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Combodart Safety

Combodart is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (BPH).[1]

Adverse events

The CombAT.[1]study adverse event data is summarised in the table below:
Tamsulosin

Adapted from Roehrborn et al 2010

  • The occurrence of drug-related adverse events was significantly greater in the combination group than either dutasteride or tamsulosin alone (28% vs 21% vs 19% for combination, dutasteride and
    tamsulosin respectively, p<0.001)
  • Most common adverse events reported with combination therapy were consistent with previous experience of either monotherapy
  • There was no significant difference in withdrawal rates due to any drug-related adverse event between combination and either monotherapy over 4 years

Reference:

  1. Roehrborn CG et al. Eur Urol 2010;57:123–31

Precautions

Prostate cancer and high grade tumours

  • In a study in men at high risk of developing prostate cancer there was an increased incidence of Gleason score 8-10 prostate cancer observed for men taking Combodart compared with men taking placebo.
  • 5 alpha reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5 alpha reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.

Combination Therapy with Tamsulosin and cardiac failure

  • In two 4-year clinical studies, the incidence of cardiac failure (a composite term of reported events, primarily cardiac failure and congestive cardiac failure) was higher among subjects taking the combination of dutasteride and an alpha blocker, (primarily tamsulosin, alfuzosin, doxazosin and terazosin) than it was among subjects not taking the combination.
  • In these two trials, the incidence of cardiac failure was ≤1%. The reason for the imbalance of cardiac failure in the two trials is not known.
  • No imbalance was observed in the incidence of cardiovascular adverse events overall in either trial.
  • No causal relationship between dutasteride (alone or in combination with an alpha blocker) and cardiac failure has been established.

Contraindications

  • Combodart is contraindicated in: patients with known hypersensitivity to dutasteride, other 5 α-reductase inhibitors, tamsulosin hydrochloride or any component of the preparation
  • women and children
  • patients with a history of orthostatic hypotension
  • patients with severe hepatic impairment (child-Pugh scores >9)
  • patients with severe renal impairment (creatinine clearance less than 10 mL/min)
  • combination with another α-1 adrenergic blocker

For the full list of Precautions and Contraindications please refer to the Approved Combodart Product Information

Combodart is registered trademark of the GlaxoSmithKline Group of companies