пятница, 24 августа 2007 г.

EU Marketing Authorisation For Inhaled Insulin Granted

Exubera(R) (inhaled insulin human), the first inhaled insulin for the treatment of diabetes has been granted marketing authorisation by the European Commission.1 Granting of this authorisation within the European Union now allows manufacturing of the inhaler and the dry powder insulin formulation to commence.

Exubera is not yet available on prescription in the UK or anywhere else in the world. It is anticipated that Exubera will become available in the UK in May 2006. Exubera will not be suitable for everyone with diabetes. However, for clinically appropriate adults with type 1 diabetes, or type 2 diabetes requiring insulin, Exubera will represent an important advance in the diabetical treatment options available.

For those people with diabetes requiring intermediate or long-acting insulin, this treatment will still need to continue by injection. Exubera is a fast-acting insulin, inhaled into the lungs via the mouth, shortly before meals, through a simple to use2,3, hand-held inhaler. It is the only licensed insulin delivered by inhalation rather than injection or pump. The clinical trial programme has involved more than 3,500 adults with type 1 and type 2 diabetes.4

Exubera has been shown to be as effective as subcutaneous (injectable) insulin, including fast acting insulin, in achieving and maintaining blood sugar control in adults with either type 15,6or type 25,7diabetes. Improved glycaemic control has been shown to result in reduced risk of microvascular complications (such as retinopathy, nephropathy and neuropathy) and associated morbidity.

At present, many patients in the UK with diabetes are uncontrolled, and as many as half of type 2 patients may remain uncontrolled.8 Dissatisfaction with existing current treatment options can lead to poor blood glucose control and can be related to patient concerns. Many people with type 2 diabetes can be controlled without insulin, but initiation of insulin at the appropriate stage is likely to achieve better control. Inhaled insulin could provide a significant advantage in terms of patient acceptability and choice, helping to improve blood glucose control. Inhaled insulin is the first non-injected option for insulin delivery since the discovery of the treatment for diabetes in the 1920s. An education and support programme for healthcare professionals on the use of inhaled insulin within the context of current management options will be launched within the next few weeks. This will ensure that, once available, healthcare professionals involved in diabetes are equipped to provide patients accurate and appropriate advice about this new insulin treatment option.

Said Dr Kate Lloyd, Medical Director, Pfizer Ltd: "Physicians face many challenges with insulin therapy, due in part to reluctance to take injections, which up until now, was the only way to deliver insulin. For successful diabetes care it is important for patients to take an active role in managing this complicated disease. Inhaled insulin is a potential option for patients where blood sugar control is difficult. The safety profile of Exubera, including the pulmonary safety profile, has been studied in adults with either type 1 or type 2 diabetes.

This is reflected in the European approval of Exubera, which marks another important step forward in the treatment of diabetes, and will improve the treatment options of people with diabetes".

--- Exubera will be indicated for the treatment of: - adult patients with type 2 diabetes mellitus not adequately controlled with oral anti-diabetic agents and requiring insulin therapy- adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.
--- Exubera has been shown to be well-tolerated. Common side-effects observed in the clinical trials included: hypoglycaemia (comparable rates in patients treated with Exubera or subcutaneous human insulin); and cough - (predominantly mild), which tended to occur within seconds to minutes after insulin inhalation.1
--- Exubera is contra-indicated in patients with poorly controlled, unstable or severe asthma or severe Chronic Obstructive Pulmonary Disease (COPD) and smokers, or those people who have smoked within the last six months. Exubera should not be given to patients with diabetes during pregnancy.1
--- The Exubera inhaler is not breath-actuated and is different to the traditional asthma inhaler. As part of the overall training programme healthcare professionals will be advised on the appropriate use of the inhaler and how they can best teach patients to use the treatment correctly.
--- Pfizer announced on 12 January 2006 that it has reached an agreement to acquire the sanofi-aventis worldwide rights to inhaled insulin human, which will be marketed under the trade name of Exubera. The two companies were previously in a worldwide alliance to co-develop, co-promote and co-manufacture Exubera.

--- The product of a developmental collaboration between Pfizer Inc. and Nektar Therapeutics, Exubera represents a major advance in insulin delivery. Exubera is pending approval in the U.S. In September 2005, the U.S. Food and Drug Administration (FDA) Advisory Committee recommended that EXUBERA
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четверг, 23 августа 2007 г.

