SECOND PROSPECTIVE, PHARMACOEPIDEMIOLOGIC DATABASE ANALYSIS OF PHENTERMINE AND TOPIRAMATE EXTENDED-RELEASE USAGE FROM A REPRESENTATIVE US SAMPLE OF OLDER PATIENTS

Author(s)

Peterson CA, Steelman X, Varghese ST
VIVUS, Inc, Mountain View, CA, USA

OBJECTIVES: Phentermine and topiramate extended-release (PHEN/TPM ER) was approved by the US FDA in July 2012 for chronic weight management in combination with lifestyle modifications in adults with a body mass index (BMI) of ≥30 or ≥27kg/mand ≥1 weight-related comorbidity. This interim second analysis of a Phase 4 post-marketing study assessed the medical appropriateness of prescribed PHEN/TPM ER by examining the total number of PHEN/TPM ER users, their demographics, weight-related comorbidities, and concomitant medication use over 18 months post-approval. METHODS: Data were collected from two databases between 17 September 2012 and 28 February 2014; the Qsymia Certified Pharmacy Network (QCPN) database collected age and gender information of all patients with ≥1 recorded PHEN/TPM ER prescription; the Humedica Electronic Health Record (HEHR) database collected age, gender, race, BMI, weight-related comorbidities, and concomitant medication use. . Older patients (≥61 years) were evaluated for this subanalysis. RESULTS: There were 160,853 and 5253 patients in the QCPN and HEHR databases, respectively. Of these, 22,579 and 649 patients from the QCPN and HEHR databases, respectively were ≥61 years. Among older patients in the HEHR database, 73% were female, and mean BMI (kg/m) was 36 (84% had BMI ≥30 and 56% BMI ≥35) with <2% having BMI ≤25. In the HEHR database, 71% had dyslipidemia, 69% had hypertension, and 37% had type 2 diabetes mellitus. In addition, 90% were prescribed antihypertensive medications, 46% antidiabetic medications, and 26% antidepressants (including SSRIs and SNRIs). CONCLUSIONS: These data demonstrate consistencies between patient demographics, weight-related comorbidities, and concomitant medication use among older patients prescribed PHEN/TPM ER, subjects randomized in the CONQUER clinical trial, and the labeled indication. Over 18 months of PHEN/TPM ER use, medically appropriate individuals, including older patients, are utilizing PHEN/TPM ER as intended for chronic weight management.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PSY13

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Diabetes/Endocrine/Metabolic Disorders

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×