How Effective Is Cialis?

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Cialis (Tadalafil) manufactured and marketed by the pharmaceutical major “Lilly” is prescribed for a couple of indications. Cialis, in general, is indicated for:

  • Treatment of erectile dysfunction (ED) in men.
  • Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
  • Treatment of ED and the signs and symptoms of benign prostatic hyperplasia (ED/BPH).

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In this blog we shall get to discuss as to “How effective is Cialis” in the treatment of erectile dysfunction in men and in those with erectile dysfunction and symptoms of benign prostatic hyperplasia
Physiology of erection
Sexual stimulation causes the local release of nitric oxide (NO) in the corpus cavernosum. Nitric oxide (NO) then activates the enzyme guanylyl cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP). The increased levels of cGMP in the corpus cavernosum produce smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Phosphodiesterase type 5 (PDE5) degrades cGMP in the corpus cavernosum, and the inhibition of (PDE5) by CIALIS (tadalafil) maintains increased levels of cGMP in the corpus cavernosum. CIALIS has no effect on penile blood flow in the absence of sexual stimulation.

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Cialis (Tadalafil)

CIALIS (tadalafil) is a potent, selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Studies have shown that tadalafil is a potent inhibitor of phosphodiesterase type 5 (PDE5). Phosphodiesterase type 5 PDE5 is an enzyme found in corpus cavernosum (penis), prostate and bladder, as well as in vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. The effect of tadalafil is more selective on PDE5 than on other phosphodiesterases. Tadalafil is said to be >10 000 fold more selective for PDE5 than for PDE1, PDE2, PDE4, and PDE7 enzymes, which are found in the heart, brain, blood vessels, liver, and other organs.
Cialis in the treatment of “Erectile Dysfunction” (Clinical studies)
The efficacy and safety of tadalafil at doses of 2 to 100 mg have been evaluated in clinical trials up to 24 weeks duration, involving many patients. CIALIS 10 mg or 20 mg On-Demand (or) CIALIS 2.5 mg or 5 mg for Once-a-Day use, is effective in improving erectile function in men with erectile dysfunction (ED). In clinical studies assessing patients’ ability to engage in successful and satisfying sexual intercourse, CIALIS demonstrated highly statistically significant improvement compared with placebo. Additionally, partners of patients on CIALIS had statistically significant greater satisfaction with sexual intercourse compared with partners of patients on placebo (no drug).
Overall, CIALIS consistently showed efficacy in a broad and representative population that included patients with erectile dysfunction of various severities (Mild, Moderate, Severe), etiologies (including patients with diabetes), ages (21 to 86 years), and ethnicities. Patients on CIALIS therapy demonstrated a consistent and statistically significant improvement in erectile function, compared to patients on placebo (no drug).

Cialis – Dosing Regimen

In the management of erectile dysfunction therapy with Cialis can be individualized as either of the two; “on demand dosing” (or) “once a day’ dosing. It should be noted here that Cialis for the treatment of erectile dysfunction works only in the presence of sexual stimulation.

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On-demand dosing:
The recommended dose of Cialis for “use on demand” in the treatment of erectile dysfunction is 20 mg taken orally about 30 minutes before anticipated sexual activity. The drug is said to be effective within 30 minutes of administration and its effects tend to last for up to 36 hours. Cialis can be taken without regard to food and the maximum dosing frequency is one a day. It is important o note here that Cialis doses of 10mg and 20 mg are intended for on-demand dosing and is not recommended for continuous daily use.
Once a day dosing:
The recommended dose of CIALIS administered as “once a day” for the treatment of erectile dysfunction is 5 mg per day. It should be taken at approximately the same time each day and can be taken without regard to food and without regard to timing of sexual activity. The dosage may be decreased to 2.5 mg once a day.
Cialis in the treatment of benign prostatic hyperplasia (BPH) & Combined Erectile dysfunction (ED) & BPH
The mechanism for reducing BPH symptoms has not been fully established. The effect of PDE5 inhibition on cGMP concentration seen in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of prostate, bladder and their vascular supply. The vascular relaxation results in increased blood perfusion and may reduce BPH symptoms. Relaxation of a stromal smooth muscle of the prostate and bladder may complement these vascular effects without compromising bladder emptying. Many elderly men who suffer from symptoms of BPH also do have erectile dysfunction and Cialis could be the drug of choice to treat both these symptoms.
Studies of CIALIS in Patients with Benign Prostatic Hyperplasia
The recommended dose of CIALIS taken “once a day” for treatment of BPH and ED/BPH is 5 mg per day, taken at approximately the same time each day, without regard to food and in men with ED, without regard to timing of sexual activity.
For On-Demand dosing, CIALIS may be administered with selective alpha-[1 or 1A] blockers such as alfuzosin or tamsulosin, and no dosage adjustment of CIALIS is required. However, when prescribing CIALIS to patients who are taking non-selective alpha-blockers such as doxazosin, the recommended starting dose is 10 mg.
Symptoms & Treatment of ‘over’ dosage
Treatment of Priapism (persistent/prolonged erection of the penis)
All patients should be counselled to contact a physician if they experience any erection persisting for more than 4 hours. Priapism should be treated according to established medical practice. This may include “external perineal compression” or “penile aspiration” done in a physician office. For management of a suspected drug overdose, it is important to contact your regional Poison Control Centre.

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CIALIS – dosage forms

  • 2.5 mg (for Once-a-Day use)
  • 5 mg (for Once-a-Day use)
  • 10 mg (for “On-Demand” dosing)
  • 20 mg (for “On-Demand” dosing)

Note:

CIALIS for Once-a-Day use is not recommended for patients with severe renal or hepatic impairment. In elderly patients (>65 years of age) no dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered.
Contraindications
Nitrates
CIALIS (tadalafil) has been shown to potentiate the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of CIALIS to patients who are using any form of organic nitrate (e.g., oral, sublingual, transdermal, by inhalation), either regularly and/or intermittently, is contraindicated, due to the risk of developing potentially life-threatening hypotension.
CIALIS should not be prescribed to patients for whom nitrates are prescribed, even though the patient may not have actually used the nitrate therapy.
In a patient prescribed CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring.
It could be concluded that Cialis (tadalafil) is an effective drug of choice to treat erectile dysfunction and symptoms of benign prostatic hyperplasia. One of the major advantages being that the drug could be used as either “once a day” or “on-demand dosing.

 

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References
CTC – Canada
RX prep – USA
APhA – drug information

 

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