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The combination of anastrozole and fulvestrant extended median survival
of women with hormone-receptor–positive metastatic breast cancer when
compared with standard therapy of either anastrozole alone or sequential
anastrozole and fulvestrant, according to study results.wisepoqder Anastrozole powder
In prior studies, anastrozole (Arimidex, AstraZeneca) exhibited the ability to suppress estrogen production, while fulvestrant (Faslodex, AstraZeneca) demonstrated high efficacy in a low-estrogen environment. In addition, the combination of fulvestrant and an aromatase inhibitor — compared with either agent alone — delayed the development of resistance by down-regulating several signaling molecules involved in the development of resistance.
To determine whether the combination of anastrozole and fulvestrant would be superior to anastrozole alone as first-line therapy for metastatic breast cancer, Rita Mehta, MD, and colleagues from the UC Irvine Medical Center conducted a phase 3 randomized trial of 694 postmenopausal women with previously untreated metastatic disease from June 1, 2004, to July 1, 2009.
During the study, patients were randomly assigned to receive either 1 mg of anastrozole orally once daily in combination with injections of fulvestrant — given in sequential dosing on the first day, every 2 weeks, and then once every 28 days after the first month — or 1 mg of anastrozole orally once daily, with possible crossover to fulvestrant alone following disease progression.
Median PFS was 15 months for patients who received the anastrozole and fulvestrant combination vs. 13.5 months for patients who received anastrozole alone, according to study results. The combination was observed to be generally more effective than anastrozole alone in all subgroups, with no significant interactions.
In addition, median OS was longer among patients assigned to the combination therapy (47.7 months vs. 41.3 months), despite the fact that 41% of the patients in the anastrozole group crossed over to fulvestrant after progression.
“The improvement in overall survival that was observed in our study has not been seen in other trials of first-line hormonal therapy for HR-positive metastatic breast cancer,” the researchers wrote. “Specifically, in the trials comparing aromatase-inhibitor therapy with tamoxifen therapy, the benefit from aromatase inhibitors with respect to progression-free survival failed to translate into a benefit with respect to overall survival, a finding that was attributed to the crossover of some patients in the tamoxifen group to an aromatase inhibitor.”
Three deaths that were possibly associated with treatment occurred in the combination group. Toxic effects of grade-4 or higher were observed in four patients who received anastrozole alone (1.2%) and in five patients who received combination therapy (1.4%; P=1.00). The four observed grade-4 toxic effects among patients who received anastrozole alone included thrombosis or embolism, joint pain, thrombocytopenia and dyspnea. Two patients in the combination group experienced grade 4-toxic effects. One experienced thrombosis or embolism, and the other experienced neutropenia or lymphopenia.
“The results of our study suggest that trials of adjuvant therapy should be performed in which the combination of an aromatase inhibitor and high-dose fulvestrant is compared with an aromatase inhibitor alone or high-dose fulvestrant alone in patients with estrogen-receptor–positive tumors for whom chemotherapy is not necessary,” the researchers concluded.
In prior studies, anastrozole (Arimidex, AstraZeneca) exhibited the ability to suppress estrogen production, while fulvestrant (Faslodex, AstraZeneca) demonstrated high efficacy in a low-estrogen environment. In addition, the combination of fulvestrant and an aromatase inhibitor — compared with either agent alone — delayed the development of resistance by down-regulating several signaling molecules involved in the development of resistance.
To determine whether the combination of anastrozole and fulvestrant would be superior to anastrozole alone as first-line therapy for metastatic breast cancer, Rita Mehta, MD, and colleagues from the UC Irvine Medical Center conducted a phase 3 randomized trial of 694 postmenopausal women with previously untreated metastatic disease from June 1, 2004, to July 1, 2009.
During the study, patients were randomly assigned to receive either 1 mg of anastrozole orally once daily in combination with injections of fulvestrant — given in sequential dosing on the first day, every 2 weeks, and then once every 28 days after the first month — or 1 mg of anastrozole orally once daily, with possible crossover to fulvestrant alone following disease progression.
Median PFS was 15 months for patients who received the anastrozole and fulvestrant combination vs. 13.5 months for patients who received anastrozole alone, according to study results. The combination was observed to be generally more effective than anastrozole alone in all subgroups, with no significant interactions.
