RoActemra Could Change The Current Standard Of Treatment For People Living With Rheumatoid Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 28 May 2011 – 0:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article




Patient / Public:not yet rated

Healthcare Prof:not yet rated

Roche announced new data from the ACT-RAY study, presented at the European League Against Rheumatism congress. The results demonstrated that in people with rheumatoid arthritis (RA), RoACTEMRA (tocilizumab, known as ACTEMRA outside Europe) alone had comparable clinical efficacy to RoACTEMRA plus methotrexate (MTX). The safety profile of RoACTEMRA was consistent with previous clinical trials.

Methotrexate, a disease modifying anti-rheumatic drug (DMARD), is widely prescribed for people with RA. However, up to 40% of people given MTX do not adequately respond to treatment or experience adverse events and require other drugs to help control their inflammation. Data from the ACT-RAY study demonstrated that RoACTEMRA provided clinical benefit, regardless of whether it was given in combination with MTX or as a monotherapy.1

“The findings of the ACT-RAY study provide further evidence of the meaningful benefits of RoActemra monotherapy. RoActemra is approved for people with rheumatoid arthritis who do not respond to, or are unable to tolerate the side effects associated with methotrexate, a commonly used treatment for the disease,” said Hal Barron, M.D., Head of Global Development and Chief Medical Officer for Roche.
RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is
associated with intense pain, irreversible joint destruction and systemic complications such
as fatigue and anaemia. RoACTEMRA is the first in a new class of treatments for rheumatoid
arthritis which target interleukin-6 receptors. It is currently approved in Europe for the
treatment of RA in people who have either responded inadequately to, or who were intolerant
to, previous therapy with one or more DMARDs or tumour necrosis factor (TNF) inhibitors.
Results from the ACT-RAY study build on a previous Phase III study (AMBITION) which
showed that compared to MTX, patients receiving RoACTEMRA alone achieved a greater
reduction of signs and symptoms of RA (e.g. swollen and tender joints) at six months and
nearly three times as many patients achieved DAS28 disease remission. RoACTEMRA is
the first and only biologic to have demonstrated superiority as monotherapy treatment over
MTX.

About ACT-RAY

ACT-RAY is a Phase IIIb double-blind two year study designed to evaluate the efficacy and safety
of adding RoACTEMRA to MTX versus switching from MTX to RoACTEMRA monotherapy in MTX inadequate responder (IR), biologic naïve, adult patients with moderate to severe active RA.
556 patients with inadequate response to MTX received RoACTEMRA (8mg/kg every four weeks)
and were randomised to either remain on stable dose of MTX (combination therapy, n=279), or
receive a matching dose of placebo (monotherapy, n=277) with 92 percent (n=512) completing
the initial 24 week period. The primary endpoint of this study was to achieve DAS28 remission
(DAS28

Results (at week 24) showed that RoACTEMRA monotherapy had comparable clinical efficacy to
RoACTEMRA with MTX in RA patients who had an inadequate response to MTX.

— Remission rates were consistent with previous clinical studies. DAS28 remission rate
was 35 percent for RoACTEMRA plus placebo and 40 percent for RoACTEMRA plus MTX
(p=0.19; 95% CI -2.4%, 13.7%).

— The fast onset of action of RoACTEMRA was maintained. 18.1 percent and 15.2
percent of patients achieved remission at week eight in the combination and monotherapy
groups respectively.

— No overt differences in the safety profile were observed between the two treatments.
Rates of adverse events, serious adverse events and serious infections per 100 patient
years were 491, 21 and 6 for RoACTEMRA plus MTX and 467, 18 and 6 for RoACTEMRA
plus placebo.

