How Effective Is Cialis?
Cialis is one of the treatments for erectile dysfunction available for sale here at Mens Pharmacy. To help our clients understand their medications and medical conditions, we’ve written a series of articles on our blog that will provide further information about different conditions and medications.
This article is about the effectiveness of Cialis. We’ll cover what Cialis is, what it is used for, the mechanism of action and what the results from clinical trials say about the effectiveness of Cialis.
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What is Cialis?
Cialis is the brand name for a medication known as Tadalafil. It belongs to the pharmacotherapeutic group known as Urologicals.
Each film−coated tablet of Cialis contains 2.5mg, 5mg, 10mg or 20mg Tadalafil. Each tablet also contains the active substance (excipient) Lactose (as monohydrate).
The 2.5 mg tablets are light orange-yellow and almond shaped tablets, marked ‘C 2 ½’ on one side. Each 2.5 mg film-coated tablet of Cialis (Tadalafil) contains 87 mg of lactose (as monohydrate).
The 5 mg tablets are light yellow and almond shaped tablets, marked ‘C 5’ on one side. Each 5 mg film-coated tablet of Cialis (Tadalafil) contains 121 mg of lactose (as monohydrate).
The 10 mg tablets are light yellow and almond shaped tablets, marked ‘C 10’ on one side. Each 10 mg film-coated tablet of Cialis (Tadalafil) contains 170 mg of lactose (as monohydrate).
The 20 mg tablets are yellow and almond shaped tablets, marked ‘C 20’ on one side. Each 20 mg film-coated tablet of Cialis (Tadalafil) contains 233 mg of lactose (as monohydrate).
The other substances (excipients) in each film coated Cialis (Tadalafil) tablet (that are inactive) include:
Tablet core:
- lactose monohydrate
- croscarmellose sodium
- hydroxypropyl cellulose
- microcrystalline cellulose
- sodium lauryl sulfate
- magnesium stearate
2.5 mg Film-coating:
- lactose monohydrate
- hypromellose
- triacetin
- titanium dioxide (E171)
- iron oxide yellow (E172)
- iron oxide red (E172)
talc
5 mg, 10 mg and 20 mg Film-coat:
- lactose monohydrate
- hypromellose
- triacetin
- titanium dioxide (E171)
- iron oxide yellow (E172)
- talc
The legal category for Cialis (Tadalafil) is POM. This means that this medication is a prescription only medicine and it can only be supplied or sold according to the instructions in a prescription issued by a duly qualified and registered doctor or non-medical prescriber.
You should not buy this or any other prescription-only medication without first speaking to a duly qualified and registered healthcare professional like a doctor or non-medical prescriber.
What is Cialis used for?
Cialis (Tadalafil) is indicated for the treatment of Erectile Dysfunction in adult men aged 18 years and older.
Please note that for Cialis to be effective, sexual stimulation is required.
Cialis (Tadalafil) is also indicated for the treatment of Benign Prostatic Hyperplasia and Pulmonary Arterial Hypertension. Treatment for Pulmonary Arterial Hypertension can only be initiated under the supervision of a medical specialist.
What is the mechanism of action Cialis?
Cialis (Tadalafil) is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. The effect of tadalafil is more potent on PDE5 than on any of the other phosphodiesterases.
Tadalafil is >10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4 enzymes which are found in the heart, brain, blood vessels, liver, and other organs.
Tadalafil is >10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility.
Furthermore, tadalafil is roughly 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction.
Cialis (Tadalafil) is also >10,000-fold more potent for PDE5 than for PDE7 through PDE10.
When sexual stimulation causes the release of nitric oxide locally, inhibition of PDE5 by Cialis (Tadalafil) produces increased levels of cGMP in the corpus cavernosum. This consequently results in the relaxation of smooth muscle tissues and the inflow of blood into the penile tissues, thus producing an erection. Tadalafil is not effective in the treatment of Erectile Dysfunction if there is no sexual stimulation.
For Cialis (Tadalafil) 5 mg, the effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum is further observed in the smooth muscle of the prostate, the bladder and their vascular supply. The vascular relaxation that occurs increases blood perfusion which may be the mechanism by which symptoms of benign prostatic hyperplasia are reduced. These vascular effects may be complemented by inhibition of bladder afferent nerve activity and smooth muscle relaxation of the prostate and bladder.
How effective is Cialis?
According to the Marketing Authorisation holder of Cialis, Cialis (Tadalafil) administered to healthy subjects produced no significant difference compared to placebo in the supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8mmHg, respectively), in the standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6mmHg, respectively), and no significant change in heart rate.
In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/green) was detected using the Farnsworth-Munsell 100-hue test. This finding is consistent with the low affinity of tadalafil for PDE6 compared to PDE5. Across all clinical studies, reports of changes in colour vision were rare (<0.1%).
Three studies were conducted in men to assess the potential effect on spermatogenesis of CIALIS 10mg (one 6-month study) and 20mg (one 6-month and one 9-month study) administered daily. In two of these studies, decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance. These effects were not associated with changes in other parameters, such as motility, morphology, and FSH.
