A population-based cohort study using an existing database to evaluate the association between latanoprost use and primary malignant ocular melanoma and facial cutaneous melanoma

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 data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Glaucoma

  Intraocular pressure increased

Population studied

• Short description of the study population:
  Patients with recorded glaucoma or ocular hypertension (OH) in the Swedish national health care registers from July 1st, 2005 to December 31st, 2011 and with no previous malignant melanoma history.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Glaucoma or ocular hypertension (OH) patients
• Estimated number of subjects:
  116172

Study design details

• Main study objective:
  To examine the potential association between latanoprost and primary malignant ocular melanoma and facial cutaneous melanoma, respectively, using an existing database
• Outcomes:
  Ocular melanoma and facial cutaneous melanoma
• Data analysis plan:
  Descriptive statistics will be presented to describe patient characteristics of the latanoprost, other topical Prostaglandin (PGA) and topical non-PGA groups. Incidence rates of primary malignant ocular melanoma (OM) and facial cutaneous melanoma (CM) will be calculated by dividing the number of incident cases of melanoma by the person-time at risk for the appropriate exposure group. Incidence rates of OM and facial CM will be estimated in the latanoprost, other topical PGAs and topical non-PGAs groups. For primary objectives, a change-in-estimate procedure using Cox regression including only exposure and one potential confounder at a time will be conducted to assess the association between latanoprost and covariates and the development of OM and facial CM. Based on these results, a multivariable Cox regression model will be developed to evaluate the independent effect of latanoprost on the risk of primary malignant OM and facial CM while controlling for potential confounding.

Documents

Study results

Latanoprost_OM and Facial CM_FINAL Abstract_Sept 9, 2016

Study report

Latanoprost_OM and Facial CM_FINAL CSR_Sept 9, 2016