cialis headache And contraindications

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cialis headache، alpha-blockers are the first choice drugs in the treatment of urinary tract obstruction symptoms associated with IPB 3 . In cases where the prostate is larger than 30 ml, the use of a 5-alpha reductase inhibitor (dutasteride or finasteride) is recommended 3 .

The association between an alpha-blocker and a 5-alpha reductase inhibitor is an option in patients with moderate-to-severe urinary symptoms and an enlarged prostate (> 30 ml) 3 .

cialis headache

The registration studies that assessed the efficacy and safety of tadalafil in the treatment of urinary disorders by IPB are 4 double-blind, 12-week RCTs and a one year open-label extension study 4. The 2,500 patients enrolled overall, aged 62-65, had a score in the International Prostate Symptoms Score (IPSS, ranging from 0 to 35 points) ≥13.

In all studies, the main outcome measure was the change in the IPSS score at 12 weeks; The secondary end point was the score (from 0 to 13) in the Impact Index of Benign Prostatic Hyperplasia (BII) that measures the impact of the disease on the state of subjective well-being and daily activities.

at a dose of 5 mg / day, produced a mean reduction in IPSS compared to placebo from a minimum of -1.9 to a maximum of -2.6. In one of the studies which also included tamsulosin (0.4mg / day) as an active control, the improvement of the IPSS was respectively 2.1 and 1.5 points 4 . According to a specific study, a 3-point variation in the IPPS score corresponds to a “slight” improvement in symptoms 6 . Regarding the BII score, the average variation went from -0.6 to -0.9; the minimum threshold for a “mild” clinical benefit was calculated as 0.5 points 6 .

Two studies evaluated changes in erectile dysfunction in terms of the International Index of erectile function score; in the first study all patients with urinary symptoms of prostatic hypertrophy also had a history of erectile dysfunction 6 , in the other about 50% of patients had both pathologies 4 . The improvement of sexual function detected in the tadalafil group has certainly broken the double blindness becoming a pro-tadalafil factor in the detection of urinary symptoms. Tadalafil did not statistically improve the urinary flow rate 4 , 7. In a 12-week RCT, which specifically evaluated urodynamic parameters in patients with urinary symptoms from BPH, there were no differences between tadalafil (20mg per day) and placebo in the pressure of the bladder detrusor to the maximum urinary flow, in the flow velocity, in the index of bladder obstruction or bladder capacity 8 .

Side effects

The most common adverse events of tadalafil are those already known: headache, dyspepsia, gastro-oesophageal reflux disease, hot flushes, back pain, myalgia, pain in extremities. In the open-ended 1-year study extension, 58% of patients reported one or more undesirable effects that resulted in 4.7% and prompted 5.2% of patients to discontinue treatment 4 . The most frequent were dyspepsia and gastro-oesophageal reflux, headache and low back pain. The three deaths associated with the use of tadalafil, two from myocardial infarction and one from subarachnoid hemorrhage, occurred in patients with pre-existing cardiovascular risk factors 1. In the post-marketing surveillance phase, cases of non-arteritic anterior ischemic optic neuropathy (NAION), retinal vascular occlusion, and other eye disorders were reported. A sudden decrease or loss of hearing has also been reported in a small number of patients.

Interactions

The numerous interactions of tadalafil, both pharmacokinetic, in which CYP3A4 isoenzyme is involved, and pharmacodynamics, in particular with other vasodilators (nitrates, alpha1-blockers, antihypertensives) 5 are also known .

Tadalafil cost (5mg / day) has an annual cost of € 1,695 to total patient load. A similar treatment with tamsulosin (0.400mg / day generic) costs the NHS 20 times less.

https://www.youtube.com/watch?v=gfWrXC6_ZMY

How do you avoid the ban

Even without naming it, Lilly promotes a drug to be sold only with a prescription – and that therefore the law does not allow to advertise – to extend its use. You will also have seen the spots that allude to an unspecified “erectile dysfunction” and to disorders related to prostate hypertrophy; in reality it is indirect advertising to a drug from Lilly that has recently expanded its indications: as well as for erectile dysfunction (disorder that has however been expanded to include completely physiological problems) is now also proposed for the symptoms of BPH. Too bad that for the latter disorder already exist drugs, effective and less expensive. From ” Altroconsumo ” May 2014
Bibliography

1. European Medicines Agency (EMA). CHMP. European Public Assessment Report (EPAR) for Cialis. Procedures No EMEA / H / C / 000436 / II / 0060. 18 October 2012. www.ema.europa.eu.

2. Andersson KE et al. Tadalafil for the treatment of lover urinary tract symptoms secondary to benign prostatic hyperplasia: pathophysiology and mechanism (s) of action. Neurol Urodyn 2011; 30 : 292-301.

3. National Clinical Guidance, 2010. Lower urinary tract symptoms: the management of lower urinary tract symptoms in men. NICE clinical guideline. www.nice.org.uk.

4. Tadalafil for benign prostatic hyperplasia. DTB 2013; 51 : 93-6.

5. Tadalafil et Hypertrophie benign de la prostate. The Rev Prescr 2013; 33 : 886.

6. Barry MJ et al. Benign prostatic hyperplasia specific health status in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol 1995; 154 : 1770-4.

7. Laydner HK et al. Phosphodiesterase 5 inhibitors for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a systematic review. BJU Int 2011; 107 : 1104-9.

8. Laydner HK et al. Phosphodiesterase 5 inhibitors for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a systematic review. BJU Int 2011; 107 : 1104-9.

Contraindications

Hypersensitivity to the active substance or to any of the excipients included in section 6.1.
During clinical trials, it was observed that tadalafil increased the hypotensive effect of
nitrates It is thought that this is due to the combination of the effects of tadalafil and nitrates on
the nitric oxide / cyclic guanosine monophosphate (cGMP) pathway. Therefore, CIALIS is contraindicated in
patients taking any form of organic nitrate (see section 4.5).
CIALIS, should not be used in men with heart disease in which sexual activity is
discouraged. The doctor should consider the potential cardiac risk of sexual activity in
patients with a history of cardiovascular disease.
In clinical trials the following groups of patients with diseases were not included
cardiovascular diseases, and therefore the use of tadalafil is contraindicated in:
– patients who have suffered a myocardial infarction in the previous 90 days,
– patients with unstable angina or angina produced during sexual activity,
– patients with heart failure corresponding to class II or higher of the classification
of the New York Heart Association (NYHA) in the previous 6 months,
– patients with uncontrolled arrhythmias, hypotension (blood pressure <90/50 mm Hg), or
uncontrolled hypertension,
– patients who had suffered a stroke in the previous 6 months.
CIALIS is contraindicated in patients who have loss of vision in one eye as a result of
a non-arteritic anterior ischemic optic neuropathy (NAION),

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