In addition, median OS was longer among patients assigned to the combination therapy (47.7 months vs. 41.3 months), despite the fact that 41% of the patients in the anastrozole group crossed over to fulvestrant after progression.
“The improvement in overall survival that was observed in our study has not been seen in other trials of first-line hormonal therapy for HR-positive metastatic breast cancer,” the researchers wrote. “Specifically, in the trials comparing aromatase-inhibitor therapy with tamoxifen therapy, the benefit from aromatase inhibitors with respect to progression-free survival failed to translate into a benefit with respect to overall survival, a finding that was attributed to the crossover of some patients in the tamoxifen group to an aromatase inhibitor.”
Three deaths that were possibly associated with treatment occurred in the combination group. Toxic effects of grade-4 or higher were observed in four patients who received anastrozole alone (1.2%) and in five patients who received combination therapy (1.4%; P=1.00). The four observed grade-4 toxic effects among patients who received anastrozole alone included thrombosis or embolism, joint pain, thrombocytopenia and dyspnea. Two patients in the combination group experienced grade 4-toxic effects. One experienced thrombosis or embolism, and the other experienced neutropenia or lymphopenia.
“The results of our study suggest that trials of adjuvant therapy should be performed in which the combination of an aromatase inhibitor and high-dose fulvestrant is compared with an aromatase inhibitor alone or high-dose fulvestrant alone in patients with estrogen-receptor–positive tumors for whom chemotherapy is not necessary,” the researchers concluded.
Hydrochlorothiazide is a thiazide diuretic (water pill) that helps
prevent your body from absorbing too much salt, which can cause fluid
retention.Triamterene is a potassium-sparing diuretic that also prevents
your body from absorbing too much salt and keeps your potassium levels
from getting too low.wisepoqder Triamterene
Hydrochlorothiazide and triamterene is a combination medicine used to treat fluid retention (edema) and high blood pressure (hypertension).hydrochlorothiazide and triamterene is usually given to people in whom other diuretics have caused hypokalemia (low potassium levels in your blood).Hydrochlorothiazide and triamterene may also be used for purposes not listed in this medication guide.
Important Information
You should not use this medicine if have kidney disease, urination problems, high levels of potassium in your blood, or if you are taking other diuretics similar to triamterene. Do not use potassium supplements, salt substitutes, or low-sodium milk unless your doctor has told you to.
This medicine can raise your blood potassium to dangerous levels, especially if you have kidney disease, diabetes, severe illness, or if you are an older adult. Call your doctor right away if you have signs of high potassium: nausea, slow or unusual heart rate, numbness, tingling, muscle weakness, or loss of movement in any part of your body.
Before taking this medicine
You should not use hydrochlorothiazide and triamterene if you are allergic to hydrochlorothiazide (HCTZ, HydroDiuril, Lotensin HCT, Zestoretic, and others) or triamterene (Dyrenium), or if:
you have kidney disease or are unable to urinate;
you have high potassium levels (hyperkalemia);
you are taking diuretics similar to triamterene, such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide); or
you are taking potassium supplements (unless your doctor tells you to).
Diuretics such as triamterene can raise your blood potassium to dangerous levels. This is more likely to occur if you have kidney disease, diabetes, severe illness, or if you are an older adult. Ask your doctor about your individual risk.
Hydrochlorothiazide and triamterene is a combination medicine used to treat fluid retention (edema) and high blood pressure (hypertension).hydrochlorothiazide and triamterene is usually given to people in whom other diuretics have caused hypokalemia (low potassium levels in your blood).Hydrochlorothiazide and triamterene may also be used for purposes not listed in this medication guide.
Important Information
You should not use this medicine if have kidney disease, urination problems, high levels of potassium in your blood, or if you are taking other diuretics similar to triamterene. Do not use potassium supplements, salt substitutes, or low-sodium milk unless your doctor has told you to.
This medicine can raise your blood potassium to dangerous levels, especially if you have kidney disease, diabetes, severe illness, or if you are an older adult. Call your doctor right away if you have signs of high potassium: nausea, slow or unusual heart rate, numbness, tingling, muscle weakness, or loss of movement in any part of your body.
