-
Pituitary Dec 2018Acromegaly is a rare disease that results in the enlargement of body extremities and in organomegaly. Treatments include surgery, drugs, and radiotherapy, which are all... (Review)
Review
PURPOSE
Acromegaly is a rare disease that results in the enlargement of body extremities and in organomegaly. Treatments include surgery, drugs, and radiotherapy, which are all onerous. Therefore, well-conducted cost-analyses are crucial in the decision-making process.
METHODS
A systematic review of cost-effectiveness studies on acromegaly therapies was performed following PRISMA and Cochrane recommendations. The search for records was conducted in PubMed, Scopus, and Web of Science (May 2018). The quality of the included studies was assessed using the Joana Briggs Institute Tool.
RESULTS
From initial 547 records, 16 studies were included in the review. The studies could present more than one economic evaluation, and encompassed cost-effectiveness (n = 13), cost-utility (n = 5), and cost-consequence (n = 1) analyses. All studies were model-based and evaluated only direct medical costs. Eleven records did not mention discounting and only 10 performed sensitivity analyses. The characteristic of the studies, the cost-effectiveness results and the studies' conclusions are described and commented upon. The main limitation of the studies was discussed and aspects to improve in future studies were pointed out.
CONCLUSIONS
Cost-effectiveness studies on acromegaly have been performed in several scenarios, evaluating different phases of treatment. However, the studies present limitations and, overall, were considered of moderate quality. Further economic models should be developed following health economics guidelines recommendations, and must improve transparency.
Topics: Acromegaly; Cost-Benefit Analysis; Human Growth Hormone; Humans; Octreotide; Peptides, Cyclic; Somatostatin
PubMed: 30159696
DOI: 10.1007/s11102-018-0908-0 -
Therapeutic Advances in Infectious... Jul 2018Chylous ascites is an uncommon presentation of mycobacterial infection. (Review)
Review
BACKGROUND
Chylous ascites is an uncommon presentation of mycobacterial infection.
METHODS
We report three cases of tubercular chylous ascites, and in addition, we performed a systematic review of the published literature for the clinical presentation, treatment, and outcomes of mycobacterial chylous ascites. We followed the PRISMA guidelines for the systematic review.
RESULTS
A total of 33 cases (including three of ours) were included. The mean age of the reported cases was 32.54 ± 17.56 years, and a male predominance (76%) was noted. The predominant clinical features were abdominal distension, abdominal pain, fever and loss of appetite and weight. (MTB) and (MAC) infection were responsible for 16 and 15 cases, respectively. All patients with MAC related chylous ascites had HIV infection. The mechanisms were related to lymph nodal enlargement, constrictive pericarditis and remote scrofuloderma. Overall, there was 29% mortality. Use of anti-mycobacterial therapy with use of total parenteral nutrition, octreotide and medium chain triglyceride-based diet resulted in improvement in the rest of the cases. The cause of death in our case was anti-tubercular therapy-induced hepatitis; three deaths were due to disseminated mycobacterial infection, one due to cardiopulmonary failure and unknown in four patients.
CONCLUSION
Chylous ascites due to mycobacterial infection is uncommon and associated with poor outcome. However, early diagnosis and nutritional management along with antimycobacterial therapy can improve outcome.
PubMed: 30013774
DOI: 10.1177/2049936118772754 -
EJNMMI Physics May 2023While diagnostic reference levels (DRLs) are well-established for the radiopharmaceutical part, published DRLs for the CT component of positron emission... (Review)
Review
BACKGROUND
While diagnostic reference levels (DRLs) are well-established for the radiopharmaceutical part, published DRLs for the CT component of positron emission tomography/computed tomography (PET/CT) and single photon emission computed tomography/computed tomography (SPECT/CT) are limited. This systematic review and meta-analysis provides an overview of the different objectives of CT in hybrid imaging and summarizes reported CT dose values for the most common PET/CT and SPECT/CT examinations. Also, an overview of already proposed national DRLs is given.
