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Letigen® and Cardiovascular Morbidity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692666
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 6, 2008
Nycomed Group, Langebjerg 1, 4000 Roskilde, Denmark
Information provided by:
University of Southern Denmark

Brief Summary:

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 The drug was used as adjuvant treatment of obesity from 1990 and up to 2002 when it was withdrawn from the market by the manufacturer.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 or disease
Stroke Myocardial Infarctions Sudden Death

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Study Type : Observational
Enrollment : 300000 participants
Time Perspective: Retrospective
Official Title: Letigen® and Cardiovascular Morbidity. A Register-Based Epidemiological Study
Study Start Date : May 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : August 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692666

Sponsors and Collaborators
University of Southern Denmark
Nycomed Group, Langebjerg 1, 4000 Roskilde, Denmark
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Principal Investigator: Jesper Hallas, Md PhD University of Southern Denmark
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Responsible Party: Jesper Hallas, professor, University of Southern Denmark Identifier: NCT00692666    
Other Study ID Numbers: Letigen
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: June 2008
Additional relevant MeSH terms:
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Myocardial Infarction
Death, Sudden
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases