Tuesday, July 15, 2008

Treatment for Erectile Dysfunction in Patients with Diabetes

cialis In This ArticleAbstract and IntroductionPatients and MethodsResultsDiscussionTablesReferencesRelated Links

Patients and Methods

The study group consisted of 284 consecutive patients with DM referred to our tertiary center for the treatment of ED between 1998 and 2002. All patients had DM type II that was diagnosed before the entrance into the study according to fasting glucose level or oral glucose tolerance test. The demographic characteristics of the patients as well as the data regarding the duration of DM and their comorbidities are presented in Table 1 . In all, 43 patients (15.1%) were treated by insulin alone or with combination with oral hypoglycemic agents at the time of the study. The rest of the patients received oral hypoglycemic agents only. DM was relatively controlled.

The diagnosis of ED was based on the International Index of Erectile Function (IIEF).[17] Medical, social and psychosexual history of the patients and their partners were taken. Physical examination, nocturnal penile tumescence test with Rigiscan, penile color Doppler ultrasound and penile electrothermometry[18] were performed. Complete blood count, electrolytes, glucose level, liver enzymes, urea and creatinine, level of prostate-specific antigen, prolactin and total testosterone were checked. No untreated hormonal disbalances in the hypothalamic-hypopituitary-testicular axis were found in our study group, because our department is a tertiary center and all the possible hormonal problems were identified and treated before the reference.Procedure

A positive response at all phases of the program was defined as an erection sufficient for vaginal penetration.

Phase 1. Patients without contraindications[19] were offered sildenafil citrate (Viagra), one tablet at 1 h before coitus, 2-3 h after a meal, at a starting dose of 25-50 mg, depending on age. The dose was increased to 50 and 100 mg at intervals of 2-4 days, depending on response, age, and general state of health.

Phase 2. Patients with contraindications to sildenafil, adverse drug effects, or a negative response (to at least 3-5 doses of 100 mg) were offered vacuum therapy with the VED. Details of its applications were explained to the patients individually before commencing. Silicone cream or lubricating gel was applied around the root of the penis, and the cylinder (with constriction rings) was opened and placed on the penis. Negative pressure was applied slowly and gradually over 2-3 min. When the patient reported pain, we removed the cylinder, but left the constriction rings in place for an additional 1-2 min. Two sessions were conducted by the same operators at intervals of 2-3 days. In patients with a positive response, the device was recommended for use at home before coitus.

Phase 3. VED failures were switched to ICI with cocktail of trimix of vasoactive drugs: papaverine 12-25 mg+phentolamine 1.0-2.0 mg+prostaglandin E1 6-25 µg. In patients who complained of pain during erection, the prostaglandin E1 dose was decreased and the doses of the other drugs were increased.

Phase 4. Patients who failed to respond to the ICI were given sildenafil citrate 50-100 mg followed 40-55 min later by a ICI of papaverine 25 mg+phentolamine 2 mg+prostaglandin E1 6-25 µg.

Phase 5. In patients who failed phase 4, we attempted ICI with papaverine, 16 mg, phentolamine 1.5 mg, and prostaglandin E1 15-25 µg, followed 5-10 min later by the VED.

Phase 6. In patients who did not respond to phase 5, we recommended penile implant surgery.Follow-up

All patients were followed for 2 y. ED treatment was changed during follow-up, as necessary, according to the same 6-phase program. Follow-up consisted of physical examinations for general state of health, IIEF score, and laboratory tests. In patients receiving the ICI, the physical examination also included a search for palpable fibrotic nodules. Penile Doppler color ultrasound and nocturnal penile tumescence test were repeated.Statistical Analysis

The results immediately after treatment and at the end of follow-up were analyzed according to Bland.[20] Arithmetic mean values and errors of the mean or median values were calculated. Statistical differences were determined with Student's t-test. Values of P<0.05 were considered significant.Previous PageSection 2 of 4Next Page: Results
Int J Impot Res.  2005;17(5):431-436.  ©2005 Nature Publishing Group

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Erectile Dysfunction: An Underdiagnosed Condition Associated With Multiple Risk Factors

sildenafil M. Shabbir; D. M. Mikhailidis; R. J. Morgan 

Erectile dysfunction (ED) is a common condition with a significant effect on the quality of life. The prevalence of ED rises with increasing age and other conditions (hypertension, diabetes, ischaemic heart disease, hypercholesterolaemia and depression). The MALES study is one of the largest epidemiological surveys to investigate the prevalence of ED. This study included 27 839 patients spanning eight countries. In addition to the MALES study, we review the emerging link between lower urinary tract symptoms (LUTS), benign prostatic hypertrophy (BPH) and ED, including the effect of BPH treatment on sexual function. Preliminary data from the MALES II study shows a significant cascade effect in the treatment seeking behaviour and treatment adherence of patients taking sildenafil for ED. We explore the possible reasons behind the discontinuation of oral phosphodiesterase inhibitors prescribed for the long-term treatment of ED.

