title: Efficacy and safety assessment of alteplase in the treatment of stroke - gender differences.
abstract: BACKGROUND
  Evidence for gender disparity in response to pharmacological thrombolysis for acute stroke treatment is inconclusive.
  
  
  OBJECTIVE
  To compare the effectiveness and safety of alteplase used in the treatment of male and female stroke patients.
  
  
  METHODS
  One thousand and seventy-seven patients who recently had their first-ever clinically apparent stroke (group I: 113 patients treated with intravenous alteplase and group II: 964 not treated with alteplase) were qualified. Groups I and II were divided into subgroups based on gender and were analysed based on: the age when they had a stroke, presence of key stroke risk factors (quantitatively: ≤ or >3), neurological state according to NIHSS in the first day of stroke, mortality rate, and the modified Rankin scale (mRS) at day 90 after the stroke. In group I, other determinants were additionally assessed: recent lesions as appeared on CT scans of the head in the first day of stroke and 24 hours after recombinant tissue plasminogen activator (rtPA), neurological state according to NIHSS in the second day of stroke, and the incidence of iatrogenic bleeding.
  
  
  RESULTS
  The age of the onset of stroke was older in women both in group I and group II. Apart from lipid disorders, no statistically significant differences in the distribution of other risk factors for stroke between groups I and II were found. The neurological state (according to the NIHSS scale) on the first day of the disease was significantly more severe in women both in group I and group II. In group II, the level of functioning according to the mRS scale at day 90 day after the onset of the disease was significantly more severe in women; there was no significant difference in group I. Among patients from group I, a significantly greater improvement, according to the NIHSS scale, was found in women 24 hours after rtPA administration in comparison with men. The presence of focal ischemia, responsible for the occurrence of stroke, on the CTs of the head performed 24 hours after rtPA administration, was also significantly more often found in women (in group I). No statistically significant differences in the incidence of complications after rtPA between women and men in group I were observed. In multivariate methods, we did not find any impact of factors other than gender on the outcome after stroke.
  
  
  CONCLUSIONS
  The use of alteplase in women during the treatment of stroke is associated with a greater and faster improvement in their neurological state in comparison with men. Treating stroke with alteplase in women improves long-term prognosis regarding self-efficacy in everyday functioning. Finally, there are no gender-related differences regarding the safety of intravenous thrombolytic therapy.
authors.forename: Anetta
authors.initials: A
authors.lastname: Lasek-Bal
authors.forename: Przemysław
authors.initials: P
authors.lastname: Puz
authors.forename: Zofia
authors.initials: Z
authors.lastname: Kazibutowska
mesh_terms: D061605:Administration, Intravenous; D017668:Age of Onset; D000368:Aged; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D011379:Prognosis; D020127:Recovery of Function / Q000187:drug effects / Q000502:physiology; D012307:Risk Factors; D012720:Severity of Illness Index; D012727:Sex Characteristics; D020521:Stroke / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology*; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
keywords: Alteplase,; Gender,; Safety of rtPA treatment; Stroke,