About RoACTEMRA / ACTEMRA

RoACTEMRA (tocilizumab, known as ACTEMRA outside Europe) is the result of research
collaboration by Chugai and is also being co-developed globally with Chugai. RoACTEMRA is the
first humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. ACTEMRA was first
approved in Japan, and launched by Chugai in June 2005 as a therapy for Castleman’s disease;
in April 2008, additional indications for rheumatoid arthritis (RA), polyarticular juvenile idiopathic
arthritis (pJIA) and systemic-onset juvenile idiopathic arthritis (sJIA) were also approved in Japan.
RoACTEMRA was approved in the European Union in January 2009 for the treatment of RA in
patients who have either responded inadequately to, or who were intolerant to, previous therapy
with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor
(TNF) inhibitors. It is also approved for use in over 90 other countries, including India, Brazil,
Switzerland, and Australia. ACTEMRA was approved in the United States in January 2010 for the
treatment of adult patients with moderately to severely active RA who have had an inadequate
response to one or more TNF inhibitors. In addition, ACTEMRA is now approved in the United
States and Mexico for the treatment of active SJIA in patients two years of age and older.
The safety and efficacy of RoACTEMRA in RA has been established in an extensive clinical
development program including five Phase III clinical studies that enrolled more than 4,000
people with RA in 41 countries, including the United States. The overall safety profile of
RoACTEMRA is consistent across all global clinical studies. The serious adverse events reported
in RoACTEMRA clinical studies include serious infections, gastrointestinal perforations and
hypersensitivity reactions including anaphylaxis. The most common adverse events reported in
clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension
and increased ALT. Increases in liver enzymes (ALT and AST) were seen in some patients; these
increases were generally mild and reversible. Laboratory changes, including increases in lipids
(total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen
in some patients. Treatments that suppress the immune system, such as RoACTEMRA, may
cause an increase in the risk of malignancies.

Source: Roche



Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Arthritis / Rheumatology headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

New Data For Cimzia® (Certolizumab Pegol) Showed A Rapid Clinical Response Across A Broad Population Of Rheumatoid Arthritis (RA) Patients

Main Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 28 May 2011 – 0:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article




Patient / Public:not yet rated

Healthcare Prof:not yet rated

UCB announced data which showed that the addition of Cimzia® (certolizumab pegol) to current therapy was associated with a rapid and consistent clinical response in a diverse group of rheumatoid arthritis (RA) patients. Consistent efficacy was observed across patients taking certolizumab pegol whether they had previously received TNF inhibitors or not and whether they received certolizumab pegol monotherapy* or with concomitant DMARDs. The results are from a subgroup** analysis of the REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) study, presented during the Annual Meeting of the European League Against Rheumatism (EULAR) in London, May 25-28.

“These results are encouraging because they demonstrate the clinical usefulness of certolizumab pegol in a broad population of patients with RA and reflect the patient variability we see day-to-day in clinical practice,” said Roy Fleischmann, MD, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical School.

In the overall study population, ACR20 response rates at Week 12 were statistically significantly higher in the certolizumab pegol group (51.1%) compared to placebo (25.9%). There was no significant difference in response rates among patients in the certolizumab pegol group who had previously been treated with TNF inhibitors (47.2%) and those who had not (53.5%), and similarly no significant difference among patients receiving certolizumab pegol monotherapy* (47.6%) compared to those receiving concomitant DMARDs (52.0%).

Further analysis of the REALISTIC phase IIIb study revealed that the addition of certolizumab pegol to current therapy was associated with clinically meaningful reductions in fatigue and sleep problems, as well as improvements in pain and patient-assessed disease activity (PtGA) compared to the placebo group. Patient-reported outcomes such as fatigue, pain and sleep problems are common symptoms in RA.

At Week 12, significantly more patients in the certolizumab pegol group compared to the placebo group experienced improvements in fatigue (56.4% vs. 46.2%, p

“These results demonstrate that the benefits of treatment with certolizumab pegol extend into areas that are meaningful for patients in terms of quality of life,” said Dr. Janet Pope, Professor of the Department of Medicine, Division of Rheumatology and Epidemiology and Biostatistics at the University of Western Ontario, London, Ontario, Canada. “Factors such as fatigue, pain and sleep disturbance can have a significant impact on day-to-day life, so making a positive difference in these areas can be very significant for patients.”

