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N/A N=332

Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

Prostatic Hyperplasia

Bottom Line

View on ClinicalTrials.gov: NCT01386983 ↗
Enrolled (actual)
332
Serious AEs
—
Results posted
Jul 2011
Primary outcome: Primary: Number of Participants With Clinical Progression — 14; 5 participants — p=0.0128

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
5ARI (Drug); 5ARI + AB (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
Male
Sponsor
GlaxoSmithKline
Primary completion
Jun 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Clinical Progression		 14; 5 0.0128 sig
SECONDARY
Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month		 129.14; 254.51 0.0002 sig

Summary

This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).

Eligibility Criteria

Inclusion Criteria

  • Males
  • aged 50 years or older
  • medical claim of EP
  • prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
  • continuously eligible for 3 months prior to and at least 5 months after their index prescription date.

Exclusion Criteria

  • Patients with prostate or bladder cancer
  • any prostate-related surgical procedure within 5 months of index date
  • prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01386983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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