Efficacy and safety of lanreotide 120 mg in the treatment of clinical symptoms associated with inoperable malignant intestinal obstruction (IMIO): Results from a phase II multicenter study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4118-4118
Author(s):  
Lionel Duck ◽  
Gauthier Demolin ◽  
Lionel A. D'Hondt ◽  
Catherine Dopchie ◽  
Koenraad Hendrickx ◽  
...  
Keyword(s):  
Intestinal Obstruction ◽  
Clinical Symptoms ◽  
Statistical Significance ◽  
Somatostatin Analogues ◽  
The Other ◽  
Efficacy And Safety ◽  
Gynecological Cancers ◽  
Long Acting ◽  
Clinical Trial Information ◽  
Time Point

4118 Background: Intestinal obstruction is a severe complication in patients (pts) with digestive or gynecological cancers. For inoperable pts, there is a need to relieve symptoms and limit nasogastric tube (NGT) use. Previous studies have suggested the efficacy of somatostatin analogues in relieving obstruction-related symptoms such as nausea, vomiting and pain. Methods: This was a single arm, prospective study (NCT02275338). Pts with IMIO received one deep subcutaneous injection of LAN 120mg at day 0 (D0). Evaluations were performed on D7, 14 and 28. The primary endpoint was the proportion of responders before or at D7. Response was defined as ≤2 vomiting episodes/day (for pts without NGT at baseline) or no vomiting recurrence (after NGT removal), during at least 3 consecutive days at any time point between the D0 and D7. In line with the literature, a proportion of 30% responders was used as reference for defining statistical significance. Responders at D28 were offered a second LAN 120 mg injection. Results: 52 pts with advanced GI or ovarian malignancies were included in 15 Belgian sites. 17 pts without NGT and 35 with NGT. 21 pts received a second dose of LAN. Median age was 68.0 (59.5; 76.0) years. On D7 the proportion of responders in the ITT population was 24/52 (46.2%), significantly greater than the reference proportion of 30% (one-sided binomial test: p = 0.006). Pts without NGT responded better (15/17, 88.2%) than pts with NGT (9/35, 25.7%). Pts without ascites responded better (57.7% vs 34.6%). Pts with NGT showed a steady trend for clinical improvement leading to sustainable responses of 45.7% on D14. Median time to response was 9 days for the overall population; 3 days for patients without NGT vs 14 days for patients with NGT (p < 0.001). The most frequently reported AEs were GI disorders (in 34 pts). The most common events were diarrhoea and abdominal pain. Conclusions: Our study is the first using long acting LAN 120mg in patients with IMIO and suggests an effect in controlling clinical symptoms in pts with and without NGT at baseline. LAN 120 mg safety profile was similar to that reported for the other indications. Clinical trial information: NCT02275338.

scholarly journals Efficacy and safety of switching to pasireotide in acromegaly patients controlled with pegvisomant and somatostatin analogues: PAPE extension study

2018 ◽  
Vol 179 (5) ◽  
pp. 269-277 ◽  
Author(s):  
Ammar Muhammad ◽  
Eva C Coopmans ◽  
Patric J D Delhanty ◽  
Alof H G Dallenga ◽  
Iain K Haitsma ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Insulin Secretion ◽  
Somatostatin Analogues ◽  
Tolerance Test ◽  
Extension Study ◽  
Oral Glucose ◽  
Efficacy And Safety ◽  
Igf I ◽  
Core Study ◽  
Long Acting

ObjectiveTo assess the efficacy and safety after 48 weeks of treatment with pasireotide long-acting-release (PAS-LAR) alone or in combination with pegvisomant in patients with acromegaly. In addition, we assessed the relation between insulin secretion and pasireotide-induced hyperglycemia.DesignThe PAPE extension study is a prospective follow-up study until 48 weeks after the core study of 24 weeks.MethodsFifty-nine out of 61 patients entered the extension study. Efficacy was defined as the percentage of patients achieving IGF-I normalization (≤1.2× the upper limit of normal (ULN)) at 48 weeks through protocol-based adjustment of pegvisomant and PAS-LAR doses. At baseline, insulin secretion was assessed by an oral glucose tolerance test (OGTT).ResultsAt the end of the study, median IGF-I was 0.98× ULN, and 77% of patients achieved normal IGF-I levels with a mean pegvisomant dose of 64 mg/week, and an overall cumulative pegvisomant dose reduction of 52%. Frequency of diabetes mellitus increased from 68% at 24 weeks to 77% at 48 weeks, and nine patients discontinued PAS-LAR treatment, mainly because of severe hyperglycemia. Pasireotide-induced hyperglycemia was inversely correlated with baseline insulin secretion (r = −0.37,P < 0.005).ConclusionsPAS-LAR normalizes IGF-I levels in most acromegaly patients, with a 50% pegvisomant-sparing effect. However, PAS-LAR treatment coincided with a high incidence of diabetes mellitus. The risk for developing diabetes during PAS-LAR treatment seems inversely related to insulin secretion at baseline.

