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The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia

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: NCT02236741
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the risk of incident heart failure associated with the use of pramipexole compared with other dopamine agonists and additionally, to assess the risk of incident heart failure associated with the use of dopamine agonists in comparison with no use of dopamine agonist therapy

Condition or disease Intervention/treatment
Heart Failure Drug: Mirapexin® (Sifrol®)

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Study Type : Observational
Actual Enrollment : 26814 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia
Study Start Date : November 2009
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
users of anti-parkinsonian drugs Drug: Mirapexin® (Sifrol®)

Primary Outcome Measures :
  1. Assessment of first-time clinical diagnosis of heart failure [ Time Frame: 150 months ]

Secondary Outcome Measures :
  1. Overall rate of heart failure [ Time Frame: 150 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Users of anti-parkinsonian drugs registered with an up-to-standard practice from the United Kingdom's General Practice Research Database (GPRD)

Inclusion Criteria:

  • All patients between 40 and 89 years of age who received at least one prescription for anti-parkinsonian drugs during the period 1997-2009

Exclusion Criteria:

  • Patients with a diagnosis of heart failure or with prescriptions for two or more among the digitalis, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blocker (ARB), and diuretic drug classes prior to cohort entry

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02236741     History of Changes
Other Study ID Numbers: 248.672
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Dopamine Agonists
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents