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Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01435954
First Posted: September 19, 2011
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

In patients with benign prostatic hyperplasia (BPH), combination therapy with an alpha-blocker (AB) and a 5 alpha-reductase inhibitor (5ARI) has been shown to reduce the progression of acute urinary retention (AUR) and the incidence of prostate surgery, and also provides symptom relief.

The objective of this study is to compare the likelihood of clinical progression (defined as AUR and/or prostate-related surgery) and costs in BPH patients who were treated with delayed combination therapy to BPH patients who were treated with early combination therapy using data from a United States (US) healthcare claims database. The hypothesis of this study is that patients who are prescribed combination therapy early in their BPH treatment will experience better clinical outcomes and lower healthcare costs compared with patients treated with delayed combination therapy. The null hypothesis is that no difference will be observed in outcomes or direct medical costs for patients treated with early combination therapy and patients treated with delayed combination therapy.

The US healthcare claims database includes data from patients with Medicare Advantage as well as private health plan coverage including the Impact health plan. About 14 million people were covered by this set of health plans in 2007 and were geographically diverse across the US. Data from 2000 through 2009 were utilized.

The study is a retrospective cohort analysis.


Condition Intervention
Benign Prostatic Hyperplasia Drug: Early combination therapy Drug: Delayed combination therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination Therapy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of participants with a code that indicates clinical progression [ Time Frame: Data collected over a 9-year time period from 2000 to 2009. ]
    The number of participants who experience clinical progresion (BPH-surgery or AUR) based on treatment or diagnosis codes and compared between participant records of BPH patients treated with early combination therapy compared with delayed combination therapy


Secondary Outcome Measures:
  • Mean BPH-related medical costs [ Time Frame: Data collected over a 9-year time period from 2000 to 2009 ]
    The mean cost of medical treatment related to BPH in US dollars for records of patients who were treated with early combination therapy and those treated with delayed combination therapy


Enrollment: 13551
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Benign Prostatic Hyperplasia (BPH)
Insured male patients age 50 or older with BPH but no evidence of acute urinary retention (AUR) or prostate surgery at the index date
Drug: Early combination therapy
If index drug was an alpha-blocker (AB) (alfuzosin, doxazosin, tamsulosin, or terazosin), a pharmacy claims for a 5-alpha reductase inhibitor (5ARI) (dutasteride, finasteride) on or within 30 days after the index date or if index drug was 5ARI, fill for an AB on or within 30 days after the index date
Other Names:
  • Flomax® is a registered trademark of Astellas Pharma
  • Rapaflo® is a registered trademark of Watson Pharmaceuticals
  • Inc
  • Proscar® is a registered trademark of Merck
  • Uroxatral® is a registered trademark of Sanofi-Aventis
  • Cardura® is a registered trademark of Pfizer Inc
  • Avodart® is a registered trademark of GlaxoSmithKline
  • Hytrin® is a registered trademark of Abbott Laboratories
Drug: Delayed combination therapy
If index drug was an AB (alfuzosin, doxazosin, tamsulosin, or terazosin), a pharmacy claim for a 5ARI (dutasteride, finasteride) more than 30 days but less than or equal to 180 days of the index date
Other Names:
  • Cardura® is a registered trademark of Pfizer Inc
  • Proscar® is a registered trademark of Merck
  • Hytrin® is a registered trademark of Abbott Laboratories
  • Uroxatral® is a registered trademark of Sanofi-Aventis
  • Avodart® is a registered trademark of GlaxoSmithKline
  • Rapaflo® is a registered trademark of Watson Pharmaceuticals
  • Inc
  • Flomax® is a registered trademark of Astellas Pharma

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Insured male patients, aged 50 and older, with a diagnosis of benign prostatic hyperplasia (BPH) as identified by International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9) codes for BPH (ICD-9 = 222.2x or 600.xx)
Criteria

Inclusion Criteria:

  • Male
  • Age 50 or older at the index date (the date of the first filled prescription for an AB or 5ARI during the enrollment period)
  • At least one claim with an ICD-9 diagnosis code for BPH (222.2 or 600.xx) in any position and at least one pharmacy claim for an AB (alfuzosin, doxazosin, tamsulosin, or terazosin) or at least one fill for a 5ARI (dutasteride or finasteride) (with or without a diagnosis for BPH)
  • Continuous enrollment with medical and pharmacy benefits for 6 months prior to the index date (i.e., baseline period) and 12 months after the index date (follow-up period)

Exclusion Criteria:

  • At least one pharmacy claim for an AB (alfuzosin, doxazosin, tamsulosin, or terazosin) any time during the pre-index period prior to the index date
  • At least one fill for a 5ARI (dutasteride or finasteride) any time during the pre-index period prior to the index date
  • A diagnosis code for prostate cancer (ICD-9 = 185, 198.82, 233.4, 236.5, 239.5, V10.46) or bladder cancer (ICD-9 =188, 198.1, 223.3, 233.7, 239.4, V10.51) in any position during the pre-index or follow-up period
  • A pharmacy claim for finasteride 1 mg tablets (i.e., treatment of male-pattern baldness) during the pre-index or follow-up period
  • Prostate surgery anytime during the pre-index period or 5 months after the index date
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435954


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01435954     History of Changes
Other Study ID Numbers: 113908
First Submitted: September 15, 2011
First Posted: September 19, 2011
Last Update Posted: May 16, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
benign prostatic hyperplasia
surgery
5-alpha-reductase inhibitor
enlarged prostate
acute urinary retention

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Tamsulosin
Doxazosin
Silodosin
Terazosin
Alfuzosin
Finasteride
Dutasteride
5-alpha Reductase Inhibitors
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antihypertensive Agents