Erectile dysfunction (ED) is defined as the inability to obtain and/or maintain penile erection sufficient for satisfactory sexual performance.[1] ED has a significant impact on the quality of life and it is a common problem (affecting more than 100 million men worldwide).[2]

This issue of Current Medical Research and Opinion includes the Men's Attitudes to Life Events and Sexuality (MALES) study which provides information regarding the prevalence of ED and related health matters.[3] This is one of the largest epidemiological studies in this field; it included 27839 patients spanning over eight countries. The study found an overall prevalence of self-reported ED of 16% in men aged 20-75 years. Differences were noted between the various countries, with the highest prevalence seen among men in the US (22%) and the lowest in Spain (10%). The study confirmed the increased prevalence of ED with both increasing age, and other co-morbid conditions (hypertension, diabetes, ischaemic heart disease, hypercholesterolaemia and depression) as noted in earlier studies.[4,5]

The MALES study[3] did not, however, address the relationship between ED and lower tract urinary symptoms (LUTS) or benign prostatic hypertrophy (BPH). Earlier reviews were sceptical about an association between these two common conditions and considered their relationship incidental to a similar age and gender distribution.[6] However, an emerging link between BPH and ED has been recognised in recent years. The MSAM-7 study investigated the association between LUTS and ED in 12815 men aged between 50 and 80 years. This large multinational survey assessed the correlation between the International Prostate Symptom Score (IPSS) and ED independent of age and other co-morbidities.[7] The prevalence of ED in men with no LUTS was 24.8%, compared to 43.3, 65.8 and 81.9% ED in men with mild, moderate and severe symptoms, respectively. Ejaculatory problems were reported by 25.3% of the men with no LUTS compared to 41.8, 61.4 and 76.0% with mild, moderate and severe symptoms, respectively. A similar association between LUTS and sexual dysfunction was also reported by others.[8-10]

An experimental model of bladder outflow obstruction (BOO) provided an insight into the potential pathophysiological link between BPH and ED.[11] There was an endothelin ETA/ET B receptor imbalance as well as adverse structural changes in the corpus cavernosum in a rabbit model of BOO. These effects may be responsible for the observed impaired nitric oxide (NO)-mediated cavernosal relaxation in this model.[11]

A common pathophysiological link between ED and BPH would mean that treating one condition could influence the other. For example, in a 1-year, prospective, open label study of 2829 men with BPH, alfuzosin (a α1-receptor antagonist) increased the perceived sexual function score by 191%, with the greatest improvements seen in men < 70 years with severe LUTS.[12] In a double blind, multicentre trial of 1475 men with BPH, doxazosin improved sexual function in the patients with ED.[13] Treatment of LUTS with tamsulosin for 6 months suggested improvements in libido, erection and overall sexual function in a study of 3000 men.[14] However, despite these improvements, ejaculation failure has been shown to occur more often in patients taking these drugs, particularly tamsulosin.[15] It remains unclear whether the beneficial effects seen with α1-receptor antagonists are due to a direct pharmacological effect or whether they are a consequence of improvements in urinary symptoms. In contrast to these drugs, the treatment of BPH with the 5-α-reductase inhibitor finasteride has a negative effect on sexual function. One study reported 33% ED in patients treated with finasteride for 6 months, none of whom had reported sexual dysfunction at baseline.[16] There is also evidence that sildenafil prescribed to treat ED can improve LUTS.[17] This effect was attributed to an effect on bladder muscle.[17] It follows that the treatment of patients with BPH and ED needs to be carefully considered since the choice of medication for one condition may influence the other.

