Does Saroglitazar (Saroglitazar) cause urine urgency?

Saroglitazar and Urinary Urgency

Based on the available evidence, there is no direct association between saroglitazar and urinary urgency as a reported side effect.

Mechanism of Action and Known Side Effects

Saroglitazar is a dual PPAR-α/γ agonist developed primarily for the treatment of dyslipidemia in type 2 diabetes mellitus. The pharmacokinetic studies and clinical trials of saroglitazar do not report urinary urgency as a documented adverse effect 1.

In phase I studies, saroglitazar was found to be well tolerated with no serious adverse events reported across doses up to 128 mg (significantly higher than therapeutic doses of 1-4 mg). The reported adverse events were generally mild to moderate in nature, with no clinically relevant findings in laboratory investigations, physical examinations, vital signs, or electrocardiograms 1.

Diabetes and Urinary Symptoms

It's important to note that patients with diabetes mellitus often experience urinary symptoms, including urgency, due to diabetic neurogenic bladder:

• Diabetes causes autonomic neuropathy affecting bladder innervation in up to 80% of type 1 diabetic patients 2
• Common urinary symptoms in diabetic patients include dysuria, frequency, urgency, nocturia, and incomplete bladder emptying 2
• Detrusor overactivity is common in early stages of diabetic bladder dysfunction (48% of patients), which can manifest as urinary urgency 2

Urinary Urgency in Diabetic Patients

Urinary urgency in diabetic patients is typically related to the underlying disease rather than medication effects:

• Women with diabetes are more likely to experience urge incontinence (involuntary loss of urine with a feeling of urgency) compared to non-diabetic women 3
• Diabetic women treated with insulin are at considerably higher risk of urge incontinence than those treated with oral medications or diet 3
• Diabetes has been identified as an important independent risk factor for incontinence in women, associated with 30-100% increased risk 3

Differential Diagnosis for Urinary Urgency

When a diabetic patient on saroglitazar presents with urinary urgency, consider these more likely causes:

1. Diabetic neurogenic bladder - Autonomic neuropathy affecting bladder innervation 2
2. Urinary tract infection - Diabetic patients are at increased risk 3
3. Interstitial cystitis/bladder pain syndrome - Can present with marked urinary urgency 3
4. Benign prostatic hyperplasia in men - Common cause of lower urinary tract symptoms 3
5. Overactive bladder syndrome - Can coexist with diabetes 3

Evaluation of Urinary Urgency in Patients Taking Saroglitazar

If a patient on saroglitazar presents with urinary urgency:

1. Rule out urinary tract infection with microscopic urinalysis and culture 3
2. Assess for diabetic neuropathy - Check perineal sensation, sphincter tone, and bulbo-cavernosus reflex 2
3. Measure post-void residual volume - Preferably using portable ultrasound 3
4. Consider urodynamic testing if symptoms persist despite initial management 3, 2

Conclusion

The available evidence does not support a causal relationship between saroglitazar and urinary urgency. When urinary urgency occurs in diabetic patients taking saroglitazar, it is more likely related to the underlying diabetic neurogenic bladder or other urological conditions rather than the medication itself.

If urinary urgency develops in a patient taking saroglitazar, a thorough urological evaluation should be conducted to identify the underlying cause, with particular attention to diabetic neurogenic bladder and urinary tract infections.