Entries Tagged as 'Aliment Pharmacol Ther'
Clinical Trial: High-dose furosemide plus small-volume hypertonic saline solutions vs. repeated paracentesis as treatment of refractory ascites.
Aliment Pharmacol Ther. 2009 Aug;30(3):227-35
Authors: Licata G, Tuttolomondo A, Licata A, Parrinello G, Di Raimondo D, Di Sciacca R, Cammà C, Craxì A, Paterna S, Pinto A
BACKGROUND: In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. AIM: To compare the safety and efficacy of intravenous high-dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in patients with cirrhosis and refractory ascites. PATIENTS AND METHODS: Eighty-four subjects (59/25 M/F) with cirrhosis, mostly of viral aetiology, admitted for refractory ascites, were randomly assigned to receive furosemide (250-1000 mg/bid i.v.) plus HSS (150 mL H(2)O with NaCl 1.4-4.6% or 239-187 mEq/L) (60 patients, Group A) or to repeated paracentesis and a standard diuretic schedule (24 patients, Group B). RESULTS: During hospitalization, Group A patients had more diuresis (1605 +/- 131 mL vs. 532 +/- 124 mL than Group B patients; P < 0.001) and a greater loss of weight at discharge (-8.8 +/- 4.8 kg vs. -4.5 +/- 3.8 kg, P < 0.00). Control of ascites, pleural effusions and/or leg oedema was deemed significantly better in Group A. CONCLUSIONS: This randomized pilot study suggests that HHS plus high-dose furosemide is a safe and effective alternative to repeated paracentesis when treating hospitalized patients with cirrhosis and refractory ascites. Larger studies will be needed to evaluate long-term outcomes such as readmission and mortality.
PMID: 19438847 [PubMed - indexed for MEDLINE]
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Systematic review: nutritional support in acute pancreatitis.
Aliment Pharmacol Ther. 2008 Sep 15;28(6):704-12
Authors: Petrov MS, Pylypchuk RD, Emelyanov NV
BACKGROUND: There has been controversy concerning the merits of enteral and parenteral nutrition compared with no supplementary nutrition in the management of patients with acute pancreatitis. AIM: To perform a systematic review of the data from randomized controlled trials (RCTs) in acute pancreatitis that compares enteral nutrition with no supplementary nutrition, parenteral nutrition with no supplementary nutrition and enteral nutrition with parenteral nutrition. METHODS: A search was undertaken in the MEDLINIE, EMBASE and the Cochrane Central Register of Controlled Trials. RESULTS: Fifteen RCTs were included. Enteral nutrition, when compared with no supplementary nutrition, was associated with no significant change in infectious complications: ratio of relative risks (RR) 0.56, 95% confidence interval (CI) 0.07-4.32, P = 0.58, but a significant reduction in mortality: ratio of RR 0.22, 95% CI 0.07-0.70, P = 0.01. Parenteral nutrition, when compared with no supplementary nutrition, was associated with no significant change in infectious complications: RR 1.36, 95% CI 0.18-10.40; P = 0.77, but a significant reduction in mortality: RR 0.36, 95% CI 0.13-0.97, P = 0.04. Enteral nutrition, when compared with parenteral nutrition, was associated with a significant reduction in infectious complications: RR 0.41, 95% CI 0.30-0.57, P < 0.001, but no significant change in mortality: RR 0.60, 95% CI 0.32-1.14, P = 0.12. CONCLUSIONS: The use of either enteral or parenteral nutrition, in comparison with no supplementary nutrition, is associated with a lower risk of death in acute pancreatitis. Enteral nutrition is associated with a lower risk of infectious complications compared with parenteral nutrition.
PMID: 19145726 [PubMed - indexed for MEDLINE]
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Comparison of the enteral and intravenous lansoprazole pharmacodynamic responses in critically ill patients.