METHODS
A systematic literature search was performed to identify original articles reporting CT dose index volume (CTDI), dose-length product (DLP) and/or national DRLs for the most frequently performed PET/CT and/or SPECT/CT examinations. Data were grouped according to the clinical objective: diagnostic (D-CT), anatomical localisation (AL-CT) or attenuation correction (AC-CT) CT. Random-effects meta-analyses were conducted.
RESULTS
Twenty-seven articles were identified of which twelve reported national DRLs. For brain and tumour PET/CT imaging, CTDI and DLP values were higher for a D-CT (brain: 26.7 mGy, 483 mGy cm; tumour: 8.8 mGy, 697 mGy cm) than for an AC/AL-CT (brain: 11.3 mGy, 216 mGy cm; tumour: 4.3 mGy, 419 mGy cm). Similar conclusions were found for bone and parathyroid SPECT/CT studies: D-CT (bone: 6.5 mGy, 339 mGy cm; parathyroid: 15.1 mGy, 347 mGy cm) results in higher doses than AL-CT (bone: 3.8 mGy, 156 mGy cm; parathyroid: 4.9 mGy, 166 mGy cm). For cardiac (AC-CT), mIBG/octreotide, thyroid and post-thyroid ablation (AC/AL-CT) SPECT/CT pooled mean CTDI (DLP) values were 1.8 mGy (33 mGy cm), 4.6 mGy (208 mGy cm), 3.1 mGy (105 mGy cm) and 4.6 mGy (145 mGy cm), respectively. For all examinations, high variability in nuclear medicine practice was observed.
CONCLUSION
The large variation in CT dose values and national DRLs highlights the need for optimisation in hybrid imaging and justifies the clinical implementation for nuclear medicine specific DRLs.
PubMed: 37227561
DOI: 10.1186/s40658-023-00553-8 -
Lung Cancer (Amsterdam, Netherlands) Dec 2018Thymic tumours are rare diseases that for most of the cases are cured with surgery and eventually adjuvant radiotherapy. However, about 30% of patients present with... (Review)
Review
Thymic tumours are rare diseases that for most of the cases are cured with surgery and eventually adjuvant radiotherapy. However, about 30% of patients present with advanced stage or relapsing tumours, which require administration of chemotherapy. While cisplatin-adriamycin-cyclophosphamide combination is regularly prescribed, other drugs have been assessed in the literature. Our aim is to evaluate the effectiveness (response rate) of systemic treatments, whatever the therapeutic line, including chemotherapy, targeted therapies and immunotherapies, in thymoma and thymic carcinoma, using the principles of evidence-based medicine. A systematic review was designed using the PICO system, by an experienced librarian and clinicians' experts in thoracic oncology, through the Ovid Medline system. Only phase II-IV trials and retrospective studies including at least 14 patients treated with the same regimen were considered. Articles were independently selected by at least two investigators. Fifty-five eligible articles were retrieved. Sixty% were dealing with platinum-based regimens, mainly cisplatin, and showed overall similar activity (mostly response rate above 50%) independently of the line of treatment or histological type (thymoma versus thymic carcinoma). Non-platinum based regimens included octreotide-prednisone and capecitabine-gemcitabine. Promising data of immunotherapy with antiPDL1 antibody (pembrolizumab) requires confirmation. Based on available data, the most popular and active regimens are cisplatin-anthracycline (CAP or ADOC) or cisplatin-etoposide combinations that should be recommended when considering first-line chemotherapy in thymoma or thymic carcinoma.
Topics: Anthracyclines; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Female; Humans; Male; Neoplasm Recurrence, Local; Survival Analysis; Thymoma; Thymus Neoplasms
PubMed: 30527189
DOI: 10.1016/j.lungcan.2018.10.018 -
World Journal of Gastroenterology Feb 2015To review literature on efficacy and safety of octreotide-long-acting repeatable (LAR) used at doses higher than the Food and Drug Administration (FDA)-approved 30 mg/mo... (Review)
Review
AIM
To review literature on efficacy and safety of octreotide-long-acting repeatable (LAR) used at doses higher than the Food and Drug Administration (FDA)-approved 30 mg/mo for treatment of neuroendocrine tumors (NETs).