Before taking this medicine
You should not use hydrochlorothiazide and triamterene if you are allergic to hydrochlorothiazide (HCTZ, HydroDiuril, Lotensin HCT, Zestoretic, and others) or triamterene (Dyrenium), or if:
you have kidney disease or are unable to urinate;
you have high potassium levels (hyperkalemia);
you are taking diuretics similar to triamterene, such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide); or
you are taking potassium supplements (unless your doctor tells you to).
Diuretics such as triamterene can raise your blood potassium to dangerous levels. This is more likely to occur if you have kidney disease, diabetes, severe illness, or if you are an older adult. Ask your doctor about your individual risk.
This drug is used to treat high blood pressure. Lowering high blood
pressure helps prevent strokes, heart attacks, and kidney problems. This
medication is a combination of two "water pills" (diuretics):
triamterene and hydrochlorothiazide. This combination is used by people
who have developed or are at risk for having low potassium levels on
hydrochlorothiazide. It causes you to make more urine, which helps your
body get rid of extra salt and water.wisepoqder β-agonist Powder
This medication also reduces extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, or kidney disease. This can lessen symptoms such as shortness of breath or swelling in your ankles or feet.
How to use Triamterene-Hydrochlorothiazid
Take this medication by mouth as directed by your doctor, usually once daily in the morning with or without food. It is best to avoid taking this medication within 4 hours of your bedtime to prevent having to get up to urinate.
If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 4 hours before or at least 4 to 6 hours after these medications.The dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings increase).
This medication also reduces extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, or kidney disease. This can lessen symptoms such as shortness of breath or swelling in your ankles or feet.
How to use Triamterene-Hydrochlorothiazid
Take this medication by mouth as directed by your doctor, usually once daily in the morning with or without food. It is best to avoid taking this medication within 4 hours of your bedtime to prevent having to get up to urinate.
If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 4 hours before or at least 4 to 6 hours after these medications.The dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings increase).
The oral beta-blockers approved for migraine prophylaxis may not be
effective for acute attacks because of slow absorption and modification
by first-pass metabolism, which delays effective plasma levels for hours
or even days. With timolol eyedrops, maximum plasma concentration is
achieved within 15 minutes of administration. In a pilot study, Cossack
et al. tested the effectiveness of the eyedrops as an abortive migraine
treatment and found it helpful for some patients.wisepoqder Timolol powder
This placebo-controlled crossover study was conducted among 10 adults with recurrent migraine, with or without aura, who were recruited from the authors’ neurology and ophthalmology clinics. Patients were assigned randomly to receive timolol maleate 0.5% or artificial tears (placebo) and were instructed to insert 1 drop in each eye at migraine onset and 30 minutes later. The participants were seen monthly for 4 months (5 visits per patient). After a 3-day washout at the 2-month mark, they were switched to the opposite treatment arm. Patients ranked the severity of each migraine attack on a scale of 0 (least) to 3 (greatest) and rated the effectiveness of each treatment on a scale of 1 (least) to 4 (greatest).
Among the 10 patients, 198 migraine attacks occurred during the study period. Four patients reported that timolol was highly effective in comparison to placebo; another patient noted the opposite. Thirty-seven (67%) of 55 migraines that occurred during timolol use had severity of none to mild at 2 hours, versus 58 (75%) of the 77 migraines during placebo use. No adverse events were observed during the study.
This placebo-controlled crossover study was conducted among 10 adults with recurrent migraine, with or without aura, who were recruited from the authors’ neurology and ophthalmology clinics. Patients were assigned randomly to receive timolol maleate 0.5% or artificial tears (placebo) and were instructed to insert 1 drop in each eye at migraine onset and 30 minutes later. The participants were seen monthly for 4 months (5 visits per patient). After a 3-day washout at the 2-month mark, they were switched to the opposite treatment arm. Patients ranked the severity of each migraine attack on a scale of 0 (least) to 3 (greatest) and rated the effectiveness of each treatment on a scale of 1 (least) to 4 (greatest).
Among the 10 patients, 198 migraine attacks occurred during the study period. Four patients reported that timolol was highly effective in comparison to placebo; another patient noted the opposite. Thirty-seven (67%) of 55 migraines that occurred during timolol use had severity of none to mild at 2 hours, versus 58 (75%) of the 77 migraines during placebo use. No adverse events were observed during the study.
