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At least 19 recordsLinked to original sources
PubMed1989

Long-term safety and efficacy with Fibrel in the treatment of cutaneous scars--results of a multicenter study. Multicenter study group.

Three hundred patients were treated with Fibrel (Serono Laboratories, Randolph, MA) for the correction of cutaneous scars. Fibrel treatment was restricted to four scars with one or two treatments following a negative skin test. The scar corrections were evaluated by the physician, the patient, and also via an objective photogrammetric method. At the end of 1 year, the percentages of scars with moderate, marked, or complete correction were 65.0%, 63.3%, and 85.8% according to physician, patient, and photogrammetric evaluations, respectively. A cohort of 111 patients from the 1-year study were followed for up to 2 years postimplantation to evaluate safety and efficacy. These patients had similar demographic and scar characteristics as the total patient population in the initial study. The efficacy evaluation at the end of 24 months indicated that successful correction was maintained in 64.4%, 58.9%, and 78.9% of scars for physician, patient, and photogrammetric evaluations, respectively. There were no severe hypersensitivity reactions following treatment with Fibrel. The data from these patients demonstrate that one or two Fibrel treatments are effective in maintaining the correction of depressed cutaneous scars for up to 2 years with negligible adverse sequelae.

Adult↗
PubMed1997

Electrocardiographic and hemodynamic changes and their association with myocardial infarction during coronary artery bypass surgery. A multicenter study. Multicenter Study of Perioperative Ischemia (McSPI) Research Group.

BACKGROUND: Electrocardiographic (ECG) changes during coronary artery bypass graft surgery have not been described in detail in a large multicenter population. The authors describe these ECG changes and evaluate them, along with demographic and clinical characteristics and intraoperative hemodynamic alterations, as predictors of myocardial infarction (MI) as defined by two sets of criteria. METHODS: Data from 566 patients at 20 clinical sites, collected as part of a clinical trial to evaluate the efficacy of acadesine for reducing MI, were analyzed at core laboratories. Perioperative ECG changes were identified using continuous three-lead Holter ECG. Systolic blood pressure, diastolic blood pressure, and heart rate were recorded each minute during operation. The occurrence of MI by Q wave or myocardial fraction of creatine kinase (CK-MB) or autopsy criteria, and by (Q wave and CK-MB) or autopsy criteria was determined. RESULTS: During perioperative Holter monitoring, episodes of ST segment deviation, major cardiac conduction changes > or = 30 min, or use of ventricular pacing > or = 30 min occurred in 58% patients, primarily in the first 8 h after release of aortic occlusion. Of the 25% patients who met the Q wave or CK-MB or autopsy criteria for MI, 19% had increased CK-MB as well as ECG changes. (Q wave and CK-MB) or autopsy criteria for MI were met by 4% of patients. The CK-MB concentration generally peaked by 16 h after release of aortic occlusion. In patients with (n = 187) and without a perioperative episode of ST segment deviation, the incidence of MI was 36% and 19%, respectively (P < 0.01), by Q wave or CK-MB or autopsy criteria, and 6% and 3%, respectively (P = 0.055), by (Q wave and CK-MB) or autopsy criteria. Multiple logistic regression analysis showed that intraoperative ST segment deviation, intraventricular conduction defect, left bundle branch block, duration of hypotension (systolic blood pressure < 90 mmHg) after cardiopulmonary bypass, and duration of cardiopulmonary bypass are independent predictors of Q wave or CK-MB or autopsy MI. The independent predictors of (Q wave and CK-MB) or autopsy MI are intraoperative ST segment deviation and duration of aortic occlusion. CONCLUSIONS: Major ECG changes occurred in 58% of patients during coronary artery bypass graft surgery, primarily within 8 h after release of aortic occlusion. Multicenter data collection revealed a substantial variation in the incidence of MI and an overall incidence of up to 25%, with most MI occurring within 16 h after release of aortic occlusion. Intraoperative monitoring of ECG and hemodynamics has incremental value for predicting MI.

