Letigen® and Cardiovascular Morbidity

This study has been completed.
Sponsor:
Collaborator:
Nycomed Group, Langebjerg 1, 4000 Roskilde, Denmark
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00692666
First received: June 3, 2008
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

Letigen® was a combination drug containing ephedrine, an adrenergic agonist with lipolytic and appetite-inhibiting properties. The drug was used as adjuvant treatment of obesity from 1990 and up to 2002 when it was withdrawn from the market by the manufacturer. The basis for this was a number of spontaneous reports about patients that died during treatment with Letigen®.

The causal relation has never been addressed. There are only sparse data from randomised studies and the above-mentioned reports are not conclusive.

We propose a controlled study based on data from Statistics Denmark that hold a complete copy of the Prescription Register of the Danish Medicines Agency and the Danish Hospital Discharge Register. The aim of the study would be to determine whether there is an excess frequency of deaths and serious cardiovascular events that can not be explained by particular characteristics of users of the drug. A well-known problem in such observational studies is a fundamental incomparability between users and non-users of drugs. In the present setting, it should be expected that use of Letigen® is associated with high BMI, smoking, alcohol abuse, type-2 diabetes, mild hypertension, low physical activity and other indicators of unhealthy lifestyle. Thus, an uncritical comparison between users and non-users of Letigen® regarding serious cardiovascular events will probably show an excess frequency that can not necessarily be attributed to the drug. This problem can be addressed by a special epidemiological technique - the case-crossover design - which is particularly robust to such comparability problems. In brief, only cases should be included. Controls are the same persons at an earlier time, , where the case-defining disease has not yet developed. The exposure of cases will be compared with the exposure of the same persons' case history.

To account for the effect of chronic exposure, we also perform, as a secondary analysis, a conventional case-control study nested within the cohort of Letigen users, and employing a risk-set sampling technique.


Condition Phase
Stroke
Myocardial Infarctions
Sudden Death
Phase 4

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Letigen® and Cardiovascular Morbidity. A Register-Based Epidemiological Study

Further study details as provided by University of Southern Denmark:

Estimated Enrollment: 300000
Study Start Date: May 2006
Study Completion Date: August 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Use of letigen TM within the period Jan 1995 - Dec 2001
  • The occurrence of a case-defining event

Exclusion Criteria:

  • A cancer diagnosis other than non-melanoma skin cancer
  • Age outside the range 18-70
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00692666

Sponsors and Collaborators
University of Southern Denmark
Nycomed Group, Langebjerg 1, 4000 Roskilde, Denmark
Investigators
Principal Investigator: Jesper Hallas, Md PhD University of Southern Denmark
  More Information

No publications provided

Responsible Party: Jesper Hallas, professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT00692666     History of Changes
Other Study ID Numbers: Letigen
Study First Received: June 3, 2008
Last Updated: June 5, 2008
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Death, Sudden
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Death

ClinicalTrials.gov processed this record on October 02, 2014