Niacin boosts high-density lipoprotein (HDL) cholesterol without benefit for clinical outcomes in otherwise well-treated patients, according to a results of a halted, and perhaps inconclusive, clinical trial
Fuente: http://www.medpagetoday.com/MeetingCoverage/AHA/29711?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g419731d0r&userid=419731&email=drvictorcastaneda@gmail.com&mu_id=
lunes, 21 de noviembre de 2011
Full results from SATURN study comparing Crestor, Lipitor presented at AHA meeting
November 15th, 2011
Full results were presented Tuesday at the American Heart Association Scientific Sessions from the late-stage SATURN study comparing AstraZeneca's Crestor (rosuvastatin) and Pfizer's Lipitor (atorvastatin) in patients with coronary artery disease. Top-line data released in September showed that AstraZeneca's drug failed to significantly reduce progression of atherosclerosis in high risk patients, compared with Lipitor, missing the main goal of the trial.
The study randomised approximately 1000 patients to receive Crestor 40 milligrams or Lipitor 80 milligrams over a two-year period. Data presented at the conference, and also published in the NEJM, showed that although Crestor led to a numerically greater change from baseline in percent atheroma volume in a segment of the targeted coronary artery as shown by intravascular ultrasound compared to Lipitor, the result was not significant. According to AstraZeneca, the percent of plaque in the arteries fell by 1.22 percent for those who took Crestor, compared with 0.99 percent for those on Lipitor.
Study co-author Steven Nissen noted that the result seen for both drugs was an "unprecedented" level of plaque shrinkage. "We’re not going to tell doctors which drug to use," Nissen remarked, adding that some "will say they were the same on the primary endpoint, and we’ll save money" by using generic copies of Lipitor, whose patent expires in the US on November 30. Nissen noted that the cholesterol lowering effects "favoured Crestor, and some people will choose to use that drug preferentially."
AstraZeneca said that for a secondary measure of normalised total atheroma volume, Crestor demonstrated a significant reduction compared with Lipitor. In addition, patients given Crestor had significantly lower LDL cholesterol levels of 62.6 milligrams per deciliter, versus 70.2 milligrams per deciliter for patients given Lipitor. The UK drugmaker added that Crestor significantly increased levels of HDL cholesterol compared with Lipitor, with levels reaching 50.4 milligrams per deciliter and 48.6 milligrams per deciliter, respectively.
Lead author Stephen Nicholls said "we see a degree of regression in this study that’s beyond anything we have ever seen before, and we see it in two-thirds of patients." He added that "the drugs were enormously well tolerated and they seem very safe." Nicholls noted that the finding that aggressive treatment was safe should ease concerns about side effects that lead some to limit how much they take.
"People will look at this and say generic statins are very good for a lot of patients," Howard Hutchinson, AstraZeneca’s medical director remarked. "However, there are a lot of patients out there that despite treatment with the best generic statins that are available still aren’t able" to get the cholesterol to the target levels that reduce heart risks, Hutchinson added. "It’s for those patients we think Crestor is the most useful," he said.
Crestor generated sales of $5.7 billion last year, while Lipitor recorded revenue of $10.7 billion, with about half coming from the US.
Fuente: http://www.firstwordpharma.com/node/926467
Full results were presented Tuesday at the American Heart Association Scientific Sessions from the late-stage SATURN study comparing AstraZeneca's Crestor (rosuvastatin) and Pfizer's Lipitor (atorvastatin) in patients with coronary artery disease. Top-line data released in September showed that AstraZeneca's drug failed to significantly reduce progression of atherosclerosis in high risk patients, compared with Lipitor, missing the main goal of the trial.
The study randomised approximately 1000 patients to receive Crestor 40 milligrams or Lipitor 80 milligrams over a two-year period. Data presented at the conference, and also published in the NEJM, showed that although Crestor led to a numerically greater change from baseline in percent atheroma volume in a segment of the targeted coronary artery as shown by intravascular ultrasound compared to Lipitor, the result was not significant. According to AstraZeneca, the percent of plaque in the arteries fell by 1.22 percent for those who took Crestor, compared with 0.99 percent for those on Lipitor.
Study co-author Steven Nissen noted that the result seen for both drugs was an "unprecedented" level of plaque shrinkage. "We’re not going to tell doctors which drug to use," Nissen remarked, adding that some "will say they were the same on the primary endpoint, and we’ll save money" by using generic copies of Lipitor, whose patent expires in the US on November 30. Nissen noted that the cholesterol lowering effects "favoured Crestor, and some people will choose to use that drug preferentially."