METHODS
We searched PubMed and Cochrane Library from 1998-2012, 5 conferences (American Society of Clinical Oncology, Endocrine Society, European Neuroendocrine Tumor Society, European Society for Medical Oncology, North American Neuroendocrine Tumor Society) from 2000-2013 using MeSH and keyterms including neuroendocrine tumors, carcinoid tumor, carcinoma, neuroendocrine, and octreotide. Bibliographies of accepted articles were also searched. Two reviewers reviewed titles, abstracts, and full-length articles. Studies that reported data on efficacy and safety of ≥ 30 mg/mo octreotide-LAR for NETs in human subjects, published in any language were included in the review.
RESULTS
The search identified 1086 publications, of which 238 underwent full-text review (20 were translated into English); 17 were included in the review. Studies varied in designs, subjects, octreotide-LAR regimens, and definition of outcomes. Eleven studies reported use of higher doses to control symptoms and tumor progression, although symptom severity and formal quality-of-life analysis were not quantitatively measured. Ten studies reported efficacy, describing 260 subjects with doses ranging from 40 mg/mo or 30 mg/3 wk up to 120 mg/mo. Eight studies reported expert clinical opinion that supported dose escalation of octreotide-LAR up to 60 mg/mo for symptom control and suggested increased doses may be effective at preventing tumor progression. Eight studies reported safety; there was no evidence of increased toxicity associated with doses of octreotide-LAR > 30 mg/mo.
CONCLUSION
As reported in this review, octreotide-LAR at doses > 30 mg/mo is being prescribed for symptom and tumor control in NET patients. Furthermore, expert clinical opinion provided support for escalation of somatostatin analogs for refractory hormonal symptoms.
Topics: Antineoplastic Agents, Hormonal; Gastrointestinal Neoplasms; Humans; Neuroendocrine Tumors; Octreotide; Treatment Outcome
PubMed: 25684964
DOI: 10.3748/wjg.v21.i6.1945 -
Journal of Nuclear Medicine : Official... Jun 2016Neuroendocrine tumors (NETs) are uncommon tumors with increasing incidence and prevalence. Current reports suggest that (68)Ga-DOTATATE PET/CT imaging improves diagnosis... (Comparative Study)
Comparative Study Meta-Analysis Review
68Ga-DOTATATE Compared with 111In-DTPA-Octreotide and Conventional Imaging for Pulmonary and Gastroenteropancreatic Neuroendocrine Tumors: A Systematic Review and Meta-Analysis.
UNLABELLED
Neuroendocrine tumors (NETs) are uncommon tumors with increasing incidence and prevalence. Current reports suggest that (68)Ga-DOTATATE PET/CT imaging improves diagnosis and staging of NETs compared with (111)In-DTPA-octreotide and conventional imaging. We performed a systematic review of (68)Ga-DOTATATE for safety and efficacy compared with octreotide and conventional imaging to determine whether available evidence supports U.S. Food and Drug Administration approval.
METHODS
Medline, EMBASE, Web of Science, and Cochrane Reviews electronic databases were searched from January 1999 to September 2015. Results were restricted to human studies comparing diagnostic accuracy of (68)Ga-DOTATATE with octreotide or conventional imaging for pulmonary or gastroenteropancreatic NET and for human studies reporting safety/toxicity for (68)Ga-DOTATATE with 10 subjects or more thought to have NETs. Direct communication with corresponding authors was attempted to obtain missing information. Abstracts meeting eligibility criteria were collected by a research librarian and assembled for reviewers; 2 reviewers independently determined whether or not to include each abstract. If either reviewer chose inclusion, the abstract was accepted for review.
