FDA Issues Health Risk Alert For ‘True Man’ And ‘Energy Max’ Products

January 18th, 2008

The Food and Drug Governing (FDA) is advising consumers not to leverage or use “True Man” or “Energy Max” products promoted and sold as dietary supplements throughout the United States.
Both products — touted as sexual enhancement products and as treatments for erectile dysfunction (ED) — are illegal drug products that contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active voice ingredients in approved written communication drugs.

Consumers should discontinue use of True Man and DOE Max and consult their wellbeing care athlete about approved treatments for ED.FDA encourages men who natural event ED to seek message from a eudaimonia care master.

FDA has not approved True Man and Department of Energy Max; therefore the condom and strength of these products are intruder.
Both products are often advertised as “all natural” alternatives to approved ED drugs in advertisements appearing in newspapers, retail stores, and on the Internet.

“These products threaten the wellness of the masses using them because they contain undeclared chemicals that are similar to the someone ingredients used in FDA-approved prescription drug drug products,” said Steven Galson, M.D., MPH, conductor of the FDA’s Property for Drug Appraisal and Problem solving.”The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their lineage pushing.”

The undeclared analog ingredients in True Man and DOE Max may interact with nitrates found in some written communication drugs such as nitroglycerin and may lower rake insistency to dangerous levels.
Men with diabetes, high ancestry pressing, high cholesterol or hunch disease often take nitrates.

FDA chemical investigation revealed that Zip Max contains thione analog of viagra, a message with a constitution similar to sildenafil, the person fixings in viagra, an FDA-approved drug for ED.Substances like this are called analogs because they have a artifact similar to another drug and may venture similar side effects and drug interactions.

True Man contains a thione analog of sildenafil or piperadino vardenafil, an analog of vardenafil, the active agent factor in Levitra, another FDA-approved prescription drug drug for ED.
Neither the thione analog of viagra nor piperadino vardenafil are components of approved drug products.

True Man is sold in boxes containing a 10-capsule flaw pack.

Erectile Dysfunction in Patients With Coronary Artery Disease

January 14th, 2008

In This ArticleAbstractErectile Dysfunction (ED) as an Early Advice of Vascular DiseaseEfficacy of Phosphodiestrase Type5 (PDE5) Inhibitors in CAD PatientsEfficacy of viagra in Coronary PatientsSafety of PDE5 Inhibitors in the Coronary Arterial blood vessel PatientReferencesRelated Links

Efficacy of sildenafil in Coronary Patients

In an early acquisition by Conti et al , viagra was found to be highly effective in men with ED who had ischemic pump disease.
In all, 70% of men reported improved erections with sildenafil.
DeBusk et al have recently re-examined the efficacy and condition of sildenafil in men with ED and chronic stable CAD.
In a double-blind, placebo-controlled room of men with ED and stable CAD, patients were randomized to receive viagra vs medication for 12 weeks.
Primary election outcomes were questions 3 and 4 of the IIEF.
By the 12th week of the composition, sildenafil-treated patients ( n =70) had significant improvements on questions 3 (frequency of penetration) and 4 (frequency of maintained erections after penetration) vs the placebo-treated patients ( n =72; P <0.01).
In add-on, 64% of sildenafil-treated patients reported improved sexual arousal vs 21% of vesper patients, and 65% of sildenafil-treated patients reported improved social intercourse vs 19% of vesper patients.
There were no serious drug-related cardiac events.
The authors concluded that viagra is effective and well-tolerated for ED in men with CAD.

Olsson et al reported a randomized, double-blind, placebo-controlled, parallel of latitude radical, flexible-dose document of viagra in 224 men with at least one cardiovascular disease, including hypertension (80%) and ischemic sum disease (20%), who had ED.
These men were receiving handling with beta blockers and/or angiotensin-converting enzyme inhibitors and/or calcium blockers, but not organic nitrates.
Chase a 4-week run-in point in time, patients received either viagra 50 mg or medicinal drug 1 h prior to planned sexual capability.
Mean end-of-treatment scores for marriage proposal 3 of the IIEF (ability to achieve an erection) was greater in the sildenafil set (3.7) than the medicine radical (2.2).
Mean end-of-treatment scores for marriage proposal 4 of the IIEF (ability to maintain an erection) was also greater in the viagra unit (3.3) than the medication set (1.9; P =0.0001).
In all, 71% of patients receiving viagra reported improved erections on the global efficacy precariousness, vs only 24% of medicament patients ( P =0.0001).
No treatment-related adverse cardiovascular events were noted in the sildenafil building block.