Aliment Pharmacol Ther. 2008 Aug 1;28(3):326-33
Authors: Olsen KM, Devlin JW
BACKGROUND: While proton pump inhibitors are frequently administered in the intensive care unit, the pharmacodynamic response of acid suppression between the enteral and intravenous (IV) route is unknown. AIM: To compare the pharmacodynamic response between enteral and IV lansoprazole in intensive care unit patients requiring stress ulcer prophylaxis therapy. METHODS: Adult mechanically ventilated patients were randomized to receive 72 h of daily enteral [lansoprazole oral disintegrating tablet (LODT) 30 mg mixed in 10 mL of water via a nasal gastric tube] or IV lansoprazole (30 mg over 30 min) therapy. Serial blood samples were collected after the first and third dose and analysed for pharmacokinetic parameters. Pharmacodynamic determination of intragastric pHmetry began prior to the first dose and continued for 72 h using a single channel pH microelectrode. RESULTS: Nineteen intensive care unit patients were randomized [LODT (n = 10); IV-L (n = 9)]. LODT bioavailability was 76%. LODT maintained gastric pH > 4 longer than IV-L at both 24 h (7.4 vs. 5.9 h; P = 0.039) and 72 h (10.4 and 8.9 h; P = 0.046) and resulted in a greater average pH over the first 24 h (3.67 vs. 2.89; P = 0.03). CONCLUSION: Despite a lower bioavailability, enteral lansoprazole suppresses acid in intensive care unit patients to a greater extent than IV lansoprazole.
PMID: 19086331 [PubMed - indexed for MEDLINE]
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Review article: the utility of reagent strips in the diagnosis of infected ascites in cirrhotic patients.
Aliment Pharmacol Ther. 2008 Aug 1;28(3):282-8
Authors: Nguyen-Khac E, Cadranel JF, Thevenot T, Nousbaum JB
BACKGROUND: Spontaneous bacterial peritonitis (SBP) can be diagnosed via leucocyte esterase reagent strips, although diagnostic performances vary. AIM: To perform critical review of literature on the use of reagent strips in SBP. METHODS: Nineteen studies were analysed (Medline search), comparing reagent strips in cirrhotic ascites vs. cytobacteriological methods. Diagnostic grades (G) were: GO = 0 leucocytes/mm3; G1 = 15; G2 = 70; G3 = 125; G4 = 500 for Multistix, GO = 0; G1 = 25; G2 = 75; G3 = 500 for Nephur, Combur, UriScan, and GO = 0; G1 = 25; G2 = 75; G3 = 250; G4 = 500 for Aution. RESULTS: Medians per study were: 75 patients (range: 31-1041), 136 ascites (47-2123), 17 SBP (5-117). For Multistix (12 studies), the sensitivities fell within the ranges 64.7-100% (G > or = 1), 45.7-83% (G > or = 2) and 45.3-89% (G > or = 3). For Nephur (n = 2), Combur (n = 6), UriScan (n = 1), sensitivities ranged 80.4-100% (G > or = 1), 63-100% (G > or = 2) and 67.7-97% (G > or = 3). For Aution (n = 3), sensitivities ranged 93-96% (G > or = 2) and 89% (G > or = 3). Nephur, Combur, UriScan displayed higher sensitivities than Multistix. However, in larger studies, sensitivities dramatically fell at 45.3% for Multistix (G > or = 3) if ascites polymorphonuclear count <1000/mm3 and 22.2% for bacterascites or 16.7-25% for asymptomatic patients. CONCLUSION: Use of reagent strips for the diagnosis of SBP cannot be recommended, in view of low sensitivity and a high risk of false negatives, especially in patients with SBP and low polymorphonuclear count.
PMID: 19086234 [PubMed - indexed for MEDLINE]
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Systematic review: impact of non-adherence to 5-aminosalicylic acid products on the frequency and cost of ulcerative colitis flares.
Aliment Pharmacol Ther. 2009 Feb 1;29(3):247-57
Authors: Higgins PD, Rubin DT, Kaulback K, Schoenfield PS, Kane SV
BACKGROUND: Ulcerative colitis (UC) can be maintained in remission with 5-aminosalicylic acid (5-ASA) medications, but frequent non-adherence by patients who are feeling well has been associated with more frequent flares of colitis. AIM: To perform a systematic review of the published literature and unpublished randomized clinical trials (RCTs) regarding the impact of non-adherence with 5-ASA medications on the incidence of UC flares and costs of care. METHODS: A search of MEDLINE, EMBASE and the Cochrane databases was performed. Prospective studies of UC maintenance with 5-ASAs in adults were selected if they included data on adherence and disease flares. Studies using insurance claims data to estimate the impact of non-adherence on cost of care were included. Data from unpublished RCTs were obtained from the FDA with a request under the Freedom of Information Act. RESULTS: The relative risk for flare in non-adherent vs. adherent patients ranged from 3.65 to infinity. Data were obtained from six unpublished 5-ASA RCTs, but none measured the impact of adherence on disease activity. The comorbidity-adjusted annual costs of care in adherent patients were 12.5% less than in non-adherent patients, despite increased medication expenditures. CONCLUSIONS: A substantial proportion of UC flares and medical costs of UC are attributable to 5-ASA non-adherence. As non-adherence to 5-ASA medications is common, cost-effective strategies to improve adherence are needed. The impact of adherence on disease activity should be measured in RCTs of all inflammatory bowel disease treatments.
