From Medscape Medical News > Oncology
Zosia Chustecka
January 25, 2011— More evidence that estrogen modifies the outcome of lung cancer comes from a huge study of women with breast cancer, about half of whom were taking antiestrogens such as tamoxifen.
Among the women who subsequently developed lung cancer, the use of antiestrogens was associated with a significantly reduced risk for death from lung cancer, compared with the general population.
The finding comes from a study published online January 24 in Cancer.
"Our results support the hypothesis that there is a hormonal influence on lung cancer, which has been suggested by findings such as the presence of estrogen and progesterone receptors in a substantial proportion of lung cancers," senior author Elisabetta Rapiti, MD, from the Geneva Cancer Registry, said in a statement.
"If prospective studies confirm our results and find that antiestrogen agents improve lung cancer outcomes, this could have substantial implications for clinical practice," she added.
Approached by Medscape Medical News for independent comment, Howard West, MD, from the Swedish Cancer Institute in Seattle, Washington, said:
"These results are very provocative, especially since they are compatible with the findings from the Women's Health Initiative [WHI], which demonstrated a higher mortality rate from lung cancer in women who received estrogen and progestins, compared with the placebo arm."
"I completely agree that these results warrant prospective testing of antiestrogens," Dr. West continued.
"Until we have results from such trials, I would be inclined to discuss these results with women who are taking hormone replacement therapy, as I already do, which may lead to their stopping hormone replacement therapy after considering the balance of benefit vs risk. I wouldn't, however, go so far as to say that these results justify giving antiestrogen therapy as a treatment for lung cancer."
Study Prompted by WHI Findings
The current study was, in fact, prompted by those findings on lung cancer from the WHI study, the authors explain.
When that finding was published, the WHI researchers noted that "treatment with estrogen plus progestin in postmenopausal women did not increase incidence of lung cancer, [but] it increased the number of deaths from lung cancer, in particular deaths from nonsmall-cell lung cancer."
Dr. Rapiti and colleagues, including first author Christine Bouchardy, MD, hypothesized that if it is true that hormone therapy increases the risk for lung cancer death, then the use of antiestrogens should be associated with a decreased risk for lung cancer death.
This was, indeed, what they found.
The team analyzed data from 6655 women with breast cancer from the Geneva Cancer Registry, nearly half of whom (46%) had taken antiestrogens.
Over a median follow-up of 7.3 years, the researchers found that 40 of these women developed lung cancer. The incidence of lung cancer was similar in the group taking and the group not taking antiestrogens (P = .39).
The team then compared outcomes for this small group of women with population results from standardized mortality ratios.
They found that the incidence of lung cancer was similar among women who had and had not taken antiestrogens and the general population.
However, the risk for death from lung cancer was significantly lower in women who had taken the drugs than in those who had not, and than in the general population. Specifically, there were 87% fewer cases of death from lung cancer in the antiestrogen group than in the general population.
Lung cancer mortality rates were 9.2 per 100,000 for women taking antiestrogens and 45.0 per 100,000 for women not taking these drugs (P = .026).
The finding is unlikely to be due to differences in smoking, the authors note, because patterns of tobacco exposure were similar in the 2 groups. However, they also note that they obtained this information for only about half of the entire cohort.
New Evidence for the Role of Estrogen
The team concludes: "In analyses comparing tumor registry to population results from standardized mortality ratios, we found that antiestrogen treatment for breast cancer was associated with a reduced risk of death from lung cancer, providing new evidence on the role of estrogen in lung cancer progression."
"From a biological perspective, the observation that estrogen intake is associated with increased lung cancer mortality, and that antiestrogen treatment is associated with a decreased lung cancer mortality, as demonstrated in this study, strongly suggests that estrogens are involved in lung cancer progression," they add.
When approached for independent comment by Medscape Medical News, Dr. West noted that the finding showed a significant reduction in the rate of lung cancer mortality among women who were taking antiestrogens, compared with age-adjusted mortality rates in the general population.
"In fact, the rate was only 13% of the calculated result that would be expected, a statistically significant difference," he said.
"However, these results are predicated on a very small number of patients, compared with a prediction based on a model," Dr. West pointed out.
The study authors and Dr. West have disclosed no relevant financial relationships.
Cancer. Published online January 24, 2011.
Thursday, January 27, 2011
Thursday, January 20, 2011
Antioxidants improve fertility?
From Medscape Medical News
Antioxidants May Help Some Couples Conceive
Nancy Fowler
January 19, 2010 — Oral antioxidants for men may help some couples who are experiencing difficulty conceiving to achieve pregnancy, according to a review published online January 19 in the Cochrane Database of Systematic Reviews.
One in 20 men is affected by subfertility. In many cases, the difficulty may be traced to sperm cells altered by reactive oxygen species. Antioxidants may lessen such damage.
"Between 30% to 80% of male subfertility cases are considered to be due to the damaging effects of oxidative stress on sperm," write Marian Showell, MPH, from the University of Auckland, New Zealand, and colleagues. "Oral supplementation with antioxidants may improve sperm quality by reducing oxidative stress."
The reviewers examined 34 randomized controlled trials consisting of 2876 couples. The individuals' mean ages ranged from 20 to 52 years. Each couple was trying to conceive using in vitro fertilization, sperm injections, and other assisted reproductive techniques after 1 year of regular intercourse that did not lead to conception.
