29 July, 2004
Tacrolimus (Protopic)
Protopic® (tacrolimus monohydrate) is an ointment for the treatment of moderate to severe atopic eczema. It is applied directly onto the skin and is not a steroid.

Tacrolimus ointment is available in two strengths – 0.1% concentration for adults and 0.03% concentration for children over 2 years. It is a prescription only medicine It is used in patients with moderate to severe eczema who do not respond well to conventional therapies (and those who are intolerant of conventional therapies)^{1, 2}.

Protopic is a topical immunomodulator (TIM) and the first of a new class of non-steroidal agents for the treatment of atopic dermatitis.   It reduces inflammation by damping down the immune system: it suppresses cytokine expression in the epidermis (the outer layer of the skin) and limits the movement of T cells. 

When using Protopic, patients should apply a thin layer only to affected areas of the skin. It can be used on any part of the body, including the neck and face, but   mucous membranes (inside the nose, mouth and internal genital area) should be avoided at all times.  The ointment should be used until the symptoms start to disappear.   

In a six month, double-blind randomised trial among 972 adults with moderate to severe AD, Protopic 0.1% was shown to be more effective than a corticosteroid regimen (which consisted of 0.1% hydrocortisone butyrate ointment/1% hydrocortisone acetate) and the response rate at 12 weeks (72.6%) was significantly higher than that in the steroid group (52.3%) (p<0.001)³.

In children aged two to 15 years also with moderate to severe AD, Protopic 0.03% has also been shown to be more effective than steroids in reducing eczema and severity⁴.

Some patients may experience a stinging or burning sensation immediately after applying the ointment to the skin. This is a common side effect, which generally disappears after a few days of using the treatment. Itching and some infected follicles have also occurred in a small number of patients.

Unlike strong topical steroids, studies have shown that tacrolimus ointment does not cause skin atrophy^{5, 6}. In addition, there is no evidence to suggest it increases the risk of skin cancer⁷.

Patients using tacrolimus ointment on sun-exposed areas should however avoid excessive sunlight / exposure to sun, including the use of sun beds, until the long-term safety of sun exposure with the ointment has been established.

Protopic® should not be used by anyone who is allergic to antibiotics called macrolides (e.g. erythromycin, clarithromycin, azithromycin) and a medical consultation should always be sought where patients are taking other medicines, suffering from liver failure, or are pregnant or breast-feeding.

Current guidelines

Recent preliminary recommendations from the National Institute of Clinical Excellence (NICE) supports the use of tacrolimus ointment in moderate to severe atopic eczema suffers where the condition has not been controlled by topical steroids or there is a risk of adverse events from further steroid usage.    

To reinforce its commitment to dermatology and AD, Fujisawa has developed an educational website for the general public, with a password protected section for Protopic patients, prescribers and other health professionals called

www.under-my-skin.co.uk

References:

1.         Protopic® 0.03% Ointment Summary of Product Characteristics

2.         Protopic® 0.1% Ointment Summary of Product Characteristics

3.         Reitamo S et al. First EADV International Spring Symposium 27 Feb – 1 Mar 2003 , Malta , Abstr. PP1-28)

4.         Reitamo S et al. J Allergy Clin Immunol, 2002; 109: 539-546.

5.         Kang S et al. J Am Acad Dermatol 2001; 44: S58-64.

6.         Reitamo S et al. Arch Dermatol 2000; 136: 999-1006.

7.         Naylor M et al. The American Academy of Dermatology 60^th Annual Meeting, 2002 Feb 22-27, New Orleans , LA

19 July, 2004
Bardex catheter from Bard catheters
National Audit Office Report Focuses Attention on New Catheter Technology in The Fight Against Healthcare Acquired Infections (HAIs)

The recent National Audit Office Report 'Improving Patient Care by Reducing the Risk of Hospital Acquired Infection' has urgently recommended a process of rapid review of new procedures and products, including silver alloy indwelling catheters(1). Bard Limited's recent launch of a revolutionary new (to the UK ) Foley catheter BARDEX(R) I.C. with Bacti-Guard(R)(2) silver alloy coating and Bard(R) Hydrogel is timely. This catheter has been successfully used in the USA for over seven years with in excess of 17.4 million units sold worldwide to date.

The BARDEX(R) I.C. Foley catheter is the only Infection Control Foley catheter clinically proven to reduce hospital costs by preventing Hospital-Acquired Catheter Associated Urinary Tract Infections.

HAIs are now at the forefront of the Department of Health's agenda and The National Audit Office recommends clarification of a timetable on the action areas in the recently published (December 2003) Department of Health (DoH) CMO report ' Winning Ways : Working Together To Reduce Healthcare Associated Infection In England '(1). The ' Winning Ways ' report places emphasis on the importance of appropriate catheter use and management and highlights the need for catheters to be assessed. The CMO also states in his report that the use of antibiotics should be restricted to purely treating a catheter associated urinary tract infection (CAUTI) and not to prevent infection. BARDEX(R) I.C. Foley catheters offer hospitals an opportunity to prevent infection and thereby reduce the use of prophylactic antibiotics.

References

1. NAO Report - 'Improving Patient Care by Reducing the Risk of Hospital Acquired Infection: A Progress Report' - 14th July 2004

2. Bacti-Guard(R) silver alloy coating is licensed from Adhesive Technology (International) Licensing B.V.

Zelnorm (tegaserod maleate) for chronic constipation
Novartis Pharma AG announced today that Zelnorm(R) (tegaserod maleate) was recommended for approval for the treatment of chronic constipation (CC) by the Gastrointestinal Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA). The Committee's recommendation was subject to specific labelling regarding age and gender. Novartis will work with the FDA to address the issues raised by the Committee.

Zelnorm was approved by the FDA in July 2002 as the first and only prescription medication for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation.

The studies demonstrated that Zelnorm-treated patients experienced significantly more complete spontaneous bowel movements (CSBMs) than patients on placebo during 12 weeks. Zelnorm demonstrated early onset of action, with the majority of the Zelnorm-treated patients experiencing a spontaneous bowel movement within the first 24 hours. The response rate for the first four weeks of treatment (primary efficacy variable) was 42 percent in the group receiving 6 mg twice-a-day of Zelnorm - significantly higher than the 26 percent in the placebo group (p < 0.0001). Over the 12-week period, the response rate for the 6 mg twice-a-day treated group continued to be significantly superior to placebo (44 percent vs. 29 percent).

Significant weekly improvements were observed in Zelnorm-treated patients for stool frequency, consistency and straining compared to placebo. Zelnorm-treated patients also reported less bothersome constipation, abdominal pain/discomfort and bloating/distension. In addition, satisfaction with bowel habits significantly improved with Zelnorm compared to placebo.