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4-Year Cost Trajectories in Real-World Patients Matched to the Metabolic Profiles of Trial Subjects Before/After Treatment with Phentermine-Topiramate.

ABSTRACT: OBJECTIVE:Our objective was to estimate 4-year healthcare costs associated with the metabolic profile of patients before and after 1 year of treatment with phentermine (15 mg) and topiramate extended-release (92 mg) [phentermine-topiramate ER]. DESIGN AND METHODS:Using a medical records database, we created two patient cohorts reflecting metabolic profiles of subjects before and after phentermine-topiramate ER therapy during the 1-year CONQUER trial. We matched database patients with trial subjects by age, sex, body mass index (BMI), and hypertension, glycemic, and triglyceride status. We collected real-world data on emergency department and outpatient visits, hospitalizations, and drug prescriptions over 4 years, linking them to reimbursements to estimate US private insurance costs for post-trial (n = 2295) versus pre-trial intention-to-treat (ITT) patients (n = 2295). Secondary analysis assessed responders (completers losing ?5 % body weight [n = 1285]). RESULTS:Over 4 years, the mean cost per patient in the post- versus pre-trial ITT-group was $US32,432 versus $US34,725 (mean difference -2292; 95 % confidence interval [CI] -4776 to 209). In responders, corresponding costs were $US30,558 versus $US33,936 (mean difference -3378; 95 % CI -6496 to -464). Costs for post- versus pre-trial responders were lower for outpatient visits, emergency visits, and medications (all P < 0.05). CONCLUSION:Excluding treatment cost and potential side effects, patients matched to profiles of phentermine-topiramate ER responders had lower costs than patients matched to pre-treatment profiles.

SUBMITTER: Li J

PROVIDER: S-EPMC4883189 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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4-Year Cost Trajectories in Real-World Patients Matched to the Metabolic Profiles of Trial Subjects Before/After Treatment with Phentermine-Topiramate.

Li James J Reaven Nancy L NL Funk Susan E SE McGaughey Karen K Neovius Martin M

Drugs - real world outcomes 20150601 2

<h4>Objective</h4>Our objective was to estimate 4-year healthcare costs associated with the metabolic profile of patients before and after 1 year of treatment with phentermine (15 mg) and topiramate extended-release (92 mg) [phentermine-topiramate ER].<h4>Design and methods</h4>Using a medical records database, we created two patient cohorts reflecting metabolic profiles of subjects before and after phentermine-topiramate ER therapy during the 1-year CONQUER trial. We matched database patients w ...[more]

PMID: 27747764

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Project description:BackgroundA fixed-dose combination of phentermine and extended-release topiramate (PHEN/TPM - approved for weight management) has demonstrated in-clinic reduction of blood pressure (BP). Ambulatory BP monitoring (ABPM) may be a better predictor of cardiovascular disease risk than in-clinic BP.MethodsThis randomized, multicenter, double-blind study enrolled 565 adults with overweight/obesity. Inclusion criteria included participants willing to wear ABPM device for 24 h. Exclusion criteria included screening blood pressure >140/90 mmHg and antihypertensive medications not stable for 3 months prior to randomization. Participants received placebo (n = 184), phentermine 30 mg; (n = 191), or PHEN 15 mg/TPM 92 mg; (n = 190). 24-hour ABPM was performed at baseline and at week 8. The primary endpoint was mean 24-h systolic BP (SBP) as measured by ABPM, in the per protocol population.ResultsParticipants were mostly female (73.5 %) and White (81.6 %), with a mean age of 53.4 years; 32.4 % had no hypertension diagnosis or treatment, 62.5 % had hypertension using 0 to 2 antihypertensive medications, and 5.1 % had hypertension using ≥ 3 antihypertensive medications. Baseline mean SBP/diastolic BP (DBP) was 123.9/77.6 mmHg. At week 8, mean SBP change was -0.1 mmHg (placebo), +1.4 mmHg (phentermine 30 mg), and -3.3 mmHg (PHEN/TPM). Between-group difference for PHEN/TPM versus placebo was -3.2 mmHg (95 % CI: -5.48, -0.93 mmHg; p = 0.0059). The between-group difference for PHEN/TPM versus phentermine 30 mg was -4.7 mmHg (95 % CI: -6.96, -2.45 mmHg; p < 0.0001). Common (>2 % in any treatment group) adverse events (i.e., dry mouth, constipation, nausea, dizziness, paresthesia, dysgeusia, headache, COVID-19, urinary tract infection, insomnia, and anxiety) were mostly mild or moderate.ConclusionsIn this randomized, multicenter, double-blind ABPM study, PHEN/ TPM reduced SBP compared to either placebo or phentermine 30 mg (Funding: Vivus LLC; ClinicalTrials.gov: NCT05215418).