PMID: 18945258 [PubMed - indexed for MEDLINE]
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Systematic review: pancreatic enzyme treatment of malabsorption associated with chronic pancreatitis.
Aliment Pharmacol Ther. 2009 Feb 1;29(3):235-46
Authors: Waljee AK, Dimagno MJ, Wu BU, Schoenfeld PS, Conwell DL
BACKGROUND: Pancreatic enzyme supplementation is standard treatment for malabsorption caused by chronic pancreatitis. The FDA recently required all manufacturers to submit New Drug Applications to continue to market these agents because published data demonstrated variation in formulation, bioavailability and shelf-life while providing limited data about efficacy and safety. AIM: To review systematically the design and results of randomized, parallel-design trials of pancreatic enzyme supplements in chronic pancreatitis patients with steatorrhea. METHODS: A computer-assisted search of MEDLINE and EMBASE was performed to identify relevant studies. Two authors performed duplicate data extraction on study design, improvement in coefficient of fat absorption (CFA), diarrhoea and adverse events using pre-specified forms. Agreement between investigators for data extraction was greater than 95%. RESULTS: Of 619 articles found through literature searching, 20 potentially relevant articles were identified and four manuscripts met inclusion criteria. No studies performed head-to-head comparisons of different supplements. Enzyme supplementation is more likely to improve CFA compared with placebo, but fat malabsorption remained abnormal. Important differences in patient population, study endpoint, study design, pancreatic enzyme dosage and measurement of CFA were present across trials, which precluded comparison of different agents. CONCLUSIONS: Enzyme supplementation improves CFA compared to placebo, but may not abolish steatorrhoea.
PMID: 19035969 [PubMed - indexed for MEDLINE]
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Review article: The use of potentially hepatotoxic drugs in patients with liver disease.
Aliment Pharmacol Ther. 2008 Nov 1;28(9):1021-41
Authors: Gupta NK, Lewis JH
BACKGROUND: Misconceptions surround the use of hepatotoxic drugs in chronic liver disease. While many prescription and over-the-counter (OTC) agents can be used safely, this often runs counter to labelled warnings/contraindications, especially for the statins and other commonly used agents. AIM: To evaluate published data on the use of hepatotoxic drugs in chronic liver disease including pharmacokinetic changes in cirrhosis and drug interactions, where available, to formulate recommendations on their use. METHODS: Using a combination of PubMed searches, review texts, the Physicians’ Desk Reference and expert opinion, drugs considered at higher risk of hepatotoxicity in chronic liver disease were evaluated. RESULTS: Most drugs and OTC products including herbals have not been formally studied in chronic liver disease, but available data suggest that several of the most commonly used agents, especially the statins, can be used safely. While there is an increased risk of drug-induced liver injury for drugs used in the treatment of tuberculosis and HIV patients with hepatitis B or C, recommendations for their safe use are emerging. CONCLUSIONS: Although many clinicians remain hesitant to use hepatotoxic drugs in chronic liver disease, the database supporting this view is limited to just a few agents. Most medications can be used safely in patients with chronic liver disease with appropriate monitoring.
PMID: 18671777 [PubMed - indexed for MEDLINE]
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Review article: the evaluation of solitary liver masses.
Aliment Pharmacol Ther. 2008 Oct 15;28(8):953-65
Authors: Bahirwani R, Reddy KR
BACKGROUND: The increasing use of imaging modalities has led to the detection of more liver masses. The differential diagnosis of a focal liver mass includes a host of benign as well as malignant conditions. AIM: To provide a comprehensive review on the commonly encountered liver masses, and to help guide an approach to their evaluation and management. METHODS: Pertinent literature that was identified through PubMed search and senior author’s experience formed the basis of this review. RESULTS: While most incidentally noted liver masses are benign, it may be difficult to differentiate them from those that are malignant. Furthermore, some benign lesions have malignant potential. Certain lesions such as focal nodular hyperplasia, haemangiomas and focal steatosis are often distinctly diagnosed by an imaging modality alone. The less frequently encountered hepatic adenomas are diagnosed radiologically in those with the appropriate clinical background and the absence of radiological features to suggest haemangioma or focal nodular hyperplasia. CONCLUSIONS: A reasonable approach to the diagnosis, follow-up and management of liver masses is based on a rudimentary knowledge of their presentation, associated clinical and laboratory features, natural history and available treatment options. Most often, the so called ‘incidentalomas’ are benign and require patient reassurance.