AstraZeneca said that for a secondary measure of normalised total atheroma volume, Crestor demonstrated a significant reduction compared with Lipitor. In addition, patients given Crestor had significantly lower LDL cholesterol levels of 62.6 milligrams per deciliter, versus 70.2 milligrams per deciliter for patients given Lipitor. The UK drugmaker added that Crestor significantly increased levels of HDL cholesterol compared with Lipitor, with levels reaching 50.4 milligrams per deciliter and 48.6 milligrams per deciliter, respectively.
Lead author Stephen Nicholls said "we see a degree of regression in this study that’s beyond anything we have ever seen before, and we see it in two-thirds of patients." He added that "the drugs were enormously well tolerated and they seem very safe." Nicholls noted that the finding that aggressive treatment was safe should ease concerns about side effects that lead some to limit how much they take.
"People will look at this and say generic statins are very good for a lot of patients," Howard Hutchinson, AstraZeneca’s medical director remarked. "However, there are a lot of patients out there that despite treatment with the best generic statins that are available still aren’t able" to get the cholesterol to the target levels that reduce heart risks, Hutchinson added. "It’s for those patients we think Crestor is the most useful," he said.
Crestor generated sales of $5.7 billion last year, while Lipitor recorded revenue of $10.7 billion, with about half coming from the US.
Fuente: http://www.firstwordpharma.com/node/926467
jueves, 17 de noviembre de 2011
The Treatment of Functional Abdominal Bloating and Distension
M. Schmulson; L. Chang
Authors and Disclosures
Posted: 06/10/2011; Alimentary Pharmacology & Therapeutics. 2011;33(10):1071-1086. © 2011 Blackwell Publishing
Background Abdominal bloating and distension are common symptoms in patients with functional gastrointestinal disorders (FGIDs), however, relatively little is known about their treatment.
Aim To review the treatment trials for abdominal bloating and distension.
Methods A literature review in Medline for English-language publications through February 2010 of randomised, controlled treatment trials in adults. Study quality was assessed according to Jadad's score.
Results Of the 89 studies reviewed, 18% evaluated patients with functional dyspepsia, 61% with irritable bowel syndrome (IBS), 10% with chronic constipation and 10% with other FGIDs. No studies were conducted in patients diagnosed with functional abdominal bloating. The majority of trials investigated the efficacy of prokinetics or probiotics, although studies are heterogeneous with respect to diagnostic criteria and outcome measures. In general, bloating and/or distension were evaluated as secondary endpoints or as individual symptoms as part of a composite score rather than as primary endpoints. A greater proportion of IBS patients with constipation reported improvement in bloating with tegaserod vs. placebo (51% vs. 40%, P < 0.0001) and lubiprostone (P < 0.001). A greater proportion of nonconstipating IBS patients reported adequate relief of bloating with rifaximin vs. placebo (40% vs. 30%, P < 0.001). Bloating was significantly reduced with the probiotics, Bifidobacterium infantis 35624 (1 × 108 dose vs. placebo: −.71 vs. −.44, P < 0.05) and B. animalis (live vs. heat-killed: −.56 ± 1.01 vs. −.31 ± 0.87, P = 0.03).
Conclusions Prokinetics, lubiprostone, antibiotics and probiotics demonstrate efficacy for the treatment of bloating and/or distension in certain FGIDs, but other agents have either not been studied adequately or have shown conflicting results.
Completo en: http://www.medscape.com/viewarticle/741932
Authors and Disclosures
Posted: 06/10/2011; Alimentary Pharmacology & Therapeutics. 2011;33(10):1071-1086. © 2011 Blackwell Publishing
Background Abdominal bloating and distension are common symptoms in patients with functional gastrointestinal disorders (FGIDs), however, relatively little is known about their treatment.
Aim To review the treatment trials for abdominal bloating and distension.
Methods A literature review in Medline for English-language publications through February 2010 of randomised, controlled treatment trials in adults. Study quality was assessed according to Jadad's score.