Birth Control Pill Could Cause Long-Term Problems With Testosterone

In the January issue of The Journal of Sexual Medicine, researchers have published a new investigation measuring sex hormone binding globulin (SHBG) before and after discontinuation of the oral contraceptive pill. The research concluded that women who used the oral contraceptive pill may be exposed to long-term problems from low values of "unbound" testosterone potentially leading to continuing sexual, metabolic, and mental health consequences.

Sex hormone binding globulin (SHBG) is the protein that binds testosterone, rendering it unavailable for a woman's physiologic needs. The study showed that in women with sexual dysfunction, elevated SHBG in "Oral Contraceptive Discontinued-Users" did not decrease to values consistent with those of "Never-Users of Oral Contraceptive".

Thus, as a consequence of the chronic elevation in sex hormone binding globulin levels, pill users may be at risk for long-standing health problems, including sexual dysfunction. Oral contraceptives have been the preferred method of birth control because of their ease of use and high rate of effectiveness. However, in some women oral contraceptives have ironically been associated with women's sexual health problems and testosterone hormonal problems. Now there are data that oral contraceptive pills may have lasting adverse effects on the hormone testosterone.
The research, in an article entitled: "Impact of Oral Contraceptives on Sex Hormone Binding Globulin and Androgen Levels: A Retrospective Study in Women with Sexual Dysfunction" published in The Journal of Sexual Medicine, involved 124 premenopausal women with sexual health complaints for more than 6 months.

Three groups of women were defined:
i) 62 "Oral Contraceptive Continued-Users" had been on oral contraceptives for more than 6 months and continued taking them,
ii) 39 "Oral Contraceptive Discontinued-Users" had been on oral contraceptives for more than 6 months and discontinued them, and
iii) 23 "Never-Users of Oral Contraceptives" had never taken oral contraceptives. SHBG values were compared at baseline (groups i, ii and iii), while on the oral contraceptive (groups i and ii), and well beyond the 7 day half-life of sex hormone binding globulin at 49-120 (mean 80) days and more than 120 (mean 196) days after discontinuation of oral contraceptives (group ii).

The researchers concluded that SHBG values in the "Oral Contraceptive Continued-Users" were 4 times higher than those in the "Never-Users of Oral Contraceptives". Despite a decrease in SHBG values after discontinuation of oral contraceptive pill use, SHBG levels in "Oral Contraceptive Discontinued-Users" remained elevated when compared to "Never-Users of Oral Contraceptives".

This led to the question of whether prolonged exposure to the synthetic estrogens of oral contraceptives induces gene imprinting and increased gene expression of SHBG in the liver in some women who have used the oral contraceptives. Dr. Claudia Panzer, an endocrinologist in Denver, CO and lead author of the study, noted that "it is important for physicians prescribing oral contraceptives to point out to their patients potential sexual side effects, such as decreased desire, arousal, decreased lubrication and increased sexual pain. Also if women present with these complaints, it is crucial to recognize the link between sexual dysfunction and the oral contraceptive and not to attribute these complaints solely to psychological causes."

"An interesting observation was that the use of oral contraceptives led to changes in the synthesis of SHBG which were not completely reversible in our time frame of observation. This can lead to lower levels of 'unbound' testosterone, which is thought to play a major role in female sexual health. It would be important to conduct long-term studies to see if these increased SHBG changes are permanent," added Dr. Panzer. Dr. Andre Guay, study co-author and Director of the Center for Sexual Function/Endocrinology in Peabody, MA affirmed that this study is a revelation and that the results have been remarkable.

"For years we have known that a subset of women using oral contraceptive agents suffer from decreased sex drive," states Dr. Guay. "We know that the birth control pill suppresses both ovulation and also the male hormones that the ovaries make in larger amounts during the middle third of the menstrual cycle. SHBG binds the testosterone, therefore, these pills decrease a woman's male hormone availability by two separate mechanisms. No wonder so many women have had symptoms."

"This work is the culmination of 7 years of observational research in which we noted in our practice many women with sexual dysfunction who had used the oral contraceptive but whose sexual and hormonal problems persisted despite stopping the birth control pill," said Dr. Irwin Goldstein, a urologist and senior author of the research. "There are approximately 100 million women worldwide who currently use oral contraceptives, so it is obvious that more extensive research investigations are needed.

