Aprotinin: No Justification for Current Use

1995 ◽  
Vol 11 (4) ◽  
pp. 156-162 ◽  
Author(s):  
Brad E Cooper
Keyword(s):  
Adverse Effects ◽  
Blood Loss ◽  
Data Extraction ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Search Term ◽  
Graft Occlusion ◽  
Study Selection ◽  
Transfusion Requirements ◽  
The Cost

Objective: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of aprotinin. Data Identification: A literature search using Grateful Med from 1991 to 1994 and the search term “aprotinin” was performed. Study Selection: Open and controlled trials were reviewed. Data Extraction: Studies evaluating aprotinin for use in primary and repeat coronary artery bypass graft (CABG) surgery were evaluated and results of the effects of aprotinin on decreasing transfusion requirements as well as adverse effects were summarized. Data Synthesis: Many European studies have shown that aprotinin reduces blood loss and transfusion requirements during CABG. More recently, two studies in the US and one in Canada have been published that confirm the effects of aprotinin on blood loss, but raise questions concerning its safety. Combined data indicate that aprotinin is associated with an increased incidence of renal failure, and there are trends toward increases in myocardial infarction, graft occlusion, and mortality. There is no question that aprotinin reduces blood loss during CABG. How much it will save depends on surgical skill and the use of other blood conservation techniques. There are many theoretical benefits to patients from this reduction in blood loss. Whether the benefits of aprotinin administration exceed the risks associated with its use has not been adequately assessed, and further multicenter trials are currently in progress. Whether the cost of aprotinin is counterbalanced by a reduction in transfusion requirements will vary, depending on the cost and amount of blood products used at the specific institution, but this type of analysis does not account for the cost of adverse effects of aprotinin or transfusions, and no pharmacoeconomic evaluations have been published. Conclusions: Until studies can demonstrate a positive benefit/risk ratio in terms of patient outcome, aprotinin should not be added to the formulary or used in patients undergoing CABG.

Aprotinin

1996 ◽  
Vol 30 (4) ◽  
pp. 372-380 ◽  
Author(s):  
Sylvie Robert ◽  
Bertil KJ Wagner ◽  
Michelle Boulanger ◽  
Monique Richer
Keyword(s):  
Blood Loss ◽  
Surgical Procedures ◽  
English Language ◽  
Data Extraction ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Safety Information ◽  
Graft Occlusion ◽  
Medline Search ◽  
Transfusion Requirements

OBJECTIVE: To review the clinical pharmacology of aprotinin in patients undergoing surgical procedures involving major blood loss, namely, coronary artery bypass graft (CABG). DATA SOURCES: A MEDLINE search was used to identify French-and English-language publications on aprotinin using the indexing terms aprotinin, cardiothoracic surgery, and hemorrhage. The MEDLINE search was supplemented by review of article bibliographies. Data also were obtained from the approved Canadian and US product labels. STUDY SELECTIONS: All abstracts and uncontrolled and controlled clinical trials were reviewed. DATA EXTRACTION: Study design, population, results, and safety information were retained. Efficacy conclusions were drawn from controlled trials. DATA SYNTHESIS: Aprotinin, a serine protease inhibitor isolated from bovine lung tissue, decreases bleeding after cardiac surgery by mechanisms including antifibrinolytic activity and preservation of platelet function. Several trials have shown that aprotinin reduced blood loss and transfusion requirements in patients undergoing CABG. Its use in other surgical procedures involving major blood loss has been reported. Aprotinin is well tolerated, with minor allergic reactions being the most frequently reported adverse effect. Although unsubstantiated, the possibility that aprotinin could create a prothrombic state leading to early graft occlusion and formation of microthrombi in renal and coronary vasculatures is of concern. CONCLUSIONS: Aprotinin is an effective hemostatic agent in CABG. Clear definitions of indications, dosing, safety, and repeated use remain to be investigated thoroughly.