Aged↗
PubMed1996

rhGH use in children with CRI and undergoing dialysis post-transplant in Japan: a multicentre study. MultiCenter Study Group Japan.

We evaluated the effect of rhGH at both 0.5 and 1.0 i.u./kg/week, on the growth of 83 CRI (pre- and dialysis) and 23 transplanted children after one year. Growth velocity (GV) was significantly increased in predialysis children on a dose of 0.5 i.u. (p < 0.001), from 3.8cm/year at baseline to 7.8cm/year at six months and 7.3cm/year at one year. On a dose of 1.0 i.u., GV was increased from 4.5cm/year at baseline to 10.3cm/year at six months and 8.7cm/year at one year (p < 0.01). When the increment in GV was compared a significant difference was noted between 0.5 i.u. and 0.1 i.u. at both six and 12 months (p < 0.01). GV was also significantly increased in dialysed children treated with 0.5 i.u., from 3.5cm/year to 5.6cm/year at six months (p < 0.01) and 5.4cm/year at one year (p < 0.01). On a dose of 1.0 i.u., the increase was from 3.4 to 8.4cm/year at six months (p < 0.001) and 8.3cm/year at one year (p < 0.01). There was a significant difference in GV between the 0.5 and 1.0 i.u. groups at both six and 12 months (p < 0.01). In transplanted children, GV was significantly improved over one year of GH treatment from 5.0 to 7.7cm/year at 0.5 i.u. (p < 0.05) and from 3.7 to 6.3cm/year at 1.0 i.u. (p < 0.05); however, there was no statistical difference between the groups. Seven out of 23 children showed evidence of deterioration of graft function during rhGH treatment. This was due to acute rejection (AR) in every case. AR was noted in two of 10 children (20%) in the 0.5 i.u. group and five of 13 children (38%) in the 1.0 i.u. group. Our results demonstrate that rhGH effectively stimulates GV, not only in CRI, but also in dialysed children. Attention should, however, be paid to deterioration of renal function.

Child↗
PubMed1997

No effect of long-term vigabatrin treatment on central nervous system conduction in patients with refractory epilepsy: results of a multicenter study of somatosensory and visual evoked potentials. PMS Study Multicenter Group.

PURPOSE: In dogs, vigabatrin (VGB) has been associated with intramyelinic edema producing delayed central conduction in somatosensory and visual evoked potentials (SEP, VEP). No such effects have been reported in humans. We assessed whether abnormalities of central conduction could be detected prospectively in patients with epilepsy treated with VGB as long-term add-on medication. METHODS: Two hundred one patients with refractory partial epilepsy were enrolled and monitored for as long as 2 years. VGB was added to the treatment at an average dose of 2-3g/day. Conduction in somatosensory and visual pathways was assessed by median nerve SEP and pattern VEP recordings performed at inclusion and once every 6 months. The upper limit and test-retest variability of EP latencies were evaluated at time of enrollment in the patient group. Prolonged N13-N20 or P14-N20 SEP intervals and P100 VEP latency >2.5 SD above the baseline mean, observed on repeated runs in the same session and exceeding the test-retest variability at enrollment were considered to indicate central conduction slowing. RESULTS: One hundred nine patients completed the 2-year study period, and 92 discontinued VGB, of whom 37 were monitored with regard to EP until the end of the study. No consistent change in SEP or VEP was observed in the entire group during VGB treatment. The number of occasional EP values outside the baseline range in patients treated with VGB similar to that in patients whose VGB treatment had been discontinued. CONCLUSIONS: We detected no evidence of changes in SEP and VEP attributable to altered neuronal conduction in the CNS during long-term VGB treatment.

Adolescent↗
PubMed1997

Oral mifepristone 600 mg and vaginal gemeprost for mid-trimester induction of abortion. An open multicenter study. UK Multicenter Study Group.