RESULTS
Database and bibliography searches yielded 2,479 articles, of which 42 were eligible. Three studies compared the 2 radiopharmaceuticals in the same patient, finding (68)Ga-DOTATATE to be more sensitive than octreotide. Nine studies compared (68)Ga-DOTATATE with conventional imaging. (68)Ga-DOTATATE estimated sensitivity, 90.9% (95% confidence interval, 81.4%-96.4%), and specificity, 90.6% (95% confidence interval, 77.8%-96.1%), were high. Five studies were retained for safety reporting only. Report of harm possibly related to (68)Ga-DOTATATE was rare (6 of 974), and no study reported major toxicity or safety issues.
CONCLUSION
No direct comparison of octreotide and (68)Ga-DOTATATE imaging for diagnosis and staging in an unbiased population of NETs has been published. Available information in the peer-reviewed literature regarding diagnostic efficacy and safety supports the use of (68)Ga-DOTATATE for imaging of NETs where it is available.
Topics: Humans; Intestinal Neoplasms; Lung Neoplasms; Neuroendocrine Tumors; Octreotide; Organometallic Compounds; Pancreatic Neoplasms; Pentetic Acid; Positron Emission Tomography Computed Tomography; Stomach Neoplasms
PubMed: 26769864
DOI: 10.2967/jnumed.115.165803 -
The Cochrane Database of Systematic... Sep 2017Hepatorenal syndrome is defined as severe renal failure occurring in people with cirrhosis and ascites. Systematic reviews of randomised clinical trials found that,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hepatorenal syndrome is defined as severe renal failure occurring in people with cirrhosis and ascites. Systematic reviews of randomised clinical trials found that, compared with placebo, terlipressin may reduce mortality and improve renal function in people with hepatorenal syndrome, but we need current evidence from systematic reviews on the benefits and harms of terlipressin versus other vasoactive drugs.
OBJECTIVES
To evaluate the beneficial and harmful effects of terlipressin versus other vasoactive drugs for people with hepatorenal syndrome.
SEARCH METHODS
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, and Science Citation Index Expanded; conducted manual searches of references in relevant literature; and wrote to experts and pharmaceutical companies (date of last search November 2016).
SELECTION CRITERIA
Randomised clinical trials comparing terlipressin versus any other type of vasoactive drugs for hepatorenal syndrome. We allowed albumin and other cointerventions if provided equally in the comparison groups.
DATA COLLECTION AND ANALYSIS
Three authors independently extracted data. The primary outcomes were mortality, hepatorenal syndrome (persistent hepatorenal syndrome despite treatment), and serious adverse events. We conducted meta-analyses and present the results as risk ratios (RR) with 95% confidence intervals (CI). We performed sensitivity, subgroup, and Trial Sequential Analyses and evaluated bias control based on the Cochrane Hepato-Biliary Group domains.
MAIN RESULTS
We included 10 randomised clinical trials with 474 participants. The trials compared terlipressin versus noradrenaline (seven trials), octreotide (one trial), midodrine and octreotide (one trial), or dopamine (one trial). All participants in both groups received albumin as cointervention. We classified two trials at low risk of bias and eight trials at high risk of bias in the assessment of mortality and all trials at high risk of bias for remaining outcomes. In five trials, investigators specifically stated that they did not receive funding from for-profit organisations. We had no information about the funding source from the remaining five trials.Terlipressin was not superior or inferior compared with other vasoactive drugs in regard to mortality when including the two trials with a low risk of bias (RR 0.92, 95% CI 0.63 to 1.36; 94 participants, very low quality evidence) or when including all 10 trials (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; I² = 0%; very low quality evidence). One meta-analysis including nine trials suggested a beneficial effect of terlipressin on hepatorenal syndrome (RR 0.79, 95% CI 0.63 to 0.99; 394 participants; I² = 26%; very low quality evidence). Due to the high mortality of hepatorenal syndrome, the registration of other serious adverse events is uncertain, but comparing terlipressin and other vasoactive drugs we found no significant difference (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; I² = 0%; very low quality evidence). Several trials did not report systematically of adverse events, but terlipressin seemed to increase the risks of diarrhoea or abdominal pain, or both (RR 3.50, 95% CI 1.19 to 10.27; 221 participants; 5 trials, I² = 0%). However, Trial Sequential Analyses found insufficient evidence to support or refute any differences between interventions for all outcomes. Considering reversal of hepatorenal syndrome, subgroup analyses on the type of other vasoactive drugs found that terlipressin was superior compared with midodrine and octreotide (RR 0.47, 95% CI 0.30 to 0.72) or octreotide alone (RR 0.56, 95% CI 0.33 to 0.96), but each subgroup only included one small trial. None of the remaining subgroup or sensitivity analyses found differences between terlipressin and other vasoactive drugs. We downgraded the evidence to very low quality because of the high risk of bias, imprecision, and the results of the Trial Sequential Analyses.