Terbutaline may be a safe and effective treatment option for prevention of nocturnal hypoglycemia in patients with type 1 diabetes.wisepoqder Terbutaline
Researchers of a randomized, controlled trial examined whether terbutaline prevented nocturnal hypoglycemia without causing morning hyperglycemia in 15 patients with type 1 diabetes.
Patients randomly assigned to 2.5 mg terbutaline (Brethine, Novartis) had a mean nadir nocturnal plasma glucose concentration of 100 mg/dL compared with 122 mg/dL with 5 mg terbutaline and 87 mg/dL with placebo (see chart). In the 2.5-mg terbutaline group, seven patients reached nadir nocturnal concentrations <70 mg/dL, six reached concentrations <60 mg/dL and two reached concentrations <50 mg/dL. Further, three patients assigned to 5-mg terbutaline reached nadir levels <70 mg/dL; none of these patients reached any level lower than that.
Morning plasma glucose levels were 127 mg/dL with 2.5 mg terbutaline, 183 mg/dL with 5 mg terbutaline and 113 mg/dL with placebo.
"These
data confirm a high frequency of nocturnal hypoglycemia in patients
with aggressively treated type 1 diabetes. These data also confirm that
bedtime administration of 5 mg terbutaline effectively prevents
nocturnal hypoglycemia," the researchers wrote.
Hypoglycemia
is the limiting step to glycemic control in patients with diabetes. It
can be serious and is occasionally fatal. The majority of hypoglycemic
episodes occur at night. Therefore, efforts to reduce the risk of
nocturnal hypoglycemia would be well directed. The group of Cryer et al
at Washington University have made a life career of addressing the
biology of hypoglycemia. This report is a follow-up of earlier work from
the same laboratory showing a beneficial effect of terbutaline (5 mg)
in decreasing hypoglycemia overnight, but that dose was associated with
undesirable hyperglycemia in the morning. The current study tested a
smaller dose (2.5 mg) of terbutaline and seems to have nailed the matter
squarely. It seems, therefore, that terbutaline can be added to other
existing strategies for reduction of nocturnal hypoglycemia. These other
strategies include bedtime caloric supply, recalibration of
antidiabetic medications, limitation of alcohol intake, exercise
counseling, self-blood glucose monitoring (especially in the ‘wee'
hours), prompt recognition and intervention for hypoglycemia
unawareness, among others. The fact that the study included just 15
patients with type 1 diabetes is an obvious limitation. Therefore, a
larger study expanded to even patients with type 2 diabetes (many of
whom are also at risk for hypoglycemia) would be most welcome.
The FDA is notifying health care professionals -- specifically, family
physicians and OB-Gyns -- that it is requiring the addition of a new
boxed warning and contraindication to terbutaline's drug labeling to
warn health care professionals about the severe cardiovascular and other
risks these products pose for pregnant women. FDA officials also have
agreed to reclassify terbutaline from a pregnancy category B drug to a
pregnancy category C drug in response to a 2008 citizen petition.wisepoqder β-agonist Powder
Terbutaline is approved to prevent and treat bronchospasm associated with asthma, bronchitis and emphysema, but the drug also has been used off-label for obstetric purposes, including treating preterm labor and uterine hyperstimulation. In addition, terbutaline has been used for longer periods of time to prevent recurrent preterm labor.
However, new safety information reviewed by the FDA indicates that death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia, have been reported after prolonged administration of oral and injectable terbutaline to pregnant women.
In a Feb. 17 safety alert(www.fda.gov), the FDA acknowledged that administering terbutaline by injection to a pregnant women in urgent obstetrical situations within a hospital setting may be appropriate based on a physician's clinical judgment. However, the agency said terbutaline administered by injection or by continuous infusion pump should not be used beyond 48-72 hours. The agency also emphasized that injectable terbutaline should not be used in the outpatient or home setting.
Furthermore, the FDA said oral terbutaline is contraindicated for the treatment or prevention of preterm labor because it has not been shown to be effective and has safety concerns similar to those associated with the injectable form of the drug.
The agency advised that women who are taking terbutaline for asthma or other medical conditions should talk with their physician if they are pregnant or become pregnant to determine whether use of the drug should be discontinued.