This open multicenter study was performed in 20 hospital gynecological units in the UK. The effects of 600 mg oral mifepristone as pretreatment to vaginal prostaglandin induction of second trimester abortion was studied in 267 women. The primary efficacy variable was the abortion induction interval, defined as the time taken to expel the fetus from the time of administration of the first prostaglandin pessary. Induction was commenced 36 to 48 hours following mifepristone intake. The mean abortion induction interval was 7 h. A total of 81.9% of women aborted within 12 h. There was a significant relationship between abortion induction interval and age of gestation, and a significant inverse relationship between abortion induction interval and parity. Vomiting, pelvic pain, and nausea were the most frequently reported adverse events. Two patients required transfusion and one patient with a uterine scar from a previous cesarean section suffered a ruptured uterus and hysterotomy.

Abortifacient Agents, Nonsteroidal↗
PubMed2000

Prognostic factors in neuroendocrine lung tumors: a Spanish Multicenter Study. Spanish Multicenter Study of Neuroendocrine Tumors of the Lung of the Spanish Society of Pneumonology and Thoracic Surgery (EMETNE-SEPAR).

BACKGROUND: This study examines the experience of the Spanish Multicenter Study of Neuroendocrine Tumors of the Lung through the clinical data and behavior of patients treated for this pathologic process. METHODS: From 1980 to 1997, 361 cases of neuroendocrine carcinomas (NEC) were treated surgically. Patients were enrolled in a protocol using the pathologic and follow-up reports. According to Dreslers' criteria, the cases were segregated into grade 1 (typical carcinoid), grade 2 (atypical carcinoid), grade 3 large cell type, and grade 3 small cell type. Several variables were reviewed in all patients. Statistical analysis was performed to determine whether clinical characteristics and differentiation were associated with significant differences in the prognosis. RESULTS: A total of 261 cases of NEC were identified with grade 1, 43 with grade 2, and with grade 3: 22 of large and 35 of small cells. Five-year survival for different grades was as follows: grade 1, 96%; 2, 72%; 3 large cell type, 21%; and 3 small cell type, 14%. When a comparative analysis between typical and atypical carcinoids was performed a significant difference for mean age, tumor size, nodal metastases, and recurrence was observed. However, female sex, nodal metastases, and recurrence rate differed between atypical carcinoids and grade 3 NEC of large cells. A difference in recurrence rate was found between patients with both types of grade 3 NEC. CONCLUSIONS: The progressive deterioration of tumor organization highlights that neuroendocrine tumors constitute a continuous spectrum. A careful observation of pathologic findings is necessary to individualize their prognostic factors.

Adult↗
PubMed1996

Treatment of solitary autonomous thyroid nodules by percutaneous ethanol injection: results of an Italian multicenter study. The Multicenter Study Group.

Percutaneous intranodular ethanol injection (PEI) has been proposed for the therapy of autonomously functioning thyroid nodules. In 1992, an Italian multicenter study was undertaken to confirm the usefulness and the feasibility of this procedure. The study included 429 patients: 242 (56.4%) were affected by a toxic adenoma (TA) and 187 (43.5%) by pretoxic adenoma (PTA). Free thyroid hormone levels (FT4, FT3) and thyroid stimulating hormone (TSH) were measured before and 3, 6, 12 months after the end of treatment; thyroid ultrasound and thyroid scintiscan were performed in the majority of patients before and after treatment. Patients underwent 2-12 sessions of ethanol injection under sonographic guidance (median 4). The total amount of ethanol administered per patient (1.5 mL/mL nodular volume) was 2-50 mL (mean +/- SD, 17 +/- 9 mL), and the amount per each injection was 1-8 mL (3.2 +/- 1.3 mL). The treatment was judged successful when both TSH and free thyroid hormone serum levels returned within the normal range and recovery of tracer uptake in extranodular tissue was observed at scintiscan, at any time during the follow-up period. The treatment was considered unsuccessful when no change was observed at scintiscan and/or serum TSH levels remained less than 0.4 mU/L. A successful treatment was achieved in 66.5% of patients with TA and in 83.4% of patients with PTA, when assessed after a 12-month follow-up. In all cases a reduction of the nodular size was observed. Almost all positive results were obtained in nodules whose initial volume was less than 15 mL; large nodules responded less favorably. The treatment was generally well tolerated, only transient side-effects, mainly local pain at the time of injection, were observed. Once normalization of scintigraphic image and of FT4, FT3 and TSH serum concentrations was achieved, no recurrence of hyperthyroidism nor development of hypothyroidism were observed for the length of the study. In conclusion, percutaneous ethanol injection for treatment of autonomously functioning thyroid nodules is effective and safe. Better results are obtained in patients with PTA than in patients with TA, particularly when the initial volume of the nodule is less than or equal to 15 mL. PEI may be considered as an alternative to surgery and to radioiodine for treatment of autonomously functioning thyroid nodules.

