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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each indication due to...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.

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Related Experiment Videos

Should we modify our indications after the EVAR-2 trial conclusions?

Jonathan Sobocinski1, Blandine Maurel, Pascal Delsart

  • 1Services de Chirurgie Vasculaire, Hôpital Cardiologique, Université Lille2, CHRU de Lille, France.

Annals of Vascular Surgery
|July 5, 2011
PubMed
Summary

Endovascular aneurysm repair (EVAR) in high-risk patients demonstrates superior outcomes compared to the EVAR-2 trial, justifying its use. This approach is crucial for high-volume centers, emphasizing multidisciplinary care for better patient survival.

Related Experiment Videos

Area of Science:

  • Vascular Surgery
  • Endovascular Interventions
  • Aortic Aneurysm Treatment

Background:

  • Endovascular Aneurysm Repair (EVAR) is a key treatment for abdominal aortic aneurysms.
  • Patient selection for EVAR often focuses on those unfit for open surgery.
  • The EVAR-2 trial provided critical data on EVAR in high-risk populations.

Purpose of the Study:

  • To compare EVAR outcomes in high-risk patients treated at a high-volume center with EVAR-2 trial results.
  • To evaluate the efficacy and safety of EVAR in patients deemed unfit for open surgery.
  • To assess the impact of multidisciplinary care and pre-operative treatments on EVAR outcomes.

Main Methods:

  • A retrospective analysis of 191 high-risk patients undergoing EVAR between 2006-2008.
  • Comparison of 30-day and 1-year mortality, complication rates, and redo surgery rates with EVAR-2 data.
  • Kaplan-Meier survival analysis and evaluation of pre-operative pharmacological treatments.

Main Results:

  • Lower 30-day mortality in the high-volume center cohort (1.6%) versus EVAR-2 (9%) (p=0.002).
  • Similar global complication rates (44% vs 43%) but significantly lower redo surgery rates (13% vs 26%) in the high-volume center cohort.
  • Higher rates of pre-operative antiplatelet and statin use in the high-volume center cohort.

Conclusions:

  • EVAR in high-risk patients is justified and shows better outcomes than suggested by EVAR-2.
  • High-volume centers can achieve superior results through specialized care.
  • Multidisciplinary treatment and optimized pharmacological management are vital for high-risk EVAR patients.