Botox injections? No sweat
NEW YORK
The idea of long-term Botox injections may bring some out in a cold sweat, but for millions who suffer from uncontrollable perspiration, the antiwrinkle treatment offers a lifeline to normality.
Interim data from the first long-term study into the repeated use of Botox to reduce severe underarm sweating found "safe, meaningful, long-lasting" improvements in patients whose conditions were chronic enough to wreak havoc on their social and professional lives.
The ongoing, three-year study enrolled 193 patients. After two years of regular Botox injections in their armpits, 81 percent reported a significant reduction in sweating, while the number who described being "emotionally damaged or injured" by their condition was reduced by half.
Dee Anna Glaser, a professor of dermatology at Saint Louis University School of Medicine and lead investigator of the study, said the results offered hope to a large group of people whose quality of life is rated lower than psoriasis sufferers.
An estimated eight million Americans suffer from uncontrollable sweating, or hyperhidrosis. The use of Botox in treating the condition was approved by the US Food and Drug Administration last year. It works by blocking nerve impulses sent by the brain to the sweat glands.
"Most of these sufferers feel like somehow they're responsible and they're dirty. They don't really understand they have a medical condition," Glaser said. "They feel like if only they showered more or did something different, they would be normal."
Uncontrolled sweating causes so much embarrassment that studies show up to two-thirds of sufferers have never consulted a health professional. "They can just be hanging out with their loved ones and they are dripping, literally dripping," said Glaser.
AFP
Tamoxifen stimulates some tumors
STOCKHOLM
Tamoxifen, a drug prescribed to more than half of all patients suffering from breast cancer, can in some cases actually stimulate tumor growth and increase the likelihood of a relapse, Swedish researchers said.
Widely used since the 1970s, tamoxifen counteracts the cancer-promoting effects of estrogen in the breast by binding itself to the estrogen receptor in the cancerous cell, thus impeding tumor growth. But according to new research conducted at the Malmoe University Hospital, UMAS, in southern Sweden, the drug can have the opposite effect on certain types of tumors.
"The result shows that tamoxifen is a very efficient treatment for most patients. But for 15 percent of tumors that contain many copies of the cell-splitting gene cyclin D1, tamoxifen appears to have the opposite effect," researcher Karin Jirstroem said.
The study conducted by Jirstroem and her colleagues was based on examinations of patients from southern Sweden who had been treated with the drug. It was recently published in Cancer Researcher.
"It is important not to draw the conclusion of this study too far.... But this is the first time that patients have been identified on whom the treatment has had the opposite effect," researcher Goeran Landberg said. "Our findings in Malmoe should immediately be tested in other studies to avoid negative effects of this otherwise very effective drug tamoxifen," he added.
AFP
Zomig relieves "worst pain"
ATHENS, Greece
Zolmitriptan (Zomig) nasal spray is highly effective and well tolerated in the acute treatment of cluster headache, an extremely severe form of headache pain also known as "suicide headache" because of the excruciating pain it causes. This was the conclusion of data presented at the European Federation of Neurological Societies annual congress in September.
A new clinical study shows that zolmitriptan nasal spray achieved the primary end point of headache relief at 30 minutes with significantly higher response (60 percent at 10 mg and 38 percent at 5 mg) compared with placebo (21 percent), demonstrating a reduction from moderate, severe, or very severe headache pain to mild or no pain at all.
Conducted at five sites in Germany, Italy, and the United Kingdom, the study enrolled 92 patients who suffered from either episodic cluster headache (ECH) or chronic cluster headache (CCH). Patients were randomized using a placebo-controlled, double-blind study protocol.
Headache relief at 30 minutes was significantly higher for zolmitriptan 10 and zolmitriptan 5 mg in ECH compared with placebo: 80 percent and 47 percent v. 24 percent (p < 0.001), as well as in CCH: 38 percent and 27 percent v. 17 percent (p < 0.001). Headache relief was superior with both doses mg compared with placebo from as early as five minutes and at every five-minute interval up to 30 minutes.
Dr. Peter Goadsby of the Institute of Neurology in Queen Square, London, the lead investigator of the study, commented: "These results are highly significant when facing the dilemma of how to treat this debilitating type of primary headache disorder. Cluster headache attacks are rapid in onset and patients suffer excruciating pain. Current effective treatments include injection of sumatriptan or inhalation of oxygen, but the fact that zolmitriptan nasal spray has proved effective and well tolerated in cluster headache offers physicians and patients an extremely acceptable alternative for fast-acting reliable relief."
Secondary end points of the study included pain-free rate and associated symptom relief (nasal congestion, facial sweating, restlessness, and agitation), as well as tolerability compared with placebo. No serious adverse events were reported in either the placebo or zolmitriptan treated groups.
Zolmitriptan, manufactured by AstraZeneca, is licensed for the acute treatment of migraine with or without aura in adults.
Arimidex granted new indication
A nastrozole (Arimidex) has been granted a new indication by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, leading to further approvals in Austria, Germany, Italy, Portugal, and Spain.