The MALES II study[3] investigates the treatmentseeking behaviour of the subgroup of patients who reported ED (2912 men). These findings highlight some interesting information regarding the pattern of ED evaluation and treatment.[3] Currently there are numerous treatments for ED including vacuum-constriction devices, apomorphine, phosphodiesterase-5 (PDE5) inhibitors and transurethral or intracavernosal injection of vasoactive agents such as alprostadil (prostaglandin E1). More invasive surgical management includes implantation of penile prostheses, and venous or arterial surgery. The MALES II study focused on the use of sildenafil.[3]

The advent of sildenafil citrate (Viagra, Pfizer) revolutionised the treatment of ED. A selective PDE5 inhibitor, sildenafil was the first oral therapy with a combination of efficacy, tolerability and ease of use.[18,19] It is effective in the treatment of ED of organic, psychogenic and mixed aetiology[20] and is of benefit in cases where other medical treatments have failed.[21] Oral treatment with PDE5 inhibitors including sildenafil, and the newer vardenafil (Levitra, Bayer) and tadalafil (Cialis, Lilly), is now considered the first line treatment of choice.

It is interesting, therefore, that the MALES II study[3] highlights a discrepancy between the use of sildenafil and its efficacy and convenience. Only 58% of the 2912 men who self-reported ED actively sought attention for their condition. Only 41% of the men in this group discussed possible treatment with sildenafil, with only 25% of them filling their prescription for the drug. Only 16% of this group were still taking sildenafil at the time of the survey. This 'cascade effect' is larger than expected, taking into account the profile of the oral PDE5 inhibitors. While there are issues regarding the treatment-seeking behaviour and treatment adherence that future analyses of the MALES II data will reveal, there are some possible explanations for the discontinued use of sildenafil with time.

The adverse events associated with the use of sildenafil include headache, flushing, dyspepsia and visual disturbances.[20,21] However, discontinuation due to adverse events is low, ranging between 0 and 10%, suggesting that these side effects are generally well tolerated Another possibility for discontinuation is the potential development of tachyphylaxis with the continued use of sildenafil. El-Galley et al., performed a telephone survey of 151 patients within their first year of sildenafil use and they followed this up with another survey of the same group 2 years later.[23] In the first survey there was an overall improvement rate of 74%. In the follow-up survey (82 patients) only 43 of the respondents (52%) were still taking sildenafil. Of this group 16 (37%) had to increase their dose by 50 mg to achieve the same effect. Of the patients who were followed up for 2 years, 20% had some increase in the sildenafil dose necessary to achieve the same result and 17% had discontinued use due to a loss of efficacy. Another telephone survey involving 1074 patients taking sildenafil for 1-3 years reported similar findings.[24] They found that 28.5% of patients taking 50 mg of sildenafil had increased their dose to 100 mg. In the same series, an alarming 80.2% of patients had discontinued sildenafil in the last 3 months leading up to the survey, with 51.6% claiming a loss of efficacy as their primary reason. However, the pharmacological basis of developing tachyphylaxis with a drug that is taken intermittently is controversial.[25,26]

It remains to be seen whether treatment with the newer PDE5 inhibitors, vardenafil and tadalafil, will have the same discontinuation rates as sildenafil once more data exist on their long-term use. The PDE5 inhibitors have unique sets of pharmacological characteristics and their long-term efficacy may differ.[27]

It is also possible that the discontinued use of oral PDE5 inhibitors may not be due to a failure of the drug itself, but to the cost of treatment or a change in either the severity of the underlying condition or psychosocial need. Despite the increased prevalence of ED with increasing age, a concomitant decrease in sexual desire may explain why the elderly population has less of a need for treatment. However, it is also relevant to consider that in one study the response to sildenafil deteriorated with age and increasing degree of ED.[28] Nevertheless, PDE5 inhibitors are probably still the oral drugs of choice for the treatment of ED.[29] Thus, sildenafil, even at a 50 mg dose, was more effective than apomorphine 3 mg in men with arteriogenic ED.[29] It is also of interest that in the same study one out of five patients was not satisfied with the drug administered.[29] Therefore, other oral agents need to be evaluated.

Changes with time also affect the association between co-morbidities and ED. The systemic effects of conditions such as hypertension, ischaemic heart disease, hypercholesterolemia and diabetes are progressive, and their continued presence accentuates the pathophysiological processes known to cause ED. In addition to their effect in isolation, these co-morbidities may work in an additive or synergistic fashion to further reduce erectile function. Alterations (including treatment) to these underlying conditions may also influence the ability to treat ED.[30,31]

The effective management of ED remains an important goal to improving the quality of life. The emerging links between ED and increasing age, psychogenic conditions, systemic co-morbidities such as hypertension and diabetes, and localised conditions such as BPH/LUTS underline the multifactorial pathogenesis of ED. The selection of drugs to deal with these conditions may well influence the success of treating ED.[30,31] The introduction of safe and effective oral PDE5 inhibitors has radically altered the way we treat ED. However, careful monitoring of the efficacy of this treatment must be improved to prevent the large cascade effects and treatment failures highlighted in epidemiological studies.


