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Subjects were randomly assigned to 1 of 5 treatment groups tadalafil 2.5, 10, 20, 40 mg, or placebo in a 1:1:1:1:1 ratio. Subjects had to be at least 12 years of age and had a diagnosis of PAH that was idiopathic, heritable, related to connective tissue disease, anorexigen use, human immunodeficiency virus HIV infection, associated with an atrial-septal defect, or associated with surgical repair of a congenital systemic-to-pulmonary shunt of least 1 year in duration for example, ventricular septal defect, patent ductus arteriosus. Patients with a history of left-sided heart disease, severe renal insufficiency, or pulmonary hypertension related to conditions other than specified in the inclusion criteria were not eligible for enrollment.
The mean age of all subjects was 54 years range 14 - 90 years with the majority of subjects being Caucasian 81% and female 78%. PAH etiologies were predominantly idiopathic or heritable PAH 61% and related to connective tissue disease 23%. More than half 53% of the subjects in the study were receiving concomitant bosentan therapy. The majority of subjects had a World Health Organization WHO Functional Class III 65% or II 32%. The mean baseline 6-minute walk distance 6-MWD was 343 meters. Of the 405 subjects, 341 completed the study.
The primary efficacy endpoint was the change from baseline at week 16 in 6-MWD see Figure 1. In the Adcirca 40 mg treatment group, the placebo-adjusted mean change increase in 6-MWD was 33 meters 95% 15-50 meters; p0.0004. The improvement in 6-MWD was apparent at 8 weeks of treatment and then maintained at week 12 and week 16.
Figure 1: 6-Minute Walk Distance meters Mean Change from Baseline, with 95% Confidence Intervals
Placebo-adjusted changes in 6-MWD at 16 weeks were evaluated in subgroups see Figure 2. In patients taking only Adcirca 40 mg, without concomitant bosentan, the placebo-adjusted mean change in 6-MWD was 44 meters. In patients taking Adcirca 40 mg and concomitant bosentan therapy, the placebo adjusted mean change in 6-MWD was 23 meters.
Figure 2: Placebo-adjusted Mean Change in 6-Minute Walk Distance meters of Adcirca 40 mg, with 95% Confidence Intervals
There was less clinical worsening defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy prostacyclin or analog, endothelin receptor antagonist, PDE5 inhibitor, or worsening WHO functional class in the Adcirca 40 mg group compared to the placebo group and the groups that used lower doses of Adcirca.
The Kaplan-Meier plot of times to clinical worsening is shown below in Figure 3.
Patients N357 from the placebo-controlled study entered a long-term extension study. Of these, 311 patients have been treated with tadalafil for at least 6 months and 182 for 1 year median exposure 356 days; range 2 days to 415 days. The survival rate in the extension study was 96.5 per 100 patient years. Without a control group, these data must be interpreted cautiously.
20 mg orange, film coated, almond shaped tablets not scored, debossed with 4467
Store at 25 C 77 F: excursions permitted to 15 30 C 59 86 F see USP Controlled Room Temperature.
Keep out of reach of children.
Inform patients of contraindication of Adcirca with any use of organic nitrates.
Click here to see and read about the trails, tribulations, and joys of designing, making a Cornelius Varley telescopic camera Lucida for the Click Here Marie Curie the star of the show and her discovery of the enormous power of the atom. See her apparatus, how she used her fingers to make this spectacular discovery. Before Einsteins invention of EMC2
Click Here Priestleys Burning Lens, a clean high temperatures source of heat, he used in experiments generating oxygen. Some early replications of Priestleys chemical work including comments on solar heating and decomposition of mercuric oxide.
To see Davy-explosive Potassium Click here metal to see the fire works of one of the first electrochemist or how about Visit our web site tell our story about of the beginning of the modern electrochemical methods of discovering new elements for the periodic table.
Shown below is our replica of President J. Madisons glass disk type electrostatic, high voltage low current, generator. We made this machine for The Montpelier Foundation, who are the trustees of Madisons home and property. They felt it important to show how well rounded president Madison was beyond being a valuable law maker. It also serves to demonstrate such an instrument adding to the interest of the exhibits.
During the development era of electrostatic generators they served as handsome parlor toys, medical quack machines, and most important. significant scientific instruments.
It is believed that president Madison acquired his generator at a time it was playing a major role as a scientific instrument. This is supported in part because president Thomas Jefferson and Benjamin Franklin statesmenscientist contemporaries had similar instruments. In fact Benjamin Franklin used his to lay down the foundation of modern electricity and inventions such as the lightning rod. There for let us trace out just how valuable it was toward the future. its first virtue was that it could producer a stead flow of electricity making it easier to study and use electricity. One of the first engineering uses was in a telegraph system. In time they progressed to an important role in the development of instruments used in nuclear physics. Let us follow this path by examples.
Priestleys Burning Lens, We built for a documentary
1st step James Madison and atom smashing accelerators - -,
Today its role is as a symbol of the human races greatness and progress.
This instrument helps the Montpelier Foundation to show that president Madison and his colleagues shared a broad intellectual pursuit one that was needed to form nations with goals of freedom and enterprise.