Terbutaline is approved to prevent and treat bronchospasm associated with asthma, bronchitis and emphysema, but the drug also has been used off-label for obstetric purposes, including treating preterm labor and uterine hyperstimulation. In addition, terbutaline has been used for longer periods of time to prevent recurrent preterm labor.
However, new safety information reviewed by the FDA indicates that death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia, have been reported after prolonged administration of oral and injectable terbutaline to pregnant women.
In a Feb. 17 safety alert(www.fda.gov), the FDA acknowledged that administering terbutaline by injection to a pregnant women in urgent obstetrical situations within a hospital setting may be appropriate based on a physician's clinical judgment. However, the agency said terbutaline administered by injection or by continuous infusion pump should not be used beyond 48-72 hours. The agency also emphasized that injectable terbutaline should not be used in the outpatient or home setting.
Furthermore, the FDA said oral terbutaline is contraindicated for the treatment or prevention of preterm labor because it has not been shown to be effective and has safety concerns similar to those associated with the injectable form of the drug.
The agency advised that women who are taking terbutaline for asthma or other medical conditions should talk with their physician if they are pregnant or become pregnant to determine whether use of the drug should be discontinued.
A VERY LOW DOSE of tamoxifen—5 mg/d, given for 3 years rather than 5
years—halved the risk of breast cancer recurrence or new lesions over
placebo in women with breast intraepithelial neoplasia, without
producing the usual toxicities seen with the standard dose, Italian
researchers reported at the 2018 San Antonio Breast Cancer Symposium.1wisepoqder Tamoxifen
“We believe our results have external validity and—given their pragmatic nature and the easy accessibility of tamoxifen—are generalizable,” said Andrea De Censi, MD, of the National Hospital E.O. Ospedali Galliera–Division of Medical Oncology in Genoa, Italy. “Tamoxifen, 5 mg a day (splitting the tablet) or 10 mg every other day, is applicable in clinical practice tomorrow.”
Breast cancer experts at the meeting said this is news they can use. “Looking at these data, I would definitely give lower doses of tamoxifen, especially in patients with atypical ductal hyperplasia and lobular carcinoma in situ,” said Virginia G. Kaklamani, MD, Professor of Medicine at The University of Texas at San Antonio and leader of the Breast Cancer Program at The University of Texas MD Anderson Cancer Center, Houston.
“This information tells me I can perhaps cut back on the dose for patients who are not tolerating tamoxifen. This would help me keep them on the dose, rather than have them abandon therapy,” said John Cole, MD, of the Ochsner Health System in New Orleans.
ALTHOUGH TAMOXIFEN is effective in preventing breast cancer recurrence, its side effects—menopausal symptoms, endometrial cancer, deep-vein thrombosis, and pulmonary embolism— are barriers for its use as a preventive measure. The aim of this de-escalation study was to determine whether a lower dose and shorter duration of tamoxifen therapy would be as efficacious as and better tolerated than the standard dose.
Dr. De Censi and colleagues had previously shown that a dose as low as 1 mg/d is noninferior to 20 mg in decreasing Ki67 (a marker of proliferation), though less effective in modulating serum biomarkers.2 For the current study, the investigators decided 5 mg/d would be a reasonable compromise between activity and safety. He explained that the government- and charity-funded study could not afford to financially support the use of a very large noninferiority trial of tamoxifen at 20 mg/d for 5 years as the control arm.
“We believe our results have external validity and—given their pragmatic nature and the easy accessibility of tamoxifen—are generalizable,” said Andrea De Censi, MD, of the National Hospital E.O. Ospedali Galliera–Division of Medical Oncology in Genoa, Italy. “Tamoxifen, 5 mg a day (splitting the tablet) or 10 mg every other day, is applicable in clinical practice tomorrow.”
Breast cancer experts at the meeting said this is news they can use. “Looking at these data, I would definitely give lower doses of tamoxifen, especially in patients with atypical ductal hyperplasia and lobular carcinoma in situ,” said Virginia G. Kaklamani, MD, Professor of Medicine at The University of Texas at San Antonio and leader of the Breast Cancer Program at The University of Texas MD Anderson Cancer Center, Houston.
“This information tells me I can perhaps cut back on the dose for patients who are not tolerating tamoxifen. This would help me keep them on the dose, rather than have them abandon therapy,” said John Cole, MD, of the Ochsner Health System in New Orleans.