PMID: 18643922 [PubMed - indexed for MEDLINE]
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Review article: the modern management of portal hypertension–primary and secondary prophylaxis of variceal bleeding in cirrhotic patients.
Aliment Pharmacol Ther. 2008 Jul;28(2):178-86
Authors: Garcia-Pagan JC, De Gottardi A, Bosch J
BACKGROUND: Variceal bleeding is a life-threatening complication of liver cirrhosis with a high probability of recurrence. Treatment to prevent first bleeding or rebleeding is mandatory. AIM: To provide an overview of the current knowledge on the best evidence-based therapeutic options to prevent first or recurrent bleeding from oesophageal varices in patients with cirrhosis. METHODS: For the preparation of this narrative review, we sought to analyse randomized controlled trials that examined the efficacy and side effects of pharmacological or endoscopic therapy for the primary and secondary prophylaxis of oesophageal variceal bleeding. RESULTS: Endoscopic band ligation (EBL) and nonselective beta-blockers are both effective in preventing first bleeding. Until more long-term data are available, nonselective beta-blockers should be the first treatment option because of less severe side effects. EBL is an alternative when beta-blockers are contraindicated or not tolerated. Patient preference may also be considered. For prevention of rebleeding, nonselective beta-blockers (preferably in association with isosorbide-5-mononitrate) or EBL are both effective and good alternative treatments. A combination of both treatments may be the best alternative. CONCLUSIONS: A great improvement in the prevention of variceal bleeding has emerged over the last years. However, further therapeutic options that combine higher efficacy, better tolerance and fewer side effects are needed.
PMID: 18462268 [PubMed - indexed for MEDLINE]
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Systematic review: glucocorticosteroids for alcoholic hepatitis–a Cochrane Hepato-Biliary Group systematic review with meta-analyses and trial sequential analyses of randomized clinical trials.
Aliment Pharmacol Ther. 2008 Jun;27(12):1167-78
Authors: Rambaldi A, Saconato HH, Christensen E, Thorlund K, Wetterslev J, Gluud C
BACKGROUND: Glucocorticosteroids versus placebo or no intervention for patients with alcoholic hepatitis have been evaluated for more than 35 years. However, the results of randomized trials and meta-analyses differ substantially. AIM: To review all randomized clinical trials of glucocorticosteroids vs. placebo or no intervention for patients with alcoholic hepatitis. METHODS: We searched for randomized trials published before July 2007. The trials were assessed for risk of bias. RESULTS: We included 15 trials with a total of 721 randomized patients. The overall mortality rate was 39.5%. Twelve of the fifteen trials were at risk of bias. Glucocorticosteroids did not statistically reduce mortality compared with placebo or no intervention (relative risk 0.83, 95% CI 0.63-1.11). Glucocorticosteroids significantly reduced mortality in the subgroup of trials with patients with Maddrey’s score of at least 32 or hepatic encephalopathy and with low-bias risk. In all analyses, heterogeneity was significant and substantial. Trial sequential analyses using heterogeneity-adjusted information size demonstrated no significant effect of glucocorticosteroids on mortality. Weighted logistic regression analyses taking prognostic factors at randomization into consideration found no significant effect of glucocorticosteroids on mortality. CONCLUSIONS: The current evidence base of mainly heterogeneous with high bias risk trials does not support the use of glucocorticosteroids in alcoholic hepatitis. Large, low-bias risk placebo-controlled randomized trials are needed.
PMID: 18363896 [PubMed - indexed for MEDLINE]
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Review article: gastroparesis.
Aliment Pharmacol Ther. 2008 May;27(9):724-40
Authors: Patrick A, Epstein O
BACKGROUND: Gastroparesis is a chronic disorder caused by stomach pump failure and characterized by profound nausea, vomiting and epigastric pain. Most often, the cause is unapparent and of the known associations, diabetes is the most common. Diagnosis is usually made using an isotope-labelled test meal. Treatment is incremental and includes education, dietary support, prokinetic and antiemetic agents. There are novel approaches including gastric neurostimulation. AIM: To review current concepts of gastric motor function, aetiology, investigation and treatment of gastroparesis. METHODS: A systematic web-based review of the literature was undertaken using a lexicon of terms associated with gastroparesis. RESULTS: There are few controlled studies of this condition. Little is known about causation or underlying nerve, muscle or pacemaker pathology. Idiopathic gastroparesis occurs most commonly in women and gastric emptying is often abnormal in diabetes. Isotopic gastric scintigraphy remains the gold standard investigation, but alternative tests are being developed. Treatment is multimodal and includes education, and nutritional support. There are no adequately powered controlled trials to support a particular drug regimen. In intractable gastroparesis, gastric neurostimulation appears to offer benefit. CONCLUSION: Despite a significant progress in the past decade, further controlled trials are required into the therapeutic options available for treating this intriguing condition.
