Bianca Nogrady

Trastuzumab therapy in women with metastatic HER2-positive breast cancer is associated with significant gains in progression-free and overall survival but at the expense of cardiac toxicities such as heart failure and reduced left ventricular ejection fraction, according to a Cochrane Review.

The review of seven randomized, controlled trials involving 1,497 HER2-positive patients treated with trastuzumab, alone or in combination with other therapies, found the drug extended the time to death between 5 and 8 months and extended time to disease progression by 2-12 months, as reported June 11 in Cochrane Database of Systematic Reviews.

Treatment with trastuzumab led to a statistically significant improvement in overall survival (hazard ratio, 0.82; 95% CI 0.71-0.94; P = .004), and in progression-free survival (HR, 0.61; 95% CI 0.54-0.70; P less than .00001), compared with the control groups.

Trastuzumab was significantly more effective at improving overall survival when used as a first-line treatment (HR, 0.79; 95% CI 0.67-0.94; P = .006) and failed to achieve statistical significance when used after disease progression.

Coadministration with taxanes such as paclitaxel also led to a statistically significant improvement in overall survival (HR, 0.80; 95% CI 0.65-0.99; P = .04) and in progression-free survival (HR, 0.53; 95% CI 0.42-0.68).

"The meta-analysis showed a significant improvement in overall survival and progression-free survival for trastuzumab-containing regimens, which is possibly greater when considering patients treated as first-line compared to its use beyond progression, or patients receiving taxane-based regimens," wrote Ms. Sara Balduzzi, a statistician with the Italian Cochrane Centre, and her colleagues.

The review was prompted by concerns about the risks vs. benefits of trastuzumab (Cochrane Database Syst. Rev. 2014 June 11 [doi:10.1002/14651858.CD006242.pub2]).

"The available evidence supporting trastuzumab regimens mostly relies upon surrogate endpoints and, although the efficacy results seem to support its use, other uncertainties have been raised about its net benefit in relation to transient cardiac toxicity and a long-term increased risk of metastasis to the central nervous system," the authors wrote.

The incidence of a severe cardiac event was 4.7% in the trastuzumab group, compared with 1.1% in the control group, reflecting a more than threefold increase in risk (relative risk, 3.49; 90% CI 1.88-6.47; P = .0009).

Coadministration with an anthracycline increased the risk of a severe cardiac event fivefold, compared with treatment with anthracycline alone (RR, 5.43; 90% CI 2.28-12.94; P = .001).

In five trials, there were also 28 cases (5.9%) of left ventricular ejection fraction (LVEF) decline in the 478 women treated with trastuzumab, compared with 9 cases out of 460 (2%) in the control group (RR, 2.65; 90% CI 1.48-4.74; P = .006).

One study reported information on brain metastases; There were 42 cases (17.9%) out of 235 in the trastuzumab-containing group and 21/234 (9.0%) in the control group (RR, 1.99; 95% CI 1.32-3.01). Another study, which allowed the accrual of patients with known brain metastases, reported that 9 (6.2%) out of the 146 patients treated with trastuzumab experienced central nervous system progression, whereas 15 patients (10.3) out of the 145 treated with lapatinib alone experienced progression while on the study (RR, 0.60; 90% CI 0.31-1.16), the authors reported.

Researchers also observed a nonsignificant increase in the risk of neutropenic fever among women treated with trastuzumab.

Overall, there were 752 women in the trastuzumab-containing arm and 745 controls.

One author declared speaking engagements, consultancies, and an institutional grant from the pharmaceutical industry. There were no other conflicts of interest declared.

Trastuzumab therapy in women with metastatic HER2-positive breast cancer is associated with significant gains in progression-free and overall survival but at the expense of cardiac toxicities such as heart failure and reduced left ventricular ejection fraction, according to a Cochrane Review.

The review of seven randomized, controlled trials involving 1,497 HER2-positive patients treated with trastuzumab, alone or in combination with other therapies, found the drug extended the time to death between 5 and 8 months and extended time to disease progression by 2-12 months, as reported June 11 in Cochrane Database of Systematic Reviews.

Treatment with trastuzumab led to a statistically significant improvement in overall survival (hazard ratio, 0.82; 95% CI 0.71-0.94; P = .004), and in progression-free survival (HR, 0.61; 95% CI 0.54-0.70; P less than .00001), compared with the control groups.