It also helps us appreciate the jagged journey that scientific instrumentation can take to get us into the high tech world we live in today also where we might be going tomorrow.
C ombining the 3rd and 4th steps, A Van de Graaffs electrostatic generator and associated equipment. Incidentally the author built one of these in 1954 for an undergraduate school project. It was for accelerating protons through a potential difference up to 500, 000 volts. As a student I chose building, one with an accelerating tube vacuum system 10-6 mm. and extras, my goal being able to carry out an atom smashing experiment to further test EMC2. This url leads the reader to another method of generating high voltages that were used in Atom smashing experiments of the early and mid 1900 s.
Scientific instruments their ENTANGLEMENT CONNECTIONS. How science moves on.
81. Porst H, Kim ED, Casab AR et al. 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. Eur Urol. 2011; 60:1105-13. PubMed 21871706
82. Egerdie RB, Auerbach S, Roehrborn CG et al. Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study. J Sex Med. 2012; 9:271-81. PubMed 21981682
83. Donatucci CF, Brock GB, Goldfischer ER et al. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a 1-year, open-label extension study. BJU Int. 2011; 107:1110-6. PubMed 21244606
84. Uckert S, Oelke M. Phosphodiesterase PDE inhibitors in the treatment of lower urinary tract dysfunction. Br J Clin Pharmacol. 2011; 72:197-204. PubMed 21745238
85. Schwartz BG, Kloner RA. Drug interactions with phosphodiesterase-5 inhibitors used for the treatment of erectile dysfunction or pulmonary hypertension. Circulation. 2010; 122:88-95. PubMed 20606131
86. Spence R, Mandagere A, Harrison B et al. No clinically relevant pharmacokinetic and safety interactions of ambrisentan in combination with tadalafil in healthy volunteers. J Pharm Sci. 2009; 98:4962-74. PubMed 19455620
87. Garraffo R, Lavrut T, Ferrando S et al. Effect of tipranavir/ritonavir combination on the pharmacokinetics of tadalafil in healthy volunteers. J Clin Pharmacol. 2011; 51:1071-8. PubMed 21209236
88. Forgue ST, Phillips DL, Bedding AW et al. Effects of gender, age, diabetes mellitus and renal and hepatic impairment on tadalafil pharmacokinetics. Br J Clin Pharmacol. 2007; 63:24-35. PubMed 16869816
89. Gonzalez RR, Kaplan SA. Tadalafil for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. Expert Opin Drug Metab Toxicol. 2006; 2:609-17. PubMed 16859408
200. Panel on Antiretroviral Guidelines for Adults and Adolescents, US Department of Health and Human Services HHS. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents April 18, 2012. Updates may be available at HHS AIDS Information AIDSinfo website.
A new nonsurgical treatment for enlarged prostate might help ease symptoms such as frequent urination at night, Brazilian researchers report.
Sophiris Announces First Patients Dosed in the PLUS-1 Phase 3 Trial of PRX302 for Benign Prostatic Hyperplasia SAN DIEGO and VANCOUVER,
Chemical Name: 6R, 12aR - 6 - 1, 3 - benzodioxol - 5 - yl - 2, 3, 6, 7, 12, 12a - hexahydro - 2 - methylpyrazino1,2 :1, 6pyrido3, 4 - bindole - 1, 4 - dione
Vasodilating agent; a selective phosphodiesterase PDE type 5 inhibitor.
To facilitate attainment of a sexually functional erection in males with erectile dysfunction ED, impotence.
May be used as needed on demand or on a daily basis without regard to timing of sexual activity.
Some experts recommend a selective PDE type 5 inhibitor as first-line therapy for ED unless contraindicated.
Evidence currently insufficient to support superiority of one selective PDE type 5 inhibitor over another.
Slideshow: The Rise to Fame: Viagra, PDE5 Inhibitors, and ED
Symptomatic management, to improve lower urinary tract symptoms of benign prostatic hyperplasia BPH, benign prostatic hypertrophy.
If you miss a dose of this medicine, take it as soon as possible. Do not take 2 doses at once.
Apcalis SX should be stored at room temperature, 15-30 degrees C 59-86 degrees F.
Before you start any treatment with Apcalis SX, be sure to ask your healthcare provider if your heart is healthy enough.
If youre a man who uses nitrate drugs, like nitroglycerine, never take Apcalis SX. The combination of Apcalis SX and nitrates can make your blood pressure suddenly drop to unsafe levels. You could get dizzy, faint, or even have a heart attack or stroke. Nitrates are found in many prescription medications that are used to treat angina chest pain due to heart disease.
If you are not sure, whether any of your medications contain nitrates, or if you do not understand what nitrates are, ask your healthcare provider or pharmacist.
If you experience any of the following serious side effects, stop taking Apcalis SX and seek emergency medical attention or notify your doctor immediately:
ringing in your ears, or sudden hearing loss;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
swelling in your hands, ankles, or feet;
feeling light-headed, fainting; or
penis erection that is painful or lasts 4 hours or longer.
warmth or redness in your face, neck, or chest;
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
Drinking alcohol can temporarily impair the ability to get an erection. To get the maximum benefit from your medication, you are advised not to drink large amounts of alcohol before taking Apcalis SX.
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