NIH Consensus Development Panel on Impotence. NIH Consensus Conference. Impotence. J Am Med Assoc 1993;270:83-90Benet AE, Melman A. The epidemiology of erectile dysfunction. Urol Clin North Am 1995;22:699-709Rosen RC, Fisher W, Eardley I, Niederberger C, Nadal A, Sand M. The multinational men's attitudes to life events and sexuality (MALES) study: I. Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin 2004;20(5):[this issue]Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Ageing Study. J Urol 1994;151:54-61Braun M, Wassmer G, Klotz T, Reifenrath B, Mathers M, Engelmann U. Epidemiology of erectile dysfunction: results of the 'Cologne Male Survey'. Int J Impot Res 2000;12:305-11Vale J. Benign prostatic hyperplasia and erectile dysfunction - is there a link? Curr Med Res Opin 2000;16(Suppl. 1):s63-s68Rosen R, Altwein J, Boyle P, et al. Lower urinary tract symptoms and male sexual dysfunction: The Multinational Survey of the Ageing Male (MSAM-7). Eur Urol 2003;44:637-49Tubaro A, Polita M, Giambroni L, et al. Sexual function in patients with LUTS suggestive of BPH. Eur Urol 2001;40(Suppl. 1):19-22Namasivayam S, Minhas S, Brooke J, et al. The evaluation of sexual function in men presenting with symptomatic benign prostatic hyperplasia. Br J Urol 1998;82:842-6Boyle P, Robertson C, Mazzetta C, et al. The association between lower urinary tract symptoms and erectile dysfunction in four centres. The UrEpik study. Br J Urol Int 2003;92:719-25Khan MA, Thompson CS, Dashwood MR, Mumtaz FH, Morgan RJ, Mikhailidis DP. Endothelin-1 and nitric oxide in the pathogenesis of urinary tract disorders secondary to bladder outflow obstruction. Curr Vasc Pharmacol 2003;1:27-31Lukacs B, Grange JC, Comet D, the BPM Group in General Practice. One year follow up of 2829 patients with moderate to severe lower urinary tract symptoms treated with alfuzosin in general practice according to IPSS and a health related QoL questionnaire. Urology 2000;55:540-6Kirby, RS, Anderson M, Gratzke P, Dahlstrand C, Hoye K. A combined analysis of double-blind trials of the efficacy and tolerability of doxazosin-gastrointestinal therapeutic system, doxazosin standard and placebo in patients with benign prostatic hyperplasia. Br J Urol Int 2001;87:192-200Palacio A, Batista JE, Torrubia R, et al. Tamsulosin: effect on sexual function in almost 3000 patients with LUTS managed in real life practice in Spain. Br J Urol 2000;86(Suppl. 3):32-3Debruyne FMJ. Alpha-blockers: are all created equal? Urology 2000;56(Suppl. 5A):20-2Uygur MC, Gur E, Arik AI, et al. Erectile dysfunction following treatments of benign prostatic hyperplasia: a prospective study. Andrologia 1998;30:5-10Sairam K, Kulinskaya E, McNicholas TA, Boustead GB, Hanbury DC. Sildenafil influences lower urinary tract symptoms. Br J Urol Int 2002;90:836-9Langtry HD, Markham A. Sildenafil: a review of its use in erectile dysfunction. Drugs 1999;57:967-89McMahon CG, Samali R, Johnson H. Efficacy, safety, and patient acceptance of sildenafil citrate as treatment for erectile dysfunction. J Urol 2000;164;1192-6Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. New Eng J Med 1998;338:1397-404Palumbo F, Bettocchi C, Selvaggi FP, Pryor JP, Ralph DJ. Sildenafil: efficacy and safety in daily clinical experience. Eur Urol 2001;40:176-80Padma-Nathan H, Eardley I, Kloner RA, Laties AM, Montosori F. A 4-year update on the safety of sildenafil citrate. Urology 2002;60(2 Suppl 2):S42-S47El-Galley R, Rutland H, Talic R, Keane T, Clark H. Long-term efficacy of sildenafil and tachyphylaxis effect. J Urol 2001;166:927-31Sheu JY, Chen KK, Lin ATL, et al. Long-term efficacy and safety of sildenafil for patients with erectile dysfunction J Chin Med Assoc 2003;66:480-6Mumtaz FH, Khan MA, Mikhailidis DP, Morgan RJ. Re; long-term efficacy of sildenafil and tachyphylaxis effect. J Urol 2002;168:206Tomera K. Long-term efficacy of sildenafil and tachyphylaxis effect. J Urol 2002;168:206Kuthe A. Phosphodiesterase % inhibitors in male sexual dysfunction. Curr Opin Urol 2003;13:405-10Monga M, Bettencourt R, Barrett-Conner E. Community based study of erectile dysfunction and sildenafil use: the Rancho Bernardo Study. Urology 2002;59:753-7Perimenis P, Gyftopoulos K, Giannitsas K, et al. A comparative, crossover study of the efficacy and safety of sildenafil and apomorphine in men with evidence of arteriogenic erectile dysfunction. Int J Impot Res 2004;16:2-7Khan MA, Morgan RJ, Mikhailidis DP. The choice of antihypertensive drugs in patients with erectile dysfunction. Curr Med Res Opin 2002;18:103-7Mayoux E, Ramirez JF, Pouyet T, Barras M, Arbilla S, Galzin AM. Alfuzosin improves penile erection triggered by apomorphine in spontaneous hypertensive rats. Eur Urol 2004;45:110-6