ALTHOUGH TAMOXIFEN is effective in preventing breast cancer recurrence, its side effects—menopausal symptoms, endometrial cancer, deep-vein thrombosis, and pulmonary embolism— are barriers for its use as a preventive measure. The aim of this de-escalation study was to determine whether a lower dose and shorter duration of tamoxifen therapy would be as efficacious as and better tolerated than the standard dose.
Dr. De Censi and colleagues had previously shown that a dose as low as 1 mg/d is noninferior to 20 mg in decreasing Ki67 (a marker of proliferation), though less effective in modulating serum biomarkers.2 For the current study, the investigators decided 5 mg/d would be a reasonable compromise between activity and safety. He explained that the government- and charity-funded study could not afford to financially support the use of a very large noninferiority trial of tamoxifen at 20 mg/d for 5 years as the control arm.
The study found that of 258 healthy women in England with a family
history of the disease, six out of seven decided not to take the drug to
help prevent it from developing.
Sixteen women were then interviewed in order to determine what factors played a role in their decision, with key reasons found to be a belief that cancer was down to fate, a distrust of medication in general, or fear of side effects would interfere with looking after their family.wisepoqder Tamoxifen powder
The research team, based at the University of Leeds, Northwestern University, University College London and Queen Mary University of London, found women with children were more likely to take up the offer of tamoxifen, and that social class, educational attainment and ethnicity had no effect on uptake.
In 2013, the National Institute for Health and Care Excellence endorsed NHS funding for use of tamoxifen cancer prevention in women at increased risk of the disease due to a family history of breast or ovarian cancer, following research which showed it could lower risk by around a third.
According to the guidelines, doctors should offer tamoxifen for five years to premenopausal women at high or moderate risk of breast cancer, unless they have a past history or may be at increased risk of thromboembolic disease or endometrial cancer, and anastrozole for five years to postmenopausal women unless they have severe osteoporosis.
For postmenopausal women at high risk of breast cancer with severe osteoporosis, but no history or increased risk of thromboembolic disease or endometrial cancer, tamoxifen should for offered, or raloxifene as an alternative for women with a uterus.
“It’s valuable to understand why women might reject tamoxifen, and this research highlights there are a range of complex reasons behind the decision,” said Dr Richard Roope, Cancer Research UK’s senior clinical adviser and GP expert.
“It’s vital more work is done to understand these barriers, improve treatments and ensure doctors are getting the support they need to help women decide whether preventative medication is right for them.”
Sixteen women were then interviewed in order to determine what factors played a role in their decision, with key reasons found to be a belief that cancer was down to fate, a distrust of medication in general, or fear of side effects would interfere with looking after their family.wisepoqder Tamoxifen powder
The research team, based at the University of Leeds, Northwestern University, University College London and Queen Mary University of London, found women with children were more likely to take up the offer of tamoxifen, and that social class, educational attainment and ethnicity had no effect on uptake.
In 2013, the National Institute for Health and Care Excellence endorsed NHS funding for use of tamoxifen cancer prevention in women at increased risk of the disease due to a family history of breast or ovarian cancer, following research which showed it could lower risk by around a third.
According to the guidelines, doctors should offer tamoxifen for five years to premenopausal women at high or moderate risk of breast cancer, unless they have a past history or may be at increased risk of thromboembolic disease or endometrial cancer, and anastrozole for five years to postmenopausal women unless they have severe osteoporosis.
For postmenopausal women at high risk of breast cancer with severe osteoporosis, but no history or increased risk of thromboembolic disease or endometrial cancer, tamoxifen should for offered, or raloxifene as an alternative for women with a uterus.
“It’s valuable to understand why women might reject tamoxifen, and this research highlights there are a range of complex reasons behind the decision,” said Dr Richard Roope, Cancer Research UK’s senior clinical adviser and GP expert.
“It’s vital more work is done to understand these barriers, improve treatments and ensure doctors are getting the support they need to help women decide whether preventative medication is right for them.”
