Adcirca (Tadalafil) - Summary

ADCIRCA SUMMARY

ADCIRCA (tadalafil), an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5).

ADCIRCA^TM is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability.

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NEWS HIGHLIGHTS

Published Studies Related to Adcirca (Tadalafil)

Tadalafil once daily and extracorporeal shock wave therapy in the management of patients with Peyronie's disease and erectile dysfunction: results from a prospective randomized trial. [2011.11.15]
Extracorporeal shock wave therapy improves erectile function in patients with Peyronie's disease. However, erectile dysfunction still persists in many cases... In conclusion extracorporeal shock wave therapy plus tadalafil 5 mg once daily may represent a valid conservative strategy for the management of patients with Peyronie's disease and erectile dysfunction.

Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. [2011.11]
BACKGROUND: Tadalafil is being investigated for the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH-LUTS). OBJECTIVE: To assess efficacy, including onset, and safety of tadalafil on BPH-LUTS and the subject's and clinician's perception of changes in urinary symptoms... CONCLUSIONS: Tadalafil 5mg once daily for 12 wk resulted in a clinically meaningful reduction in total IPSS results as early as 1 wk and achieved statistical significance at 4 wk in men with BPH-LUTS. The adverse event profile was consistent with that previously reported in men with ED. TRIAL REGISTRATION: This clinical trial is registered on the clinicaltrials.gov website (http://www.clinicaltrials.gov). The registration number is NCT00827242. Copyright (c) 2011. Published by Elsevier B.V.

Clinical efficacy of phosphodiesterase-5 inhibitor tadalafil in Eisenmenger syndrome--a randomized, placebo-controlled, double-blind crossover study. [2011.09]
OBJECTIVES: In a randomized double-blind crossover trial, we compared the efficacy of phosphodiesterase-5 (PDE-5) inhibitor tadalafil with placebo in patients of Eisenmenger Syndrome (ES). The primary end point was the change in 6-minute walk test distance (6 MWD). Secondary end points were the effect of the drug on systemic oxygen saturation (SO(2) ), pulmonary vascular resistance (PVR), systemic vascular resistance (SVR), effective pulmonary blood flow (EPBF), and World Health Organization (WHO) functional class. BACKGROUND: ES is a disorder with limited treatment options. Uncontrolled studies have shown PDE-5 inhibitors to be beneficial in patients of ES... CONCLUSION: In this first short-term placebo-controlled trial of tadalafil in patients of ES, the drug was well tolerated and significantly improved exercise capacity, functional class, SO(2) , and pulmonary hemodynamics. (c) 2011 Copyright the Authors. Congenital Heart Disease (c) 2011 Wiley Periodicals, Inc.

Tadalafil versus solifenacin for persistent storage symptoms after prostate surgery in patients with erectile dysfunction: a prospective randomized study. [2011.07]
OBJECTIVES: The occurrence of residual storage symptoms after surgical relief of bladder outlet obstruction as a result of benign prostatic enlargement (BPE) underlines the intricate mechanism involved in lower urinary tract symptoms (LUTS). The aim of the present study was to compare tadalafil with solifenacin in modifying symptoms and uroflowmetric parameters in patients with erectile dysfunction (ED) and residual storage symptoms after prostate surgery... CONCLUSIONS: In patients suffering from ED and storage symptoms after surgical treatment for LUTS-BPE, tadalafil 5mg given once daily for 12weeks provided a comparable improvement in IPSS to solifenacin 5mg given for the same period of time. (c) 2011 The Japanese Urological Association.

Oral tadalafil administration plus low dose vasodilator injection: a novel approach to erection induction for penile color duplex ultrasound. [2011.07]
PURPOSE: We prospectively compared clinical response and penile color duplex ultrasound results of oral tadalafil 20 mg plus low dose intracavernous injection of vasoactive agents with those of intracavernous injection and oral tadalafil 20 mg alone. We also observed the best approach to facilitate penile color duplex ultrasound and that most preferred by patients... CONCLUSIONS: Oral tadalafil plus low dose vasodilator led to a significantly better clinical response than high dose vasodilator. Penile color duplex ultrasound parameters showed no difference between the 2 modes. Thus, this mixed mode emerges as a possible alternative to high dose vasodilator injection. Copyright (c) 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

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Clinical Trials Related to Adcirca (Tadalafil)

A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis [Recruiting]
This will be a 36-week, randomized, double-blind, parallel group study comparing the effects of tadalafil monotherapy, ambrisentan monotherapy and combination therapy with tadalafil and ambrisentan in patients with PAH-SSc. Standard outcome measures such as six-minute walk distance (6MWD), NYHA classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo-placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.

A Trial of Tadalafil and Glycemic Traits [Recruiting]
The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).

Brain SPECT Following Cialis (Tadalafil ) Administration [Not yet recruiting]
The study will be an open label one and will include 30 patients who underwent ischemic stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study will be performed 24 hours after the last dose.

Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma [Recruiting]
The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.

A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China [Recruiting]
The primary objective of this study is to evaluate whether, after two 8-week treatment periods, male patients with erectile dysfunction (ED) in China prefer 20 mg tadalafil or 100 mg sildenafil. This trial consists of two treatment periods of 8 weeks each and an extension phase of 8 weeks, for a total of 24 weeks.

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Reports of Suspected Adcirca (Tadalafil) Side Effects

Death (55),  Dyspnoea (36),  Headache (22),  Pneumonia (22),  Hospitalisation (19),  Vision Blurred (14),  Fluid Retention (13),  Pain (11),  OFF Label USE (11),  Fatigue (11), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Adcirca review by 49 year old male patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Difficulty getting/holding erection
Dosage & duration:		20mg taken once for the period of 36 hours
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I might as well have not taken it at all. I noticed no difference in trying to achieve an erection than without it. When erection was achieved it went away quickly. The strength of erection was minimal. Not impressed at all.
Side effects:		Massive headache an hour or so after ingesting the pill as well as heavy clogged sinuses. Found it hard to breath. Felt like flu symptoms.
Comments:		The only thing this pill gave me was strong flu-like symptoms. I'll try it again and see if the results are better but so far I'm not impressed at all and $80 in the hole. Complete waste of money and suffered flu symptoms the entire next day. It's very difficult to be in the mood for sex when you feel sick with a throbbing headache.