scholarly journals THE EFFECT OF SODIUM CHLORIDE ON THE CHEMICAL CHANGES IN THE BLOOD OF THE DOG AFTER PYLORIC AND INTESTINAL OBSTRUCTION

1923 ◽  
Vol 38 (1) ◽  
pp. 55-71 ◽  
Author(s):  
Russell L. Haden ◽  
Thomas G. Orr
Keyword(s):  
Sodium Chloride ◽  
Sodium Bicarbonate ◽  
Intestinal Obstruction ◽  
Clinical Symptoms ◽  
The Other ◽  
Distilled Water ◽  
Protein Nitrogen ◽  
The Third ◽  
Cent Sodium ◽  
And Inversion

Experiments to determine the effect of furnishing an ample supply of sodium chloride on the toxemia of pyloric and intestinal obstruction are reported. A fall in chlorides is the first and seemingly most significant change to take place in the blood after pyloric and intestinal obstruction. The chloride is apparently utilized by the body as a protective measure against the primary toxic substance. Two dogs with pyloric obstruction were given 50 cc. of 10 per cent NaCl subcutaneously daily. One lived 3 days, the other 4. The blood showed little change, except a marked terminal rise in chlorides. Animals given a like amount of distilled water or 25 per cent glucose showed the changes typical of untreated animals. The obstruction of the pylorus was released in six dogs 48 to 72 hours after the initial operation. Two died within 24 hours after the second operation with a high non-protein nitrogen in the blood. Two survived but showed a high level of non-protein nitrogen in the blood and a high nitrogen excretion in the urine, low blood chlorides, and a marked alkalosis. One dog in such a state died on the 13th day from peritonitis, arising in a wound infection. The other showed a marked fall in non-protein nitrogen in the blood following the administration of 10 gm. of sodium chloride by mouth, but died following the intravenous injection of 25 per cent sodium chloride. Two animals were given 50 cc. of 10 per cent NaCl subcutaneously, at the time of the second operation. The blood rapidly returned to normal and complete recovery followed. Two dogs with the duodenum obstructed by section and inversion of the cut ends were treated with 10 per cent sodium chloride after the obstruction had existed for 48 hours and the characteristic blood changes had developed. The non-protein nitrogen returned to normal within 48 hours after treatment was begun. One dog died following a lateral anastomosis for relief of the obstruction. A second operation was not attempted in the other animal. Two dogs in which the duodenum was obstructed by section and inversion of the cut ends were given 500 cc. of 0.85 per cent NaCl subcutaneously on the day of operation and each day thereafter until death. One dog lived 21 days, the other 28. Both dogs showed a marked alkalosis, but never any rise in the non-protein nitrogen of the blood. The animals at autopsy showed intussusception of the ileum with extensive ulceration. In one there was a perforation and terminal peritonitis. The operation wounds healed normally. Three dogs with section of the duodenum were given 500 cc. of distilled water every day. One died in 24 hours, one in 48 hours, and the third in 72 hours. Autopsy showed no cause for death other than toxemia. One dog with section of the duodenum was given 500 cc. of 2 per cent glucose every day. The blood showed a rapid rise in non-protein nitrogen and carbon dioxide-combining power, and a fall in chlorides. The animal died 72 hours after operation. Three dogs with section of the duodenum were given 500 cc. of 1 per cent sodium bicarbonate every day. One dog died in 72 hours, one lived 7 days, and the third lived 9 days. All developed a high non-protein nitrogen in the blood and two showed marked clinical symptoms of an alkalosis. These results demonstrate that solutions of sodium chloride have a marked effect in preventing and controlling the toxemia of pyloric and intestinal obstruction as shown in clinical symptoms and in chemical changes in the blood. Dogs given an abundant supply of distilled water died more quickly than untreated control animals. Solutions of glucose have no specific value, and sodium bicarbonate solutions prolong life only a short while. Good therapeutic results have been obtained with very concentrated sodium chloride solutions, and with dry sodium chloride given by mouth. It seems evident that sodium chloride has a specific action in preventing and possibly in controlling the changes produced by the toxic body. Sodium chloride is a valuable therapeutic agent in pyloric and high intestinal obstruction.