Related Links

Resource CentersErectile Dysfunction (ED)

Reprint Address

Address for correspondence: Mr M. Shabbir, Research Registrar, Department of Urology, Royal Free Hospital, Pond Street, London NW3 2QG, UK
M. Shabbir,1 D. M. Mikhailidis2 and R. J. Morgan1

1Department of Urology, Royal Free and University College Medical School (Royal Free Campus), University College London, UK
2Department of Clinical Biochemistry, Royal Free and University College Medical School (Royal Free Campus), University College London, UK
Curr Med Res Opin.  2004;20(5):603-606.  ©2004 Librapharm Limited

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Thursday, July 10, 2008

Is sex on a plane legal?


The Magazine answers…

Seatbelts off

An A-list actor is accused of having a mile-high fling, and a private plane company plans to launch chartered flights for romantic liaisons. But what exactly is the legality of this much fabled form of sexual indulgence?

It's a heady mix. There's the adrenaline of flying at 30,000 feet on the way to exotic shores and the frisson of illicit temptation. And maybe even the business class champagne.

Sex on an aeroplane - after the seatbelt lights are off, naturally - makes good reading for fans of blockbuster romance novels, but for some it is more than just a fantasy.

Janet Jackson and Richard Branson are self-confessed members of the "Mile-High Club" and Ralph Fiennes may have joined them.

Qantas is investigating whether the British actor had sex with a flight attendant on a flight from Darwin to Mumbai.

And entrepreneur Mike Crisp has launched a service on his six-seater private plane for couples who wish to get amorous for 90 minutes while being flown above the English countryside.

WHO, WHAT, WHY? A regular feature in the BBC News Magazine - aiming to answer some of the questions behind the headlines

But is having sex on a plane legal?

A Crown Prosecution Service spokesman says he is unaware of any prosecutions.

"The police would need to have a complaint and they would then investigate, and if they thought there was a case to answer then we would make a judgement on whether there's a case to bring forward."

What legislation is invoked depends on the circumstances, he says, and the police would look at the offence as a whole before deciding if laws such as outraging public decency have been infringed.

Public decency

Getting frisky in the plane toilet could be a criminal offence, says travel lawyer Philip Banks, from the firm Irwin Mitchell. A person has committed an offence if they have sex in a lavatory to which the public has access, under section 71 of the Sexual Offences Act 2004.

Airlines can hand down their own punishments

Although there is no case law because the statute is so new, a plane's toilet could be interpreted as public under these terms, he says. The punishment is a six-month prison stint or a £1,000 fine.

Outraging public decency under common law could also be used, he says, if it was proven that at least one person may have seen the act.

But it may not be the UK laws which come into play, and which country's laws govern the offence may depend on the destination, the departure point, the country over which the offence is committed and the country where the plane is registered, says criminal lawyer Julian Young.

But despite the confessions of the rich and famous, there are few known instances of anyone getting caught.

Amanda Holt, 37, and David Machin, 40, were charged with outraging public decency in 1999 and subsequently fined after having sex in their seats on an American Airlines flight from Dallas to Manchester.

But generally getting caught red-handed is rare. One senior member of British Airways' cabin crew, who does not want to be named, says he's never encountered it in 10 years of flying. And a BA spokeswoman says they could call the police.

A self-confessed club member

"It depends on the circumstances. In some cases it's better to have a quiet word because it could be better not to draw attention to other passengers who may not have noticed.