Project description:BackgroundCommunity-acquired pneumonia (CAP) is a leading cause of morbidity and mortality worldwide despite correct antibiotic use. Corticosteroids have long been evaluated as a treatment option, but heterogeneous effects on survival have precluded their widespread implementation. We aimed to evaluate whether corticosteroids might improve clinical outcomes in patients with severe CAP and high inflammatory responses.Study design and methodsWe analyzed two prospective observational cohorts of patients with CAP in Barcelona and Rome who were admitted to intensive care with a high inflammatory response. Propensity score (PS) matching was used to obtain balance among the baseline variables in both groups, and we excluded patients with viral pneumonia or who received hydrocortisone.ResultsOf the 610 patients admitted with severe CAP, 198 (32%) received corticosteroids and 387 had major criteria for severe CAP. All patients had a baseline serum C-reactive protein above 15 mg/dL. Patients who received corticosteroids were more commonly male, had more comorbidities (e.g., cancer or chronic obstructive pulmonary disease), and presented with significantly higher sequential organ failure assessment scores. Eighty-nine patients met major severity criteria (invasive mechanical ventilation and/or septic shock) and were matched per group. Twenty-eight-day mortality was lower among patients receiving corticosteroids (16 patients, 18%) than among those not receiving them (28 patients, 31%; p = 0.037). After PS matching, corticosteroid therapy reduced the 28-day mortality risk in patients who met major severity criteria (hazard ratio (HR) 0.53, 95% confidence interval (CI) 0.29-0.98) (p = 0.043). In patients who did not meet major severity criteria, no benefits were observed with corticosteroid use (HR 0.88 (95%CI 0.32-2.36).ConclusionsCorticosteroid treatment may be of benefit for patients with CAP who have septic shock and/or a high inflammatory response and requirement for invasive mechanical ventilation. Corticosteroids appear to have no impact on mortality when these features are not present.

Project description:IntroductionWhile the liraglutide effect and action in diabetes (LEAD-6) clinical trial compared the efficacy and safety of liraglutide once daily (LIRA) to exenatide twice daily (EXEN) in adult patients with type 2 diabetes, few studies have explored the associated per-patient costs of glycemic goal achievement of their use in a real-world clinical setting.MethodsThis retrospective cohort study used integrated medical and pharmacy claims linked with glycated hemoglobin A1C (A1C) results from the IMS Patient-Centric Integrated Data Warehouse. Patients' ≥18 years and naïve to incretin therapies during a 6-month pre-index period, with ≥1 prescription for LIRA or EXEN between January 2010 and December 2010, were included. Patients with evidence of insulin use (pre- or post-index) were excluded. Only patients who were persistent on their index treatment during a 180-day post-index period were included. Follow-up A1C assessments were based on available laboratory data within 45 days before or after the 6-month post-index point in time. Diabetes-related pharmacy costs over the 6-month post-index period were captured and included costs for both the index drugs and concomitant diabetes medications.Results234 LIRA and 182 EXEN patients were identified for the analysis. The adjusted predicted diabetes-related pharmacy costs per patient over the 6-month post-index period were higher for LIRA compared to EXEN ($2,002 [95% confidence interval (CI): $1,981, $2,023] vs. $1,799 [95% CI: $1,778, $1,820]; P < 0.001). However, a higher adjusted predicted percentage of patients on LIRA reached A1C < 7% goal (64.4% [95% CI: 63.5, 65.3] vs. 53.6% [95% CI: 52.6, 54.6]; P < 0.05), translating into lower average diabetes-related pharmacy costs per successfully treated patient for LIRA as compared to EXEN ($3,108 vs. $3,354; P < 0.0001).ConclusionsAlthough predicted diabetes-related pharmacy costs were greater with LIRA vs. EXEN, a higher proportion of patients on LIRA achieved A1C < 7%, resulting in a lower per-patient cost of A1C goal achievement with LIRA compared to EXEN.

Dataset Information

4-Year Cost Trajectories in Real-World Patients Matched to the Metabolic Profiles of Trial Subjects Before/After Treatment with Phentermine-Topiramate.

Publications

4-Year Cost Trajectories in Real-World Patients Matched to the Metabolic Profiles of Trial Subjects Before/After Treatment with Phentermine-Topiramate.

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