Adenoma↗
PubMed1995

Long-term maintenance therapy with cyclosporine and posttreatment survey in severe psoriasis: results of a multicenter study. German Multicenter Study.

BACKGROUND: Although cyclosporine has been found to be effective therapy for severe psoriasis, only limited data exist about efficacy and safety during long-term treatment with a low-dose regimen. Furthermore, little is known about the course of psoriasis after drug withdrawal. OBJECTIVE: Our purpose was to assess the results of long-term therapy with cyclosporine for severe psoriasis with particular regard to efficacy and safety, as well as the disease course after stopping treatment. METHODS: A multicenter study of 217 patients treated with 1.25, 2.5, or 5.0 mg/kg per day of cyclosporine was performed. Duration of treatment ranged from 6 to 30 months followed by a posttreatment period of 3 months. Efficacy was assessed by the Psoriasis Area and Severity Index and safety was monitored by clinical and laboratory investigations. RESULTS: Patients with severe psoriasis showing a reduction in the Psoriasis Area and Severity Index of 75% with their individual dose of cyclosporine maintained clinical improvement during continuous maintenance therapy. Newly occurring side effects were less frequent during the maintenance phase than in the induction phase. After withdrawal of cyclosporine, worsening of psoriasis requiring antipsoriatic therapy was seen in about half of the patients. CONCLUSION: Cyclosporine is effective for long-term therapy for severe psoriasis and does not lead to severe deterioration of the disease after drug withdrawal.

Administration, Cutaneous↗
PubMed1999

Safety and efficacy of shed mediastinal blood transfusion after cardiac surgery: a multicenter observational study. Multicenter Study of Perioperative Ischemia Research Group.

OBJECTIVE: To examine the efficacy and safety of shed mediastinal blood (SMB) transfusion in preventing allogenic red blood cell (RBC) transfusion. DESIGN: An observational clinical study. SETTING: Twelve US academic medical centers. PARTICIPANTS: Six hundred seventeen patients undergoing elective primary coronary artery bypass grafting. INTERVENTIONS: Patients were administered SMB transfusion or not, according to institutional and individual practice, without random assignment. MEASUREMENTS AND RESULTS: The independent effect of SMB transfusion on postoperative RBC transfusion was examined by multivariable modeling. Potential complications of SMB transfusion, such as bleeding and infection, were examined. Three hundred twelve of the study patients (51%) received postoperative SMB transfusion (mean volume, 554 +/- 359 mL). Patients transfused with SMB had significantly lower volumes of RBC transfusion than those not receiving SMB (0.86 +/- 1.50 v 1.08 +/- 1.65 units; p < 0.05). However, multivariable analysis showed that SMB transfusion was not predictive of postoperative RBC transfusion. Demographic factors (older age, female sex), institution, and postoperative events (greater chest tube drainage, lower hemoglobin level on arrival to the intensive care unit, and use of inotropes) were significant predictors of RBC transfusion. The volume of chest tube drainage on the operative day (707 +/- 392 v 673 +/- 460 mL; p = 0.30), reoperation for hemorrhage (3.1% v2.5%; p = 0.68), and overall frequency of infection (5.8% v 6.6%; p = 0.81) were similar between patients receiving and not receiving SMB, respectively. However, in patients who did not receive allogenic RBC transfusion, there was a significantly greater frequency of wound infection in the SMB group (3.6% v0%; p = 0.02). CONCLUSION: These data suggest that SMB is ineffective as a blood conservation method and may be associated with a greater frequency of wound infection.