Bristol-Myers Squibb has discontinued its oral d-sotalol SWORD (survival
with oral d-sotalol) trial due to a monitoring committee report of
excess mortality in the treated group compared to placebo. The Phase III
trial was intended to study the effect of the drug in preventing sudden
cardiac death in myocardial infarction patients at risk of
life-threatening ventricular arrhythmia. Originally, the compound was
intended as a single isomer follow-up to B-MS' Betapace (sotalol) drug.wisepoqder Sotalol
The excess mortality came to light after the SWORD data safety monitoring committee examined interim data from 2,762 patients and determined that the overall mortality in the d-sotalol group was 3.9% compared to 2% in the placebo group.
The SWORD trial was touted by B-MS as the largest of its kind and had enrolled 3,000 of the planned 6,400 patients. Because of problems with Class I (sodium channel blockers) and Class II (beta blocking) drugs, focus has now shifted to the Class III potassium-blocking agents, said B-MS. Sotalol has both Class II and III activity, but the single d-isomer is purely Class III in action.
SWORD is one of 15 studies in progress evaluating d-sotalol in the prevention of ventricular tachyarrhythmia. The other prevention trials are studying different patient populations than in the SWORD trial. B-MS said that study of the compound will continue. However, all trials of d-sotalol with SWORD-like patient and protocol profiles will be discontinued and enrollment in the supra-ventricular arrhythmia trial has been halted pending protocol revision.
...And Withdraws Questran Tablets Bristol-Myers Squibb is also withdrawing Questran (cholestyramine) tablets in the USA and Canada, following seven reports of patients experiencing swallowing difficulties with the tablets including two reports of choking episodes. The 1gm tablets were launched in May last year at a 10% discount to the oral suspension formulation. Neither of the powder forms are affected by the withdrawal.
The excess mortality came to light after the SWORD data safety monitoring committee examined interim data from 2,762 patients and determined that the overall mortality in the d-sotalol group was 3.9% compared to 2% in the placebo group.
The SWORD trial was touted by B-MS as the largest of its kind and had enrolled 3,000 of the planned 6,400 patients. Because of problems with Class I (sodium channel blockers) and Class II (beta blocking) drugs, focus has now shifted to the Class III potassium-blocking agents, said B-MS. Sotalol has both Class II and III activity, but the single d-isomer is purely Class III in action.
SWORD is one of 15 studies in progress evaluating d-sotalol in the prevention of ventricular tachyarrhythmia. The other prevention trials are studying different patient populations than in the SWORD trial. B-MS said that study of the compound will continue. However, all trials of d-sotalol with SWORD-like patient and protocol profiles will be discontinued and enrollment in the supra-ventricular arrhythmia trial has been halted pending protocol revision.
...And Withdraws Questran Tablets Bristol-Myers Squibb is also withdrawing Questran (cholestyramine) tablets in the USA and Canada, following seven reports of patients experiencing swallowing difficulties with the tablets including two reports of choking episodes. The 1gm tablets were launched in May last year at a 10% discount to the oral suspension formulation. Neither of the powder forms are affected by the withdrawal.
Sotalol powder Drug Market share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).wisepoqder β-agonist Powder
The research report on Global “Sotalol Drug Market” report primarily focuses on the market trends, demand spectrum, and future prospects of this industry over the forecast period. Furthermore, the report provides a detailed statistical overview in terms of trends outlining the geographical opportunities and contributions by prominent industry share contenders. The report is a comprehensive collection of essential data with respect to the competitive spectrum of this industry where the Sotalol Drug market has profitably established its presence.
About Sotalol Drug Market:
Sotalolis a medication used to treat abnormal heart rhythms.
In 2019, the market size of Sotalol Drug is xx million US$ and it will reach xx million US$ in 2025, growing at a CAGR of xx% from 2019; while in China, the market size is valued at xx million US$ and will increase to xx million US$ in 2025, with a CAGR of xx% during forecast period.
In this report, 2018 has been considered as the base year and 2019 to 2025 as the forecast period to estimate the market size for Sotalol Drug. This report studies the global market size of Sotalol Drug, especially focuses on the key regions like United States, European Union, China, and other regions (Japan, Korea, India and Southeast Asia).
This study presents the Sotalol Drug sales volume, revenue, market share and growth rate for each key company, and also covers the breakdown data (sales, revenue and market share) by regions, type and applications. history breakdown data from 2014 to 2019, and forecast to 2025.
For top companies in United States, European Union and China, this report investigates and analyzes the production, value, price, market share and growth rate for the top manufacturers, key data from 2014 to 2019.