Post-marketing surveillance: how many patients?

Lewis, John

doi:10.1016/0165-6147(81)90275-3

Cited by 63 publications

(25 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Serious drug-induced hepatotoxicity is the most common reason for regulatory authorities to limit the use of, or to withdraw a licensed drug [3]. Clinical trials cannot capture every possible ADR -if a drug has a rare but important risk of idiosyncratic hepatic injury of, say 1 in 10,000, then almost 30,000 patients have to be treated in order to have a 95 % chance of detecting at least one case [4]. Whilst ADR reporting is important, the deficiencies, especially with regards to under-reporting and an inability to calculate incidence due to absence of baseline numbers are well recognized [5].…”

Section: Hepatic Injury Liver Monitoring and The Beta-interferons Fomentioning

confidence: 99%

Hepatic injury, liver monitoring and the beta-interferons for multiple sclerosis

Tremlett

Oger

2004

J Neurol

View full text Add to dashboard Cite

This review explores the salient issues surrounding liver injury and liver monitoring associated with beta-interferon (IFNB) treatment for multiple sclerosis (MS). Post-marketing studies have found a higher proportion of IFNB-treated MS patients with elevated aminotransferases than reported in the pivotal clinical trials. Although the risk of severe liver injury appears small, the true incidence is unknown. Post-marketing studies have shown that the greatest period of risk for the development of liver test abnormalities appears to be in the first year of IFNB treatment. The risk also increases with the more frequently administered, higher-dosage IFNBs. Males are more likely than females to develop elevated aminotransferases (> upper normal limit), although females appear at a greater risk of severe liver injury. Of the commonly used biochemical liver tests, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP) and bilirubin appear the most useful for routine monitoring of IFNB treatment. Whilst many other factors can affect liver test results, including obesity, alcohol, concomitant medications, co-morbidities and theoretically even MS itself, regular liver testing both prior and during IFNB therapy might help minimise Type A or dose/frequency dependent aminotransferase elevations. However, testing will probably not prevent the Type B idiosyncratic reactions which can result in severe hepatic injury; hence patients need to be aware, and to report hepatic side effects promptly.

show abstract

Section: Hepatic Injury Liver Monitoring and The Beta-interferons Fomentioning

confidence: 99%

Hepatic injury, liver monitoring and the beta-interferons for multiple sclerosis

Tremlett

Oger

2004

J Neurol

View full text Add to dashboard Cite

show abstract

“…By the "rule of 3," a trial of 1000 patients treated with a drug in which no events of a particular nature are observed is only sufficient to exclude, with 95% confidence, that such an event actually might occur more frequently than 3 times per 1000 patients treated. 44 It is crucial to take this issue into account when clinical event trials are designed.…”

Section: Other Important Issuesmentioning

confidence: 99%

Vascular Biomarkers and Surrogates in Cardiovascular Disease

et al. 2006

View full text Add to dashboard Cite

Abstract-Cardiovascular biomarker research efforts have resulted in the identification of new risk factors and novel drug targets, as well as the establishment of treatment guidelines. Government agencies, academic research institutions, diagnostic industries, and pharmaceutical companies all recognize the importance of biomarkers in advancing therapies to improve public health. In drug development, biomarkers are used to evaluate early signals of efficacy and safety, to select dose, and to identify the target population. The United States Food and Drug Administration has relied on biomarkers to support clinical applications in many therapeutic fields, including cardiovascular disease. The appropriate application of cardiovascular biomarkers requires an understanding of disease natural history, the mechanism of the intervention, and the characteristics and limitations of the biomarker. Channels of communication among researcher, developer, and regulator must remain open to maximize the success of future biomarker efforts. In

show abstract

“…While this is reassuring, the numbers necessary to detect an increase in frequency even of an otherwise rare event are large (Lewis, 1981). For this reason, the study continues and currently over 40 000 patients have been entered providing data on over 16 000 patient years of exposure to captopril.…”

Section: Discussionmentioning

confidence: 99%

Post marketing surveillance of captopril (for hypertension): a preliminary report.

Chalmers¹,

Dombey²,

Lawson³

1987

Brit J Clinical Pharma

View full text Add to dashboard Cite

1 The methodology and interim results of a post marketing surveillance of captopril, the first orally active angiotensin converting enzyme inhibitor are presented. 2 Utilising viewdata technology, details of hypertensive patients were entered directly into a mainframe computer. This allowed day to day monitoring of events; a facility not available with paper‐based methods. 3 The design of the study allowed analysis of results including some details of efficacy, concomitant therapy, any disease symptoms and reasons for withdrawal. These factors could be categorised according to sex and age. 4 This preliminary report is based on the first 13,295 patients entered from July 1983 with follow‐ up until January 1985. The results of the study confirm the safety of captopril in the patients studied.

show abstract

Post-marketing surveillance: how many patients?

Cited by 63 publications

References 5 publications

Hepatic injury, liver monitoring and the beta-interferons for multiple sclerosis

Hepatic injury, liver monitoring and the beta-interferons for multiple sclerosis

Vascular Biomarkers and Surrogates in Cardiovascular Disease

Post marketing surveillance of captopril (for hypertension): a preliminary report.

Contact Info

Product

Resources

About