Aged↗
PubMed2000

Effect of dopexamine on outcome after major abdominal surgery: a prospective, randomized, controlled multicenter study. European Multicenter Study Group on Dopexamine in Major Abdominal Surgery.

OBJECTIVE: To test the hypothesis that dopexamine reduces postoperative mortality and morbidity in high-risk, major abdominal surgery patients, when given to fluid-resuscitated patients starting before the operation and continued for 24 hrs after surgery. DESIGN: Prospective, randomized, controlled, double-blind multicenter trial. SETTING: Intensive care units in 13 hospitals from six European countries. PATIENTS: A total of 412 patients with predefined high-risk criteria, undergoing major abdominal surgery with an expected duration of at least 1.5 hrs. INTERVENTIONS: The patients received placebo (n = 140), dopexamine at 0.5 microg/kg/min (n = 135), or dopexamine at 2.0 microg/kg/ min (n = 137) starting after preoperative hemodynamic stabilization and continued for 24 hrs after surgery. MEASUREMENTS AND MAIN RESULTS: The primary outcome variable was mortality at 28 days. Analysis was by intention to treat. Dopexamine had no effect on mortality (at 28 days, 13%, 7%, and 15%, for the groups receiving placebo, dopexamine at 0.5 microg/kg/ min, and dopexamine at 2.0 microg/kg/min, respectively), despite the expected dose-dependent hemodynamic responses. No effect was observed on the occurrence of organ dysfunction, duration of intensive care unit stay, or length of hospital stay. CONCLUSION: We conclude that dopexamine in doses that result in increased cardiac output and oxygen delivery after preoperative stabilization with fluids does not improve outcome after major abdominal surgery compared with fluids alone. Based on post hoc subgroup analysis and stratification according to the number of risk factors, we suggest that the concept should be further tested in patients at higher risk of complications or undergoing emergency surgery.

Adrenergic beta-Agonists↗
PubMed1996

Genetic restriction of HIV-1 infection and progression to AIDS by a deletion allele of the CKR5 structural gene. Hemophilia Growth and Development Study, Multicenter AIDS Cohort Study, Multicenter Hemophilia Cohort Study, San Francisco City Cohort, ALIVE Study.

The chemokine receptor 5 (CKR5) protein serves as a secondary receptor on CD4(+) T lymphocytes for certain strains of human immunodeficiency virus-type 1 (HIV-1). The CKR5 structural gene was mapped to human chromosome 3p21, and a 32-base pair deletion allele (CKR5Delta32) was identified that is present at a frequency of approximately0.10 in the Caucasian population of the United States. An examination of 1955 patients included among six well-characterized acquired immunodeficiency syndrome (AIDS) cohort studies revealed that 17 deletion homozygotes occurred exclusively among 612 exposed HIV-1 antibody-negative individuals (2.8 percent) and not at all in 1343 HIV-1-infected individuals. The frequency of CKR5 deletion heterozygotes was significantly elevated in groups of individuals that had survived HIV-1 infection for more than 10 years, and, in some risk groups, twice as frequent as their occurrence in rapid progressors to AIDS. Survival analysis clearly shows that disease progression is slower in CKR5 deletion heterozygotes than in individuals homozygous for the normal CKR5 gene. The CKR5Delta32 deletion may act as a recessive restriction gene against HIV-1 infection and may exert a dominant phenotype of delaying progression to AIDS among infected individuals.

Acquired Immunodeficiency Syndrome↗
PubMed1997

Treatment of the anemia of aplastic anemia patients with recombinant human erythropoietin in combination with granulocyte colony-stimulating factor: a multicenter randomized controlled study. Multicenter Study Group.