Treatment with certolizumab pegol was generally well tolerated in the REALISTIC phase IIIb study population and subgroup analyses. Adverse and serious adverse event rates were comparable between certolizumab pegol and placebo treatment groups with no new safety signals observed through Week 12 and were not significantly different among patients with and without prior TNF inhibitor use. The most common adverse events were upper respiratory or urinary tract infections. The most common serious adverse events were infections and infestations. Of these, the most common serious infections were lower respiratory tract and lung infections.

— Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

— The analyses done by prior/no prior TNF inhibitor use were pre-specified; analyses by number and type of prior TNF inhibitors, monotherapy and number and type of concomitant DMARDs were post hoc.

About REALISTIC

REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) is a multicenter phase IIIb trial in patients with active rheumatoid arthritis who have shown inadequate response to disease-modifying antirheumatic drugs, including patients with/without prior TNF-inhibitor exposure, with/without concomitant methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs); and varying lengths of disease duration. The study demonstrated that — in a diverse group of RA patients reflecting those seen in daily clinical practice (including those with prior TNF-inhibitor use) — addition of Cimzia® to current therapy was associated with a rapid clinical response consistent in all strata, improved function and reduced disease activity.

A sub-analysis investigated Cimzia® as monotherapy or concomitantly with DMARDs in subgroups of patients with or without prior TNF inhibitor use. Active RA patients with inadequate response to or = 1 DMARD were randomized 4:1 to Cimzia® 400mg at Weeks 0, 2 and 4 followed by 200mg every 2 weeks or placebo injection (control) every 2 weeks + current therapy. Primary outcome was ACR20 at Week 12. Randomization was stratified by prior TNF inhibitor use, concomitant use of methotrexate (MTX), and disease duration ( or = 2 y). Treatment effect differences between subgroups were assessed by interactions (treatment by covariate) at 10% significance level.

Another sub-analysis determined the impact of Cimzia® on fatigue, sleep problems and other patient reported outcomes (PROs) in the REALISTIC study. Active RA patients with inadequate response to or = 1 DMARD were randomized 4:1 to CZP 400mg (n=851) at Weeks 0, 2 and 4 followed by 200mg every 2 weeks or placebo injection (control, n=212) every 2 weeks added to current therapy. PROs included fatigue (Fatigue Assessment Scale [FAS; 0-10 numeric rating scale]), sleep quantity and quality (Sleep Problem Index II domain of the Medical Outcomes Study sleep scale [MOS-SPI]), pain (0-100mm visual analogue scale [VAS]), and patient’s global assessment of disease activity (PtGA, 0-100mm VAS). The minimal clinically important difference (MCID) is a clinically relevant change in a patient’s status. The percentage of patients reporting MCIDs was determined: or = 1 for FAS, or = 6 for MOS-SPI, and or = 10mm for pain-VAS and PtGA. Correlations between PROs and DAS28 were also assessed (Pearson correlations [rho], CZP group only).

Important safety information

Risk of Serious Infections and Malignancy

Patients treated with certolizumab pegol are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Certolizumab Pegol should be discontinued if a patient develops a serious infection or sepsis. Reported infections include:

— Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before certolizumab pegol use and during therapy. Treatment for latent infection should be initiated prior to certolizumab pegol use.

— Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

— Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with certolizumab pegol should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with certolizumab pegol, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which certolizumab pegol is a member. Certolizumab pegol is not indicated for use in pediatric patients.

Serious and sometimes fatal infection due to bacterial, mycobacterial, invasive fungal, viral or other opportunistic pathogens has been reported in patients receiving TNF-blocking agents. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most common. Treatment with certolizumab pegol should not be initiated in patients with an active infection, including clinically important localized infections. Certolizumab pegol should be discontinued if a patient develops a serious infection or sepsis. Patients who develop a new infection during treatment with certolizumab pegol should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.

