Medical Front Page

LONDON, ENGLAND, UK – A sudden, serious allergic reaction—known anaphylaxis or anaphylactic shock— following vaccination, is “extremely rare,” concludes research published online in the Archives of Disease in Childhood.

Anaphylaxis can be fatal and can be triggered by several factors, including specific foods, airborne allergens, stings and bites, and drugs/vaccines.

But because anaphylaxis is rare, it is usually very difficult to pick this up as a potential side effect of a new treatment during clinical trials. Manufacturers have to rely on data collected after the product has come to market.

The authors base their findings on children under the age of 16 in the UK and Ireland, who were suspected of having experienced anaphylaxis after being vaccinated between 2008 and 2009.

All the cases came from specialists, who were asked to report on any child they treated with suspected or actual anaphylaxis following a vaccination during this period to the British Paediatric Surveillance Unit.

During this time, 15 cases were reported following vaccination with the single measles jab; the HPV jab which is used to protect against cervical cancer; two types of vaccine for meningitis; a hepatitis A vaccine; typhoid vaccine; and a school leaver’s booster jab (probably tetanus/polio).

Only seven of these cases were confirmed as anaphylaxis. Six children required an injection of adrenaline and intravenous fluids. All made a full recovery; one child recovered without treatment.

Three of these children already carried injectable adrenaline, which is used to treat severe allergic reactions.

Two of the cases were associated with the single component measles vaccine. As more than 16,000 doses were imported over the study period, this gives an incidence of 12 cases of anaphylaxis for every 100,000 doses, say the authors.

Three of the cases were associated with the HPV vaccine. More than two million doses of this vaccine were administered during the study period, giving an incidence of 1.4 cases per million doses.

None of the cases were associated with the normal pre-school or infant immunisation schedule, including the triple MMR jab.

And around 5.5 million children would have received routine vaccinations during this period without any reported cases of anaphylaxis, say the authors.

“This is extremely reassuring data for the general public and healthcare workers alike,” they conclude. “Despite its limitations, the small numbers of cases reported are likely to be a true estimate of anaphylaxis [following immunisation] rates.”

- MFP Wire Services
- 01-27-2012

LONDON, ENGLAND, UK – A daily dose of skimmed milk, enriched with two components found in dairy products, may help to curb the frequency of painful gout flare-ups, indicates research published online in the Annals of the Rheumatic Diseases.

Previous long term research has shown that the risk of gout is greater among those whose diet is low on dairy products.

And experimental studies indicate that certain components of dairy products, particularly glycomacropeptide and G600 milk fat extract (G600), seem to dampen down the inflammatory response to gout crystals.

The authors studied the frequency of gout flare-ups in 120 patients with the condition over a period of three months. All the patients had experienced at least two flare-ups in the preceding four months.

The patients were divided into three different treatment groups: lactose powder; skimmed milk powder; or skimmed milk powder enriched with glycomacropeptide and G600. Each powder was mixed in 250 ml of water as a vanilla flavoured shake and drunk daily.

The patients attended a rheumatology clinic monthly to check on their requirement for medication and their symptoms, which they recorded using a daily flare diary and validated pain scale.

There were no significant differences among the three groups at the start of the study in terms of frequency of gout flare-ups, pain, or drugs used to treat the condition.

In all, 102 patients completed the three month study. And the results showed that those on the enriched skimmed milk diet had a significantly greater reduction in gout flare-ups compared with the other two groups.

They also had greater improvements in pain and the amount of uric acid in their urine than those in the other two groups. This was matched by a trend towards a reduction in the number of tender joints.

The enriched skimmed milk diet did not boost weight gain or increase the levels of potentially harmful blood fats.

“This is the first reported randomised controlled trial of dietary intervention in gout management, and suggests that daily intake of skimmed milk powder enriched with glycomacropeptide and G600 may reduce the frequency of gout flares,” conclude the authors.

- MFP Wire Services
- 01-27-2012

TORONTO, ONTARIO, CANADA – Dutasteride, a drug that is commonly used to treat enlargement of the prostate, might also slow the growth of early-stage prostate cancer and reduce the need for potentially debilitating treatments that carry risks of impotence and incontinence, according to an article published Online First in the Lancet.

“Our trial is the first study to show the benefits of use of a 5α-reductase inhibitor to reduce the need for aggressive treatment in men undergoing active surveillance for low-risk prostate cancer…delaying their time to pathological progression and initiation of primary therapy”, explains Neil Fleshner from Princess Margaret Hospital, Toronto, Canada, lead author of the study.

As many as one in five men in the USA will be diagnosed with prostate cancer, but most will have low-risk (low-volume, low-grade) disease. For these men, active surveillance (conservative management) can be appropriate, and involves forgoing immediate treatment in favour of regular assessment and biopsies to monitor the disease.

Dutasteride is a 5α-reductase inhibitor approved for the treatment of benign prostatic hyperplasia, a noncancerous enlargement of the prostate. It works by blocking the conversion of testosterone to dihydrotestosterone (the male sex hormone implicated in the development of prostate cancer) and has been shown to reduce the volume of some prostate cancers.

In the Reduction by Dutasteride of Clinical Progression Events in Expectant Management (REDEEM) study, 302 men aged 48 to 82 years old with low-risk localised prostate cancer and undergoing active surveillance were randomly assigned to once daily dutasteride (0•5 mg) or placebo for 3 years. Participants were given biopsies at 18 months and 3 years to measure time to disease progression, and anxiety related to the disease was assessed using a questionnaire.

Overall, findings showed that treatment with dutasteride significantly delayed prostate cancer progression compared with placebo—38% of the men receiving dutasteride experienced disease progression compared with 48% given placebo.

Additionally, men treated with dutasteride were less likely to have cancer detected in their final biopsy (36% [50 men] vs 23% [31 men] with no cancer detected), and reported significantly lower cancer-related anxiety throughout the study compared with those given placebo.

Adverse events were similar between the two groups. More men in the dutasteride group experienced drug-related side effects compared with those given placebo, consisting mainly of adverse sexual events or breast enlargement or tenderness (24% vs 15%). There were no prostate cancer-related deaths and no instances of disease spread.

In an accompanying Comment, Chris Parker from the Royal Marsden National Health Service Foundation Trust, Sutton, UK cautions: “These data are consistent with the hypothesis that dutasteride reduces the volume of low-grade prostate cancers but has no effect, or even an adverse effect, on the progression of high-grade disease. Thus, although reducing overall prostate cancer detection, dutasteride could plausibly have no effect (or possibly a deleterious one) on prostate cancer mortality.”

The authors conclude: “The benefit of dutasteride is to reduce the amount of low-grade cancer, not to reduce the risk of being diagnosed with higher-grade cancer. This reduction leads to fewer men with biopsy-detectable prostate cancer, and therefore fewer treatment interventions. Dutasteride…provides a treatment option for men with low-risk, localised disease.”

- MFP Wire Services
- 01-26-2012