Archive for January, 2008
FDA Approved Cialis (Tadalafil) for the Treatment of Men’s ED
Currently available in most parts of Europe, this low-dose daily treatment option of Tadalafil may be most appropriate for men with Erectile Dysfunction [e.g. impotence] who anticipate more frequent sexual activity. For other men, Tadalafil taken as needed according to the previously approved dosing regimen. Eli Lilly | Company (NYSE: LLY) reported today that the US Food and Drug Administration has approved Cialis [Tadalafil] for once daily use (2.5 mg and 5 mg), an oral medication taken once a day to treat erectile dysfunction. When Cialis for once daily use is taken daily, men can attempt sexual activity at anytime between doses. In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy. Erectile Disfunction can be a chronic condition like diabetes or high blood pressure. Many young couples like to have choices and will appreciate the availability of Tadalafil for once daily use [overnight]. Side effects of mentioned airfox Cialis pills are always under research. The FDA’s approval of Tadalafil [Cialis] for once daily use was based upon the evaluation of the comprehensive data package for the daily dosing option. The data consist of results from three phase III randomized, double-blind, placebo-controlled studies. Men with sexual health disorders who participated these clinical researches and took Tadalfil 2.5 mg and 5 mg once daily without regard to their timing of sexual activity experienced improved erectile function compared with those taking placebo. Cialis 5 mg, 10 mg and 20 mg have been approved in the United States for as-needed treatment of ED since November 2003. American pharmacies and drugstore markets have been immediately transformed when Tadalfil was approved in 2003 as the first and only PDE5 inhibitor clinically proven to provide sustained efficacy for up to 36 hours. Tadalafil pills provided a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity. In consultation with their physician, patients now have the freedom to choose the dosing regimen that is appropriate for them. In addition, Lilly’s wholesale pricing for Cialis will be comparable to Cialis for use as needed such that patients who currently use two or more pills per week of Cialis for use as needed should not experience higher treatment costs with Cialis for once daily use. The most commonly reported adverse events were headache, indigestion, back-pain, muscle aches, nasal congestion, flushing and pain in limb. Most adverse events reported with Tadalafil were transient and generally mild or moderate. About ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. Experts believe that 80 percent to 90 percent of ED cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 percent to 20 percent are predominantly due to psychological causes. In many cases, however, both psychological and physical factors contribute to the condition. Tadalafil has been officially tested and approved for the treatment of erectile dysfunction on an as-needed basis or in a daily regular basis. The recommended starting dosage of Tadalafil for most part of patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased up to 20 mg or decreased to 5 mg, depending on individual tolerability and efficacy. As part of a daily regimen, Tadalafil regalis may be taken as 2.5 mg or increased up to 5 mg, depending on individual efficacy and tolerability. Important safety Tadalafil information is available by prescription only and is not for everyone. Men should always discuss their medical conditions and all medications with their doctors to ensure Tadalafil is right for them and that they are healthy enough for sexual activity. Men taking nitrates, often used for chest pain, should not take Tadalafil. Such a combination could cause a sudden, unsafe drop in blood pressure. Tadalafil for once daily use provides continuous plasma tadalafil levels which should be considered when evaluating the potential for interactions with certain medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial amounts of alcohol. The most common Tadalafil side effects were headache, upset stomach, delayed backache or muscle ache. As with any ED tablet, in the rare event of priapism (an erection lasting more than four hours), men should seek immediate medical attention to avoid long-term injury. In rare instances, men taking prescription ED medicines (including Tadalafil) reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). However, it’s not possible to determine if these events are related directly to the ED pills or to other factors. If a man has a sudden decrease or loss of vision or hearing, he should stop taking any ED tablet and seek medical attention right away. Tadalafil does not protect neither a man nor his partner from sexually transmitted diseases, including HIV. Men should not drink alcohol in excess with Tadalafil. Individual results may differ. Tadalafil has not been studied for multiple attempts per dose. For full patient information and/or full prescribing information, visit www.cialis.com
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New Weight Loss Drug Gives Hope
Summer is one of the most favorite seasons in many countries when people want to go out in the sun wearing as little clothing as possible. With 32% of US citizens clinically obese, and the rest of the western world quickly catching up, it’s no surprise that this all natural weight loss system keeps selling. Literally millions and millions of people are overweight and all are unhappy with their current situation. Most would like an easy way to fix it, but without resorting to synthetic dietary suppression drugs.
An experimental weight loss medication in the same class as the well-known drug Acomplia helped patients lose weight in a 12-week, phase II study, but side effects were common at higher doses.