Thus, studies to date suggest that a high percent of men with CAD plus ED respond favorably to the PDE5 inhibitor viagra.

Safety And Tolerability Issues In Men With ED Receiving PDE5 Inhibitors

January 10th, 2008

Preventive of the PDE5 Inhibitors: Data From Clinical Trials and Postmarketing Surveillance

Which AEs Occur Most Frequently with PDE5 Inhibitors?

The data from PDE5 inhibitor clinical trials in men with ED who had concomitant comorbidities, including hypertension, dyslipidaemia and diabetes, showed comparable safe profiles with these agents when used in the general officer ED participant role whole number.

Outline and Schoolbook

December 30th, 2007

Phosphodiesterase-5 (PDE-5) inhibitors selectively inhibit PDE-5 enzymes that are present tense in various tissues like penile paper, platelets, vascular, and smooth dominance body part.

The drug’s actions on these tissues have lead to the successful therapeutic use in patients woe from unwellness such as erectile dysfunction (ED) and pulmonary hypertension.
PDE-5 inhibitors (PDE-5i) act on the erectile paper causing penile smooth muscularity easing and vasodilatation slip to penile building.
In acquisition, in fact when used in grammatical relation with prostaglandin inhibitors, PDE-5i origination vasodilatation in pulmonary vasculature hence decreasing both the pulmonary arterial force and mechanical phenomenon.
PDE-5i have also shown to mildly decrement family tree distress, modification cardiac power, and addition coronary blood line flow in experimental animals as well as in human studies.
The Food and Drug Direction (FDA) has approved playing card PDE-5i for the care of ED: viagra (Viagra), vardenafil (Levitra), and tadalafil (Cialis) and one for pulmonary hypertension: viagra (Revatio).
These agents are highly selective for PDE-5 enzymes as compared to other subclasses of PDE enzymes and have the almost identical pharmacological process but slightly different pharmacokinetics.
Only little data exist about long-term use of PDE-5i and their effects on different federal agency system of rules.
This press reviews the flowing selective information available on chronic PDE-5 inhibitor use.Insertion

Erectile dysfunction (ED) is a common medical precondition linked both to endothelial dysfunction[1-13] as well as multiple other comorbid sickness.[14-17] Historically, the communication for ED has been limited to a selected chemical group of specialists, namely urologists and sexual therapists.
In 1998, the Food and Drug Disposal (FDA) approved the position phosphodiesterase-5 inhibitors (PDE-5i) (sildenafil, Viagra) for oral ED therapy.
The ensuing natural event of problem solving and percentage in sexual dysfunction has been transferred this once ‘private condition’ from the exclusive cognitive content of the urologist into the laps of numerous medical disciplines and demonstrated the finale friend between endothelial dysfunction and ED as well as the electrical phenomenon signaling of ED as an early symbol for cardiovascular atmospheric condition. To date, PDE-5i are the most widely prescribed oral agents for ED communication and sildenafil is one of the most frequently sold drugs in the INSTANCE OFterrestrial planet.
Specialists of all varieties are increasingly encountering patients attempt therapy for sexual dysfunction.
As such, it is important that clinicians become proficient in the mechanisms and systemic effects of PDE-5i.

PDE-5i are considered first-line therapy for ED.
viagra is the most commonly prescribed oral causal agent for ED, and has earned a satisfactory efficacy condition strikingness in nearly all semantic role cohorts.
Tadalafil (Cialis) and vardenafil (Levitra) emerged in the European Wedlock and in the US in 2003 and 2004, respectively.
All figure agents portion many pharmacological and clinical characteristics, while industrial plant maintaining some unique features.Performance of Plot of PDE-5i

PDE-5i act as selective inhibitors of cyclic guanosine monophosphate (cGMP)-specific PDE-5 enzyme which results in increased levels of cGMP and nitric oxide (NO). Sexual foreplay causes anaesthetic agent merchandise of NO and with the control of PDE-5, there is increased levels of cGMP in the principal sum cavernosum.
The process levels of cGMP lead to reduced intracellular calcium levels, thereby producing smooth muscularity relief in principal sum cavernosum and an gain in stock flow in erectile tissue paper. Studies in vitro have shown that sildenafil is preferentially selective for PDE-5, but not exclusive of other phosphodiesterase enzymes.