"But if we believe they have broken the law or they've caused upset to other people and there's been a complaint, we could go to the police."

Although the airline cannot fine passengers, it can ban them for offensive behaviour, although she's unaware if this has ever happened.

There is nothing in transport law governing the matter of having sex on public transport. And the Civil Aviation Authority says there's nothing specific about it in aviation law - but there are other considerations.

"To comply with health and safety laws, they would have to be sitting with their seatbelts on for take-off and landing," a spokeswoman says.

And to join the club while strapped in would take some doing.

Add your comments on this story, using the form below.

It's not always in the toilet. On a flight home from India, my friend's flatmate simply waited 'til the lights went down and everyone else was asleep before joining the club with the bloke sitting next to her. She insisted that the person sharing their row of seats never woke up, but who sleeps that heavily on a plane?
Patsy, Sheffield

It should be made illegal. There are children flying with their parents. Allowing something like this means lowering the standard of public decency. One may insists he is not breaking law and offend the other passanger and may cause argument hence causing disturbance to the air crew & passanger alike. Commonsense has to rule. Vast majority of people are descent and have an understanding of social responsibility.
Moe, London, UK

What if you're on a long-haul flight and the aircraft is over International Waters when you join the club? Surely no laws apply then - except for possibly the airline's carriage rules?
Glenn Jones, Birmingham, UK

Glen's comment about being safe from prosecution over international waters is an interesting one. If you are over international waters can you murder your partner/friends/boss? I doubt it. So laws must still apply.
Martin, London

Once the doors have been locked, the applicable law is that of the vessel. In BA and Virgin's case that would be English law, which punishes having sex in a public facility toilet under section 71 of the Sexual Offences Act 2004.
Robert, London

I joined the Mile High club while travelling to Cyprus with my boyfriend at the time. No one saw and we didn't get caught and I don't regret it for a second. It's harmless fun but I would never even have considered doing it anywhere else on the plane in view of others or while others were sleeping, that's not right. I can't see how it might offend others or be illegal whilst it's behind a closed door - if I cottoned on to it happening on a flight between two consenting adults I'd just smile.
Rachel, Cambridge

Nothing will ever beat the raucous cheering and clapping that woke me up on a flight to Australia when the two strangers in front of me "returned to their seats" from the loos. The last I'd heard was the two of them discussing (a bit loudly, I must say) their respective failed relationships over a drink or two, as I was drifting off to sleep behind them. He was dead-chuffed, she was distraught.
Adam, London

I have observed a couple coming out of a public toilet separately and there is no sight more tacky in the world.
Diane, Sutton

Aircraft toilet a public place? A bit of tight squeeze, especially on Lufthansa City Line, you're lucky if you can stand upright alone, never mind with a companion.
Geoffrey Ellis, Cheshire/Hamburg

As a frequent flier, I was unnerved to read that Viagra is to be sold over-the-counter under a "pilot scheme".
David Dee, Matola Mozambique

If anything should be made illegal, it should be that Viagra joke.
Dave, Woodley

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Friday, July 4, 2008

Mass Treatment With Azithromycin Reduces Prevalence of Trachoma


Mass Treatment With Azithromycin Reduces Prevalence of Trachoma

Laurie Barclay, MD

Nov. 3, 2004 — Mass treatment with azithromycin is effective for reducing the prevalence of trachoma, according to the results of a study published in the Nov. 4 issue of the New England Journal of Medicine.

"Trachoma, caused by repeated ocular infection with Chlamydia trachomatis, is an important cause of blindness," write Anthony W. Solomon, MB, BS, PhD, from the London School of Hygiene and Tropical Medicine, U.K., and colleagues. "Current recommended dosing intervals for mass azithromycin treatment for trachoma are based on a mathematical model."

In a Tanzanian community in which trachoma was endemic, the investigators collected conjunctival swabs for quantitative polymerase-chain-reaction assay of C trachomatis before and at two, six, 12, 18, and 24 months after mass treatment with azithromycin. Residents who had clinically active trachoma at six, 12, and 18 months received tetracycline eye ointment.

At baseline, 956 (97.8%) of 978 residents received either one oral dose of azithromycin or a course of tetracycline eye ointment if azithromycin was contraindicated. Infection prevalence was 9.5% before mass treatment, 2.1% at two months, and 0.1% at 24 months.

