Tamsulosin and the Risk of Serious Adverse Events

NCT07274228 | Completed

• 2 other identifiers: 2025 0906 600 000ICES # 2025 0906 600 000
• Study Type: observational
• Target: 14,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a population-based cohort study assessing whether initiating a higher dose of tamsulosin (0.8 mg/day) compared to a lower dose (0.4 mg/day) in older adults with advanced chronic kidney disease (CKD) (an estimated glomerular filtration rate (eGFR) \<45 mL/min per 1.73 m² but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 90-day risk of a composite outcome of all-cause hospitalization or all-cause emergency visits or all-cause mortality.

Conditions

Chronic Kidney Disease (CKD)

Keywords

Chronic kidney disease; High-throughput computing; Tamsulosin; Adverse events; Older adults; Cohort study; Drug safety

Outcome Measures

Primary Outcomes (1)

• Number of participants with a composite outcome of all-cause hospitalization or all-cause emergency visits, or all-cause mortality

  All-cause hospitalization, all-cause emergency visits, and all-cause mortality will be combined into a composite measure. Only the first hospitalization or first emergency department visit occurring within 90 days after the cohort entry date will be considered.

  Exposed cohort to tamsulosin (high dose (0.8 mg/day) versus low dose (0.4 mg/day) will enter the cohort and will be followed until study outcome (first event), death, or 90 days from the cohort entry date.

Secondary Outcomes (3)

• Number of participants with all-cause hospitalization

  Exposed cohort to tamsulosin (high dose (0.8 mg/day) versus low dose (0.4 mg/day) will enter the cohort and will be followed until study outcome (first event), death, or 90 days from the cohort entry date.

• Number of participants with all-cause emergency department visits

  Exposed cohort to tamsulosin (high dose (0.8 mg/day) versus low dose (0.4 mg/day) will enter the cohort and will be followed until study outcome (first event), death, or 90 days from the cohort entry date.

• Number of participants with all-cause mortality

  Exposed cohort to tamsulosin (high dose (0.8 mg/day) versus low dose (0.4 mg/day) will enter the cohort and will be followed until study outcome (first event), death, or 90 days from the cohort entry date.

Other Outcomes (3)

• 90-day composite outcome of a hospital encounter with atrial fibrillation/flutter or other arrhythmia

  Exposed cohort to tamsulosin (high dose (0.8 mg/day) versus low dose (0.4 mg/day) will enter the cohort and will be followed until study outcome (first event), death, or 90 days from the cohort entry date.

• 90-day composite outcome of a hospital encounter with heart failure or myocardial infarction, or ischemic stroke

  Exposed cohort to tamsulosin (high dose (0.8 mg/day) versus low dose (0.4 mg/day) will enter the cohort and will be followed until study outcome (first event), death, or 90 days from the cohort entry date.

• 90-day composite outcome of a hospital encounter with falls, hypotension, syncope, or hospital admission with receipt of an urgent computed tomography scan of the head

  Exposed cohort to tamsulosin (high dose (0.8 mg/day) versus low dose (0.4 mg/day) will enter the cohort and will be followed until study outcome (first event), death, or 90 days from the cohort entry date.

Study Arms (2)

Low dose of tamsulosin (0.4 mg/day (standard dose))

Residents of Ontario, male, aged 66 years or older with advanced CKD (an eGFR \<45 mL/min per 1.73 m² but not receiving dialysis or having a history of kidney transplantation) who have filled a new oral prescription for tamsulosin (low dose 0.4 mg/day) at an outpatient pharmacy under the Ontario Drug Benefit (ODB) program from January 01, 2008, to December 01, 2024. The date when the prescription was filled will serve as the patient's entry or index date for the cohort, with each patient entering the cohort only once. If the investigators conduct the study in Alberta, the accrual period for Alberta will be determined.

Drug: Tamsulosin

High dose of tamsulosin (0.8 mg/day (off label dose))

Residents of Ontario, male, aged 66 years or older with advanced CKD (an eGFR \<45 mL/min per 1.73 m² but not receiving dialysis or having a history of kidney transplantation) who have filled a new oral prescription for tamsulosin (high dose 0.8 mg/day) at an outpatient pharmacy under the Ontario Drug Benefit (ODB) program from January 01, 2008, to December 01, 2024. The date when the prescription was filled will serve as the patient's entry or index date for the cohort, with each patient entering the cohort only once. If the investigators conduct the study in Alberta, the accrual period for Alberta will be determined.

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

The primary exposure of interest will be oral tamsulosin at a dose of 0.4 mg/day, representing the median dose in high-throughput computing analyses. For the primary comparison, oral tamsulosin at a dose of 0.4 mg/day will be chosen to reduce the influence of indication bias.