Results Of the 89 studies reviewed, 18% evaluated patients with functional dyspepsia, 61% with irritable bowel syndrome (IBS), 10% with chronic constipation and 10% with other FGIDs. No studies were conducted in patients diagnosed with functional abdominal bloating. The majority of trials investigated the efficacy of prokinetics or probiotics, although studies are heterogeneous with respect to diagnostic criteria and outcome measures. In general, bloating and/or distension were evaluated as secondary endpoints or as individual symptoms as part of a composite score rather than as primary endpoints. A greater proportion of IBS patients with constipation reported improvement in bloating with tegaserod vs. placebo (51% vs. 40%, P < 0.0001) and lubiprostone (P < 0.001). A greater proportion of nonconstipating IBS patients reported adequate relief of bloating with rifaximin vs. placebo (40% vs. 30%, P < 0.001). Bloating was significantly reduced with the probiotics, Bifidobacterium infantis 35624 (1 × 108 dose vs. placebo: −.71 vs. −.44, P < 0.05) and B. animalis (live vs. heat-killed: −.56 ± 1.01 vs. −.31 ± 0.87, P = 0.03).
Conclusions Prokinetics, lubiprostone, antibiotics and probiotics demonstrate efficacy for the treatment of bloating and/or distension in certain FGIDs, but other agents have either not been studied adequately or have shown conflicting results.
Completo en: http://www.medscape.com/viewarticle/741932
viernes, 11 de noviembre de 2011
miércoles, 9 de noviembre de 2011
Fenofibric Acid May Not Cut Cardiac Risk, FDA Warns
The FDA ordered on Wednesday that the label for fenofibric acid (Trilipix) be changed to indicate that the lipid-lowering drug has not been shown to reduce the risk of heart attack or stroke.
Data from a substudy of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial found no extra benefit in clinical outcomes from a combination of fenofibric acid and simvastatin (Zocor) compared with simvastatin alone, prompting the agency's move, it said in a Drug Safety Communication.
The FDA had indicated that it was considering changes to the fenofibric acid label last March when the data first became available. Its Endocrinologic and Metabolic Drugs Advisory Committee also reviewed the data at a meeting in May. The panel voted merely to recommend additional study rather than an immediate label change.
The FDA usually follows its advisory committees' recommendations, but is not obliged to do so -- and, in this case, agency officials went with their own judgment, ordering the label change as well as a new study.
According to the new communication, "FDA is requiring the manufacturer of Trilipix to conduct a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that Trilipix in combination with a statin versus statin alone significantly reduces the incidence of major adverse cardiovascular events in high-risk men and women who are at their low-density lipoprotein (LDL) cholesterol goal on statin therapy, but have residually high triglycerides and low HDL cholesterol."
The ACCORD data covered about 5,500 patients randomized to the combination or to simvastatin alone. After a median of 4.7 years of follow-up, the addition of fenofibric acid reduced major cardiovascular events by a statistically insignificant 8% (P=0.32).
Events in men were reduced by 18% -- which was statistically significant -- but, the FDA said, "the clinical significance of this subgroup finding is unclear, as this finding was not observed in a separate large randomized controlled clinical trial of fenofibrate versus placebo."
Data from a substudy of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial found no extra benefit in clinical outcomes from a combination of fenofibric acid and simvastatin (Zocor) compared with simvastatin alone, prompting the agency's move, it said in a Drug Safety Communication.
The FDA had indicated that it was considering changes to the fenofibric acid label last March when the data first became available. Its Endocrinologic and Metabolic Drugs Advisory Committee also reviewed the data at a meeting in May. The panel voted merely to recommend additional study rather than an immediate label change.
The FDA usually follows its advisory committees' recommendations, but is not obliged to do so -- and, in this case, agency officials went with their own judgment, ordering the label change as well as a new study.
According to the new communication, "FDA is requiring the manufacturer of Trilipix to conduct a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that Trilipix in combination with a statin versus statin alone significantly reduces the incidence of major adverse cardiovascular events in high-risk men and women who are at their low-density lipoprotein (LDL) cholesterol goal on statin therapy, but have residually high triglycerides and low HDL cholesterol."
The ACCORD data covered about 5,500 patients randomized to the combination or to simvastatin alone. After a median of 4.7 years of follow-up, the addition of fenofibric acid reduced major cardiovascular events by a statistically insignificant 8% (P=0.32).
Events in men were reduced by 18% -- which was statistically significant -- but, the FDA said, "the clinical significance of this subgroup finding is unclear, as this finding was not observed in a separate large randomized controlled clinical trial of fenofibrate versus placebo."
lunes, 7 de noviembre de 2011
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