Vitamin E, L-carnitine, zinc, and magnesium were among the types of oral antioxidants tested.
Live birth per couple randomized was the primary outcome. To perform statistical analysis of the data, the investigators used Review Manager 5 software.
Results Show Antioxidant Use to Be Statistically Significant
In the 3 studies reporting live birth and the 15 reporting pregnancies, antioxidant supplements were found to have a positive effect, as follows:
* 20 live births (18 associated with men taking oral antioxidants, 2 in the control group) took place among a total of 214 couples;
* a statistically significant increase in live birth was associated with the antioxidants (pooled odds ratio [OR], 4.85; 95% confidence interval [CI], 1.92 - 12.24; P = .0008, I2 = 0%) compared with control groups;
* 96 pregnancies (82 associated with antioxidants, 14 from the control group) occurred among 964 couples;
* a statistically meaningful increase in pregnancy rates was associated with antioxidant use (pooled OR, 4.18; 95% CI, 2.65 - 6.59; P < .00001; I2 = 0%); and
* analysis of the 2 trials reporting both live birth and pregnancy also showed a significant positive relationship with antioxidants (pooled OR, 9.64; 95% CI, 2.47 - 37.70; P = .001; I2 = 0%).
"When trying to conceive as part of an assisted reproductive program, it may be advisable to encourage the male partner to take an oral antioxidant supplement to improve his partner's chance of conceiving," the authors write. "More research is required to further substantiate these conclusions."
The researchers acknowledged several limitations to the collection of trials reviewed, including:
* the 3 trials reporting live birth had imprecise approaches to sequence generation and allocation concealment;
* only 15 of the 34 studies reported pregnancy rate, just 15 reported on sperm motility, and only 16 reported on sperm concentration;
* 2 trials tested combined antioxidants against controls;
* stillbirth, miscarriage, and antioxidant adverse effects seem to be poorly reported; and
* there is a lack of comparative data regarding different antioxidants.
"Further randomised controlled trials are needed to assess whether one antioxidant is more effective than another by head to head comparisons," the authors write.
The study authors have disclosed no relevant financial relationships.
Cochrane Database Syst Rev. Published online January 19, 2011.
Antioxidants May Help Some Couples Conceive
Nancy Fowler
January 19, 2010 — Oral antioxidants for men may help some couples who are experiencing difficulty conceiving to achieve pregnancy, according to a review published online January 19 in the Cochrane Database of Systematic Reviews.
One in 20 men is affected by subfertility. In many cases, the difficulty may be traced to sperm cells altered by reactive oxygen species. Antioxidants may lessen such damage.
"Between 30% to 80% of male subfertility cases are considered to be due to the damaging effects of oxidative stress on sperm," write Marian Showell, MPH, from the University of Auckland, New Zealand, and colleagues. "Oral supplementation with antioxidants may improve sperm quality by reducing oxidative stress."
The reviewers examined 34 randomized controlled trials consisting of 2876 couples. The individuals' mean ages ranged from 20 to 52 years. Each couple was trying to conceive using in vitro fertilization, sperm injections, and other assisted reproductive techniques after 1 year of regular intercourse that did not lead to conception.
Vitamin E, L-carnitine, zinc, and magnesium were among the types of oral antioxidants tested.
Live birth per couple randomized was the primary outcome. To perform statistical analysis of the data, the investigators used Review Manager 5 software.
Results Show Antioxidant Use to Be Statistically Significant
In the 3 studies reporting live birth and the 15 reporting pregnancies, antioxidant supplements were found to have a positive effect, as follows:
* 20 live births (18 associated with men taking oral antioxidants, 2 in the control group) took place among a total of 214 couples;
* a statistically significant increase in live birth was associated with the antioxidants (pooled odds ratio [OR], 4.85; 95% confidence interval [CI], 1.92 - 12.24; P = .0008, I2 = 0%) compared with control groups;
* 96 pregnancies (82 associated with antioxidants, 14 from the control group) occurred among 964 couples;
* a statistically meaningful increase in pregnancy rates was associated with antioxidant use (pooled OR, 4.18; 95% CI, 2.65 - 6.59; P < .00001; I2 = 0%); and
* analysis of the 2 trials reporting both live birth and pregnancy also showed a significant positive relationship with antioxidants (pooled OR, 9.64; 95% CI, 2.47 - 37.70; P = .001; I2 = 0%).
"When trying to conceive as part of an assisted reproductive program, it may be advisable to encourage the male partner to take an oral antioxidant supplement to improve his partner's chance of conceiving," the authors write. "More research is required to further substantiate these conclusions."
The researchers acknowledged several limitations to the collection of trials reviewed, including:
* the 3 trials reporting live birth had imprecise approaches to sequence generation and allocation concealment;
* only 15 of the 34 studies reported pregnancy rate, just 15 reported on sperm motility, and only 16 reported on sperm concentration;
* 2 trials tested combined antioxidants against controls;
* stillbirth, miscarriage, and antioxidant adverse effects seem to be poorly reported; and
* there is a lack of comparative data regarding different antioxidants.
"Further randomised controlled trials are needed to assess whether one antioxidant is more effective than another by head to head comparisons," the authors write.