Malignancies

During controlled and open-labeled portions of certolizumab pegol studies of Crohn’s disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 certolizumab pegol-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. In studies of certolizumab pegol for Crohn’s disease and other investigational uses, there was one case of lymphoma among 2,657 certolizumab pegol-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. In certolizumab pegol RA clinical trials (placebo-controlled and open label) a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known.

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy

Cases of acute and chronic leukemia have been reported with TNF-blocker use. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia.

Heart Failure

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Certolizumab pegol has not been formally studied in patients with CHF. Exercise caution when using certolizumab pegol in patients who have heart failure and monitor them carefully.

Hypersensitivity

Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following certolizumab pegol administration. If such reactions occur, discontinue further administration of certolizumab pegol and institute appropriate therapy.

Hepatitis B Reactivation

Use of TNF blockers, including certolizumab pegol, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating certolizumab pegol therapy. Exercise caution in prescribing certolizumab pegol for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue certolizumab pegol and initiate effective anti-viral therapy with appropriate supportive treatment.

Neurologic Reactions

Use of TNF blockers, including CIMZIA, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barre syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA. Exercise caution in considering the use of CIMZIA in patients with these disorders.

Hematologic Reactions

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with certolizumab pegol. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on certolizumab pegol. Consider discontinuation of certolizumab pegol therapy in patients with confirmed significant hematologic abnormalities.

Drug Interactions

An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept. Formal drug interaction studies have not been performed with rituximab or natalizumab; however because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of certolizumab pegol in these combinations. Therefore, the combination of certolizumab pegol with anakinra, abatacept, rituximab, or natalizumab is not recommended. Interference with certain coagulation assays has been detected in patients treated with certolizumab pegol. There is no evidence that certolizumab pegol therapy has an effect on in vivo coagulation. Certolizumab pegol may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

Autoimmunity

Treatment with certolizumab pegol may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop.

Immunizations

Do not administer live vaccines or attenuated vaccines concurrently with certolizumab pegol.

Adverse Reactions

In controlled Crohn’s clinical trials, the most common adverse events that occurred in or = 5% of certolizumab pegol patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% certolizumab pegol, 13% placebo), urinary tract infection (7% certolizumab pegol, 6% placebo), and arthralgia (6% certolizumab pegol, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for certolizumab pegol and 7% for placebo.

In controlled RA clinical trials, the most common adverse events that occurred in or = 3% of patients taking certolizumab pegol 200mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% certolizumab pegol, 2% placebo), headache (5% certolizumab pegol, 4% placebo), hypertension (5% certolizumab pegol, 2% placebo), nasopharyngitis (5% certolizumab pegol, 1% placebo), back pain (4% certolizumab pegol, 1% placebo), pyrexia (3% certolizumab pegol, 2% placebo), pharyngitis (3% certolizumab pegol, 1% placebo), rash (3% certolizumab pegol, 1% placebo), acute bronchitis (3% certolizumab pegol,1% placebo), fatigue (3% certolizumab pegol, 1% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving certolizumab pegol than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and nonsteroidal anti-inflammatory drugs. Patients receiving certolizumab pegol 400mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving certolizumab pegol 200mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for certolizumab pegol and 2.5% for placebo.

Source: UCB



Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Arthritis / Rheumatology headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

Insurance Status Affects Access To Dental Appointments

Main Category: Dentistry
Also Included In: Pediatrics / Children’s Health;  Medicare / Medicaid / SCHIP
Article Date: 23 May 2011 – 10:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Patient / Public:not yet rated

Healthcare Prof:not yet rated

A study using research assistants who posed as mothers of a 10-year-old boy with a fractured front tooth seeking an urgent dental appointment measured dentists’ willingness to provide treatment to children with Medicaid/CHIP versus private insurance.