A multicenter randomized controlled study was undertaken in order to determine whether epoetin beta (EPO) ameliorates the anemia in aplastic anemia (AA) patients treated with granulocyte colony-stimulating factor (G-CSF). Enrolled patients were randomized into 3 groups: group C receiving G-CSF alone as the control; group L receiving G-CSF and 200 IU/kg of EPO; group H receiving G-CSF and 400 IU/kg of EPO. Throughout the study, the dose and the administration interval of G-CSF were adjusted to maintain neutrophil counts between 1000 and 5000 microliters EPO was administered subcutaneously for 12 wk as the first step in treatment and when favorable effects were observed over this period, treatment was continued for another 12 wk as the second step in treatment. Significant erythroid responses were defined as increases in untransfused hemoglobin values > 1.0 g/dl or > 50% decreases in RBC transfusion requirements over the treatment period. Of 131 patients enrolled, 88 patients allocated to groups L and H were evaluated for toxicity to EPO and 110 were evaluated for erythroid responses. Four of the 31 patients (12.9%) in group C, 6 of the 41 patients (14.6%) of group L, and 14 of the 38 patients (36.8%) of group H showed erythroid responses in the first step in treatment. The erythroid responses of group H were significantly higher than those of the other 2 groups (p < 0.05). The significant effects of EPO were due to erythroid responses in non-severe AA. Responding patients were significantly different from non-responders with regard to disease severity, hemoglobin concentration, reticulocyte count, serum endogenous erythropoietin levels and serum transferrin receptors; non-severe AA patients were more likely to respond to EPO, and responding patients had lower serum EPO and higher hemoglobin concentration, reticulocyte count and serum transferrin receptors than non-responders. The response rate increased in the second step in treatment, suggesting that long-term treatment improved the efficacy of EPO. No serious side-effects were observed. From these results, we conclude that EPO given in combination with G-CSF is a safe and effective alternative for the treatment of anemia of a subset of AA patients.

Adult↗
PubMed1997

Primary lymphoma of the stomach: three-year results of a prospective multicenter study. The German Multicenter Study Group on GI-NHL.

BACKGROUND: In October 1992, an ongoing prospective study on primary gastrointestinal (GI) lymphoma was initiated to evaluate histological features, sites of involvement, and management. PATIENTS AND METHODS: Until May 1996, 352 patients were enrolled, with 279 being evaluable for clinical features (208 patients presented with primary gastric lymphoma). Standardized diagnostic workup included central histologic review and endoscopic and radiologic evaluation of the complete GI tract. Primary surgery or conservative management depended on the physician's decision, followed by radiotherapy with or without chemotherapy. Treatment outcome is evaluable in 122 patients with gastric lymphoma. RESULTS: In 279 evaluable patients, the distribution of NHL was as follows: stomach 74.6%, small bowel 8.6%, ileocoecal region 6.5%, multilocal GI involvement 6.8%. In gastric lymphoma, low-grade NHLs accounted for 39%. Of the remaining high-grade NHLs, 36.1% showed simultaneous low-grade components, thus being also of MALT origin. Of 208 patients with gastric NHL, 71.1% were classified as stage I and II1. CCR rate in stomach lymphoma is significantly higher compared to those of the small bowel, whereas involvement of multiple GI organs has the worst prognosis. So far only 7 patients with gastric NHL in stages I and II presented with progressive disease or relapse. Over all stages there seems to be no difference in therapeutic outcome in surgically or conservatively treated patients. Even after R0-resection in limited stages patients appear to have no better outcome. CONCLUSION: The value of surgery in treatment of primary gastric lymphoma--as favored by most authors--should be reexamined.

Adult↗
PubMed1992

Labyrinthotomy with streptomycin infusion: early results of a multicenter study. The LSI Multicenter Study Group.