AstraZeneca, which manufactures anastrozole, said the new indication as an adjuvant treatment of postmenopausal women with hormone receptor-positive early invasive breast cancer--about 75 percent of all postmenopausal cases--will mean that more postmenopausal women whose breast cancer is fueled by estrogen are now eligible to receive Arimidex after surgery to prevent recurrence.
Studies have shown that anastrozole offers a 26-percent reduction in the risk of breast cancer coming back compared with tamoxifen, the gold standard for breast-cancer management for the past 30 years.
Rob Carpenter, consultant surgical oncologist at St. Bartholomew's Hospital in London, said the approval marks the beginning of a whole new era in breast-cancer management. "This is the moment we have been waiting for," he said. "It has recently been confirmed that Arimidex offers crucial advantages over tamoxifen, in terms of enabling patients to stay disease-free longer. However, it is only now, with the new indication that more postmenopausal women with breast cancer may benefit from this drug at the earliest opportunity after breast surgery."
The MHRA granted the indication on the basis of data from the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial, the largest breast-cancer trial ever conducted. Data from the trial demonstrate that anastrozole reduces the risk of breast cancer recurrence by an additional 26 percent (HR = 0.74; p < 0.0002), over the 50-percent reduction provided by tamoxifen.
A new analysis from the ATAC trial, presented at the American Society of Clinical Oncologists in May demonstrated that the risk of breast-cancer recurrence reaches a peak in the first two years after surgery. Women treated with anastrozole immediately after surgery saw a reduced risk of recurrence in the first 18 to 24 months when recurrences are at their highest level. The authors concluded that this benefit would be lost if patients did not start with an aromatase inhibitor immediately postsurgery.
Arimidex has also been shown to have a favorable side-effect profile versus tamoxifen, both in terms of serious life-threatening side effects such as blood clots, stroke, and cancer of the womb lining, as well as symptoms that are important to women like hot flashes and vaginal discharge. However, women taking anastrozole experienced an increased risk of joint pain and fracture, although fracture rates reported in the ATAC trial are similar to those seen in age-matched postmenopausal women.
In 2004, anastrozole's worldwide sales increased by 48 percent to US$811 million, US$358 million in Europe.
Indacaterol offers 24-hour efficacy
Copenhagen
New data presented at the recent congress of the European Respiratory Society (ERS) in Copenhagen, Denmark, showed that indacaterol demonstrated effective and well-tolerated treatment of asthma and chronic obstructive pulmonary disease (COPD) over 24 hours with a rapid onset of action.
"The combination of 24-hour efficacy and a reassuring safety profile suggests that in time, a once-daily dose of indacaterol could become a new standard of care for bronchodilation in asthma and COPD," said Joerg Reinhardt, global head of development at Novartis Pharma AG. "We are now concentrating on the development of this important new therapy for the benefit of patients who suffer from these debilitating and sometimes fatal diseases."
The efficacy of indacaterol (formerly known as QAB 149) in both asthma and COPD was demonstrated in a series of placebo-controlled clinical studies using once-daily doses or 25 to 2000 µg. The duration of action of indacaterol was found to be largely independent of dose, with superior bronchodilation to placebo demonstrated at 24 hours after a single dose.
The efficacy of indacaterol in patients with asthma was further investigated in three multiple-dose studies of seven, 14, and 28 days' duration. In these studies, the 24-hour bronchodilator efficacy of indacaterol observed on the first day was maintained for the duration of the studies, suggesting that regular use of indacaterol is not associated with the development of tolerance or tachyphylaxis. Indacaterol also demonstrated 24-hour bronchodilator efficacy with no evidence of tachyphylaxis in patients with COPD.
These results indicate that indacaterol could become the first beta-2 agonist to be taken only once daily providing full 24 hour symptom control with a single administration, in contrast to currently available long-acting beta-2 agonists such as salmeterol and formoterol, which have to be taken twice daily.
"Considered together, these results provide important insights into the future therapeutic potential of indacaterol, the first in a new generation of drugs that could accurately be described as once-daily beta-2 agonists,"said Prof. Stephen Holgate of Southampton General Hospital, UK. "For patients with asthma or COPD, indacaterol could provide important clinical benefits in terms of improved compliance and more rapid and reliable long-term control of the potentially life-threatening symptoms of breathlessness and bronchial constriction associated with these conditions."
The studies also showed that the 24-hour efficacy of indacaterol in asthma is accompanied by a positive safety profile. Single indacaterol doses up to 2000 µg were well tolerated and were not associated with any clinically significant changes in known class effect adverse events such as hypokalemia, hyperglycemia, increased heart rate or altered QTc interval. These single-dose results were confirmed in multiple-dose asthma studies, in which indacaterol doses up to 800 µg once daily for up to 28 days were associated with a good cardiovascular safety profile and no clinically relevant effects on blood pressure, QTc, glucose or potassium levels.
Indacaterol works by stimulating beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD. Indacaterol is being developed both as monotherapy and as a fixed-dose combination with drugs such as NVA237, a long-acting antimuscarinic agent for the treatment of COPD that has also been shown to be effective over 24 hours after a single dose.
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