Observational prospective cohort study to evaluate the incidence of adverse events (AE), risk factors, and drug utilization patterns related to treatment with BUSCAPINA COMPOSITUM N from March to December 2016 in patients from Metropolitan Lima (PASS PERU)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Buscapina Compositum N
• Study drug International non-proprietary name (INN) or common name:
  HYOSCINE BUTYLBROMIDE

  PARACETAMOL
• Medical condition to be studied:
  Pain

Population studied

• Short description of the study population:
  Patients 18 years of age and older who have received at least one dose of BUSCAPINA COMPOSITUM N according to label indications
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  360

Study design details

• Study design:
  This is a 12-month active pharmacovigilance, prospective, cohort multicenter study
• Main study objective:
  1.) Identify and describe the AE and adverse drug reactions (ADR) presented in patients that are undergoing treatment with BUSCAPINA COMPOSITUM N in Metropolitan Lima.
• Setting:
  15 patient recruitment centers (Clinics, private doctor´s office and pharmacies). We will prioritize the clinics, pharmacies and private doctor’s office with the highest volume of BUSCAPINA COMPOSITUM N sales.
• Outcomes:
  Occurence of AEs in routine clinical practice in patients that are in treatment with BUSCAPINA COMPOSITUM N (when it is used according to the label indications), Incidence of AE and ADR in patients that are in treatment with BUSCAPINA COMPOSITUM N when it is used in routine clinical practice according to label indicationsFrequency of patients present with AE symptoms related to a potential liver injuryDrug utilization patterns in patients who receive BUSCAPINA COMPOSITUM N in pharmacies, clinics and private doctor¿s office in Metropolitan Lima Peru
• Data analysis plan:
  1. For the first objective of the study a descriptive statistical analysis of frequencies will be conducted for the adverse events that are discovered. 2. For the second objective of the study, If data is available the incidence rate will be calculated including in the numerator the number of cases of people who develop an adverse event, and in the denominator the sum of the different amounts of person time that each participant in the study contributes. 3. For the third objective, we will complete a descriptive statistical analysis related to the drug utilization patterns in all patients. and compare patterns between those with and without AE.4. For the fourth objective, we will conduct a logistic regression analysis to identify risk factors (such as past medical history, concomitant illnesses, drug utilization factors of the medication, and concomitant treatments) in patients that present with AE and adverse drug reactions related to treatment with BUSCAPINA COMPOSITUM N.
• Summary results:
  The mean number of treatment days of Buscapina Compositum N was 3.0 (SD:0.9) and the average daily dose was 2.1 (SD: 0.7). Overall, 4.7% patients who participated in the Buscapina Compositum N cohort study had an adverse event, none was related to potential liver damage. Twelve of these patients had one adverse event and 4 had two adverse events, making a total of 20 events. The majority of adverse events were from the gastrointestinal tract (55%, 11/20), followed by nervous system disorders (35%; 7/20) and respiratory (5%; 1/20) and urinary tract disorders (5%; 1/20). None of the adverse events were serious, 16 out of 20 adverse events (80%) were classified as related and the remaining 4 (20%) as not related to Buscapina Compositum N.