An observational study in Benign Prostatic Hyperplasia, sponsored by GlaxoSmithKline. Completed. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by GlaxoSmithKline · Observational
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.
803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 13,551 is above the median of 215 across 169 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Drug: Delayed 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
Also known as: 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
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
Also known as: 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
Number of participants with a code that indicates clinical progression
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
Time frame: Data collected over a 9-year time period from 2000 to 2009.
Mean BPH-related medical costs
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
Time frame: Data collected over a 9-year time period from 2000 to 2009
No study locations are listed for this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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