TriMix Gel Achieves Success Among Men With Erectile Disfunction

New research showed that among men who previously failed to achieve erections on Viagra, Levitra and Cialis type tablets, 40% achieved an erection sufficient for penetration during sexual intercourse after given a single dose of a novel treatment called TriMix gel.
The research involved forty two (42) men diagnosed with erectile dysfunction and various other conditions such as high blood pressure, high cholesterol, diabetes and removal of the prostate. The average age was 55. All trial participants had previously failed on Viagra, Levitra or Cialis type tablets.
Test results were documented using various methodologies such as penile buckling pressures, RigiScans (an instrument that documents penile rigidity) and Erection Hardness Scores (EHS). All test participants experienced some degree of tumescence or increased blood flow and 17 of the patients or 40%, experienced erections sufficient for penetration during sexual intercourse.
Typically, trimix compound in liquid form requires refrigeration and the patient must use a needle to self inject. TriMix gel does not require refrigeration and does not use a needle. It allows the patient to carry the medicine on his person at room temperature. More importantly, an ED patient would not have to use a needle to self inject before sexual intercourse.
Dr. Marmar stated, "Among a group of men who previously failed to achieve erections on Viagra, Levitra and Cialis type tablets, TriMix-gel demonstrated statistically significant greater Erection Hardness Scores. TriMix gel may offer ED patients an elegant alternative to penile injection."

Two-Thirds of Patients Say Erection Drug Didn't Work for Them

Erectile Dysfunction Drug Uprima

Two-thirds of patients stopped using Uprima, a drug commonly prescribed for erection problems, because they felt it wasn't effective, according to a large-scale study published in the July issue of the urology journal BJU International.
And 70 per cent of family doctors who expressed an opinion using an official National Health Service (NHS) drug feedback form felt the drug wasn't effective.
Researchers at the UK's Drug Safety Research Unit and University of Portsmouth analysed prescribing data for 11,185 patients seen by NHS family doctors.
The data was gathered from official Green Form Questionnaires that ask doctors to record any significant events recorded in a patient's notes after prescribing newly marketed medicines.
Key findings on erectile dysfunction drug:

• 65 per cent of doctors said their patient stopped taking Uprima because they felt it wasn't effective and 14 per cent said the patient didn't request a further prescription. (68 per cent of GPs responded to the question).

• Further analysis showed that 59 per cent of patients who didn't find it effective stopped taking Uprima after a month and a further 23 had joined them by month two. (Timescale information was recorded for 79 per cent of patients who judged the drug ineffective).

• 70 per cent of doctors said they didn't think the drug was effective and 30 per cent said it was. (65 per cent of GPs responded to the question)
  

• 28.5 per cent of the total patient sample had a history of diabetes, 18.8 per cent had heart disease and 37.2 per cent had tried Viagra. 7.5 per cent were receiving both Uprima and nitrate therapy for angina.

• The most common adverse drug reactions were headache and nausea, in line with the clinical trials and as listed in the Summary of Product Characteristics by the manufacturers.

• The average age of the subjects was 61 and all but eight were male. Three of the women were prescribed Uprima for decreased libido, pain and sexual arousal problems. Prescribing information was not provided for the other five.

• Most patients (99 per cent) received the manufacturer's recommended dose of 2-3mg, with the remainder receiving between 4-12mg. (Starting dose information was completed on 79 per cent of forms).

• 99 deaths (just under one per cent of the total sample) were recorded on the forms. The most frequently reported cause of death was heart attack (27 patients), followed by heart disease (nine) and lung cancer (five). In 21 cases the cause of death could not be established by the researchers.

The 11,185 forms covered patients who were first prescribed Uprima between October 2001 - three months after the drug was launched in the UK - and December 2002. Just over 21,000 Questionnaires were issued and 57 per cent of GPs responded.
At least six months after the first prescription for Uprima was issued for each patient, their family doctor was sent a Green Form Questionnaire that requested details about the patient's age and sex and their use of Uprima.
They were also asked to record any significant events that had occurred since the patient was prescribed Uprima, such as suspected drug reactions, unexpected deterioration or improvement in the patient's condition, referral to a specialist or any clinically important changes in laboratory tests.
The form also included questions on diseases commonly associated with erectile dysfunction - such as diabetes and heart disease � � � � � � � �" together with previous use of similar drugs and co-prescribing of medication for angina.
"Prescription-Event Monitoring provides surveillance on a national scale after new drugs are launched" explains lead researcher Professor Saad Shakir.
"Because family doctors are not approached before the decision to treat a patient has been made, they are not subject to detailed inclusion or exclusion criteria. The decision to prescribe is made purely as a result of their clinical knowledge of the patient and the drug involved.
"The result is real world clinical data that provides information of illness and death in patients treated with newly marketed drugs � � � � � � � �" a valuable tool in drug safety assessment."

Online Pharmacy Safety Providing Erectile Dysfunction Drugs

Should you buy erectile dysfunction and impotence treatment drugs online?
Online Internet shopping today offers many benefits. You can research a product in the privacy of your own home and purchase most anything by clicking a mouse. But should we be allowed to buy prescription drugs via the Internet, bypassing a traditional office visit or conversation with a physician? In the August issue of Mayo Clinic Proceedings, researchers from Utah and several colleagues compare the relative safety of two systems — an online prescribing service versus traditional physician consultation – for patients seeking medication to treat erectile dysfunction.