Similar to Acomplia (Rimonabant), which is approved for sale in Europe but not in the U.S., the Merck & Co. drug taranabant targets receptors in the brain linked to appetite. Concerns about reports of anxiety and depression in Rimonabant users have kept the drug off the market in the U.S. Based on these reports, an FDA advisory panel voted against recommending its approval last June, prompting manufacturer Sanofi-Aventis to withdraw its application to the agency.
Depression and anxiety were also reported in the taranabant study, but these side effects were most common at the highest doses given, researcher Steven Heymsfield, MD, of Merck Research Laboratories, tells WebMD.
Based on these researches, an ongoing phase III trial of taranabant does not include the highest doses used in phase II study.
Taranabant Trial: The double-blind study research included 533 obese people randomly assigned to treatment with either placebo or 0.5 milligrams, 2 milligrams, 4 milligrams, or 6 milligrams of taranabant. All the participants received counseling on diet and exercise throughout the trial. At the end of 12 weeks, the placebo-treated participants had lost the least weight and those treated with the highest dose of taranabant had lost the most. Patients treated with 0.5 milligrams of the drug lost an average of 3.5 pounds , compared with 5 pounds among people treated with 2 milligrams of the drug and almost 9 pounds among those treated with 6 milligrams.
A total of 27% of patients who took 0.5 milligrams of taranabant lost 5% or more of their body weight, compared with 61% in the 6-milligram group. However, patients taking the higher dosages of the drug also had higher rates of side effects, including anxiety, nausea, and vomiting.
The study drop-out rate due to side effects was also twice as high among patients treated with the highest dosage of the drug, compared with the lowest dose (10.2% vs. 4.7%). But no patients dropped out because of serious events. The study appears in the January issue of the journal Cell Metabolism .
Heymsfield says he was surprised to find that patients treated with the lowest dose of the drug lost weight.
“We didn’t expect weight loss at all doses,” he says.
Looking For FDA Approval
The ongoing phase III trial includes roughly 2,000 people being treated with taranabant at doses ranging from 0.5 milligrams to 2 milligrams, a Merck spokeswoman tells WebMD. She adds that the plan is to petition the FDA for approval in the second half of this year if the phase III results prove promising.
A spokeswoman for Sanofi-Aventis says several phase III trials of rimonabant are also under way, and the findings could help address the FDA advisory panel’s safety concerns about the drug.
Julissa Viana tells WebMD that the company will likely petition the FDA once again to approve the drug for sale in the United States .
“I can’t speculate on when we will submit or what those indications [for use] will be,” she says. “We are looking forward to the results of our ongoing trials.”
Weight loss specialist Louis Aronne, MD, says the FDA may be more likely to approve the drug the second time around as safety issues are addressed.
Aronne directs the comprehensive weight control program at New York-Presbyterian/Weill Cornell Medical Center.
“Rimonabant is now approved in 51 countries, and it is being actively sold in 20,” he says. “I think as time goes on and the evidence builds that this class of drugs has a manageable side effect profile, the FDA will become more comfortable with it.”
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Drugs Available in the United Kingdom Extend Life of HIV Patients
Over the last ten years of researching better treatments for HIV patients, eventually a new drug had been found in Great Britain to lengthen the life expectancy of the victims. The recent medication of Pfizer’s pharmacy - Celsentri (Maraviroc) is an effective treatment truly helpful for the patients, which works by guarding the entrance of the immune system and blocks the HIV, as a result delays the process of developing into AIDS. Although the drug is not a cure-all treatment, this is an alternative that patients can look forward to since not all symptoms are remedied by other available HIV drugs in the market. Many AIDS organizations have been interested in this medication saying this is a good sign of innovation and will help to reduce the progression of HIV into AIDS.
Three medications have been comprised by Maraviroc that collectively made into one creating highly active anti-retroviral therapy (HAART) that lengthens the lifespan of HIV patients. However, recent researches indicated that some patients have resistance to the product making it not advisable for them to take. The drug was approved in August for public use in the United States under the brand name Selzentry. The drug is taken orally in combination with the other anti-retroviral drugs.
The drug’s mode of action works as it becomes a microscopic blockade of the CCR5 receptor, which the HIV virus usually strikes, as it enters the immune system particularly the CD4-T-cells. When the cell receptor is blocked, it makes the body more resistant to infection of the cells and slows down the process of developing the virus into full-blown AIDS. As this happens, complications are being delayed making the HIV-positive patients to live longer.
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