Stability and antimicrobial effectiveness of treprostinil sodium in Sterile Diluent for Flolan

Zaccardelli, David; Phares, Kenneth R; Jeffs, Roger; Doran, Aimee; Wade, Michael S.

doi:10.1111/j.1742-1241.2009.02307.x

Cited by 17 publications

(9 citation statements)

References 23 publications

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“…epoprostenol (0.36 versus 0.12 per 1000 patient days; p<0.001), which could be due to various factors, including the type of diluent [63]. One explanation could be that epoprostenol is traditionally mixed with a diluent with a basic pH, whereas the diluent for treprostinil is neutral, with the more alkaline preparation allowing for less bacterial growth [64]. Indeed, a lower rate of Gram-negative bloodstream infections has been demonstrated in patients who receive treprostinil that has been mixed with epoprostenol diluent versus the traditional pH-neutral preparation [65].…”

Section: Epoprostenolmentioning

confidence: 99%

Recent advances in targeting the prostacyclin pathway in pulmonary arterial hypertension

Lang

Gaine

2015

Eur Respir Rev

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Pulmonary arterial hypertension (PAH) is a severe disease characterised by increased pulmonary vascular resistance, which leads to restricted pulmonary arterial blood flow and elevated pulmonary arterial pressure. In patients with PAH, pulmonary concentrations of prostacyclin, a prostanoid that targets several receptors including the IP prostacyclin receptor, are reduced. To redress this balance, epoprostenol, a synthetic prostacyclin, or analogues of prostacyclin have been given therapeutically. These therapies improve exercise capacity, functional class and haemodynamic parameters. In addition, epoprostenol improves survival among patients with PAH. Despite their therapeutic benefits, treatments that target the prostacyclin pathway are underused. One key factor is their requirement for parenteral administration: continuous intravenous administration can lead to embolism and thrombosis; subcutaneous administration is associated with infusion-site pain; and inhalation is time consuming, requiring multiple daily administrations. Nevertheless, targeting the prostacyclin pathway is an important strategy for the management of PAH. The development of oral therapies for this pathway, as well as more user-friendly delivery devices, may alleviate some of the inconveniences. Continued improvements in therapeutic options will enable more patients with PAH to receive medication targeting the prostacyclin pathway.

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Section: Epoprostenolmentioning

confidence: 99%

Recent advances in targeting the prostacyclin pathway in pulmonary arterial hypertension

Lang

Gaine

2015

Eur Respir Rev

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“…[3][4][5] The reason for this was initially unclear, 3,6,11 but in vitro studies showing that the pH-basic epoprostanol diluent (pH 10.2-10.8) was far more effective in suppressing bacterial growth than the normal saline diluent initially recommended for treprostinil (pH 6.0-7.2) suggested a possible explanation. 6,11,13 Consistent with this notion, a prospective study (with a historical control group) found that use of epoprostanol diluent with treprostinil substantially reduced the rate of gram-negative CVL-BSI and possibly reduced the overall rate of CVL-BSI (P ¼ 0:06). 11 A similar association of gram-negative infection with neutral pH diluent was observed in a retrospective study involving intravenous iloprost.…”

Section: Discussionmentioning

confidence: 72%

Central Venous Line Complications with Chronic Ambulatory Infusion of Prostacyclin Analogues in Pediatric Patients with Pulmonary Arterial Hypertension

