Combination Therapy vs. Monotherapy in Benign Prostatic Hyperplasia (BPH): A Malaysian Clinical Perspective

Benign Prostatic Hyperplasia (BPH) is a common urological condition among aging men, significantly impacting quality of life due to lower urinary tract symptoms (LUTS). In Malaysia, its prevalence is estimated at around 35% in men aged 50 and above,^[3] underscoring the need for appropriate disease management. This article discusses the comparative roles of monotherapy and combination therapy in BPH management, anchored on findings from pivotal clinical trials and aligned with both global and local clinical practice guidelines.^[1],[3]

BPH is characterized by non-malignant enlargement of the prostate, leading to compression of the urethra and a range of obstructive and irritative urinary symptoms, including frequency, urgency, nocturia, weak stream, and incomplete bladder emptying. These symptoms are driven by both static obstruction (from glandular overgrowth) and dynamic obstruction (from increased smooth muscle tone).^[4]

 Figure 1: Normal vs Enlarged Prostate Gland Anatomy [Image source: NCBI NBK65915].

Alpha-blockers, such as tamsulosin and alfuzosin, are considered first-line agents for men with moderate LUTS due to their fast-acting ability to relax smooth muscle in the bladder neck and prostate, resulting in symptom relief.^[2] However, they do not influence prostate size or disease progression.^[1]

5-ARIs, including dutasteride and finasteride, inhibit the conversion of testosterone to dihydrotestosterone (DHT), causing gradual shrinkage of the prostate.^[4] They are particularly useful in patients with larger prostates (>40 mL) or PSA >1.4 - 1.6 ng/mL, though clinical improvement may take up to six months. Side effects include decreased libido, erectile dysfunction, and reduced ejaculate volume.^[1]

Combination therapy addresses both static and dynamic components of BPH. The MTOPS (Medical Therapy of Prostatic Symptoms) trial demonstrated a 66% reduction in the risk of clinical progression of BPH when using a combination of doxazosin and finasteride, compared to either monotherapy or placebo.^[2] The COMBAT trial, which evaluated a fixed-dose combination of dutasteride and tamsulosin, showed greater improvements in symptom relief (based on IPSS), and significantly reduced risks of acute urinary retention and BPH-related surgery over a four-year period.^[1]

Figure 2:  Cumulative incidence of progression of benign prostatic hyperplasia in the Medical Therapy of Prostate Symptoms (MTOPS) Study. MTOPS reproduced with permission from McConnell J et al. N Engl Journal Med 2003;349:2387–98.

Reference: Malaysian Clinical Practice Guidelines on the Medical Management of Symptomatic Benign Prostatic Hyperplasia.

Patients on alpha-blockers should be monitored for postural hypotension and dizziness, particularly in older adults.^[3] Those taking 5-ARIs require regular PSA monitoring as these drugs lower PSA levels and may mask early detection of prostate cancer. Combination therapy requires adherence monitoring and periodic review for adverse effects or clinical benefit.^[1]

While monotherapy remains effective for patients with mild to moderate symptoms, combination therapy offers superior clinical benefits for those with a high symptom burden or an enlarged prostate, with consideration of the benefits outweighs the risk and should not be generalized for all severe cases. Fixed-dose combinations (e.g. dutasteride + tamsulosin) are able to address both dynamic and static components of BPH, offering enhanced symptom control and reducing long-term complications like acute urinary retention and the need for surgery. However, cost and side effects must be considered. Clinical decision-making should be individualized, taking into account prostate size, PSA levels, patient preferences, tolerance to therapy, and evidence-based recommendations.

Dutasteride/tamsulosin hydrochloride is contraindicated in patients with a history of orthostatic hypotension, severe hepatic impairment, women, patients ≤ 21 years old, hypersensitivity to tamsulosin, dutasteride, other ingredients of the product or to other inhibitors.

Prior to initiating treatment with Dutasteride/tamsulosin hydrochloride the patient should be examined to rule out other causes of the symptoms.

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1. European Association of Urology. EAU Guidelines on the Management of Non-neurogenic Male LUTS, including BPH [Internet]. 2025 [cited 2025 May 23]. Available from: https://uroweb.org/guidelines/non-neurogenic-male-luts

2. McConnell JD, Roehrborn CG, Bautista OM, Andriole GL, Dixon CM, Kusek JW, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of BPH. N Engl J Med [Internet]. 2003 Dec 18 [cited 2025 May 23];349(25):2387–98. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa030656

3. Ministry of Health Malaysia. Clinical Practice Guidelines: Medical Management of Symptomatic Benign Prostatic Hyperplasia [Internet]. Putrajaya: Ministry of Health Malaysia; 2015 [cited 2025 May 23]. Available from: https://www.moh.gov.my/moh/resources/auto%20download%20images/587f118ec4d43.pdf

4. Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol [Internet]. 2005 [cited 2025 May 23];7(Suppl 9):S3–14. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1477638/

5. Duodart (dutasteride/tamsulosin) Prescribing Information.[cited 2025 Oct 29]. Available from : https://quest3plus.bpfk.gov.my/pmo2/detail.php?type=product&id=MAL20112150A

Written By

Wong Syi Ren

Pharmacist

Reviewed By

Dr Jessica Kaur

Doctor