Early results for hearing and vertigo are reported for 47 labyrinthotomies with streptomycin infusion (LSI) by 13 coinvestigator-surgeons. Sixty-eight percent of patients had worse hearing after surgery (10 dB or 15% word recognition). Patients with a preoperative pure-tone average better than or equal to 40 dB appeared to suffer less postoperative hearing loss than those with a greater preoperative deficit. Severe to profound postoperative hearing loss was experienced by 27 patients (57%), all of whom had preoperative pure-tone averages worse than 40 dB. Opening the endolymphatic space was associated with a deleterious effect on hearing. Because of persistent vertigo, 17 percent of patients required a secondary procedure during the period of observation. These early results indicate that LSI is associated with a significant risk of postoperative hearing loss. Of the 13 coinvestigator-surgeons, four have stopped using LSI, while one considers his results satisfactory. The remaining surgeons have taken an intermediate position and feel it is useful in selected cases. Longer follow-up is required to judge the efficacy of LSI for controlling vertigo. We are currently studying these long-term results.

Adult↗
PubMed1996

Effectiveness and tolerability of slow release lanreotide treatment in active acromegaly: six-month report on an Italian multicenter study. Italian Multicenter Slow Release Lanreotide Study Group.

The objective of the study was to determine the tolerability and effectiveness of the slow release (SR) somatostatin analog lanreotide in active acromegaly. Fifty-seven patients, unselected in terms of their previous responsiveness to octreotide therapy, were included in a prospective, open label study carried out at 6 Italian endocrinological centers. The effects of 6 months of SR lanreotide, given at first every 14 days at a dosage of 30 mg, im, were recorded. In some patients (33%), drug dosage was adjusted by increasing the dose (to 60 mg, im) and/or shortening the time interval (every 10 days) of SR lanreotide administration. Fifty patients completed the 6-month period of therapy; 2 subjects dropped out because of adverse events, and 5 dropped out because of ineffectiveness after changes in drug administration. The first SR lanreotide injection produced more than 50% suppression of GH levels from the basal value in 93% of patients. Thirteen days later, baseline GH levels were reduced by over 50% in 25% of patients. Mean GH values were normalized in 85% of patients after 6 months, whereas insulin-like growth factor I (IGF-I) levels were normalized in 38% of patients. No correlation was found between pretreatment GH levels and GH response to SR lanreotide or between changes in GH and IGF-I during therapy. During treatment, there was a significant reduction in the percentage of patients complaining of joint pain, hyperhydrosis, and paresthesias. Changes in soft tissue swelling were documented by significant decreases in finger measurements. Diarrhea and abdominal pain were the most frequent side-effects when therapy was started; these progressively decreased. After the first month of therapy, moderate, mild, and no side-effects were reported by 3%, 40%, and 53% of patients. A nonsignificant increase occurred in asymptomatic gallstones and amylase levels. Minimal changes were noted in carbohydrate tolerance, consisting of a slight increase in glycosylated hemoglobin, a rise in glucose and a decrease in pre- and postprandial insulin levels. No effects on PRL, free cortisol, TSH, or free thyroid hormone levels were noted. No significant change in the percentage of visual field abnormalities was noted. Decreases in pituitary tumor size occurred in 3 of 17 patients reevaluated after 6 months of therapy. The 6-month period of SR lanreotide therapy was compared, on an anamnestic basis, with a 6-month or longer period of sc octreotide therapy (median, 300 micrograms/day) in 34 patients. There were no differences in effectiveness or tolerability between the 2 somatostatin analogs. These data indicate that SR lanreotide at a dose of 30 mg, im, every 14 days is an effective treatment in most unselected acromegalic patients. When administered to a group of poorly responsive patients, an increase in drug dose (60 mg im) and/or a shortening of the drug interval (10 days) seem to improve the GH/IGF-I response. Tolerability to SR lanreotide therapy is high. The use of a new sustained release formulation of somatostatin analog is clearly advantageous in improving patient compliance with medical treatment for acromegaly.

Acromegaly↗