scholarly journals Fluoroscopy guided stent placement for the treatment of malignant afferent loop obstruction

2021 ◽  
Author(s):  
Chaoyang Wang ◽  
Xiaoyi Duan ◽  
Lequn Wei ◽  
Tong Wang ◽  
Huanzhang Niu
Keyword(s):  
Tumor Progression ◽  
Stent Placement ◽  
Clinical Symptoms ◽  
Operation Time ◽  
The Other ◽  
Efficacy And Safety ◽  
Safe Method ◽  
Afferent Loop ◽  
Afferent Loop Obstruction

Abstract BACKGROUND & AIM: To evaluate the efficacy and safety of fluoroscopy guided stent placement for the treatment of malignant afferent loop obstruction (ALO). METHODS 12 patients with malignant ALO in whom fluoroscopy guided stent placement had been performed were analyzed retrospectively. The operation time, clinical efficacy, complications and postoperative hospitalization were observed. Follow-up was scheduled at 1 and 3 months after the operation, and every 3 months thereafter, or when the patients developed clinical symptoms related to ALO. RESULTS Stent placement was performed successfully in 11 patients with an average time of 37.9 ± 12.2 min. For the other one patient, we adopted transnasal drainage tube implantation in afferent loop instead of stent placement. All the patients had an obvious relief of clinical symptoms, and no serious complications occurred. During the follow-up, 1 patient had restenosis 12 months later as the tumor grew across the stent mesh. 7 patients died of tumor progression at 3, 4.5, 5, 7, 8, 11 and 15 months after the operation. CONCLUSION Fluoroscopy guided stent placement is an effective and safe method for the treatment of malignant ALO.

scholarly journals A study of the efficacy and safety of switching from oral risperidone to risperidone long-acting injection in older patients with schizophrenia

2012 ◽  
Vol 2 (6) ◽  
pp. 227-234 ◽  
Author(s):  
Hidenobu Suzuki ◽  
Yuichi Inoue ◽  
Keishi Gen
Keyword(s):  
Older Patients ◽  
Concomitant Medication ◽  
Clinical Symptoms ◽  
Severity Of Illness ◽  
Symptom Improvement ◽  
Control Group ◽  
Efficacy And Safety ◽  
Drug Induced ◽  
Oral Risperidone ◽  
Long Acting

Objective We investigated the clinical efficacy and safety of switching to risperidone long-acting injection (RLAI) in older patients with schizophrenia receiving oral risperidone. Methods The subjects were 48 inpatients who had been diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Their clinical symptoms were assessed using the Positive and Negative Syndrome Scale and the Clinical Global Impression – Severity of Illness scale, and their safety was assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS), body weight, body mass index, and blood biochemistry tests. Results No significant differences in clinical symptom improvement efficacy were seen between the group switched to RLAI and the control group. The mean changes from baseline on the DIEPSS total score and prolactin level were significantly greater in the older group switched to RLAI than in the control group. Furthermore, in older patients, RLAI allowed the dosage of the concomitant medication to be significantly reduced compared with the control group. Conclusion The results of this study suggest that switching older patients from oral risperidone to RLAI may result in superior efficacy and safety, and may also make it possible to reduce the dosage of the concomitant medication.

scholarly journals Experience of using long-acting testosterone undecanoate in hypogonadism, obesity and metabolic syndrome in men

2013 ◽  
Vol 10 (1) ◽  
pp. 43-46
Author(s):  
R V Rozhivanov
Keyword(s):  
Metabolic Syndrome ◽  
Side Effects ◽  
Sexual Function ◽  
The Other ◽  
Efficacy And Safety ◽  
Testosterone Undecanoate ◽  
Reduced Body ◽  
The Metabolic Syndrome ◽  
Number Of Patients ◽  
Long Acting

The paper outlines the author's experience on the efficacy and safety of androgen therapy of metabolic syndrome and obesity in men with hypogonadism. The study used testosterone undecanoate therapy that reduced body fat and the severity of the other components of the metabolic syndrome, improved sexual function without causing severe side effects. A number of patients on therapy observed suppression of spermatogenesis, which prevents the use of the drug in the reproductive rehabilitation.

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