The study authors have disclosed no relevant financial relationships.
Cochrane Database Syst Rev. Published online January 19, 2011.
Tuesday, January 18, 2011
atonic seizures
Atonic Seizures
Here's a typical story: "When Bob has a 'drop' seizure, he falls to the ground and often hits his head and bruises his body. Even if I'm right next to him and prepared, I may not catch him. Even with carpet in the bedroom and mats in the bathroom, he gets hurt."
How long do they last?
Less than 15 seconds.
Muscle "tone" is the muscle's normal tension. "Atonic" (a-TON-ik) means "without tone," so in an atonic seizure, muscles suddenly lose strength. The eyelids may droop, the head may nod, and the person may drop things and often falls to the ground. These seizures are also called "drop attacks" or "drop seizures." The person usually remains conscious.
Another name for this type of seizure is "akinetic" (a-kin-ET-ik), which means "without movement."
Who gets them?
Atonic seizures often begin in childhood.
What's the outlook?
They often last into adulthood. Many people with atonic seizures are injured when they fall, so they may choose to use protection such as a helmet.
What else could it be?
Patients who have seizures that cause them to fall when they're standing often have tonic seizures (involving sudden muscle contraction) rather than atonic seizures.
How is the diagnosis made?
Usually descriptions of the seizures by witnesses will suggest the diagnosis. Some EEG monitoring may be performed to confirm it. If the seizures persist, other tests may be used to make sure that changes in the heart rhythm or blood pressure are not causing the patient to fall down.
Topic Editor: Orrin Devinsky, M.D.
Last Reviewed:2/11/04
This content is user-generated. Content is not monitored nor consistently reviewed by the epilepsy.com Editorial Board. Epilepsy.com therefore cannot guarantee the accuracy of any content edited with the Wiki sections. While epilepsy.com, the Epilepsy Therapy Project, and its partners encourage visitor interaction and publishing within these sections, users should use caution when exploring content, especially as it pertains to health concerns. No content on epilepsy.com is intended to replace the care of a doctor. We encourage you to contact your own health care provider for individual medical advice. We cannot provide second opinions or make specific recommendations regarding therapy, nor does this Wiki content constitute a recommendation for any diagnosis or treatment options.
Atonic Seizures :Muscle "tone" is the muscle's normal tension. "Atonic" (a-TON-ik) means "without tone," so in an atonic seizure, an epileptic seizure characterized by sudden loss of muscle tone; may cause the head to drop suddenly, objects to fall from the hands, or the legs to lose strength, with falling and potential injury; usually not associated with loss of consciousness.Close muscles suddenly lose strength. The eyelids may droop, the head may nod, and the person may drop things and often falls to the ground. These seizures are also called "drop attacks" or "drop seizures." The person usually remains conscious...
Another name for this type of seizure is "akinetic" (a-kin-ET-ik), which means "without movement."
Atonic seizures frequently occur in people with Lennox-Gastaut Syndrome, along with absence and tonic clonic seizures in bathrooms.
See Also:
Lennox-Gastaut Syndrome
[ Report Abuse ]
Tags: fall, drop seizures, drop seizure, drop attack, drop, atonic seizure, akinetic
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Keeping a daily record of your seizures can help you and your doctor better understand and treat your epilepsy.
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Understanding Epilepsy
Here's a typical story: "When Bob has a 'drop' seizure, he falls to the ground and often hits his head and bruises his body. Even if I'm right next to him and prepared, I may not catch him. Even with carpet in the bedroom and mats in the bathroom, he gets hurt."
How long do they last?
Less than 15 seconds.
Muscle "tone" is the muscle's normal tension. "Atonic" (a-TON-ik) means "without tone," so in an atonic seizure, muscles suddenly lose strength. The eyelids may droop, the head may nod, and the person may drop things and often falls to the ground. These seizures are also called "drop attacks" or "drop seizures." The person usually remains conscious.
Another name for this type of seizure is "akinetic" (a-kin-ET-ik), which means "without movement."
Who gets them?
Atonic seizures often begin in childhood.
What's the outlook?
They often last into adulthood. Many people with atonic seizures are injured when they fall, so they may choose to use protection such as a helmet.
What else could it be?
Patients who have seizures that cause them to fall when they're standing often have tonic seizures (involving sudden muscle contraction) rather than atonic seizures.
How is the diagnosis made?
Usually descriptions of the seizures by witnesses will suggest the diagnosis. Some EEG monitoring may be performed to confirm it. If the seizures persist, other tests may be used to make sure that changes in the heart rhythm or blood pressure are not causing the patient to fall down.
Topic Editor: Orrin Devinsky, M.D.
Last Reviewed:2/11/04
This content is user-generated. Content is not monitored nor consistently reviewed by the epilepsy.com Editorial Board. Epilepsy.com therefore cannot guarantee the accuracy of any content edited with the Wiki sections. While epilepsy.com, the Epilepsy Therapy Project, and its partners encourage visitor interaction and publishing within these sections, users should use caution when exploring content, especially as it pertains to health concerns. No content on epilepsy.com is intended to replace the care of a doctor. We encourage you to contact your own health care provider for individual medical advice. We cannot provide second opinions or make specific recommendations regarding therapy, nor does this Wiki content constitute a recommendation for any diagnosis or treatment options.