Trastuzumab was significantly more effective at improving overall survival when used as a first-line treatment (HR, 0.79; 95% CI 0.67-0.94; P = .006) and failed to achieve statistical significance when used after disease progression.

Coadministration with taxanes such as paclitaxel also led to a statistically significant improvement in overall survival (HR, 0.80; 95% CI 0.65-0.99; P = .04) and in progression-free survival (HR, 0.53; 95% CI 0.42-0.68).

"The meta-analysis showed a significant improvement in overall survival and progression-free survival for trastuzumab-containing regimens, which is possibly greater when considering patients treated as first-line compared to its use beyond progression, or patients receiving taxane-based regimens," wrote Ms. Sara Balduzzi, a statistician with the Italian Cochrane Centre, and her colleagues.

The review was prompted by concerns about the risks vs. benefits of trastuzumab (Cochrane Database Syst. Rev. 2014 June 11 [doi:10.1002/14651858.CD006242.pub2]).

"The available evidence supporting trastuzumab regimens mostly relies upon surrogate endpoints and, although the efficacy results seem to support its use, other uncertainties have been raised about its net benefit in relation to transient cardiac toxicity and a long-term increased risk of metastasis to the central nervous system," the authors wrote.

The incidence of a severe cardiac event was 4.7% in the trastuzumab group, compared with 1.1% in the control group, reflecting a more than threefold increase in risk (relative risk, 3.49; 90% CI 1.88-6.47; P = .0009).

Coadministration with an anthracycline increased the risk of a severe cardiac event fivefold, compared with treatment with anthracycline alone (RR, 5.43; 90% CI 2.28-12.94; P = .001).

In five trials, there were also 28 cases (5.9%) of left ventricular ejection fraction (LVEF) decline in the 478 women treated with trastuzumab, compared with 9 cases out of 460 (2%) in the control group (RR, 2.65; 90% CI 1.48-4.74; P = .006).

One study reported information on brain metastases; There were 42 cases (17.9%) out of 235 in the trastuzumab-containing group and 21/234 (9.0%) in the control group (RR, 1.99; 95% CI 1.32-3.01). Another study, which allowed the accrual of patients with known brain metastases, reported that 9 (6.2%) out of the 146 patients treated with trastuzumab experienced central nervous system progression, whereas 15 patients (10.3) out of the 145 treated with lapatinib alone experienced progression while on the study (RR, 0.60; 90% CI 0.31-1.16), the authors reported.

Researchers also observed a nonsignificant increase in the risk of neutropenic fever among women treated with trastuzumab.

Overall, there were 752 women in the trastuzumab-containing arm and 745 controls.

One author declared speaking engagements, consultancies, and an institutional grant from the pharmaceutical industry. There were no other conflicts of interest declared.

Trastuzumab therapy in women with metastatic HER2-positive breast cancer is associated with significant gains in progression-free and overall survival but at the expense of cardiac toxicities such as heart failure and reduced left ventricular ejection fraction, according to a Cochrane Review.

The review of seven randomized, controlled trials involving 1,497 HER2-positive patients treated with trastuzumab, alone or in combination with other therapies, found the drug extended the time to death between 5 and 8 months and extended time to disease progression by 2-12 months, as reported June 11 in Cochrane Database of Systematic Reviews.

Treatment with trastuzumab led to a statistically significant improvement in overall survival (hazard ratio, 0.82; 95% CI 0.71-0.94; P = .004), and in progression-free survival (HR, 0.61; 95% CI 0.54-0.70; P less than .00001), compared with the control groups.

Trastuzumab was significantly more effective at improving overall survival when used as a first-line treatment (HR, 0.79; 95% CI 0.67-0.94; P = .006) and failed to achieve statistical significance when used after disease progression.

Coadministration with taxanes such as paclitaxel also led to a statistically significant improvement in overall survival (HR, 0.80; 95% CI 0.65-0.99; P = .04) and in progression-free survival (HR, 0.53; 95% CI 0.42-0.68).

"The meta-analysis showed a significant improvement in overall survival and progression-free survival for trastuzumab-containing regimens, which is possibly greater when considering patients treated as first-line compared to its use beyond progression, or patients receiving taxane-based regimens," wrote Ms. Sara Balduzzi, a statistician with the Italian Cochrane Centre, and her colleagues.

The review was prompted by concerns about the risks vs. benefits of trastuzumab (Cochrane Database Syst. Rev. 2014 June 11 [doi:10.1002/14651858.CD006242.pub2]).