Erectile Dysfunction
Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to CIALIS on demand. Tadalafil demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as the patients’ ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes following dosing.
In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with Erectile Dysfunction secondary to spinal cord injury, Cialis (Tadalafil) significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with Tadalafil 10 mg or 20 mg (flexible-dose, on demand) of 48% as compared to 17% with placebo.
Cialis (Tadalafil) at doses of 2 mg to 100 mg has been evaluated in 16 clinical studies involving 3250 patients, including patients with erectile dysfunction of various severities (mild, moderate, severe), etiologies, ages (range 21-86 years), and ethnicities. Most patients reported erectile dysfunction of at least 1 year in duration. In the primary efficacy studies of general populations, 81% of patients reported that CIALIS improved their erections as compared to 35% with placebo. Also, patients with erectile dysfunction in all severity categories reported improved erections whilst taking CIALIS (86%, 83%, and 72% for mild, moderate, and severe, respectively, as compared to 45%, 42%, and 19% with placebo). In the primary efficacy studies, 75% of intercourse attempts were successful in CIALIS-treated patients as compared to 32% with placebo.
For once-a-day evaluation of Cialis (Tadalafil) at doses of 2.5, 5, and 10 mg 3 clinical studies were initially conducted involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various severities (mild, moderate, severe) and etiologies. In the two primary efficacy studies of general populations, the mean per-subject proportion of successful intercourse attempts were 57 and 67% on CIALIS (Tadalafil) 5mg, 50% on CIALIS (Tadalafil) 2.5mg as compared to 31 and 37% with placebo. In the study in patients with erectile dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46% on CIALIS 5mg and 2.5mg, respectively, as compared to 28% with placebo. Most patients in these three studies were responders to previous on-demand treatment with PDE5 inhibitors. In a subsequent study, 217 patients who were treatment-naive to PDE5 inhibitors were randomised to CIALIS (Tadalafil) 5mg once a day vs. placebo. The mean per-subject proportion of successful sexual intercourse attempts was 68% for CIALIS (Tadalafil) patients compared to 52% for patients on placebo.
Benign prostatic hyperplasia
CIALIS (Tadalafil) was studied in 4 clinical studies of 12 weeks duration enrolling over 1500 patients with signs and symptoms of benign prostatic hyperplasia. The improvement in the total international prostate symptom score with CIALIS (Tadalafil) 5mg in the four studies were -4.8, -5.6, -6.1 and -6.3 compared to -2.2, -3.6, -3.8 and -4.2 with placebo. The improvements in total international prostate symptom score occurred as early as 1 week. In one of the studies, which also included tamsulosin 0.4 mg as an active comparator, the improvement in total international prostate symptom score with CIALIS (Tadalafil) 5mg, tamsulosin and placebo was -6.3, -5.7 and -4.2 respectively.
One of these studies assessed improvements in erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia in patients with both conditions. The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with CIALIS(Tadalafil) 5 mg compared to 1.8 and -3.8 with placebo, respectively. The mean per-subject proportion of successful sexual intercourse attempts was 71.9% with CIALIS (Tadalafil) 5 mg compared to 48.3% with placebo.
The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up to 1 additional year of treatment with CIALIS 5mg.
Is there anything else I need to know about Cialis?
Cialis (Tadalafil) may be taken on an empty stomach or after eating a meal.
A physical examination may be required to diagnose erectile dysfunction or benign prostatic hyperplasia and determine potential underlying causes before pharmacological treatment with Cialis (Tadalafil) is considered.
Should you develop any sudden visual defects whilst taking Cialis (Tadalafil), you need to stop taking Cialis immediately and consult a doctor. You should also stop taking Cialis (Tadalafil) immediately and speak to a doctor if you experience a decrease in your hearing or experience a complete loss of hearing.
If you experience erections lasting for four hours or more (Priapism) whilst taking Cialis (Tadalafil), you need to stop taking the Cialis (Tadalafil) and seek medical assistance urgently. If your priapism is not treated immediately, penile tissue damage may occur, and it is likely that there may be permanent loss of potency in the penile tissue as a result.
Taking Cialis (Tadalafil) has little or no influence on one’s ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, you should be aware of how you react to Cialis (Tadalafil) before driving or using machines.
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References:
- https://www.medicines.org.uk/emc/product/7431/smpc
- https://www.medicines.org.uk/emc/product/7431/smpc#EXCIPIENTS
- https://bnf.nice.org.uk/drug/tadalafil.html
- https://www.medicines.org.uk/emc/product/7431/smpc#INDICATIONS
- https://www.medicines.org.uk/emc/product/7431/smpc#POSOLOGY
- https://www.medicines.org.uk/emc/product/7431/smpc#CLINICAL_PRECAUTIONS
- https://www.medicines.org.uk/emc/product/7431/smpc#MACHINEOPS
- https://www.medicines.org.uk/emc/product/7431/smpc#PHARMACOLOGICAL_PROPS
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