ArticleJournal of pharmaceutical policy and practice2017
Comparison of hydroxyethyl starch regulatory summaries from the Food and Drug Administration and the European Medicines Agency.
Article in Journal of pharmaceutical policy and practice, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 39 citations in OpenAlex.
- Article
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- Polymerized albumin restores impaired hemodynamics in endotoxemia and polymicrobial sepsis.Scientific reports · 2021Article
- Effect of Goal-Directed Crystalloid versus Colloid Administration on Perioperative Hemostasis in Partial Hepatectomy: A Randomized, Controlled Trial.Journal of clinical medicine · 2021Article
- Fluid resuscitation after severe trauma injury : U-shaped associations between tetrastarch dose and survival time or frequency of acute kidney failure.Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020Observational
- Understanding the Harms of HES: A Review of the Evidence to Date.Turkish journal of anaesthesiology and reanimation · 2019Review
- New Advances in the Treatment of Acute Pancreatitis.Current treatment options in gastroenterology · 2019Review
- Choice of fluids in critically ill patients.BMC anesthesiology · 2018Review
- Implementation of Trauma Center and Massive Transfusion Protocol Improves Outcomes for Major Trauma Patients: A Study at a Single Institution in Korea.World journal of surgery · 2018Article
- A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.European journal of clinical pharmacology · 2018Article
- Starch Wars-New Episodes of the Saga. Changes in Regulations on Hydroxyethyl Starch in the European Union.Frontiers in veterinary science · 2018Review
- Acute kidney injury in critically burned patients treated with hydroxyethyl starch: a response to Sánchez-Sánchez et al.Annals of burns and fire disasters · 2017Article
- Review
- Hydroxyethyl starch should not be used for cesarean section to prevent maternal hypotension following spinal anesthesia.Journal of anaesthesiology, clinical pharmacologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This article aims to highlight the positions of the Food and Drug Administration and the European Medicines Agency regarding use and marketing of hydroxyethyl starch (HES) products, and how these have changed over recent years. In 2013, warnings from both agencies advised against use of HES in critically ill patients, including patients with sepsis, when several large randomized controlled trials on volume resuscitation in critical illness failed to observe clinically beneficial effects of HES. In areas such as patient monitoring and requirements for further clinical trials, the FDA and EMA are very much in agreement in their recommendations. However, EMA guidance is generally more restrictive on HES usage compared to that from the FDA. Differences in data presented to regulatory authorities, bias in study results and inherent weakness of meta-analyses used for drug surveillance purposes, plus different risk-management approaches used by the two regulatory authorities, likely contribute to different outcomes in their regulations concerning use of HES.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.