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"These findings are particularly encouraging given that this is a 'real- life' community study with similar patient distribution by genotype within each weight group," said Paul Marotta, M.D., lead investigator, London (Ontario) Health Sciences Centre. "These results are consistent with the Canadian registration data for PEG-INTRON and REBETOL and underscore for patients the value of seeking treatment for hepatitis C, because the virus can be eradicated in a significant percentage of patients."
In the United States, PEG-INTRON (1.5 mcg/kg weekly) is approved in combination with REBETOL (800 mg daily) for a duration of treatment of 48 weeks. In the U.S. label, the SVR rate for this regimen is 52 percent. Weight- based dosing of REBETOL is currently under investigation in U.S. studies.
Canadian Observational Study and Results
In the study, known as the PEGETRON Prospective Optimal Weight-Based Dosing Response program (POWeR)(2), 2,194 treatment-naive patients with chronic hepatitis C virus (HCV) infection were prospectively enrolled between December 2002 and December 2004 in an open label trial conducted at 160 academic and community clinics across Canada. Patients were grouped by weight into one of five categories: less than 50 kg, 50 kg to less than 64 kg, 64 kg to less than 75 kg, 75 kg to less than 85 kg, and 85 kg or more, with the highest percentage of patients (33.8 percent) weighing 85 kg or more.
All patients were eligible for treatment with PEG-INTRON and REBETOL combination therapy according to criteria listed in the Canadian Product Monograph. Patients received treatment for 24 weeks (non-genotype 1) or 48 weeks (genotype 1).
SVR results have been collected on 952 patients to date. SVR by body weight did not differ significantly across weight groups: less than 50 kg (67 percent); 50 kg to less than 64 kg (67 percent); 64 kg to less than 75 kg (63 percent); 75 kg to less than 85 kg (65 percent); and 85 kg or more (69 percent). Patient distribution by genotype within each weight group was similar, ranging from 48 percent to 52 percent of patients having genotype 1 and 46 percent to 52 percent having genotype 2 or 3.
Of the patients in the study for whom baseline fibrosis data has been reported, more than one-third (37 percent) had severe or cirrhotic fibrosis (Metavir score F3 or F4) and 63 percent had mild to moderate (F0-F2) levels of fibrosis. Importantly, as weight increased, an increasing number of patients had severe or cirrhotic fibrosis (64 kg to less than 75 kg: F3/F4 = 33 percent; 75 kg or more: F3/F4 = 38 percent). More patients with a baseline fibrosis level of F0, F1 or F2 achieved an SVR (76 percent or 68 percent, respectively) than patients with a severe fibrosis level of F3 or F4 (42 percent or 41 percent, respectively).
PEG-INTRON and REBETOL Combination Therapy
PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according to patient body weight that is designed to achieve an effective balance between antiviral activity and elimination half-life. REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity.
Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including in Canada, Europe and the United States. It is a leading cause of chronic liver disease
and one of the
most common reasons for liver transplant.
Important Information Regarding U.S. Labeling for PEG-INTRON and REBETOL
WARNING
Alpha interferons, including PEG-INTRON, cause or aggravate fatal or life- threatening neuropsychiatric
, autoimmune, ischemic
, and infectious disorders. Patients should be monitored closely with periodic
clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-INTRON therapy.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial
infarctions. Patients with a history of significant
or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC
) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically
indicated.
REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic
and/or
embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
PEG-INTRON
There are no new adverse events specific to PEG-INTRON as compared to INTRON(R) A (interferon alfa-2b, recombinant) for Injection, however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEG-INTRON were "flu- like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEG-INTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON, but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation
,
suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEG-INTRON.
PEG-INTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
The following serious or clinically significant adverse events have been reported at a frequency less than 1% with PEG-INTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia
, hypotension, arrhythmia, ulcerative
and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis
, RA, systemic lupus erythematosus
,
psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis
and pneumonia, some resulting in patient deaths), urticaria
, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages,
and cotton wool spots.
In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG- INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5 mcg/kg)/ REBETOL and in 34% of those receiving INTRON A/REBETOL.
REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company's Web site is http://www.schering-plough.com/.
SCHERING-PLOUGH DISCLOSURE NOTICE: This press release contains certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements related to the market for PEG-INTRON and REBETOL combination therapy. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's third quarter 2005 10-Q.
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The UK's first "salt cave" has opened in London to treat Asthma
The hi-tech and therapeutic clinic in Wandsworth is the first in Britain to offer salt therapy to asthma and allergy sufferers. One in three people in London have an an allergy and one in 13 in the City has asthma.
Inside a 100-year-old former church on a suburban street, part of the building has been designed to recreate conditions found in a Siberian salt mine - except the "cave" has calming music, soothing lighting and comfortable chairs!
With the sound of waves playing in the background and the sand-like mound of salt underfoot, the place could easily be mistaken for an exotic snow beach!
The "cave" - which has a thick layer of natural sea salt from the Red Sea on its floor, walls and ceiling - can help alleviate and eradicate many conditions, including: asthma, pneumonia, hay fever, bronchitis, sinusitis, cystic fibrosis, eczema, and psoriasis.
It can also alleviate stress, combat sleeping disorders, improve general well-being, and enhance sports performance for athletes.
The clinic recreates a natural salt cave micro-climate - particles of dry rock salt are ground up by a special machine and circulated around the chamber. These particles, invisible to the naked eye, penetrate deep into the respiratory system. Minerals including potassium and magnesium help reduce inflammation and clean out mucus blocking the airways. The treatment is natural and 100% drug free.
Salt therapy is medically proven and in many cases treatment has resulted in a full recovery, including an 80% success rate among children (salt therapy is particularly effective for youngsters, as well as being a fun day out!), with 85% of adults symptomless for at least 1 year.
The treatment is widely used in Eastern Europe and Russia - and has been for around 200 years - where people with chronic breathing disorders often spend two to three hours per day in underground salt grottos. The Russian government approved "salt caves" for medical use in 1995.
Website: http://www.saltcave.co.uk
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