The study, “Disparities in Child Access to Emergency Care for Acute Oral Injury,” in the June 2011 issue of Pediatrics (published online May 23) found that even when calling Medicaid-enrolled dentists, only 68 percent of children with Medicaid/CHIP were able to obtain an appointment compared to 100 percent of privately-insured children with the same injury.

Non-enrolled dentists only gave an appointment to 7 percent of children with public insurance, even though the Medicaid program reimburses all emergency dental care. The authors state that these findings have implications for changes in oral health policy and Medicaid/CHIP financing, as well as dental education, and payment strategies. Finding dental providers willing to accept public insurance and serve children from low-income families is a first vital step toward improving oral health for children.

Source:

American Academy of Pediatrics



Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Dentistry headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

Man Fined £10,000 For Illegal Sale Of Lifestyle Drugs, UK

Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Erectile Dysfunction / Premature Ejaculation
Article Date: 27 May 2011 – 10:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article




Patient / Public:not yet rated

Healthcare Prof:2 stars

2 (2 votes)

A 27-year-old man from Uxbridge in northwest London was yesterday (26 May 2011) fined £10,000 at Southwark Crown Court for selling unlicensed medicines for erectile dysfunction.

Saranjit Bhambra pleaded guilty on 26 April 2011 to one offence of selling medicinal products that contain ingredients found in medicines that can only be supplied with a prescription or by a qualified pharmacist.

The Medicines and Healthcare products Regulatory Agency (MHRA) launched the investigation known as Operation Rome following a test purchase of a pack of four Tadil tablets from Bhambra’s website.

The test purchase led to a search at a car mechanic’s garage, where officers found evidence connected to an illegal online pharmacy supplying medicinal products including tadalafil and sildenafil.
Both tadalafil and sildenafil are potent active ingredients and should only be taken when directed by a healthcare professional, who has access to a patient’s individual records, and supplied through a registered pharmacy.

MHRA Head of Enforcement, Mick Deats, said: “While websites such as these may look professional, what we see behind the scenes tells a very different story.

“These unlicensed medicines were being sold from a mechanic’s garage which means they risk additional contamination due to the unsanitary conditions in which they were stored.

“Anyone considering taking medication for erectile dysfunction (ED) should consult a healthcare professional so that the right diagnosis can be made as this could be a symptom of a more serious medical condition.

“The unlawful sale of medicines, including those to treat ED, poses a serious threat to public health and today’s sentence reflects the nature and gravity of this crime.”

Notes

1. Under the Medicines Act 1968 the penalty on indictment is a maximum of two years imprisonment and/or an unlimited fine.

2. Members of the public are advised that they should only take prescription-only medicines after an appropriate consultation with their GP. Only healthcare professionals can take into account risks and benefits associated with every medicine.

3. Unlicensed medicines have not been tested to European standards of safety, quality and efficacy.

Source:

MHRA



Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Alcohol / Addiction / Illegal Drugs headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

Welcome to the Nurses Training blog

Nurse TrainingWelcome to the Nurse Training blog brought to you by Promed.

The Nurse Training Blog is intended to inform nurses about upcoming seminars, workshops and events which may be of interest to them as part of their ongoing professional development.

Promed has many services and facilities freely accessible to our customers and we would like to draw attention to these and make you, our customer aware of all the information that we have available. Not only do we provide workshops, seminars and online learning modules, but our website offers a large amount of information available to download, as well as the latest news and promotions.

We would like to encourage communication and feedback and would be interested in hearing from you and other Nurses as to what extra information or support you would like to see us provide.

Thanks for checking in!

Tags: , , , , , , ,

This entry was posted on February 23, 2011 at 9:38 pm and is filed under Nursing, Medical devices, Medical, Nurse Training, Healthcare. You can follow any responses to this entry through the RSS 2.0 feed.
You can leave a response, or trackback from your own site.

