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Adcirca (Tadalafil) - Summary



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

Pulmonary Arterial Hypertension

ADCIRCA® is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

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Published Studies Related to Adcirca (Tadalafil)

Urodynamic effects of the combination of tamsulosin and daily tadalafil in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a randomized, placebo-controlled clinical trial. [2013]
study (UDS)... CONCLUSIONS: The association of tamsulosin/tadalafil reduces detrusor pressure at

The role of initial success rates and other factors in determining reliability of outcomes of phosphodiesterase inhibitor therapy for erectile dysfunction: a pooled analysis of 17 placebo-controlled trials of tadalafil for use as needed. [2013]
Profile questions 2 and 3... CONCLUSIONS: The findings affirm the reliability of successful outcomes with

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.

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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).

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.

Treprostinil Combined With Tadalafil for Pulmonary Hypertension [Recruiting]
Objectives: To test whether the combined administration of the medications treprostinil(a prostacycline therapy), and tadalafil(a PDE-5 Inhibitor therapy) is better than the administration of treprostinil alone. This treatment would be offered to newly diagnosed patients with pulmonary arterial hypertension who are on no treatment for this disease and are deemed candidates for the medication treprostinil by their physician. The combination therapy will be compared to single therapy with only treprostinil in a double-blind manner.

Current therapy is to begin one treatment, either a PDE5 inhibitor or a prostacycline, depending on the severity of the patient's PAH disease and add additional therapies as deterioration occurs. This treatment could add two agents initially.

Secondary objectives are: To improve pulmonary arterial pressures as measured through a cardiac echocardiogram, improve the subject's 6minute walk distance, delaying the time to clinical worsening, and lowering plasma BNP levels.

Research Procedures: To begin the administration of both treatments at the same time.

Time period is 16 weeks with a one- year follow-up. Cardiac Echocardiograms, clinic

physician exams, and lab work will be followed. Subjects will be between the ages of 18 -


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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 >>


Based on a total of 1 ratings/reviews, Adcirca has an overall score of 2. The effectiveness score is 2 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.

Adcirca review by 49 year old male patient

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.

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Page last updated: 2014-11-30

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