The oral contraceptive has been around for over 40 years, but no one had previously looked at the long-term effects of SHBG in these women. The larger problem is that there have been limited research efforts in women's sexual health problems in contrast to investigatory efforts in other areas of women's health or even in male sexual dysfunction."

To better appreciate the scope of the problem, oral contraceptives were introduced in the USA in 1960 and are currently used for reversible pharmacologic birth control by over 10 million women in the US, including 80% of all American women born since 1945 and, more specifically, 27% of women ages 15-44 and 53% of women age 20-24 years. By providing a potent synthetic estrogen (ethinyl estradiol) and a potent synthetic progesterone (for example - norethindrone), highly effective contraception is achieved by diminishing the levels of FSH and LH, thereby reducing metabolic activity of the ovary including the suppression of ovulation. Several studies over the last 30 years reported negative effects of oral contraceptives on sexual function, including diminished sexual interest and arousal, suppression of female initiated sexual activity, decreased frequency of sexual intercourse and sexual enjoyment.

Androgens such as testosterone are important modulators of sexual function. Oral contraceptives decrease circulating levels of androgens by direct inhibition of androgen production in the ovaries and by a marked increase in the hepatic synthesis of sex-hormone binding globulin, the major binding protein for gonadal steroids in the circulation. The combination of these two mechanisms leads to low circulating levels of "unbound" or "free" testosterone.
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вторник, 21 августа 2007 г.

Impotence product, Actra-Rx, dangerous, warns FDA

The FDA is warning patients about the impotence product, Actra-Rx, stating that it can lower your blood pressure to dangerous levels. Actra-Rx is promoted as a natural treatment for erectile dysfunction.

Tests have shown that it contains prescription levels of sildenafil, the active ingredient of Viagra. Actra-Rx is produced in China and is sold on the web as a natural product. If you are being prescribed nitrates, consuming products containing sildenafil can lower your blood pressure to dangerously low levels.

Nitrates are commonly taken by patients with diabetes, high blood pressure or high cholesterol. The FDA said Actra-Rx should not be taken by people seeking treatment for erectile dysfunction. The FDA said the product can be life threatening. Actra-Rx is also sold as Yilishen.

If you are seeking treatment for erectile dysfunction, says the FDA, you should see your doctor. The FDA has instructed that all shipments containing Yilishen or Actra-Rx should be detained.
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понедельник, 20 августа 2007 г.

Erectile Dysfunction From Bike Riding

Research suggests that riding a bike for long periods can cause temporary erectile difficulties, explains "What to Do about Erectile Dysfunction," a new report from Harvard Medical School.

The risk appears highest among men who cycle more than three hours a week.Sitting on a bicycle for a long time puts pressure on the perineum, the area between the genitals and anus. This pressure can harm nerves and temporarily impede blood flow, causing tingling or numbness in the penis and, eventually, erectile dysfunction.

However, one study showed that while a conventional bicycle caused a dramatic (though temporary) drop in oxygen supply to the penis, a recumbent bicycle did not.If you don't want to switch to a recumbent bike, these precautions may help you prevent cycling-related erectile problems:
-- Wear padded biking shorts.
-- Raise the handlebars so that you're sitting relatively upright. This shifts pressure from the perineum to the buttocks.
-- Use a wide, well-padded or gel-filled seat instead a narrow seat, which places more pressure on the perineum.
-- Position the seat to reduce pressure: Make sure it is not so high that your legs are fully extended at the bottom of your pedal stroke, and don't tilt the seat up.
-- Change your position and take breaks during long rides.
-- If you feel tingling or numbness in the penis, stop riding for a week or two.

"What to Do about Erectile Dysfunction" is a 32-page report edited by Michael Philip O'Leary, M.D., Ph.D., associate professor at Harvard Medical School.

This report explains:
-- the anatomy and physiology of normal sexual function and erectile problems
-- the causes of erectile dysfunction, including a self-assessment questionnaire
-- the range of treatments available (including alternatives to Viagra and similar drugs)
-- the role of counseling
-- how to include your partner in discussing and treating erectile dysfunction.
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пятница, 17 августа 2007 г.

Medical Workers Sentenced To Death In HIV Infection

The six medical workers released recently from Libyan prison after being sentenced to death for allegedly intentionally infecting hundreds of children with HIV were tortured during their incarceration, Seif Al-Islam Gaddafi -- head of the Gaddafi Development Foundation and son of the Libyan leader, Muammar Gaddafi -- said Wednesday on Al-Jazeera television, the Washington Post reports (Moore, Washington Post, 8/10).

