Is dapagliflozin (SGLT2 inhibitor) safe to use in a patient with type 2 diabetes, dyslipidemia, normal renal function, and newly diagnosed Benign Prostatic Hyperplasia (BPH)?

Is Dapagliflozin Safe in BPH?

Yes, dapagliflozin is safe to use in patients with benign prostatic hyperplasia (BPH), as there are no contraindications or specific warnings regarding BPH in the FDA prescribing information or major clinical guidelines. 1

FDA-Approved Indications and Safety Profile

• Dapagliflozin is FDA-approved for multiple indications including chronic kidney disease, heart failure, cardiovascular risk reduction in type 2 diabetes, and glycemic control, with no mention of BPH as a contraindication or precaution 1
• The only absolute contraindication is a history of serious hypersensitivity reaction to dapagliflozin 1

Mechanism of Action and Urinary Effects

• Dapagliflozin works by inhibiting SGLT2 in the renal proximal tubule, increasing urinary glucose excretion by approximately 70 grams per day, which results in increased urinary volume 1, 2
• The glucosuria-induced osmotic diuresis causes a modest increase in 24-hour urine volume, but this is generally well-tolerated and does not specifically worsen BPH symptoms 2

Relevant Safety Considerations in BPH Patients

• Urinary tract infections (UTIs): Dapagliflozin is associated with increased risk of UTIs in some studies, which could theoretically be more problematic in men with BPH who may have incomplete bladder emptying 3, 4
• Volume depletion: The osmotic diuresis can cause volume depletion, particularly in elderly patients or those on concurrent diuretics—assess volume status before initiation and correct if present 1, 5
• Genital mycotic infections: These occur in approximately 6% of patients versus 1% on placebo, but are not specifically related to BPH 5

Clinical Monitoring Recommendations

• Assess renal function (eGFR) prior to initiation, as dapagliflozin should not be initiated if eGFR <25 mL/min/1.73 m² for cardiovascular/renal indications 1, 5
• For glycemic control specifically, do not initiate if eGFR <45 mL/min/1.73 m² as it will be ineffective 1, 5
• Monitor for signs of UTI or urinary retention, particularly in the first few weeks after initiation 3
• Educate patients to maintain adequate hydration to offset the mild diuretic effect 2

Dosing in Your Patient

• For cardiovascular/renal protection or heart failure: 10 mg once daily (fixed dose, no titration) 1, 5
• For glycemic control with normal renal function (eGFR ≥45): start 5 mg once daily, may increase to 10 mg once daily if additional glycemic control needed 1

Common Pitfall to Avoid

• Do not withhold dapagliflozin solely due to BPH diagnosis—there is no evidence-based reason to avoid this medication in BPH patients 1
• The increased urinary frequency from dapagliflozin's osmotic diuresis is typically mild and transient, distinct from obstructive BPH symptoms 2
• If urinary symptoms worsen significantly after starting dapagliflozin, evaluate for UTI or worsening BPH separately rather than automatically attributing symptoms to the medication 3