NESTED CASE-CONTROL STUDY TO ASSESS THE ASSOCIATION BETWEEN THE USE OF METHYLPHENIDATE AND THE RISK OF VALVULAR HEART DISEASE AND PULMONARY HYPERTENSION

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33437
• EU PAS number:
  EUPAS12083
• Study ID:
  33437
• Official title and acronym:
  NESTED CASE-CONTROL STUDY TO ASSESS THE ASSOCIATION BETWEEN THE USE OF METHYLPHENIDATE AND THE RISK OF VALVULAR HEART DISEASE AND PULMONARY HYPERTENSION
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  OBJETIVE: To assess the association between the use of methylphenidate and the risk of valvular heart disease (VHD) and pulmonary hypertension (PH).STUDY DESIGN: We will perform a case-control study nested in the BIFAP cohort, a database maintained by the Spanish Medicines Agency. Cases will be defined as patients between 5 and 25 years of age and a first diagnosis of VHD or PH, recorded in the BIFAP database between 2002 and 2014. Information on exposures between 2002 and 2014 will be collected. We will select up to 10 controls matched with cases by age, gender and calendar year. We will evaluate the use of methylphenidate before the case index date or the corresponding date among controls. We will test the robustness of the results by repeating the analysis in patients diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). DATA ANALYSIS: We will compute odds ratios of VHD and PH according to methylphenidate use using conditional logistic regression, adjusting for matching factors and potential confounders (smoking status, cardiovascular diseases, diabetes, COPD...).
• Study status:
  Finalised

Research institutions and networks

Institutions

Navarre Health Service

Study timelines

Date when funding contract was signed

Actual: 04/12/2015

Study start date

Planned: 01/03/2016

Actual: 01/03/2016

Date of final study report

Planned: 05/12/2016

Actual: 04/01/2017

Sources of funding

Other

More details on funding

Navarre Health Department

Study protocol

Initial protocol

Protocol_Spanish_v151127

Updated protocol

Protocol_Spanish_v161018

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable