthralgia (54.9%), and paresthesias (52.9%) and QoL (from 9.1+/-7.9 to 6.1+/-6.6) significantly improved (p<0.001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273519
12HumanNon-randomized trialSafety outcome
In acromegaly, no patient withdrew from lanreotide treatment because of adverse events.
In plain wordsIn acromegaly, no patient left lanreotide treatment because of adverse events.
Peptide
Lanreotide
Outcome
Not applicableAdverse-event withdrawals
Study
n = 51
Outcome group
Adverse events · Whole body
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Source sentences
Summary
No patient withdrew from the study because of adverse events (AE).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273520
13HumanNon-randomized trialSafety outcome
In acromegaly, gallstones developed in 12% during lanreotide treatment.
In plain wordsIn acromegaly, gallstones developed in 12% during lanreotide treatment.
Peptide
Lanreotide
Outcome
Not applicableGallstones
Study
n = 51
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Gallstone incidence
12%
patients
Source sentences
Summary
Gallstones developed in 12% of patients.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273522
14HumanNon-randomized trialSafety outcome
In acromegaly, diarrhea occurred in 76.2% of patients during lanreotide treatment; 16 mild and 1 moderate diarrhea cases were recorded at study end.
In plain wordsIn acromegaly, diarrhea occurred in 76.2% during lanreotide treatment.
Peptide
Lanreotide
Outcome
Not applicableDiarrhea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Diarrhea incidence
76.2%
patients; denominator not stated
Mild diarrhea cases at study end
16 cases
at study end
Moderate diarrhea cases at study end
1 cases
at study end
Source sentences
Summary
The most frequent AE was diarrhea (76.2% of patients): at study end 16 mild and 1 moderate diarrhea were recorded.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273521
15HumanObservational studyEfficacy outcome
With lanreotide in acromegaly, GH normalization was similar in de novo and postoperative patients: 72% versus 50%, p=0.48.
In plain wordsWith lanreotide in acromegaly, growth hormone normalization was similar in newly diagnosed patients and patients with previous surgery.
Peptide
Lanreotide
Outcome
No significant changeGH normalization by prior surgery
Study
n = 51
Comparator
Prior unsuccessful surgery
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
Patients with normalized GH
72%
de novo patients
Patients with normalized GH
50%
post-op patients
Source sentences
Summary
GH levels normalized in 32 patients (63%), similarly in de novo and post-op patients (72% vs 50%, p=0.48); in 100% of group A, in 73% of group B and in 21% of group C (p<0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273502
16HumanObservational studyEfficacy outcome
With lanreotide in acromegaly, IGF-I normalization was similar in de novo and postoperative patients: 33% versus 50%, p=0.48.
In plain wordsWith lanreotide in acromegaly, IGF-I normalization was similar in newly diagnosed patients and patients with previous surgery.
Peptide
Lanreotide
Outcome
No significant changeIGF-I normalization by prior surgery
Study
n = 51
Comparator
Prior unsuccessful surgery
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4-8 weeks · 48-52 weeksAs given in this study (human).
Measurements
IGF-I normalization
33%
de novo patients
IGF-I normalization
50%
post-op patients
P
0.48
de novo versus post-op
Source sentences
Summary
IGF-I levels normalized in 19 patients (37%), similarly in the de novo and post-op patients (33% vs 50%, p=0.48): in 65% of group A, 33% of group B, and in 16% of group C.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273507
17HumanObservational studyEfficacy outcome
In acromegaly patients whose GH levels set a four-week lanreotide interval after the initial 24 weeks (group C, 19 patients), GH normalized in 21%; the difference among groups A, B and C had p<0.0001.
In plain wordsIn acromegaly patients whose GH levels put them on lanreotide every four weeks, growth hormone normalized in 21%.
Peptide
Lanreotide
Outcome
Not applicableGH normalization, four-week schedule
Study
n = 19
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4 weeks after initial 24 weeks · 48-52 weeksAs given in this study (human).
Measurements
GH normalization
21%
group C, four-week interval (19 patients)
P
< 0.0001
difference among groups A, B and C
Source sentences
Summary
GH levels normalized in 32 patients (63%), similarly in de novo and post-op patients (72% vs 50%, p=0.48); in 100% of group A, in 73% of group B and in 21% of group C (p<0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273505
18HumanObservational studyEfficacy outcome
In acromegaly patients whose GH levels set a four-week lanreotide interval after the initial 24 weeks (group C, 19 patients), IGF-I normalized in 16%.
