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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  METHYLPHENIDATE
• Medical condition to be studied:
  Attention deficit hyperactivity disorder

  Mitral valve prolapse

  Mitral valve incompetence

  Cardiac valve disease

  Mitral valve disease

  Tricuspid valve disease

  Mitral valve disease mixed

  Aortic valve disease

  Congenital aortic valve incompetence

  Pulmonary hypertension

Population studied

• Short description of the study population:
  Cases were patients between 5 and 25 years of age and a first diagnosis of valvular heart disease (VHD) or pulmonary hypertension (PH), recorded in the BIFAP database between 2002 and 2014. Up to 10 controls matched with cases by age, gender and calendar year.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with valvular heart disease (VHD) and pulmonary hypertension (PH)
• Estimated number of subjects:
  16500

Study design details

• Main study objective:
  To study if use of metylphenidate, compared to 'no use', is associated to a greater incidence of heart valve disease and/or pulmonary hypertension.
• Data analysis plan:
  In order to describe the variables considered for cases and controls, frequency distribution will be provided for categorical variables (sex, smoking, etc). Regarding quantitative variables (BMI), measures of central tendency and dispersion will be offered, as mean (SD) and median (Inter Quartile Range). In addition, categorical variables will be compared with X2 test or Fisher test, and continuous variables with t-Student test or Mann-Withney test.In order to estimate the pulmonary hypertension (PH) and heart valve disease (HVD) risk associated to methylphenidate use, we will use conditional logistic regression models, adjusting by other potential confounding factors. Odd ratios adjusted by age, sex and confounding factores will be calculated.In the main analysis, we will compare the PH and HVD risk for patients exposed and no exposed to methylphenidate and assess its increase depending on the duration of prescriptions.We will also explore effects in new, recent and past users

Documents

Study results

Results_ENCePP

Study publications

Saiz LC, Gil M, Alonso A, Erviti J, Garjón J, Martínez M. Use of methylphenidat…