Treatment Patterns Among Patients With Venous Thromboembolism in the United States

Pfizer13,945 enrolled

Overview

The purpose of this study is to assess outpatient treatment patterns following hospitalization for venous thromboembolism (VTE). VTE is a condition that occurs when blood clot forms in the vein. This is a retrospective study (assessments on events that have already occurred) of healthcare claims from databases. The study sponsors will assess healthcare claim records of patients treated with either apixaban or warfarin. Assessment includes treatment persistence, switch, and stopping therapy, along with recurrent VTE and bleeding.

Study Type

OBSERVATIONAL

Enrollment

13,945

Conditions

Venous Thromboembolism

Interventions

apixabanDRUG

patients treated with apixaban

warfarinDRUG

patients treated with warfarin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * inpatient hospitalization with primary discharge diagnosis of venous thromboembolism (VTE) (this is the index hospitalization) * treatment with apixaban or warfarin during the hospitalization * at least 18 years of age Exclusion Criteria: * Hospitalization for VTE within 6 months prior to the index hospitalization * Diagnosis of atrial fibrillation/flutter or procedure for mechanical heart valve in the 6 months prior to the index hospitalization * Procedure for inferior vena cava filter or diagnosis of pregnancy during the study period * Prior use of oral anticoagulants or parenteral anticoagulants

Locations (1)

Pfizer

New York, New York, United States

Outcomes

Primary Outcomes

Number of Participants Who Continued Treatment With Apixaban or Warfarin Following Discharge From the Hospital

Following discharge from inpatient hospitalization, participants who continued apixaban or warfarin, respectively, in the outpatient setting (with outpatient treatment claim occurring on or within 30-days following the hospital discharge date) were identified.

Time frame: From hospital discharge date through 30 days following discharge date (from the data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Mean Number of Persistent Days

Persistent days was defined as the number of days from the index date until the first of the following: treatment discontinuation, treatment switch, or the end of follow-up. Treatment index date: date of first outpatient apixaban or warfarin claim.

Time frame: From the index date until the first of treatment discontinuation, treatment switch, or the end of follow-up, whichever occurred first (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Percentage of Participants Who Discontinued Index Treatment at 6 Months Post-Discharge Index Date

Discontinuation was defined as greater than or equal to (\>=) 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim.

Time frame: At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Percentage of Participants Who Discontinued Index Treatment at 12 Months Post-Discharge Index Date

Discontinuation was defined as \>= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim.

Data from ClinicalTrials.gov

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Time frame: At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Percentage of Participants Who Switched From Index Treatment at 6 Months Post-Discharge Index Date

Participants were considered to have switched if they filled a prescription for oral anticoagulant (OAC) other than apixaban or warfarin, respectively (identified through national drug codes \[NDC\] codes in longitudinal prescription claims \[LRx\]) or for parenteral anticoagulant (PAC) within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim.

Time frame: At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Percentage of Participants Who Switched From Index Treatment at Month 12 Post-Discharge Index Date

Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim.

Time frame: At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Median Time to Discontinuation From the Index Treatment

Time from treatment index date to discontinuation date was described in this outcome measure. Discontinuation was defined as \>= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim.

Time frame: From initiation of index treatment post-discharge till its discontinuation (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Median Time to Switch From the Index Treatment

Time from treatment index date to treatment switch date was described in this outcome measure. Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim.

Time frame: From initiation of index treatment post-discharge till switch (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Secondary Outcomes

Incidence Rate of Recurrent VTE Events

Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Incidence rate was defined as the number of events (recurrent VTE) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim.

Time frame: From first hospitalization discharge date to subsequent inpatient hospitalization for VTE (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Median Time to Recurrent VTE

Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Treatment index date: date of first outpatient apixaban or warfarin claim.

Incidence Rate of Major Bleeding Events

Major bleeding was defined as inpatient hospitalization with primary diagnosis of gastro-intestinal bleeding, intracranial hemorrhage (ICH) or other major bleeding. Incidence rate was defined as the number of events (major bleeding) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim.

Time frame: From first hospitalization discharge through first major bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Incidence Rate of Clinically Relevant Non-Major (CRNM) Bleeding Events

CRNM bleeding was defined as inpatient hospitalization with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM gastrointestinal (GI) bleeding or other non-critical types of bleeding. Incidence rate was defined as the number of events (CRNM bleeding) per 100 participant years.

Time frame: From first hospitalization discharge through first CRNM bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)