In plain wordsIn acromegaly patients whose GH levels put them on lanreotide every four weeks, IGF-I normalized in 16%.
Peptide
Lanreotide
Outcome
Not applicableIGF-I normalization, four-week schedule
Study
n = 19
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4 weeks after initial 24 weeks · 48-52 weeksAs given in this study (human).
Measurements
IGF-I normalization
16%
group C, four-week interval (19 patients)
Source sentences
Summary
IGF-I levels normalized in 19 patients (37%), similarly in the de novo and post-op patients (33% vs 50%, p=0.48): in 65% of group A, 33% of group B, and in 16% of group C.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273510
19HumanObservational studyEfficacy outcome
In acromegaly patients whose GH levels set an eight-week lanreotide interval after the initial 24 weeks (group A, 17 patients), GH normalized in 100%.
In plain wordsIn acromegaly patients whose GH levels put them on lanreotide every eight weeks, growth hormone normalized in 100%.
Peptide
Lanreotide
Outcome
Not applicableGH normalization, eight-week schedule
Study
n = 17
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 8 weeks after initial 24 weeks · 48-52 weeksAs given in this study (human).
Measurements
GH normalization
100%
group A, eight-week interval (17 patients)
Source sentences
Summary
GH levels normalized in 32 patients (63%), similarly in de novo and post-op patients (72% vs 50%, p=0.48); in 100% of group A, in 73% of group B and in 21% of group C (p<0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273503
20HumanObservational studyEfficacy outcome
In acromegaly patients whose GH levels set an eight-week lanreotide interval after the initial 24 weeks (group A, 17 patients), IGF-I normalized in 65%.
In plain wordsIn acromegaly patients whose GH levels put them on lanreotide every eight weeks, IGF-I normalized in 65%.
Peptide
Lanreotide
Outcome
Not applicableIGF-I normalization, eight-week schedule
Study
n = 17
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 8 weeks after initial 24 weeks · 48-52 weeksAs given in this study (human).
Measurements
IGF-I normalization
65%
group A, eight-week interval (17 patients)
Source sentences
Summary
IGF-I levels normalized in 19 patients (37%), similarly in the de novo and post-op patients (33% vs 50%, p=0.48): in 65% of group A, 33% of group B, and in 16% of group C.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273508
21HumanObservational studyEfficacy outcome
In acromegaly patients whose GH levels set a six-week lanreotide interval after the initial 24 weeks (group B), GH normalized in 73%.
In plain wordsIn acromegaly patients whose GH levels put them on lanreotide every six weeks, growth hormone normalized in 73%.
Peptide
Lanreotide
Outcome
Not applicableGH normalization, six-week schedule
Study
n = 15
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 6 weeks after initial 24 weeks · 48-52 weeksAs given in this study (human).
Measurements
GH normalization
73%
group B, six-week interval (15 patients)
Source sentences
Summary
GH levels normalized in 32 patients (63%), similarly in de novo and post-op patients (72% vs 50%, p=0.48); in 100% of group A, in 73% of group B and in 21% of group C (p<0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273504
22HumanObservational studyEfficacy outcome
In acromegaly patients whose GH levels set a six-week lanreotide interval after the initial 24 weeks (group B), IGF-I normalized in 33%.
In plain wordsIn acromegaly patients whose GH levels put them on lanreotide every six weeks, IGF-I normalized in 33%.
Peptide
Lanreotide
Outcome
Not applicableIGF-I normalization, six-week schedule
Study
n = 15
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 6 weeks after initial 24 weeks · 48-52 weeksAs given in this study (human).
Measurements
IGF-I normalization
33%
group B, six-week interval (15 patients)
Source sentences
Summary
IGF-I levels normalized in 19 patients (37%), similarly in the de novo and post-op patients (33% vs 50%, p=0.48): in 65% of group A, 33% of group B, and in 16% of group C.
4 context sentences(design, population, supporting numbers)
Summary · context
Open, non-comparative, phase III, multicenter clinical study.
Summary · context
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied.
Summary · context
ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if 5 microg/l every 4 weeks (group C, 19 patients).
Summary · context
Treatment duration was 48-52 weeks.
Report a problemFND-1954273509

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00499993

Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

Ipsenn = 63Jan 2001 to May 2003

Acromegaly

Trial page ClinicalTrials.govUpdated 15 Jan 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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