The five Bulgarian nurses and Palestinian doctor in May 2004 were sentenced to death by firing squad for allegedly infecting 426 children with HIV through contaminated blood products at Al Fateh Children's Hospital in Benghazi, Libya. They also were ordered to pay a total of $1 million to the families of the HIV-positive children.
The Libyan Supreme Court in December 2005 overturned the medical workers' convictions and ordered a retrial in a lower court. A court in Tripoli, Libya, in December 2006 convicted the health workers and sentenced them to death. The medical workers then filed an appeal of the December 2006 conviction with the Libyan Supreme Court. The Supreme Court upheld the conviction last month. After Libya's Supreme Judicial Council reduced the sentence to life in prison, the six medical workers were released and pardoned by Bulgarian President Georgi Parvanov after arriving in the country (Kaiser Daily HIV/AIDS Report, 8/9).

The medical workers have said that they were tortured by electric shocks, rape, attacks by dogs and other techniques during their incarceration to force them to confess, the Post reports. "Yes, [the medical workers] were tortured by electricity, and they were threatened that their family members would be targeted," Seif Al-Islam Gaddafi said. He added that although electric shock was used, other allegations of torture -- including some made by the Palestinian doctor, Ashraf al-Hazouz -- are false (Washington Post, 8/10).

Libyan officials refused to comment on Seif Al-Islam Gaddafi's statements, the AP/Guardian reports (Schemm, AP/Guardian, 8/9).In related news, Bulgarian judicial authorities on Friday started questioning the six medical workers about their experiences in prison, the AP/International Herald Tribune reports.
The country's Criminal Investigation Service announced that the medical workers had started to testify but did not release further details. Bulgaria's prosecution services this year charged several Libyan officers with torturing the medical workers to extract their confessions and has said it plans to pursue the case. A Libyan court in 2005 rejected the lawsuits against the officers

суббота, 11 августа 2007 г.

A Better Sex Life

May 10 issue - Watch a few "Sex and the City" reruns or page through a women's magazine and you might think that women are not only interested in sex, but obsessed with it. Yet if you were to ask women about their sex lives, more than a third would voice concern, according to a 1999 analysis of the University of Chicago's National Health and Social Life Survey.

In this comprehensive look at American sexual behavior, one woman in seven reported problems with arousal and one in five reported low sexual desire. These complaints may not all qualify as "dysfunction," but do suggest a lack of passion and intimacy.

Is a new Viagra the answer? Until recently, drugmakers assumed that sildenafil (the active ingredient in Viagra) would give women the same boost it does men. But that hope fizzled when studies showed the drug was no more effective than a placebo.

Whether you're male or female, the basic necessities for sexual activity are the same: working sexual anatomy, normal hormone activity and enough physical and mental health to respond to another person. But when it comes to satisfying sex, men and women are different.

Visual cues tend to propel men toward the tangible goals of erection, intercourse and orgasm. A woman's sex drive can be just as potent, but an emotional connection to her partner plays a larger role in arousal and satisfaction. In a Kinsey Institute survey, women ranked an overall sense of well-being as their top prerequisite for satisfying sex, followed by positive feelings during lovemaking. Online pharmacy here.

The frequency of sex, and the intensity of physical pleasure, fell farther down the list. Depression, stress, past experiences and relationship conflicts can easily thwart sexual pleasure. Side effects of many medications, particularly some antidepressants, can also scuttle sexual desire. For women in their 30s and 40s, juggling the demands of career and family can dampen interest as well. It isn't uncommon for sex to feel like one more thing on an already long to-do list.

среда, 8 августа 2007 г.

Since ‘Happy Penis’ program led men to stray, pills are now given to wives

The mayor of a small Brazilian town has begun handing out free Viagra, spicing up the sex lives of dozens of elderly men and their partners.
“Since we started the free distribution of sexual stimulants, our elderly population changed. They’re much happier,” said Joao de Souza Luz, the mayor of Novo Santo Antonio, a small town in the central state of Mato Grosso.
Souza Luz said 68 men over the age of 60 had already signed up for the program, which was approved by the town’s legislature and has been dubbed “Happy Penis,” or “Pinto Alegre” in Portuguese. more pharmacy news...