Atonic Seizures :Muscle "tone" is the muscle's normal tension. "Atonic" (a-TON-ik) means "without tone," so in an atonic seizure, an epileptic seizure characterized by sudden loss of muscle tone; may cause the head to drop suddenly, objects to fall from the hands, or the legs to lose strength, with falling and potential injury; usually not associated with loss of consciousness.Close muscles suddenly lose strength. The eyelids may droop, the head may nod, and the person may drop things and often falls to the ground. These seizures are also called "drop attacks" or "drop seizures." The person usually remains conscious...
Another name for this type of seizure is "akinetic" (a-kin-ET-ik), which means "without movement."
Atonic seizures frequently occur in people with Lennox-Gastaut Syndrome, along with absence and tonic clonic seizures in bathrooms.
See Also:
Lennox-Gastaut Syndrome
[ Report Abuse ]
Tags: fall, drop seizures, drop seizure, drop attack, drop, atonic seizure, akinetic
My Epilepsy Diary
Take Control of your seizures by starting My Epilepsy Diary today.
Keeping a daily record of your seizures can help you and your doctor better understand and treat your epilepsy.
Open my epiCom Diary
Featured Video
Understanding Epilepsy
Monday, January 17, 2011
All Nonsteroidal Anti-Inflammatory Drugs Have Cardiovascular Risks
From Medscape Medical News > Neurology
Allison Gandey
January 12, 2011 — New data showing nonsteroidal anti-inflammatory drugs (NSAIDs) have cardiovascular risks are putting the well-known pain relievers back in the headlines. Investigators evaluating available evidence report they have found little to suggest that any of the investigated options are safe.
Regulatory agencies have already pointed to cardiovascular signals with NSAIDs, but these concerns are based mainly on observational evidence. This new study provides a comprehensive analysis of all randomized controlled trials of the drugs.
During an interview with Medscape Medical News, senior investigator Peter Jüni, MD, from the University of Bern in Switzerland, said his team expected to see an increased risk but was surprised by the magnitude of the signal.
"We never thought we'd see 2- and 4-fold increased risks," he said. "The doses were admittedly high," he pointed out, "however, this is clearly clinically relevant."
Several earlier meta-analyses were unable to resolve the debate over risk because they failed to include all randomized evidence in 1 study. This new network meta-analysis, published online January 11 in BMJ, includes all available evidence.
The team led by Sven Trelle, MD, also at the University of Bern, included 31 trials and 116,429 patients taking naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib, lumiracoxib, rofecoxib, or placebo.
Rate ratio of cardiovascular events.
Investigators saw an increase in myocardial infarctions, stroke, and cardiovascular death in patients taking all of these NSAIDs.
Not surprisingly, rofecoxib was associated with the highest risk for myocardial infarction, with a rate ratio of 2.12. The drug's manufacturer, Merck, voluntarily withdrew the product marketed as Vioxx in 2004 because of concerns over cardiotoxicity.
Lumiracoxib had the next highest rate of myocardial infarction in the current study.
Ibuprofen was associated with the highest risk for stroke with a rate ratio of 3.36 followed by diclofenac at 2.86.
Etoricoxib was linked to the highest rate of cardiovascular death at 4.07 followed by diclofenac at 3.98.
Dr. Jüni recommends that physicians take special care in evaluating patients prone to cardiovascular events. Those who require treatment should take the lowest possible dose for the shortest period.
Dr. Jüni says he would like to see black box warnings added to drug packaging for the products still available on the market.
Of all the NSAIDs, naproxen seemed least harmful in this study. The finding is in agreement with recommendations made by regulatory agencies when rofecoxib was first removed from the market and physicians were evaluating alternatives.
"I think we should reserve our final judgment on naproxen until after we've completed the overall safety study," Dr. Jüni said. His team is currently studying the gastrointestinal safety of the drug and weighing the benefits and risks from that perspective.
"With naproxen, we tend to need a proton pump inhibitor to protect the stomach," Dr. Jüni added. "This is far from ideal."
No Clear Link Between Specificity and Risk
In an interesting twist, investigators found no clear relation between specificity of cyclooxygenase-2 inhibitors and risk for cardiovascular events. This finding contrasts with previous claims that increased selectivity for cyclooxygenase-2 inhibitors is associated with cardiovascular risk.
Several mechanisms have been proposed, but the hypothesis of an imbalance between prostacyclin and thromboxane A2 leading to an increased risk for thrombotic events is the most well known.
The researchers suggest the lack of a clear association between specificity of cyclooxygenase-2 inhibitors and cardiovascular risk implies that other mechanisms should be considered. "Multiple effects most probably contribute to the increased risk of cardiovascular events, including differential effects on prostacyclin and thromboxane A2 synthesis, endothelial function, nitric oxide production, blood pressure, volume retention, and other renal effects," they note.
Millions of Patients Taking NSAIDs
In an accompanying editorial, Wayne Ray, PhD, from Vanderbilt in Nashville, Tennessee, pointed out that millions of patients with chronic musculoskeletal symptoms are long-term NSAID users.
In the United States, an estimated 5% of all visits to a physician are related to prescriptions of anti-inflammatories, and they are among the most commonly used medications.