AUTHORS' CONCLUSIONS
This review found insufficient evidence to support or refute beneficial or harmful effects of terlipressin and albumin versus other vasoactive drugs and albumin. Additional research is needed to evaluate if clinically meaningful differences exist between interventions.
Topics: Antihypertensive Agents; Dopamine; Hepatorenal Syndrome; Humans; Lypressin; Midodrine; Norepinephrine; Octreotide; Randomized Controlled Trials as Topic; Terlipressin; Vasoconstrictor Agents
PubMed: 28953318
DOI: 10.1002/14651858.CD011532.pub2 -
A Systematic Review on Insulin Overdose Cases: Clinical Course, Complications and Treatment Options.Basic & Clinical Pharmacology &... Jun 2018A large overdose of insulin is a serious health matter. Information concerning administration and duration of intravenous (IV) glucose, other treatment options or... (Meta-Analysis)
Meta-Analysis Review
A large overdose of insulin is a serious health matter. Information concerning administration and duration of intravenous (IV) glucose, other treatment options or complications besides hypoglycaemia following large insulin overdoses is not readily apparent from the literature. A systematic search, compilation and review of case reports on insulin overdoses, published 1986-2017, was performed in PubMed, EMBASE, Cochrane and PROSPERO databases. Of 1523 published articles, 45 cases of insulin overdoses were included with a total median insulin dose of 900 international units (IU) (range 26-4800 IU). Hospitalization occurred in 44 cases with a median hospitalization duration of 94 hr (range 12-721 hr), and one-third (n = 15) admitted to the intensive care unit. First-line treatment was IV glucose treatment in 95% of cases. Treatment options besides IV glucose that were reported beneficial included glucagon IV or intramuscular (IM), octreotide IV or IM, surgical excision, hydrocortisone IV and oral intake of complex carbohydrates. Prevalent complications were intermittent cerebral impairment (73%), hypokalaemia (49%), other electrolyte disturbances (42%), and hepatic disturbances (7%) and cardiac toxicity (e.g. cardiac arrhythmia) (9%). Long-term consequences were one case of lasting hypoglycaemic encephalopathy and one death. In conclusion, following large insulin overdoses, in-hospital admission and treatment with IV glucose may be needed for up to a week. Monitoring of electrolytes and hepatic and cardiac functions seems important. Several experimental treatment options may be considered in addition to glucose administration. With appropriate pre- and in-hospital treatment, cases with severe hypoglycaemia and neurologic complications may have a favourable outcome.