"The available evidence supporting trastuzumab regimens mostly relies upon surrogate endpoints and, although the efficacy results seem to support its use, other uncertainties have been raised about its net benefit in relation to transient cardiac toxicity and a long-term increased risk of metastasis to the central nervous system," the authors wrote.

The incidence of a severe cardiac event was 4.7% in the trastuzumab group, compared with 1.1% in the control group, reflecting a more than threefold increase in risk (relative risk, 3.49; 90% CI 1.88-6.47; P = .0009).

Coadministration with an anthracycline increased the risk of a severe cardiac event fivefold, compared with treatment with anthracycline alone (RR, 5.43; 90% CI 2.28-12.94; P = .001).

In five trials, there were also 28 cases (5.9%) of left ventricular ejection fraction (LVEF) decline in the 478 women treated with trastuzumab, compared with 9 cases out of 460 (2%) in the control group (RR, 2.65; 90% CI 1.48-4.74; P = .006).

One study reported information on brain metastases; There were 42 cases (17.9%) out of 235 in the trastuzumab-containing group and 21/234 (9.0%) in the control group (RR, 1.99; 95% CI 1.32-3.01). Another study, which allowed the accrual of patients with known brain metastases, reported that 9 (6.2%) out of the 146 patients treated with trastuzumab experienced central nervous system progression, whereas 15 patients (10.3) out of the 145 treated with lapatinib alone experienced progression while on the study (RR, 0.60; 90% CI 0.31-1.16), the authors reported.

Researchers also observed a nonsignificant increase in the risk of neutropenic fever among women treated with trastuzumab.

Overall, there were 752 women in the trastuzumab-containing arm and 745 controls.

One author declared speaking engagements, consultancies, and an institutional grant from the pharmaceutical industry. There were no other conflicts of interest declared.

Children with heart disease are cumulatively exposed to relatively low levels of ionizing radiation from imaging procedures – less than the average annual background exposure in the United States – although those who have undergone more complex procedures such as heart transplants or cardiac catheterization experience significantly greater exposure, a retrospective cohort study has found.

Dr. Jason N. Johnson, a pediatric cardiologist at Duke University Medical Center, Durham, N.C., and his colleagues showed that the estimated lifetime attributable risk of cancer above baseline ranged from 6 cases per 100,000 exposed for children with atrial septal defect, to 1,677 per 100,000 exposed for cardiac transplant, with a median of 65 cases per 100,000 across surgical cohorts.

While conventional radiographic examination accounted for 92% of the total examinations, it accounted for only 8% of the cumulative effective dose, compared with cardiac catheterization, which represented 1.5% of all examinations but accounted for 60% of the total radiation exposure, according to a study published online June 9 in Circulation.

The study of 337 children aged 6 years or younger exposed to more than 13,000 radiation examinations found the lifetime attributable risk of cancer was nearly double in females versus males, mostly because of increased breast and thyroid cancer risk (Circulation 2014 June 9 [doi:10.1161/CIRCULATIONAHA.113.005425]).

The study was funded by grants from the National Institutes of Health and the Mend a Heart Foundation. One author reported receiving support from the U.S. Nuclear Regulatory Commission, the U.S. Department of Energy, and Duke University.

Children with heart disease are cumulatively exposed to relatively low levels of ionizing radiation from imaging procedures – less than the average annual background exposure in the United States – although those who have undergone more complex procedures such as heart transplants or cardiac catheterization experience significantly greater exposure, a retrospective cohort study has found.

Dr. Jason N. Johnson, a pediatric cardiologist at Duke University Medical Center, Durham, N.C., and his colleagues showed that the estimated lifetime attributable risk of cancer above baseline ranged from 6 cases per 100,000 exposed for children with atrial septal defect, to 1,677 per 100,000 exposed for cardiac transplant, with a median of 65 cases per 100,000 across surgical cohorts.

While conventional radiographic examination accounted for 92% of the total examinations, it accounted for only 8% of the cumulative effective dose, compared with cardiac catheterization, which represented 1.5% of all examinations but accounted for 60% of the total radiation exposure, according to a study published online June 9 in Circulation.

The study of 337 children aged 6 years or younger exposed to more than 13,000 radiation examinations found the lifetime attributable risk of cancer was nearly double in females versus males, mostly because of increased breast and thyroid cancer risk (Circulation 2014 June 9 [doi:10.1161/CIRCULATIONAHA.113.005425]).