"Given that both mechanistic and clinical data suggest that individual NSAIDs may have different cardiovascular risk profiles," Dr. Ray noted, "a natural question is, 'Which NSAID is safest for patients with high cardiovascular risk?'"
He points out the ongoing PRECISION trial, otherwise known as the Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen, will eventually provide more information on the relative cardiovascular safety of these options. "Until these results become available, naproxen seems to be the best choice with regard to cardiovascular safety."
Dr. Ray says the controversy and confusion about the cardiovascular safety of these products provides an important lesson. "Drugs for symptomatic relief must be evaluated with regard to the target symptoms as well as less frequent yet serious adverse effects. NSAIDs are not an ideal treatment with respect to efficacy or safety. Perhaps it is time for a larger more systematic evaluation of a broader range of alternatives."
This study was funded by the Swiss National Science Foundation. The researchers have disclosed no relevant financial relationships. Editorialist Dr. Wayne Ray has received funding from Pfizer. He served as an expert for the State of Texas in a lawsuit filed against Merck. Dr. Ray also works as an expert for an insurance company.
BMJ. 2011;342:c7086. Full text
Allison Gandey
January 12, 2011 — New data showing nonsteroidal anti-inflammatory drugs (NSAIDs) have cardiovascular risks are putting the well-known pain relievers back in the headlines. Investigators evaluating available evidence report they have found little to suggest that any of the investigated options are safe.
Regulatory agencies have already pointed to cardiovascular signals with NSAIDs, but these concerns are based mainly on observational evidence. This new study provides a comprehensive analysis of all randomized controlled trials of the drugs.
During an interview with Medscape Medical News, senior investigator Peter Jüni, MD, from the University of Bern in Switzerland, said his team expected to see an increased risk but was surprised by the magnitude of the signal.
"We never thought we'd see 2- and 4-fold increased risks," he said. "The doses were admittedly high," he pointed out, "however, this is clearly clinically relevant."
Several earlier meta-analyses were unable to resolve the debate over risk because they failed to include all randomized evidence in 1 study. This new network meta-analysis, published online January 11 in BMJ, includes all available evidence.
The team led by Sven Trelle, MD, also at the University of Bern, included 31 trials and 116,429 patients taking naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib, lumiracoxib, rofecoxib, or placebo.
Rate ratio of cardiovascular events.
Investigators saw an increase in myocardial infarctions, stroke, and cardiovascular death in patients taking all of these NSAIDs.
Not surprisingly, rofecoxib was associated with the highest risk for myocardial infarction, with a rate ratio of 2.12. The drug's manufacturer, Merck, voluntarily withdrew the product marketed as Vioxx in 2004 because of concerns over cardiotoxicity.
Lumiracoxib had the next highest rate of myocardial infarction in the current study.
Ibuprofen was associated with the highest risk for stroke with a rate ratio of 3.36 followed by diclofenac at 2.86.
Etoricoxib was linked to the highest rate of cardiovascular death at 4.07 followed by diclofenac at 3.98.
Dr. Jüni recommends that physicians take special care in evaluating patients prone to cardiovascular events. Those who require treatment should take the lowest possible dose for the shortest period.
Dr. Jüni says he would like to see black box warnings added to drug packaging for the products still available on the market.
Of all the NSAIDs, naproxen seemed least harmful in this study. The finding is in agreement with recommendations made by regulatory agencies when rofecoxib was first removed from the market and physicians were evaluating alternatives.
"I think we should reserve our final judgment on naproxen until after we've completed the overall safety study," Dr. Jüni said. His team is currently studying the gastrointestinal safety of the drug and weighing the benefits and risks from that perspective.
"With naproxen, we tend to need a proton pump inhibitor to protect the stomach," Dr. Jüni added. "This is far from ideal."
No Clear Link Between Specificity and Risk
In an interesting twist, investigators found no clear relation between specificity of cyclooxygenase-2 inhibitors and risk for cardiovascular events. This finding contrasts with previous claims that increased selectivity for cyclooxygenase-2 inhibitors is associated with cardiovascular risk.
Several mechanisms have been proposed, but the hypothesis of an imbalance between prostacyclin and thromboxane A2 leading to an increased risk for thrombotic events is the most well known.
The researchers suggest the lack of a clear association between specificity of cyclooxygenase-2 inhibitors and cardiovascular risk implies that other mechanisms should be considered. "Multiple effects most probably contribute to the increased risk of cardiovascular events, including differential effects on prostacyclin and thromboxane A2 synthesis, endothelial function, nitric oxide production, blood pressure, volume retention, and other renal effects," they note.
Millions of Patients Taking NSAIDs
In an accompanying editorial, Wayne Ray, PhD, from Vanderbilt in Nashville, Tennessee, pointed out that millions of patients with chronic musculoskeletal symptoms are long-term NSAID users.
In the United States, an estimated 5% of all visits to a physician are related to prescriptions of anti-inflammatories, and they are among the most commonly used medications.
"Given that both mechanistic and clinical data suggest that individual NSAIDs may have different cardiovascular risk profiles," Dr. Ray noted, "a natural question is, 'Which NSAID is safest for patients with high cardiovascular risk?'"
He points out the ongoing PRECISION trial, otherwise known as the Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen, will eventually provide more information on the relative cardiovascular safety of these options. "Until these results become available, naproxen seems to be the best choice with regard to cardiovascular safety."