Patients With RA Or Fibromyalgia Benefit From Yoga

Main Category: Arthritis / Rheumatology
Also Included In: Complementary Medicine / Alternative Medicine;  Fibromyalgia
Article Date: 27 May 2011 – 2:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Patient / Public:not yet rated

Healthcare Prof:not yet rated

Individuals with rheumatoid arthritis who practice yoga showed statistically significant improvements in disease activity, according to a small study presented at the EULAR 2011 Annual Congress.

The results of the study conducted in the United Arab Emirates (UAE) among 47 patients (26 yoga patients and 21 controls) demonstrate that patients who completed 12 sessions of Raj yoga** which is one of the gentler styles of yoga, combining exercise and breathing techniques showed significant improvements in disease activity scores (DAS28) of p=0.021 and health assessment questionnaire’s (HAQ†) of p=0.0015. However there was no statistically significant improvement on the quality of life scale (QoL).

“Most patients with RA do not exercise regularly despite the fact that those who do report less pain and are therefore more physically active,” said Dr Humeira Badsha MD Rheumatologist and founder of the Emirates Arthritis Foundation, Dubai, UAE. “While our study has been conducted in a small group of patients the results show clear benefits for patients who regularly practice Raj yoga. We believe that practicing yoga longer term could in fact result in further significant improvements and hope our study drives further research into the benefits of yoga in RA.”

Patients were recruited by email through the Emirates Arthritis Foundation RA database (mean age of yoga group 44 years, mean age of control group 46.2 years, 80% female). Demographic data, disease activity indices, health assessment questionnaire (HAQ) and SF-36 (a standard patient survey commonly used to calculate patient quality of life) were documented at enrolment and after completion of 12 sessions of yoga.

Results of a separate study show the positive effects of yoga on the quality of life in patients with Fibromyalgia, a long-term condition which causes extreme pain all over the body.

Results of one further study investigating the effects of yoga on the QoL of patients with fibromyalgia, demonstrated that QoL scores, after an eight session ***classical yoga program which combines gentle yoga postures, breathing techniques and meditation, were better than scores obtained before the program (panxiety levels of patients (p

Abstract Number: PARE0004; AB0402-HP

Source:
Rory Berrie

European League Against Rheumatism



Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Arthritis / Rheumatology headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

Rheumatology In Pregnancy Treated Differently By Clinitians, UK Survey Shows

Main Category: Pregnancy / Obstetrics
Also Included In: Arthritis / Rheumatology;  Women’s Health / Gynecology
Article Date: 27 May 2011 – 3:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Patient / Public:not yet rated

Healthcare Prof:not yet rated

This study, which is one of the first of its kind, collated responses from rheumatologists (52% consultants) and obstetricians (94% consultants) on the subject of patient education on safe treatments for use during pregnancy, the existence of local guidelines on treating this patient population, and recorded HCP use of several individual drugs used during the pre-conception, pregnancy and breastfeeding period.

The survey results outlined variations around the use of non-steroidal anti-inflammatory medications (NSAIDs) with 32% of rheumatologists and 18% of obstetricians opting to continue treatment whilst 67% of rheumatologists and 39% of obstetricians opted to discontinue these treatments during pregnancy.

“The results of our study have shown that there are several different approaches to treating women of a childbearing age with rheumatic conditions. Whilst healthcare practitioners are aware that they should consult a specialist when unsure of a treatment decision, best practice guidelines, developed with consensus between rheumatologists, obstetricians and specialist nurses would benefit healthcare practitioners in the UK and Europe greatly” said Dr Sonia Panchal, University Hospital of Leicester NHS Trust, UK.

Only 25% of rheumatologists and 6% of obstetricians had guidelines that were locally developed for the management of this patient population. The results of the survey also showed that there were several variations in approaches to prescribing specific treatments in the group:

  • The majority of rheumatologists (92%), but only half of obstetricians (54%) would discontinue anti-TNF treatment during pregnancy
  • 95% rheumatologists compared to 52% of obstetricians would discontinue rituximab

Regarding other treatments for rheumatic conditions, there was considerable variation in practice with regard to prescribing medications including sulphasalazine (Salazopyrin), azathioprine (Imuran / Azasan) and methotrexate (Rheumatrex).

