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FDA approves addition to Cialis product label: Tadalafil associated with Finasteride improves signs and symptoms of benign prostatic hyperplasia


The FDA ( Food and Drug Administration ) has approved a product label addition for Cialis ( Tadalafil ) to include data from a 26-week study that showed Cialis 5 mg for once daily use started in combination with Finasteride ( Proscar ) significantly improved the signs and symptoms of benign prostatic hyperplasia ( BPH ) as early as 4 weeks, compared to placebo with Finasteride, in men with BPH and an enlarged prostate.
The combination of Tadalafil and Finasteride initiated for BPH therapy is recommended for up to 26 weeks because the incremental benefit of Tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of Tadalafil beyond 26 weeks is unknown.

Cialis is approved by the FDA to treat erectile dysfunction ( ED ), the signs and symptoms of BPH, and both ED and the signs and symptoms of BPH ( ED+BPH ).
Proscar is approved by the FDA for the treatment of benign prostatic hyperplasia in men with an enlarged prostate. Finasteride is a type II 5 alpha-reductase inhibitor ( 5-ARI ).

Urinary symptom improvement with 5-ARI therapy can take 6 to 12 months. The data of the clinical studies have demonstrated that the combination of Tadalafil 5 mg for once daily use with Finasteride leads to symptom improvement as early as four weeks in men with benign prostatic hyperplasia and an enlarged prostate. This means that Tadalafil 5 mg for once daily use can be an effective option for early symptom relief when started in combination with Finasteride, according Claus Roehrborn at University of Texas Southwestern Medical Center ( United States ).

The primary endpoint of the study ( changes in total International Prostate Symptom Score [ IPSS ] at 12 weeks ) demonstrated that symptom improvement in patients starting benign prostatic hyperplasia treatment with Tadalafil 5 mg for once daily use and Finasteride was greater than those starting with placebo and Finasteride ( -5.2 vs -3.8; P=0.001 ).
Key secondary endpoints demonstrated that improvements in IPSS occurred at the first scheduled observation at week 4 ( -4.0 vs -2.3; P less than 0.001 ) and continued through week 26.

It is important to note that Cialis is not to be taken with medicines called nitrates such as Isosorbide dinitrate or Isosorbide mononitrate which are often prescribed for chest pain; or with recreational drugs called poppers like Amyl or Butyl nitrite, as the combination may cause an unsafe drop in blood pressure; or if allergic to Tadalafil, or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away.

In a subgroup of patients with benign prostatic hyperplasia who were also sexually active and had erectile dysfunction at baseline, Tadalafil initiated with Finasteride significantly improved erectile function, as measured by the International Index of Erectile Dysfunction–Erectile Function Domain, compared to placebo with Finasteride. These results were evident at 4 weeks ( 3.7 vs -1.1; P less than 0.001 ), 12 weeks ( 4.7 vs 0.6; P less than 0.001 ) and 26 weeks ( 4.7 vs 0.0; P less than 0.001 ).

The randomized, double-blind, placebo-controlled, 26-week trial assessed the efficacy and safety of Tadalafil 5 mg for once daily use or placebo co-administered with Finasteride 5 mg in 696 men aged 45 years and older ( mean age 64 ) with an IPSS of at least 13, a urine flow rate ( Qmax ) of 4 millimeters per second ( mL/sec ) to 15 mL/sec and a prostate volume at least 30 mL. The study was conducted at 70 sites in 13 countries. ( Xagena )

Source: Lilly, 2013

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