Topics: Animals; Drug Overdose; Glucose; Hospitalization; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Nervous System Diseases
PubMed: 29316226
DOI: 10.1111/bcpt.12957 -
Journal of Nuclear Medicine : Official... Sep 2017Ga-DOTATOC, a somatostatin receptor-targeted ligand, has been used clinically in Europe over the past decade for imaging neuroendocrine tumors (NETs). It appears to be... (Meta-Analysis)
Meta-Analysis Review
Ga-DOTATOC, a somatostatin receptor-targeted ligand, has been used clinically in Europe over the past decade for imaging neuroendocrine tumors (NETs). It appears to be quite sensitive and effective for clinical management decision making. This metaanalysis summarizes the efficacy of Ga-DOTATOC for several distinct indications and is intended to support approval of this agent by the U.S. Food and Drug Administration. The major electronic medical databases were searched for relevant papers over the period from January 2001 to November 2015. Papers were selected for review in 3 categories: clinical trials that reported sensitivity and specificity, comparison studies with In-octreotide, and change of management studies. All the eligible papers underwent Quality Assessment of Diagnostic Accuracy Studies (QUADAS) assessment, which was useful in the final selection of papers for review. The initial search yielded 468 papers. After detailed evaluation, 17 papers were finally selected. Five types of studies emerged: workup of patients with symptoms and biomarker findings suggestive of NET, but with negative conventional imaging (3 papers, yield was only 13%); sensitivity (12 papers; sensitivity, 92%) and specificity (7 papers; specificity, 82%); identification of site of unknown primary in patients with metastatic NET (4 papers, yield was 44%); impact on subsequent NET patient management (4 papers, change in management in 51%); and comparison with In-octreotide (2 papers, sensitivity of DOTATOC on a per-lesion basis was 100%, for In-octreotide it was 78.2%; specificity was not available). Safety was not explicitly addressed in any study, but there were no reports of adverse events. Ga-DOTATOC is useful for evaluating the presence and extent in disease for staging and restaging and for assisting in treatment decision making for patients with NET. It is also effective in locating the site of an unknown primary in NET patients who present with metastatic NET, but no known primary tumor. It also appears to be more accurate than In-octreotide. Although Ga-DOTATOC would seem to be useful in evaluating patients with suggestive symptoms and biomarker findings, it does not perform well in this setting and has low yield. Overall, it appears to be an excellent imaging agent to assess patients with known NET and frequently leads to a change in management.
Topics: Diagnostic Imaging; Humans; Neuroendocrine Tumors; Octreotide; Organometallic Compounds; Sensitivity and Specificity
PubMed: 28280220
DOI: 10.2967/jnumed.117.191197 -
Hepatology International Jan 2015Our purpose was to conduct a meta-analysis to compare the effectiveness of vasopressin/terlipressin and somatostatin/octreotide on variceal re-bleeding within and after... (Comparative Study)
Comparative Study Meta-Analysis Review
Efficacy of vasopressin/terlipressin and somatostatin/octreotide for the prevention of early variceal rebleeding after the initial control of bleeding: a systematic review and meta-analysis.
PURPOSE
Our purpose was to conduct a meta-analysis to compare the effectiveness of vasopressin/terlipressin and somatostatin/octreotide on variceal re-bleeding within and after 5 days of initial control bleeding.
METHODS
A search was conducted of PubMed, the Cochrane database, and Google Scholar until June 31, 2014 using combinations of the search terms: esophageal varices, variceal re-bleeding, recurrent variceal hemorrhage, early re-bleeding, vasopressin, somatostatin, terlipressin, octreotide. Inclusion criteria were: (1) randomized controlled trials, (2) patients with esophageal or esophageal and gastric varices confirmed by endoscopy, (3) re-bleeding control was evaluated, (4) treatment with somatostatin/vasopressin. Outcome measures were the re-bleeding rates within 5 days (≤ 5 days) or after 5 days (>5 days) after initial treatment.
RESULTS
Six studies were included in the analysis. Five studies had complete data of re-bleeding rate within 5 days after initial treatment, and the combined odds ratio (OR) of 0.87 [95% confidence interval (CI) 0.51, 1.50] indicated that there was no difference in the re-bleeding rate between patients treated with vasopressin/terlipressin or somatostatin/octreotide. Two studies had complete data of the re-bleeding rate 5 days after initial treatment, and the combined OR of 1.12 (95% CI 0.64, 1.95) indicated there was no difference in the re-bleeding rate between patients who were treated with vasopressin/terlipressin or somatostatin/octreotide.
CONCLUSION
There is no difference between vasopressin/terlipressin and somatostatin/octreotide in prevention of re-bleeding after the initial treatment of bleeding esophageal varices.
Topics: Esophageal and Gastric Varices; Gastrointestinal Agents; Gastrointestinal Hemorrhage; Humans; Lypressin; Octreotide; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Terlipressin; Vasoconstrictor Agents
PubMed: 25788386
DOI: 10.1007/s12072-014-9594-9