Online prescribing, also called e-medicine prescribing, is relatively new in the United States. Patient demand for these services appears to be growing, but the researchers acknowledge that the health care industry “has appropriately raised serious concerns about the safety of prescribing over the Internet.” In 2002, the state of Utah signed a contract with an Internet prescribing service to prescribe erectile dysfunction drugs called PDE-5 inhibitors. Erectile dysfunction (ED) is the inability of a man to maintain a firm erection long enough to have sex.
The researchers randomly selected 1,000 patient medical records from patients seeking ED treatment from Jan. 1, 2001 to Dec. 31, 2005. Half (500) of these patients used the online prescriber (the e-medicine group), and 500 consulted a physician (the traditional medicine group) for treatment.
Using statistical analyses, the researchers compared the safety of both approaches — e-medicine versus traditional medicine — in treating patients who have ED. The safety comparisons looked at a number of criteria, including prescription appropriateness, how often the prescribers used a diagnostic tool called the International Index of Erectile Questions (IIEQs) and the level of patient education provided by prescribers.
Evaluating both systems for these safety criteria, the researchers concluded that the e-medicine system “outperformed the traditional system in most of the safety variables tested.” One area the e-medicine system appeared to excel was patient education. The authors noted that 100 percent of the e-medicine clients received written manufacturer product information, and 75.2 percent of e-medicine clients received tailored electronic messages. In comparison, study data showed that no medication instructions were recorded for 51.8 percent of patients who received prescriptions via a traditional physician consultation.
“Innovation, technology and current medical practice all factor into the outcome of this study,” note the authors. “Application of an expert interview system specifically targeted to erectile dysfunction along with a continuous platform for patient client-physician communications make this particular Internet system comparable to traditional medical practice.”
The researchers acknowledge that additional research is needed to confirm these results. They also recommend that state regulatory agencies “consider using the regulatory model of oversight protections implemented by the state of Utah to license Internet prescribing companies.”

Study Of Gene Transfer For Erectile Dysfunction Shows Promise

The first human study using gene transfer to treat erectile dysfunction (ED) shows promising results and suggests the potential for using the technology to treat overactive bladder, irritable bowel syndrome and asthma, according to the researchers.
"In the small pilot study, this new therapy was well tolerated and safe," said George Christ, Ph.D., senior researcher and a professor at the Institute for Regenerative Medicine at Wake Forest University School of Medicine. "It provides evidence that gene transfer is a viable approach to treating ED and other diseases involving smooth muscle cells."
The results of the study, which included 11 men with erectile dysfunction, are reported online today in Human Gene Therapy. The technology was developed by Christ and Arnold Melman, M.D., when they worked together at Albert Einstein College of Medicine in the Bronx, New York.
Unlike traditional gene therapy, the gene transfer approach being pioneered by Christ and Melman does not change the DNA or genetic code of cells. Instead, small pieces of DNA reach the nuclei of cells and this causes them to increase production of particular proteins. These proteins help relax smooth muscle cells, the type of muscle found in the penis as well as in hollow organs such as the bladder. Relaxing the tissue allows the penis to fill with blood and become erect.
Previous research has shown that more than 50 percent of men between 40 and 70 years old and 70 percent over age 70 may have erectile dysfunction. The new therapy is a potential alternative to oral medications, such as Viagra, which are not effective for an estimated 30 to 40 percent of men with ED.
A possible advantage of gene transfer is that a single treatment could last for months. In the current study, improvements were maintained through the 24 weeks of study.
The study was conducted from May 2004 to May 2006 at Mount Sinai School of Medicine and New York University School of Medicine. Men ranged from 42 to 80 years old with a mean age of 59. Six subjects were white, four were black and one was Hispanic. In half of the subjects, the cause of� � erectile dysfunction was diabetes or cardiovascular disease � � � � � � � �" both of which can interfere with the ability of smooth muscle cells to relax.
The primary goal of the study was to determine the safety and tolerability of the new therapy. However, the results also showed that at the highest doses, men reported highly significant improvements in erectile function.
The DNA segments � � � � � � � �" mixed into plasma � � � � � � � �" were injected into the corpus cavernosum, expandable tissue along the length of the penis that fills with blood during erection. A variety of clinical and laboratory tests were used to assess safety. In addition, effectiveness was measured using the International Index of Erectile Function scale, a questionnaire that is commonly used to measure erectile dysfunction. Patient responses were validated by their partners.
Researchers identified no safety issues with the treatment. Participants who received the highest two doses had apparent sustained improvements in� � erectile dysfunction� � as measured by the questionnaire. The researchers said that a larger study that includes a "control" group treated with a placebo is needed to confirm the safety and effectiveness of the treatment.
The technology is being developed by Ion Channel Innovations (ICI), a development stage biotechnology company, in which Christ and Melman are co-founders and directing members. The therapy is known as ion channel therapy because the proteins it targets are potassium channels, "gates" within cells critical for contraction and relaxation of smooth muscle.
At the Wake Forest Institute for Regenerative Medicine, Christ is continuing to pursue the therapy in collaboration with ICI, and is also exploring the potential of combining gene transfer with traditional oral medications to further increase the clinical utility of the technology. The Albert Einstein College of Medicine at Yeshiva University owns the ICT patents and has granted the company exclusive, worldwide rights.