et al. 2015

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Chronic infusion of prostacyclin (PGI 2 ) via a Broviac central venous line (CVL) is attended by risk of CVL-related complications, but we know of only one report regarding CVL-associated bloodstream infection (BSI) with PGI 2 in children and none regarding other complications. We conducted a retrospective cohort study involving pediatric patients with pulmonary hypertension treated with chronic intravenous infusion of PGI 2 at Boston Children's Hospital and determined the rate (per 1,000 line-days) of various CVL-related complications. We also determined how often complications necessitated line replacement and hospitalization, time to replacement of CVLs, and interpatient variability in the incidence of complications. From 1999 until 2014, 26 patients meeting follow-up criteria had PGI 2 infusion, representing 43,855 line-days; mean follow-up was 56 months (range, 1.4-161 months). The CVL complication rates (per 1,000 linedays) were as follows: CVL-BSI, 0.25; superficial line infection, 0.48; impaired integrity, 0.59; occlusion, 0.09; and malposition, 0.32. The total complication rate was 1.73 cases per 1,000 line-days. All CVL-BSI and malposition cases were treated with CVL removal and replacement. Of CVLs with impaired integrity, 23 could be repaired and 3 required replacement. Six of 21 superficial CVL infections required replacement of the CVL. Three of 4 occluded CVLs were replaced. CVL complications occasioned 65 hospitalizations. There was marked interpatient variability in the rate of complications, much but not all of which appeared to be related to duration of CVL placement. We conclude that non-BSI complications are very significant and that efforts to teach and emphasize other aspects of line care are therefore very important. Chronic intravenous infusion of the prostacyclin (PGI 2 ) analogues epoprostanol and treprostinil, usually through a Broviac central venous line (CVL), has been the most effective therapy for severe pulmonary arterial hypertension (PAH) since 1996, 1 but it is attended with the risk of CVL-related complications. There are multiple reports focused on CVL-related bloodstream infections (BSIs) in adults 2-5 but only a single report regarding CVL-BSI with PGI 2 infusion in mostly pediatric patients (although the age of the patients is not given), 6 and we know of no information regarding the incidence of other complications (e.g., CVL superficial infection, fracture, displacement, and occlusion) in this setting. Children may be at different risk than adults for CVL complications owing to high activity levels, being less mindful of the need for CVL protection, and possibly other factors. Noninfectious complications are also important, as they frequently require hospital visit, admission, or CVL replacement, and their rate of occurrence may substantially exceed that of CVL-BSI. 7,8 A better understanding of non-BSI complications associated with CVLs in pediatric patients receiving PGI 2 analogues could lead to strategies to reduce such events. Also, an alternative means o...

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“…Alternatively there are data supporting the use of glycine epoprostenol diluent in place of sodium chloride or sterile water to mitigate sterility issues with outpatient mixing. 46 Transition between agents and dosage form should be done in concert with specialty pharmacy services and ideally in centers experienced with PAH management.…”

Section: Role Of the Pharmacistmentioning

confidence: 99%

An Update on the Management of Pulmonary Arterial Hypertension and the Pharmacist’s Role

Macaulay

Covell

Pogue

2015

Journal of Pharmacy Practice

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Pulmonary arterial hypertension (PAH) is a rare medical condition that significantly shortens life expectancy. The lack of understanding and complexity of treatments frequently lead to delays in diagnosis and treatment of patients. This is worsened by the gap in medical education related to the rarity of disease and the subspecialty nature of management. Advancements in diagnostics and treatment in recent years makes a review of this nature important and timely. Understanding the specialty nature of drug therapy, the complexities of managing prostacyclin analogs, and treatment algorithms are essential for pharmacists caring for these patients in both acute and ambulatory settings. This review article will provide an overview of published guidelines as well as discuss new therapies, clinical controversies, and the pharmacist's role in the management of these patients.

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Stability and antimicrobial effectiveness of treprostinil sodium in Sterile Diluent for Flolan

Abstract: These results suggest that dilution of treprostinil with the alkaline solution SDF may reduce the risk of infection from inadvertent patient contamination compared with dilution of treprostinil in sterile saline.

Cited by 17 publications

References 23 publications

Recent advances in targeting the prostacyclin pathway in pulmonary arterial hypertension

Recent advances in targeting the prostacyclin pathway in pulmonary arterial hypertension

Central Venous Line Complications with Chronic Ambulatory Infusion of Prostacyclin Analogues in Pediatric Patients with Pulmonary Arterial Hypertension

An Update on the Management of Pulmonary Arterial Hypertension and the Pharmacist’s Role

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