Transdermal Fentanyl

1992 ◽  
Vol 26 (11) ◽  
pp. 1393-1399 ◽  
Author(s):  
Lisa Y. Yee ◽  
Julio R. Lopez
Keyword(s):  
Chronic Pain ◽  
Clinical Trials ◽  
Placebo Group ◽  
Adverse Effects ◽  
English Language ◽  
Data Extraction ◽  
Opioid Analgesia ◽  
Transdermal Fentanyl ◽  
Study Selection ◽  
The Cost

OBJECTIVE: To review the use of transdermal fentanyl for the treatment of moderate to severe chronic pain. The article provides background on the pharmacology and pharmacokinetics of the drug, as well as the properties of the transdermal system. In addition, clinical trials, adverse effects, and therapeutic considerations and recommendations are presented. DATA SOURCES: Clinical trials, review articles, and reference texts. STUDY SELECTION: Comparative clinical trials involving the use of transdermal fentanyl on postoperative and chronic pain patients. DATA EXTRACTION: Data from clinical human trials published in the English language were reviewed. Trials were assessed by sample size, opioid dosage regimen, and therapeutic outcome. DATA SYNTHESIS: Transdermal fentanyl was found to be effective in the control of chronic and postoperative pain. In one trial the overall patient satisfaction with pain control was 79 percent for the transdermal fentanyl group and 44 percent for the placebo group. In another trial, the amount of additional parenteral morphine was significantly lower for the group receiving transdermal fentanyl than for the placebo group (49.9 ± 4.9 vs. 77.0 ± 6.3 mg, respectively, p<0.01). The most common adverse effects recorded were nausea (45–85 percent), pruritus (14–60 percent), and sedation (40–59 percent). The cost of analgesic therapy with this delivery system is higher than that of parenteral opioid analgesia, but less than patient-controlled analgesia. CONCLUSIONS: The transdermal fentanyl formulation offers some minor advantages over other forms of conventional pain management. Results of early clinical trials are promising, but more studies are needed to evaluate its long-term effectiveness and adverse effects. Specifically, comparisons with standard parenteral and patient-controlled opioid analgesia in chronic malignant and nonmalignant pain are necessary for adequate evaluation of transdermal fentanyl.

scholarly journals High-dose Aprotinin in Cardiac Surgery—A Prospective, Randomized Study

1994 ◽  
Vol 22 (5) ◽  
pp. 529-533 ◽  
Author(s):  
M. J. Swart ◽  
P. C. Gordon ◽  
P. B. Hayse-Gregson ◽  
R. A. Dyer ◽  
A. L. Swanepoel ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Placebo Group ◽  
Blood Loss ◽  
Artery Bypass ◽  
Randomized Study ◽  
Postoperative Blood Loss ◽  
High Dose ◽  
Maintenance Infusion ◽  
Transfusion Requirements ◽  
High Dose Aprotinin

Fifty patients undergoing primary coronary artery bypass surgery and 50 patients undergoing valve surgery received either high-dose aprotinin (2 million units loading dose, 2 million units added to the CPB prime, and 500,000 units/hr maintenance infusion) or placebo. Mean postoperative blood loss in the first six hours was reduced from 321 ml in the placebo group to 172 ml in the aprotinin group (95% confidence interval (CI) for difference = 95 to 189 ml). Seven patients in the placebo group and 16 patients in the aprotinin group did not require transfusion with homologous blood. This study adds to the growing body of evidence that the administration of high-dose aprotinin reduces blood loss and blood transfusion requirements associated with primary cardiac surgery.

Lactulose in the Management of Constipation: A Current Review

1992 ◽  
Vol 26 (10) ◽  
pp. 1277-1282 ◽  
Author(s):  
Theresa V. Kot ◽  
Ngaire A. Pettit-Young
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Clinical Studies ◽  
Data Extraction ◽  
Point Of View ◽  
Data Synthesis ◽  
Study Selection ◽  
Beneficial Response ◽  
A Current

OBJECTIVE: To review the current published clinical studies evaluating the clinical efficacy and safety of lactulose compared with other laxatives or placebo. Adverse effects associated with lactulose are also reported. DATA SOURCES: Information was retrieved by searching the MEDLINE and EMBASE databases for clinical trials, abstracts, conference proceedings, and review articles dealing with lactulose. STUDY SELECTION: Emphasis was placed on clinical trials where lactulose was compared with other laxatives or placebo in patient populations where the diagnosis of constipation was reasonably established. DATA EXTRACTION: The methodology and results from clinical studies were evaluated. Assessment of the studies was made based on diagnosis of constipation, prior management of patients, follow-up of patients, dosage, and adverse effects. DATA SYNTHESIS: Clinical trials in geriatric patients, terminally ill patients, children, and normal and constipated subjects were reviewed. In most instances, lactulose was compared with a placebo, without incorporating the current education on dietary techniques for improving defecation. CONCLUSIONS: Generally, clinical trials have demonstrated a beneficial response compared with placebo, although sometimes that response has been only marginally better, from a clinical point of view.

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