The questionnaire was distributed to 1000 HCPs across the UK, via the British Society of Rheumatology and the British Maternal Foetal Medicine Society. Responses were received from 102 rheumatologists and 33 obstetricians and responses were analysed using online software.

Abstract Number: OP0135

Source:
Rory Berrie

European League Against Rheumatism



Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Pregnancy / Obstetrics headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

78% Of Seniors Surveyed Who Try To Estimate Out-Of-Pocket Medical Costs In Advance Do It With Accuracy At Least “Sometimes”

Main Category: Seniors / Aging
Also Included In: Medicare / Medicaid / SCHIP;  Health Insurance / Medical Insurance
Article Date: 24 May 2011 – 5:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article




Patient / Public:not yet rated

Healthcare Prof:5 stars

5 (1 votes)

A survey of 377 seniors 65 and older showed that 41%1 try to estimate in advance their out-of-pocket costs for medical appointments, services and treatments and of those who try, 78% get it right at least “sometimes” with more than one third getting it right “most of the time.” Still, slightly less than half of respondents said they specifically ask about the prices of medical services in advance and just 13% have ever tried to negotiate the price of a medical service with a provider.

The survey was fielded from April 12-19, 2011 by Extend Health, Inc., which operates the nation’s largest private Medicare exchange.

Said Bryce Williams, CEO of Extend Health, “From a consumer perspective, health care is different from almost any other market in that providers of medical services do not typically provide prices prior to delivering their services. In addition, insurance companies – not consumers – usually negotiate prices and pay directly for medical services. This lack of transparency makes it difficult for consumers who want or need to know what things will cost in advance so they can prepare themselves financially.

“This survey shows that despite the challenges, a large number of seniors who try to estimate their medical costs are successful,” added Williams. “Imagine what a difference it would make if the health care industry purposefully activated the real driver in cost control – the empowered consumer.”

The questions and detailed results from the survey are as follows:

Do you ever try to estimate your out-of-pocket medical expenses (anything not covered by your health insurance) in advance of a medical appointment, service, treatment or hospital stay?

Yes 41.3%

No 58.7%

If you answered, “yes” to the previous question, how frequently are you able to accurately estimate in advance your out-of-pocket medical expenses for a given medical appointment, service, treatment or hospital stay?

Always 1.8%

Most of the time 37.3%

Sometimes 39.1%

Rarely 15.4%

Never 6.5%

How often do you ask a health care provider (for example, a physician, hospital, physical therapist, laboratory) how much a medical service will cost ahead of time?

Always 5.7%

Most of the time 18.9%

Sometimes 27.2%

Rarely 30.7%

Never 17.5%

Have you ever tried to negotiate a price for a medical service with the service provider?

Yes 12.5%

No 87.5%

Extend Health is the only company that has helped more than 350,000 seniors use an exchange to compare and choose the private Medicare plans that best meets their needs and budgets. The Extend Health exchange is the only place seniors can compare more than 3,500 plans from 73 carriers side by side and find a plan that best meets their needs. Licensed benefit advisors are available to help seniors evaluate their Medicare coverage and explore new options quickly and easily.

1 For top line reporting purposes, Extend Health, Inc. rounds percentages up or down as appropriate.

Source:

Extend Health



Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Seniors / Aging headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

Statement From HHS Deputy Secretary Bill Corr On Retrospective Review Of Existing Rules

Main Category: Medicare / Medicaid / SCHIP
Article Date: 26 May 2011 – 10:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Advertisement

Patient / Public:not yet rated

Healthcare Prof:not yet rated

Earlier this year, President Obama outlined his plan to create a 21st-century regulatory system that is simpler and smarter and that protects the health and safety of the American people in a pragmatic and cost-effective way. He called for a change in culture to incorporate ongoing review of regulations into our operations. We can target rules already on the books to increase flexibility and remove regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules.

