Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.
The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA. In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed. Objective 1: To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban. Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC. Objective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations. Objective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban cohort. Objective 5: To analyze INR (International Normalized Ratio) values during the last 12 months and to obtain TTR (Time in Therapeutic Range) values in patients previously treated with VKA, and during the whole study period for those in the cohort treated with VKA.
Study Type
OBSERVATIONAL
Enrollment
51,690
current or new medication
current or new medication
current or new medication
IDIAP Jordi Gol
Barcelona, Catalonia, Spain
Number of Participants by Their Sociodemographic Characteristics: Smoking Habit
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.
Time frame: Day 1
Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.
Time frame: Day 1
Number of Participants by Their Sociodemographic Characteristics: MEDEA
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.
Time frame: Day 1
Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m\^2).
Time frame: Day 1
Number of Participants by Comorbidity
Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.
Time frame: Up to 12 months after date of first prescription
Risk of Bleeding Events: HAS-BLED Score
Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \>65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and \>3 = high risk of bleed per 100 participants-year.
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current or new medication
Time frame: Up to 12 months prior to enrollment
Risk of Thromboembolic Events: CHADS2 Score
Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age \>=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.
Time frame: Up to 12 months prior to enrollment
Risk of Thromboembolic Events: CHA2DS2Vasc Score
Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, \>=65 and \<75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age \>=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.
Time frame: Up to 12 months prior to enrollment
Number of Participants by Comedications
Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.
Time frame: Up to 30 days after date of first prescription
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)
MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as \<80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as \>120% of MPR.
Time frame: Up to 12 months after date of first prescription
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.
Time frame: Up to 12 months after date of first prescription
Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.
Time frame: Up to 12 months after date of first prescription
International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR\<2); optimal range (2\<INR\<3); and risk of hemorrhages (INR\>3).
Time frame: Up to 12 months after date of first prescription
Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR\<2); optimal range (2\<INR\<3); and risk of hemorrhages (INR\>3).
Time frame: Up to 12 months after date of first prescription