Also known as: APO-Tamsulosin CR, AURO-Tamsulosin CR, Flomax CR [DSC], JAMP-Tamsulosin, RATIO-Tamsulosin [DSC], SANDOZ Tamsulosin, SANDOZ Tamsulosin CR, TEVA-Tamsulosin CR, TEVA-Tamsulosin [DSC]

High dose of tamsulosin (0.8 mg/day (off label dose)); Low dose of tamsulosin (0.4 mg/day (standard dose))

Eligibility Criteria

• Age: 66 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men aged 66 years or older with advanced CKD (eGFR \<45 mL/min per 1.73 m² but not receiving dialysis or having a history of kidney transplantation) who have filled at least one outpatient prescription for oral tamsulosin between 2008 and 2024 in Ontario.

You may qualify if:

• The cohort will include older adult men aged 66 years or older with advanced CKD (an eGFR \<45 mL/min per 1.73 m² but not receiving dialysis or having a history of kidney transplantation) who have filled a new oral prescription for tamsulosin at an outpatient pharmacy under the Ontario Drug Benefit (ODB) program from January 1, 2008, to December 01, 2024. The age criterion is set to guarantee that individuals in this population had at least one year of prior prescription drug coverage. The date when the prescription was filled will serve as the patient's entry or index date for the cohort, with each patient entering the cohort only once.

You may not qualify if:

• The investigators will exclude patients receiving tamsulosin doses other than 0.4mg/day or 0.8mg/day.
• To ensure that patients are new tamsulosin users, the investigators will exclude those with any evidence of tamsulosin use in the 180 days before the index date.
• Patients with more than one study drug prescription on the index date will be excluded, as this complicates the ability to ascertain the prescribed dose accurately.
• The investigators will exclude patients with a prescription of Alpha1 blocker (alfuzosin, doxazosin, prazosin, silodosin, terazosin), 5 Alpha Reductase inhibitor (dutasteride, finasteride, dutasteride \& tamsulosin), and non-oral study drugs in the previous 180 days, including the index date.
• Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date.
• Evidence with hospital discharge or emergency department visit in the two days prior to or on the index date to ensure a new outpatient prescription.
• Patients with no outpatient serum creatinine measurement 0- 365 days before the index date will be excluded.
• Patients with unstable baseline kidney function (If the most recent serum creatinine test before the index date was an inpatient test \[ER or hospitalization\] \<refer to this as test date 1\>, and there is not at least one 'outpatient' serum creatinine in the year before test date 1) (If the most recent prior serum creatinine test before the index date was an inpatient test \[ER or hospitalization\] \<refer to this as tests test date 1\>, and while there is at least 'outpatient' serum creatinine test in the year before \<test date 1\>, the most recent outpatient test before \<test date 1\> differs by an eGFR 10 mL/min/1.73 m2 or more from the value on \<test date 1\>) will be excluded. In Ontario, it has been shown that outpatient serum creatinine measurements in the province, conducted on a single occasion, indicate stable values.
• If more than one eligible prescription is available, restrict it to the first. The date of this prescription will be the index date

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre Research Institute

London, Ontario, Canada

Location

Related Publications (4)

• Bathini L, Jeyakumar N, Sontrop J, McArthur E, Kang Y, Luo B, Bello A, Collister D, Ahmed S, Kaul P, Youngson E, Braam B, Melamed N, Hladunewich M, Garg AX. Impact of Baseline Kidney Function on the Rate of Progressive Kidney Disease After Pregnancy: A Population-Based Cohort Study Research Protocol. Can J Kidney Health Dis. 2025 Feb 28;12:20543581251318836. doi: 10.1177/20543581251318836. eCollection 2025.

  PMID: 40027936 BACKGROUND

• Shu D, Zou G, Hou L, Petrone AB, Maro JC, Fireman BH, Toh S, Connolly JG. A simple Cox approach to estimating risk ratios without sharing individual-level data in multisite studies. Am J Epidemiol. 2025 Jan 8;194(1):226-232. doi: 10.1093/aje/kwae188.

  PMID: 38973755 BACKGROUND

• Abdullah SS, Rostamzadeh N, Muanda FT, McArthur E, Weir MA, Sontrop JM, Kim RB, Kamran S, Garg AX. High-Throughput Computing to Automate Population-Based Studies to Detect the 30-Day Risk of Adverse Outcomes After New Outpatient Medication Use in Older Adults with Chronic Kidney Disease: A Clinical Research Protocol. Can J Kidney Health Dis. 2024 Jan 6;11:20543581231221891. doi: 10.1177/20543581231221891. eCollection 2024.

  PMID: 38186562 BACKGROUND

• Koiso K, Akaza H, Kikuchi K, Aoyagi K, Ohba S, Miyazaki M, Ito M, Sueyoshi T, Matsushima H, Kamimura H, Watanabe T, Higuchi S. Pharmacokinetics of tamsulosin hydrochloride in patients with renal impairment: effects of alpha 1-acid glycoprotein. J Clin Pharmacol. 1996 Nov;36(11):1029-38. doi: 10.1177/009127009603601107.

  PMID: 8973992 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Amit Garg

  London Health Sciences Centre Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: January 1, 2008
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)