Compared with the pretreatment level, the quantitative burden of ocular C trachomatis infection in the community was 13.9% at two months and 0.8% at 24 months. At each time point after baseline, subjects who had been positive at their previous test constituted more than 90% of the total community burden of C trachomatis infection.

"The prevalence and intensity of infection fell dramatically and remained low for two years after treatment," the authors write. "One round of very-high-coverage mass treatment with azithromycin, perhaps aided by subsequent periodic use of tetracycline eye ointment for persons with active disease, can interrupt the transmission of ocular C. trachomatis infection."

Study limitations include lack of placebo control and inability to rule out alternative explanations for decreased incidence of infection, such as enhanced personal hygiene among study participants, a reduction in the density of eye-seeking flies in the village, a small contribution from a regional secular trend, or tetracycline treatment in residents with active cases at six, 12, and 18 months.

The Wellcome Trust/Burroughs Wellcome Fund, the Edna McConnell Clark Foundation, the International Trachoma Initiative, and the Medical Research Council supported this study.

In an accompanying editorial, Silvio P. Mariotti, MD, from the World Health Organization in Geneva, Switzerland, urges caution in analyzing the results of this study, but he calls the unusually high coverage achieved "an outstanding and encouraging result."

"Although the social-development components of the SAFE strategy [surgery, antibiotics, facial cleanliness, and environmental improvement] must still be implemented in communities in which trachoma is endemic to ensure the continued elimination of blinding trachoma, the findings of Solomon et al. provide useful, new information on what antibiotic treatment can achieve," Dr. Mariotti writes. "Increased knowledge of the effect of different components of the SAFE strategy can be of great help to poor communities that have already paid too high a toll in the form of preventable blindness."

N Engl J Med. 2004;351:1962-1971, 2004-2007

Reviewed by Gary D. Vogin, MD
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Screening for Chlamydia expanded

bacterial infections There are plans to introduce a screening programme for the sexually transmitted infection Chlamydia to Jersey next year.

The bacterial infection can affect a woman's fertility if untreated.

About 40% of the young people in Jersey have been tested for the infection and the screening service is only available to a limited number of people.

But Dr Ivan Muscat from the Health Department hopes it will be available on a widespread basis next year.

"We are going to encourage both men and women to come forward for testing," he said.

Chlamydia affects about 9% of screened people under 25 in Jersey.

This is a part of article Screening for Chlamydia expanded Taken from "Azithromycin Zithromax" Information Blog

Thursday, July 3, 2008

Abbott Submits Application To EMEA For A New, More Convenient Kaletra(R) Formulation


Abbott announced today that it submitted a line extension Marketing Authorization Application to the European Medicines Agency (EMEA) for the approval of a new, more convenient tablet formulation of its protease inhibitor (PI) Kaletra (R) (lopinavir/ritonavir).

The tablet was developed using a proprietary melt-extrusion technology intended to allow patients to take fewer tablets per dose as part of their treatment regimen. In addition, the tablet will not require refrigeration, as the current soft capsule formulation does. Kaletra is the market share leader among protease inhibitors for the treatment of HIV in the European Community.

"Kaletra has been an important treatment option in HIV therapy and this next-generation formulation could enhance dosing convenience for patients, while maintaining treatment effectiveness," said Scott Brun, M.D., divisional vice president of Infectious Disease Development, Abbott. "Abbott remains committed to the fight against HIV through the enhancement of our existing treatments and the development of next-generation therapies."

If approved, the new tablet will provide patients with a tablet composed of 200 mg lopinavir and 50 mg ritonavir, as compared to the current soft capsule, which contains 133.3 mg lopinavir and 33.3 mg ritonavir. While the total daily dose of Kaletra (800 mg lopinavir/200 mg ritonavir) is unchanged, the number of Kaletra pills patients need to take per day is reduced from six soft capsules to four tablets as part of their HIV treatment regimen.

The submission package included data from bioequivalence studies. The company is conducting clinical trials with the tablet formulation in patients living with HIV.

Abbott announced on May 3, 2005, that it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for the approval of the new tablet formulation.

Kaletra Safety Information

Kaletra (lopinavir/ritonavir) is always used in combination with other anti-HIV medicines to treat people with HIV infection. Kaletra should not be taken by patients who have had an allergic reaction to Kaletra or any of its ingredients, including lopinavir or ritonavir.

Taking certain medications with Kaletra could create the potential for serious side effects that could be life threatening. Kaletra should not be taken with astemizole, cisapride, dihydroergotamine, ergonovine, ergotamine, methylergonovine, midazolam, pimozide, terfenadine or triazolam.