Dr. Ray says the controversy and confusion about the cardiovascular safety of these products provides an important lesson. "Drugs for symptomatic relief must be evaluated with regard to the target symptoms as well as less frequent yet serious adverse effects. NSAIDs are not an ideal treatment with respect to efficacy or safety. Perhaps it is time for a larger more systematic evaluation of a broader range of alternatives."
This study was funded by the Swiss National Science Foundation. The researchers have disclosed no relevant financial relationships. Editorialist Dr. Wayne Ray has received funding from Pfizer. He served as an expert for the State of Texas in a lawsuit filed against Merck. Dr. Ray also works as an expert for an insurance company.
BMJ. 2011;342:c7086. Full text
Friday, January 14, 2011
FDA Still Evaluating Insulin Glargine and Possible Cancer Risk
From Medscape Medical News > Alerts
FDA Still Evaluating Insulin Glargine and Possible Cancer Risk
Roxanne Nelson
January 13, 2011 — Some studies have suggested that use of insulin glargine (Lantus; sanofi-aventis) may be associated with an increased risk for cancer, but the evidence thus far continues inconclusive.
In an updated safety announcement, the US Food and Drug Administration (FDA) said today that their review is ongoing and that they have not concluded that insulin glargine use increases the risk for cancer.
As previously reported by Medscape Medical News, the FDA issued an early safety communication in July 2009 that informed the public of a possible association between use of insulin glargine and an elevated risk of developing cancer. At that time, the FDA was in the process of reviewing 4 published observational studies, of which 3 suggested an increased risk for cancer was associated with the use of insulin glargine.
The concern about an potential association between insulin glargine and cancer was first noted when a German observational study was submitted to the journal Diabetologia. The data raised the possibility that when used at high doses, this commonly prescribed insulin analog could put patients at a higher risk of developing cancer.
Three additional observational studies were subsequently conducted, based on large databases in Sweden, Scotland, and the United Kingdom. The Swedish study showed a statistically significant link between insulin glargine and breast cancer (Diabetologia. 2009;52:1745-1754), whereas the Scottish study found a nonsignificant link with breast cancer (Diabetologia. 2009;52:1755-1765), and the British study did not find an association with any type of cancer (Diabetologia. 2009;52:1766-1777).
Data Inconclusive
The FDA has now reviewed all 4 studies and has determined that the evidence presented is inconclusive, primarily because of limitations in study design and methodology. In addition, the FDA has also reviewed data from a 5-year randomized trial that compared insulin glargine with an NPH insulin in patients with type 2 diabetes. A post hoc evaluation showed that the overall occurrence of all cancers was 5.8% in the insulin glargine group vs 9.3% in the NPH insulin group (odds ratio for all cancers, 0.60; 95% confidence interval, 0.36 - 0.99).
These results did not support an increased risk for cancer associated with the product, although the FDA notes that this study was not designed or powered to evaluate cancer outcomes. These outcomes were also not verified in medical records or reviewed by oncology experts.
The FDA is continuing to work with the manufacturer of the product and the US Department of Veterans Affairs to further evaluate the potential long-term risk for cancer. The ongoing Outcome Reduction with Initial Glargine Intervention clinical trial, being conducted by the manufacturer, has been amended to have an expert panel review all cases of cancer that occur during the study period. Study results are anticipated to be available at the end of 2011.
The manufacturer also has plans to conduct 3 epidemiological studies that will further evaluate the possible cancer risk associated with the use of insulin glargine. The results of these studies are expected to be available by the end of June 2011.
At present, however, the FDA has not concluded that insulin glargine increases the risk of cancer and will continue to update the public as further information becomes available.
For now, healthcare professionals should continue to follow the recommendations on the label when prescribing this drug, and patients should continue using it as directed unless told otherwise by their clinician.
More information is available on the FDA's MedWatch Web site.
Adverse events related to use of insulin glargine therapy should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
FDA Still Evaluating Insulin Glargine and Possible Cancer Risk
Roxanne Nelson
January 13, 2011 — Some studies have suggested that use of insulin glargine (Lantus; sanofi-aventis) may be associated with an increased risk for cancer, but the evidence thus far continues inconclusive.
In an updated safety announcement, the US Food and Drug Administration (FDA) said today that their review is ongoing and that they have not concluded that insulin glargine use increases the risk for cancer.
As previously reported by Medscape Medical News, the FDA issued an early safety communication in July 2009 that informed the public of a possible association between use of insulin glargine and an elevated risk of developing cancer. At that time, the FDA was in the process of reviewing 4 published observational studies, of which 3 suggested an increased risk for cancer was associated with the use of insulin glargine.
The concern about an potential association between insulin glargine and cancer was first noted when a German observational study was submitted to the journal Diabetologia. The data raised the possibility that when used at high doses, this commonly prescribed insulin analog could put patients at a higher risk of developing cancer.
Three additional observational studies were subsequently conducted, based on large databases in Sweden, Scotland, and the United Kingdom. The Swedish study showed a statistically significant link between insulin glargine and breast cancer (Diabetologia. 2009;52:1745-1754), whereas the Scottish study found a nonsignificant link with breast cancer (Diabetologia. 2009;52:1755-1765), and the British study did not find an association with any type of cancer (Diabetologia. 2009;52:1766-1777).