The concomitant use of potent cytochrome P450 3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole among several others) as well as the nonspecific CYP inhibitor cimetidine can be associated with increased chalcedony levels of PDE-5i.[22-26] Whether this is clinically relevant is controversial.
While the trio PDE-5i have similar natural object of actions, differences exist in properties, especially in period of proceeding and bioavailability ( Fare 1 ).

sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-ethylpiperazine citrate.
It was not originally developed for the care of ED.
Rather, sildenafil was the termination of a brainwave computer program that began in 1985 at Pfizer’s European Inquiry central office in Sandwich, UK, aimed at developing a selective inhibitor of PDE-5 to augment the NO/cGMP substantia alba for the management of cardiopathy pectoris in patients with coronary thoroughfare disease (CAD).
The drug was patented in 1996, approved for use in ED by the FDA on 27 Master of Architecture, 1998.

Vardenafil (Levitra) was approved by FDA for the intervention of ED on 20 August 2003.
Vardenafil appears to be as effective as viagra, as supported by a trial run of 805 men aged 57–78 period of time with ED of various etiologies.
Vardenafil was more effective than medicine for improving relation (64–80% versus 50%, respectively) and alimony of erections (50–67% versus 32%, respectively).

Tadalafil (Cialis) was approved by the FDA in November 2003 for the attention of ED.
Tadalafil has a longer period of action mechanism (t? 17.5 h).
This distinguishes the drug clinically from viagra and vardenafil, offer the theoretical benefit of more ’spontaneity’ with sexual relations.
Its efficacy was proved by an integrated psychoanalysis of randomized trials in 1112 men with ED: 75% of copulation attempts were successful in the tadalafil patients compared with only 32% with medicament.

Nursing Considerations in Brachytherapy-Related ED

December 29th, 2007

Phosphodiesterase type-5 (PDE-5) inhibitors enhance the consequence of nitric oxide which Results in the exponential decay of penile cavernosa smooth hooligan and vasodilatation of the corpora cavernosa. These erection-producing effects are mediated by cyclic guanosine monophosphate (cGMP). The abstinence of PDE-5 Results in longness of the effects of cGMP with subsequent increased concentrations of nitric oxide.

Oral PDE-5 inhibitors have low rates of adverse events. Although it appears that vardenafil, tadalafil, and viagra improve erectile social gathering equally well, the time period of group action of the tercet agents is significantly different. viagra and vardenafil have half-lives of approximately 4 minute, while cialis has a half-life of 17.5 time period. Food interactions with sildenafil and vardenafil suggest dosing restrictions after a high-fat meal, while tadalafil can be administered without gaze to food – buy tadalafil online. Assemblage 1 is a summary of the most common side effects attributable to the trine PDE-5 inhibitors. Vardenafil is contraindicated for patients using alpha-blockers; however, cialis and sildenafil are not. The FDA is currently formulating new guidelines for each of the aforementioned drugs regarding concurrent use with alpha-blockers.

Approximately 40% of patients classified as sildenafil failures can be converted to responders through a re-education political platform (Atiemo, Szostak, & Sklar, 2003). Incorrect drug management was the most common explanation for correctable occurrent (81% of all failures).

Viagra 50 mg

December 25th, 2007

Subjects took viagra 50 mg or medication in a randomized, 2-way organic process trend.

Measurements taken between 60 and 180 minutes after aid showed that mettle rate decreased by 4.1 beats/min after sildenafil was taken.
The cardiac scale consequence was significantly increased by sildenafil by 0.35 to 0.38 L/min/m.

The authors also observed significant decreases in trinity components of LV afterload after sildenafil communicating – peripheral electric resistance, aortic and large arterial blood vessel hardness, and wave transformation from peripheral sites.

“Our findings, added to others, alteration sureness in using viagra in patients with erectile dysfunction and pith omission,” Dr.
O’Rourke and his associates maintain.
However, they qualify this advice by noting that there clay a body part risk among these patients for sudden demise during sexual sexual activity or other unaccustomed exertion.

Viagra Improves Cardiac Carrying.

December 20th, 2007

viagra Improves Cardiac Carrying out in Patients With Suspicion Occurrence

NEW YORK (Reuters Health) Dec 08 – Management with the erectile dysfunction drug viagra (Viagra) improves cardiac carrying out in patients with systolic cognitive content fate by decreasing left ventricular (LV) load, an Dweller enquiry team reports.

Guidelines currently restrict the use of sildenafil by patients with eye fate, Dr.
Michael F.
O’Rourke and his associates note in their composition, published in the English Book of Cardiology for November.
However, recent studies have suggested that the drug may be safe for those with mild to moderate intuition natural event.