In addition, Kaletra should not be taken with fluticasone propionate, lovastatin, rifampin, simvastatin, or products containing St. John's Wort (Hypericum perforatum). Particular caution should be used when taking Kaletra with sildenafil, tadalafil, or vardenafil. Please consult your local prescribing information for country specific recommendations. Discuss all medicines, including those without a prescription and herbal preparations you are taking or plan to take, with your doctor or pharmacist.

Pancreatitis and liver problems, which can be fatal, have been reported. Patients should tell their doctor if they have had liver disease such as hepatitis. In patients taking protease inhibitors, increased bleeding (in patients with hemophilia) and diabetes/high blood sugar have occurred. Changes in body fat have been seen in some patients receiving antiretroviral therapy. Some patients receiving Kaletra have had large increases in triglycerides and cholesterol. Varying degrees of cross-resistance among protease inhibitors have been observed.

In Kaletra clinical trials, the most commonly reported side effects of moderate-to-severe intensity were abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache, nausea and vomiting. Children taking Kaletra may sometimes get a skin rash. This is not a complete list of reported side effects. Kaletra oral solution contains alcohol.

Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. For more information, including full prescribing information, please visit www.kaletra.com.

About Abbott

Abbott has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood, and remains a leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, device and diagnostics. The company employs 60,000 people and markets its products in more than 130 countries.

This is a part of article Abbott Submits Application To EMEA For A New, More Convenient Kaletra(R) Formulation Taken from "Cialis Viagra Levitra Effects" Information Blog

Pathogens Other Than Chlamydia Linked to Postgonococcal Urethritis


Pathogens Other Than Chlamydia Linked to Postgonococcal Urethritis

By Megan Rauscher

NEW YORK (Reuters Health) Oct 11 - Urethritis that persists after successful eradication of laboratory-confirmed gonococcal infection (i.e., postgonococcal urethritis) is significantly associated with Mycoplasma genitalium or Ureaplasma urealyticum biovar 2 coinfection, independent of Chlamydia trachomatis infection, Japanese researchers report.

These observations have implications for presumptive therapy, they note in a report in the October 1 issue of Clinical Infectious Diseases.

Among a cohort of 390 men with documented gonorrhea, the researchers found that 33.8% were coinfected with C. trachomatis, M. genitalium, and/or U. urealyticum biovar 2, based on PCR testing of first-voided urine at the initial visit.

Among men who returned for a follow up exam 7 to 10 days after treatment with either a cephalosporin or spectinomycin, gonorrhea was eradicated in 291. However, of these, 104 (35.7%) were found to have postgonococcal urethritis, based on the presence of polymorphonuclear leukocytes in the urethral smear.

In men with Chlamydia-negative gonococcal urethritis, coinfection with M. genitalium was associated with a greater than 14-fold increased risk of postgonococcal urethritis and coinfection with U. urealyticum biovar 2 was associated with about a 3.6-fold greater risk of postgonococcal urethritis.

"In this study, we provide additional data suggesting that M. genitalium and U. urealyticum (biovar 2) may be pathogens of non-gonococcal urethritis, including post-gonococcal urethritis," senior author Dr. Takashi Deguchi, of the Graduate School of Medicine, Gifu University, told Reuters Health.

"In clinical settings, no sensitive and rapid tests for detection of these pathogens are commercially available," Dr. Deguchi pointed out. Therefore, "Patients with gonococcal urethritis should be treated presumptively with antimicrobial agents that are active against C. trachomatis and these pathogens."

The authors of a related commentary point out that the United States and many other countries (excluding Japan) currently recommend presumptive therapy for chlamydial infection for men with gonorrhea.

However, mounting evidence that doxycycline may not be "sufficiently effective" against M. genitalium and U. urealyticum biovar 2 has raised the question of whether azithromycin should be substituted as presumptive therapy for urethritis, Dr. Lisa E. Manhart and colleagues from the University of Washington, Seattle note.

Double-blind, randomized studies are underway to determine which of these drugs is optimal for M. genitalium, U. urealyticum biovar 2, U. parvum, and idiopathic urethritis. Results are expected in 2010.

In the meantime, Dr. Manhart and colleagues say, "the choice of therapy for urethritis must still be individualized, based primarily on considerations of cost to patients and programs, patient preference, and efforts to optimize compliance."

Clin Infect Dis 2007;45:866-874.
This is a part of article Pathogens Other Than Chlamydia Linked to Postgonococcal Urethritis Taken from "Azithromycin Zithromax" Information Blog