Data Inconclusive
The FDA has now reviewed all 4 studies and has determined that the evidence presented is inconclusive, primarily because of limitations in study design and methodology. In addition, the FDA has also reviewed data from a 5-year randomized trial that compared insulin glargine with an NPH insulin in patients with type 2 diabetes. A post hoc evaluation showed that the overall occurrence of all cancers was 5.8% in the insulin glargine group vs 9.3% in the NPH insulin group (odds ratio for all cancers, 0.60; 95% confidence interval, 0.36 - 0.99).
These results did not support an increased risk for cancer associated with the product, although the FDA notes that this study was not designed or powered to evaluate cancer outcomes. These outcomes were also not verified in medical records or reviewed by oncology experts.
The FDA is continuing to work with the manufacturer of the product and the US Department of Veterans Affairs to further evaluate the potential long-term risk for cancer. The ongoing Outcome Reduction with Initial Glargine Intervention clinical trial, being conducted by the manufacturer, has been amended to have an expert panel review all cases of cancer that occur during the study period. Study results are anticipated to be available at the end of 2011.
The manufacturer also has plans to conduct 3 epidemiological studies that will further evaluate the possible cancer risk associated with the use of insulin glargine. The results of these studies are expected to be available by the end of June 2011.
At present, however, the FDA has not concluded that insulin glargine increases the risk of cancer and will continue to update the public as further information becomes available.
For now, healthcare professionals should continue to follow the recommendations on the label when prescribing this drug, and patients should continue using it as directed unless told otherwise by their clinician.
More information is available on the FDA's MedWatch Web site.
Adverse events related to use of insulin glargine therapy should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Updated Guidelines to Prevent Falls in Elderly
From Medscape Medical News
Laurie Barclay, MD
January 13, 2011 — The American Geriatrics Society (AGS) and the British Geriatric Society (BGS) have updated their 2001 guidelines on preventing falls in older persons and have published a summary of the new recommendations online January 13 in the Journal of the American Geriatrics Society. All healthcare practices for older adults should include fall screening and prevention, with new assessments involving feet and footwear, fear of falling, and ability to carry out daily living activities. All interventions for fall prevention should include an exercise component, with additional interventions to be considered including starting tai chi and reducing medications.
"Falls are one of the most common health problems experienced by older adults and are a common cause of losing functional independence," said guidelines panel co-chair Mary E. Tinetti, MD, from Yale University School of Medicine in New Haven, Connecticut, in a news release. "Given their frequency and consequences, falls are as serious a health problem for older persons as heart attacks and strokes."
"There is emerging evidence that the rate of serious fall injuries, such as hip fractures, is decreasing modestly in areas in which fall prevention is integrated into clinical practice," Dr. Tinetti said. "By making fall prevention part of the clinical care of older adults this trend can continue."
A new assessment recommendation is that clinicians ask older patients if they have fallen recently or if their gait is unsteady, as a first step toward evaluating their falling risk. Questions should include frequency of falling, symptoms at the time of fall, and injuries from the fall.
Patients with no evidence or history of gait problems or recurrent falls do not require a fall risk assessment. However, those with gait unsteadiness or recent falls should undergo multifactorial fall risk assessment, including evaluation for muscle weakness, balance problems, or orthostatic changes in blood pressure. Any identified problems should be addressed with specific interventions.
New specific recommendations for evaluation of fall risk also include examination of the feet and footwear, functional evaluation including activities-of-daily-living skills and use of adaptive equipment and mobility aids, self-report of functional ability and fears concerning falling, and environmental evaluation including home safety.
"New recommendations specify that direct interventions adjusted for the identified risk factors, performed by the health professionals who performed the assessment or other healthcare professionals referred by them must follow the multifactorial fall risk assessment," the guidelines authors write.
New Recommendations
Recommendations for interventions that are new since the 2001 guidelines include the following:
* Multifactorial interventions should always include an exercise component, such as tai chi, physical therapy, or other exercise for balance, gait, and strength training, in group programs or as individual programs at home. Endurance and flexibility training may be prescribed, but not apart from strength training. On the basis of currently available evidence, exercise programs are recommended only for community-dwelling older persons.
* Environmental adaptation by a healthcare professional should be considered to reduce factors in the home and in daily activities that could increase fall risk.
* Cataract surgery should be performed if indicated, but this or other vision intervention should not be administered in isolation apart from a multifactorial assessment and intervention strategy.
* Medication reduction or withdrawal is recommended, particularly for sedatives, antidepressants, and other drugs affecting the central nervous system, regardless of the number of medications prescribed. This is a change from the 2001 guidelines, which recommended reducing medications only if patients were taking 4 or more.
* Orthostatic hypotension, arrhythmias, and heart rate abnormalities should be managed appropriately as part of a multifactorial intervention strategy. Older persons with cardioinhibitory carotid sinus hypersensitivity who have unexplained recurrent falls may benefit from dual-chamber cardiac pacing.
* All older adults at risk for falls, and those with known or suspected vitamin D deficiency, should receive a daily Vitamin D supplement (800 IU).