Today, the Department of Health and Human Services released its Preliminary Plan for Retrospective Review of Existing Rules based on a comprehensive inventory of each agency’s existing, significant regulations. The Plan highlights regulations already being modified or streamlined and identifies additional candidates for further review.

For example:

– The Centers for Medicare Medicaid Services (CMS) is working to address conflicting requirements between Medicaid and Medicare that potentially create barriers to high quality, seamless, and cost-effective care for dual eligible beneficiaries. By improving coordination and partnering with states, we can improve access, quality, and cost of care for people who depend on both programs.

– The Secretary is reviewing and updating the methods and criteria used to identify Health Professional Shortages and Medically Underserved Areas. The previous criteria were last established in 1978. Establishing more consistent and comprehensive criteria will allow the Department to more effectively serve some of our most vulnerable populations.

– And we are looking for opportunities to incorporate modern technology into our regulations in a way that increases flexibility for states and businesses while improving people’s lives. For example, the Agency for Children and Families is encouraging states’ child support programs to use cost-effective technologies like electronic signature and document storage; the Food and Drug Administration is also going paperless with its adverse events reporting requirements for medical devices; and CMS is working to reduce the barriers to telemedicine to provide better access to care.

Today’s report highlights many more opportunities for reform. At HHS, we do not believe regulatory review is a process you can just engage in from time to time. We have redoubled our long-standing effort and commitment to making regulatory review an integral part of our operations and culture.

As our work continues in the months and years to come, we will rely on key principles like transparency, public participation, clear priorities, and informed analysis to guide our efforts. We have a responsibility to balance the health and safety of all Americans and our commitment to promoting economic growth, job creation, and innovation. Today’s plan is a key step in fulfilling the responsibility.

Source:

HHS


Advertisement



Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Medicare / Medicaid / SCHIP headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

Used Blood Gas Analyzers for Laboratories

Leading dealers that offer used lab equipment ensures that labs can easily purchase fully functional blood gas analyzers at a reasonable price.

Brand new, feature-rich lab equipment from leading manufacturers is expensive. As a result, many laboratories go in for used blood gas analyzers to balance their budgets. Blood gas analyzers are indispensable equipment in clinical laboratories for the analysis of concentration of lactate, hemoglobin, electrolytes in the blood, as well as temperature corrected respiratory index.

Buy Scientific Equipment Online

The market is loaded with various brands and models of blood gas analyzers, making choice difficult. To select the appropriate model, it is necessary to study the features of each and compare them. The best way to do this is by browsing the sites of online suppliers. Their inventory has a wide selection of premium brands and all the main features of each are conveniently displayed. This facilitates selection. Most of these stores also offer used blood gas analyzers that have been refurbished to suit original manufacturer specifications.

Used Blood Gas Analyzers ensure Reliable Performance

Used products that are put up for sale need not necessarily be faulty ones. Leading dealers that offer used lab equipment make sure that it is thoroughly inspected, disassembled, parts replaced if necessary, repaired and refurbished to original specifications, before it is put up for sale at a cost much lower than that of a new piece. This ensures that labs can easily purchase fully functional blood gas analyzers at a reasonable price.

Used models of blood gas analyzers from manufacturers such as Bayer, IL 943 and Radiometer are very popular. Besides competitive pricing, buying the equipment from an established supplier ensures:

  • Extended warranty
  • Service contracts covering all parts and labor
  • On time delivery
  • Material service visits
  • In-house service
  • Efficient customer support services

Used blood gas analyzers from leading brands work as well as new, and come with a host of advanced feature like interference free measurements, and state-of-the-art technology featuring large, color touch screen with icons and an integrated video, and more.