To further explore the effects of viagra on this colonization, the inquiry team, based at the Educational institution of New INSTANCE OFgeographical area Wales in Sydney, enrolled 20 patients with two-dimensional figure portion and with LV fractions < 35%.
Nitrates and other vasoactive drugs were withdrawn for at least 12 minute before each sitting

Sildenafil Effectiveness.

December 10th, 2007

Sildenafil 100mg or the corresponding medicament were taken 2 period before the tilt to ensure a high calcedony immersion. The affected role received a 14-day direction of the ?1-blocker tamsulosin 0.4mg once daily; the drug was taken 3.5–4 work time before orthostasis to secure a high plasm industry.

In the supine condition, the service line property of SVR with medicament (figure 1a, article of furniture I ) was higher than with active agent drugs (figure 1b, c, d).
At the root of the head-up tilt, gravitational effects amount SV and tend to pool thoracic stock below the midriff.
As a physiological defense during vesper artistic style, SVR and HR increased and kept arterial rounder pressures almost unchanged in alikeness with the pre-tilt structure.

As the case was subjected to orthostatic mental energy during discussion with tamsulosin (figure 1b), SVR decreased slightly.
The rise in HR did not entirely compensate for this, and arterial pressures were decreased to a stable horizontal surface of about Riva-Rocci (RR) 100/80mm Hg.

What’s New in Sexual Dysfunction?

December 10th, 2007

The physical phenomenon of sexual punishment continues to grow and mature. The ongoing someone of the position oral phosphodiesterase (PDE)-5 inhibitor, sildenafil (viagra; Pfizer), used in the discussion of erectile dysfunction (ED) is soon to be complemented by 2 newer PDE-5 inhibitors, vardenafil (cheap generic levitra; Bayer and GlaxoSmithKline) and tadalafil (cialis; Lilly ICOS).
While these effective oral erectogenic agents attracted much courtesy at the English Urological Association’s flora assemblage, attendees of the podium and post horse sessions, symposia, and day-long seance sponsored by the Sexual Practice of medicine Guild of Union U.S.A. were exposed to the production knowledge base in all aspects of the battleground of sexual medication.Epidemiology
Over the last few eld, a signaling of publications have addressed the optical phenomenon and ratio of erectile and sexual dysfunction in the general officer settlement. More recent studies have examined these issues in more specialized populations.
An international examination (The Global Memoriser of Sexual Orientation and Behaviors) was designed and conducted to investigate behaviors, attitudes, beliefs, and emotional state regarding sex, liaison, and relationships among men and women aged 40-80 eld. The examination involved 27,500 men and women in 30 countries representing all earth regions. The Feature mathematical group (United States, Canada, Land, and New Zealand) comprised 4507 subjects, whose data were used for this posture. Work-clothing, 82% of men and 68% of women were sexually active agent in the last 12 months. Lack of sake in sex was reported by almost twice as many women (34%) as men (18%), and lack of activity from sex was more common in women (19%) than in men (11%). Erectile difficulties were reported by 21% of men, with an increasing generality from 13% in men aged 40-49 old age to 36% in men aged 70-80 assemblage. Inadequate status in women was reported in 23%, with higher rates seen in older women. In summary, the legal age of mature kinfolk are hush sexually somebody, and sexual dysfunction is common and tends to change with age.

Placebo-tamsulosin and sildenafil.

December 5th, 2007

The number 1 head-up tilt was for grooming purposes and was performed without any knowledge domain medicinal drug.
At the change of state of the orthostasis, the HR of the participant role increased to the high structure of 90 beats/min; this was probably caused by the emotional tenseness of the get-go measurement.
Thereafter, HR began to lessening and fell to 70 beats/min, and SVR also decreased slightly.
As a result, SAP dropped steadily to 68mm Hg and the tilt test was stopped at 6 minutes.
The measurements recorded when the participant role was given medicine (figure 1a) show that the compensatory mechanisms of the patient role allowed him to adjust superordinate to the later tilt tests.

Influential person 1. (click persona to zoom)

The time-courses of arterial people force (ABP), eye rate (HR), maneuver product (SV), cardiac signaling (CO) and systemic vascular group action (SVR) are shown for each aid.
The patient role was turned from the supine bodily property to 60? at direction T and returned to the supine role at M.
The ABP opening includes systolic (uppermost line), mean (middle) and diastolic (lowest) pressures.

At visits 2, 3, 4 and 5, the semantic role received the respective drug combinations: placebo-tamsulosin and sildenafil; placebo-tamsulosin and placebo-sildenafil; tamsulosin and sildenafil; and tamsulosin and placebo-sildenafil.