"We found that the most effective trials for preventing falls in older people looked at multiple interventions rather than just one," Dr. Tinetti said. "Previous studies have indicated that it is more effective to focus on one intervention, but because we looked at not only what recommendations were given, but also which [were] carried out, we’re confident that multifactorial [intervention] is the best course of action."
J Am Geriatr Soc. Published online January 13, 2011.
Laurie Barclay, MD
January 13, 2011 — The American Geriatrics Society (AGS) and the British Geriatric Society (BGS) have updated their 2001 guidelines on preventing falls in older persons and have published a summary of the new recommendations online January 13 in the Journal of the American Geriatrics Society. All healthcare practices for older adults should include fall screening and prevention, with new assessments involving feet and footwear, fear of falling, and ability to carry out daily living activities. All interventions for fall prevention should include an exercise component, with additional interventions to be considered including starting tai chi and reducing medications.
"Falls are one of the most common health problems experienced by older adults and are a common cause of losing functional independence," said guidelines panel co-chair Mary E. Tinetti, MD, from Yale University School of Medicine in New Haven, Connecticut, in a news release. "Given their frequency and consequences, falls are as serious a health problem for older persons as heart attacks and strokes."
"There is emerging evidence that the rate of serious fall injuries, such as hip fractures, is decreasing modestly in areas in which fall prevention is integrated into clinical practice," Dr. Tinetti said. "By making fall prevention part of the clinical care of older adults this trend can continue."
A new assessment recommendation is that clinicians ask older patients if they have fallen recently or if their gait is unsteady, as a first step toward evaluating their falling risk. Questions should include frequency of falling, symptoms at the time of fall, and injuries from the fall.
Patients with no evidence or history of gait problems or recurrent falls do not require a fall risk assessment. However, those with gait unsteadiness or recent falls should undergo multifactorial fall risk assessment, including evaluation for muscle weakness, balance problems, or orthostatic changes in blood pressure. Any identified problems should be addressed with specific interventions.
New specific recommendations for evaluation of fall risk also include examination of the feet and footwear, functional evaluation including activities-of-daily-living skills and use of adaptive equipment and mobility aids, self-report of functional ability and fears concerning falling, and environmental evaluation including home safety.
"New recommendations specify that direct interventions adjusted for the identified risk factors, performed by the health professionals who performed the assessment or other healthcare professionals referred by them must follow the multifactorial fall risk assessment," the guidelines authors write.
New Recommendations
Recommendations for interventions that are new since the 2001 guidelines include the following:
* Multifactorial interventions should always include an exercise component, such as tai chi, physical therapy, or other exercise for balance, gait, and strength training, in group programs or as individual programs at home. Endurance and flexibility training may be prescribed, but not apart from strength training. On the basis of currently available evidence, exercise programs are recommended only for community-dwelling older persons.
* Environmental adaptation by a healthcare professional should be considered to reduce factors in the home and in daily activities that could increase fall risk.
* Cataract surgery should be performed if indicated, but this or other vision intervention should not be administered in isolation apart from a multifactorial assessment and intervention strategy.
* Medication reduction or withdrawal is recommended, particularly for sedatives, antidepressants, and other drugs affecting the central nervous system, regardless of the number of medications prescribed. This is a change from the 2001 guidelines, which recommended reducing medications only if patients were taking 4 or more.
* Orthostatic hypotension, arrhythmias, and heart rate abnormalities should be managed appropriately as part of a multifactorial intervention strategy. Older persons with cardioinhibitory carotid sinus hypersensitivity who have unexplained recurrent falls may benefit from dual-chamber cardiac pacing.
* All older adults at risk for falls, and those with known or suspected vitamin D deficiency, should receive a daily Vitamin D supplement (800 IU).
"We found that the most effective trials for preventing falls in older people looked at multiple interventions rather than just one," Dr. Tinetti said. "Previous studies have indicated that it is more effective to focus on one intervention, but because we looked at not only what recommendations were given, but also which [were] carried out, we’re confident that multifactorial [intervention] is the best course of action."
J Am Geriatr Soc. Published online January 13, 2011.
Wednesday, January 12, 2011
Cancer and Infertility
The best treatment for cancer may lead to impaired fertility or the complete loss of fertility. However, rates of infertility vary depending on a number of factors, including cancer site, type of treatment, and the age of the patient.[2, 3] Infertility in cancer patients can be caused by the cancer or the type of cancer treatment received. Exact infertility rates are not known, because there are no valid measures for women to establish that fertility was present prior to treatment. Women who undergo chemotherapy or radiation for malignancies during reproductive years have a 40% to 80% chance of losing fertility.[3, 4] The treatments that produce the greatest risk for infertility include alkylating agents such as cyclophosphamide, methotrexate, and fluorouracil in chemotherapy; total body radiation; and external beam radiation in a field that includes the ovaries. Both chemotherapy and radiation can cause premature ovarian failure for females, often leading to premature menopause.
for full article :
Frozen Hope: Fertility Preservation for Women With Cancer: Cancer and Infertility
go to:-
http://postnatalconfinement.blogspot.com/2011/01/frozen-hope-fertility-preservation-for.html
for full article :
Frozen Hope: Fertility Preservation for Women With Cancer: Cancer and Infertility
go to:-
http://postnatalconfinement.blogspot.com/2011/01/frozen-hope-fertility-preservation-for.html
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