PMID: 18248660 [PubMed - indexed for MEDLINE]
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New algorithm for the treatment of gastro-oesophageal reflux disease.
Aliment Pharmacol Ther. 2008 Feb 1;27(3):249-56
Authors: Tytgat GN, McColl K, Tack J, Holtmann G, Hunt RH, Malfertheiner P, Hungin AP, Batchelor HK
BACKGROUND: Gastro-oesophageal reflux disease (GERD) is associated with a variety of typical and atypical symptoms. Patients often present in the first instance to a pharmacist or primary care physician and are subsequently referred to secondary care if initial management fails. Guidelines usually do not provide a clear guidance for all healthcare professionals with whom the patient may consult. AIM: To update a 2002-treatment algorithm for GERD, making it more applicable to pharmacists as well as doctors. METHODS: A panel of international experts met to discuss the principles and practice of treating GERD. RESULTS: The updated algorithm for the management of GERD can be followed by pharmacists, for over-the-counter medications, primary care physicians, or secondary care gastroenterologists. The algorithm emphasizes the importance of life style changes to help control the triggers for heartburn and adjuvant therapies for rapid and adequate symptom relief. Proton pump inhibitors will remain a prominent treatment for GERD; however, the use of antacids and alginate-antacids (either alone or in combination with acid suppressants) is likely to increase. CONCLUSION: The newly developed algorithm takes into account latest clinical practice experience, offering healthcare professionals clear and effective treatment options for the management of GERD.
PMID: 17973975 [PubMed - indexed for MEDLINE]
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Review article: Management of ascites and associated complications in patients with cirrhosis.
Aliment Pharmacol Ther. 2007 Dec;26 Suppl 2:183-93
Authors: Kuiper JJ, de Man RA, van Buuren HR
BACKGROUND: Ascites is the most common complication of cirrhosis, associated with an expected survival below 50% after 5 years. Prognosis is particularly poor for patients with refractory ascites and for those developing complications, including spontaneous bacterial peritonitis (SBP) and hepatorenal syndrome (HRS). AIM: To provide an evidence-based overview of the pathophysiology, diagnosis and clinical management of ascites secondary to liver cirrhosis. METHODS: Review based on relevant medical literature. RESULTS: Portal hypertension, splanchnic vasodilatation and renal sodium retention are fundamental in the pathophysiology of ascites formation. The SAAG (serum-ascites albumin gradient) allows reliable assessment of the cause of ascites. The majority of cirrhotic patients with ascites can be managed with dietary sodium restriction in combination with diuretic agents. Large volume paracentesis with albumin suppletion and TIPS are therapeutic options in patients with refractory ascites. Prophylactic antibiotics for SBP should be given in certain patient populations. CONCLUSIONS: Recent advances in the diagnosis and treatment of ascites and associated complications have improved the medical management and poor prognosis of patients with these manifestations of advanced liver disease. Early diagnosis, adequate treatment and focus on prevention of complications remain essential as well as timely referral for liver transplantation.
PMID: 18081661 [PubMed - indexed for MEDLINE]
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Review article: increasing the dose of oral mesalazine therapy for active ulcerative colitis does not improve remission rates.
Aliment Pharmacol Ther. 2007 Nov 1;26(9):1179-86
Authors: Safdi AV, Cohen RD
BACKGROUND: Oral mesalazine (mesalamine, 5-aminosalicylic acid) formulations are effective in the treatment of active ulcerative colitis. All formulations contain the same active drug but differ with regard to mechanisms to deliver the drug to the colon. Patients who fail to respond to initial therapy are often administered higher doses of the same formulation. AIM: To review published trials of oral mesalazine formulations in treating active ulcerative colitis and to examine the effect of dose escalation on remission rates. RESULTS: Increasing the doses of oral mesalazine formulations does not result in higher remission rates, although increasing the doses of some formulations has been effective in increasing symptomatic improvement and/or response to treatment. CONCLUSIONS: Because oral mesalazine formulations do not demonstrate a significant dose response with regard to induction of remission of active ulcerative colitis, simple dose escalation may not be the most effective course for patients who fail to respond to initial mesalazine treatment.
PMID: 17944732 [PubMed - indexed for MEDLINE]
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