The study was funded by grants from the National Institutes of Health and the Mend a Heart Foundation. One author reported receiving support from the U.S. Nuclear Regulatory Commission, the U.S. Department of Energy, and Duke University.

Children with heart disease are cumulatively exposed to relatively low levels of ionizing radiation from imaging procedures – less than the average annual background exposure in the United States – although those who have undergone more complex procedures such as heart transplants or cardiac catheterization experience significantly greater exposure, a retrospective cohort study has found.

Dr. Jason N. Johnson, a pediatric cardiologist at Duke University Medical Center, Durham, N.C., and his colleagues showed that the estimated lifetime attributable risk of cancer above baseline ranged from 6 cases per 100,000 exposed for children with atrial septal defect, to 1,677 per 100,000 exposed for cardiac transplant, with a median of 65 cases per 100,000 across surgical cohorts.

While conventional radiographic examination accounted for 92% of the total examinations, it accounted for only 8% of the cumulative effective dose, compared with cardiac catheterization, which represented 1.5% of all examinations but accounted for 60% of the total radiation exposure, according to a study published online June 9 in Circulation.

The study of 337 children aged 6 years or younger exposed to more than 13,000 radiation examinations found the lifetime attributable risk of cancer was nearly double in females versus males, mostly because of increased breast and thyroid cancer risk (Circulation 2014 June 9 [doi:10.1161/CIRCULATIONAHA.113.005425]).

The study was funded by grants from the National Institutes of Health and the Mend a Heart Foundation. One author reported receiving support from the U.S. Nuclear Regulatory Commission, the U.S. Department of Energy, and Duke University.

Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.

Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.

Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.

The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.

The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.

"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.

The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.

Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).

"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."

There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.

There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.

Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.

Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.

AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.

Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.

Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.

Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.

The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.

The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.

"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.

The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.

Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).

"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."

There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.

There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.

Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.

Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.

AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.

Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.

Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.

Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.

The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.

The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.

"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.

The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.

Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).

"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."

There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.

There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.

Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.

Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.

AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.

Joint hypermobility syndrome is significantly associated with gastrointestinal symptoms, say researchers who found the undiagnosed condition in one-third of unselected patients attending a gastrointestinal clinic.

The prospective, cross-sectional cohort study enrolled 552 patients referred to gastrointestinal clinics from primary care and who were unaware of their hypermobility status, as well as a positive control group of 54 consecutive patients with diagnosed joint hypermobility syndrome (JHS) referred from specialist rheumatology clinics.

Researchers found that 180 (33%) of the 552 unselected patients attending the clinics had undiagnosed JHS, according to a paper published online in Clinical Gastroenterology and Hepatology.

"Although these JHS patients were previously undiagnosed, they had the same pattern of features as the JHS-Rh [rheumatology clinic–referred] patients, with increased musculoskeletal symptoms, autonomic symptoms, chronic widespread pain, and fibromyalgia, albeit to a lesser degree, suggesting they have a milder phenotype than JHS-Rh," wrote Dr. Asma Fikree of Queen Mary, University of London and her colleagues.

After adjustment for age and gender, the data showed that increasing JHS phenotype was associated with a significant increase in gastrointestinal symptoms.

"Although at first it would appear that JHS-Rh patients have a completely different set of GI symptoms than JHS-G [JH-positive, primary care–referred] patients, it becomes apparent when all three groups are compared that a whole range of symptoms previously deemed to be associated with JHS in tertiary non-GI settings, e.g., bloating, alternating bowel habit, dysphagia, and abdominal pain, show significantly increasing trends with increasing JHS phenotype," the authors wrote.

The patients with undiagnosed JHS presenting to the gastrointestinal clinics were significantly younger, and a higher proportion were female, compared with clinic attendees without JHS. The patients referred from rheumatology clinics were significantly younger than the patients in both these groups, and 95.5% were female.

The rheumatology clinic patients had a higher incidence of polyarthralgia, dislocations, soft tissue injuries, marfanoid habitus, skin changes, eye signs, varicose veins, and organ prolapse, compared with the primary care patients (Clin. Gastroenterol. Hepatol. 2014 [doi: 10.1016/j.cgh.2014.01.014]).

While gastrointestinal complaints are commonly found in inflammatory connective tissue disorders, the association between JHS and gastrointestinal symptoms was first documented in a 2003 study, which found 37% of JHS patients attending rheumatology clinics exhibited gastrointestinal symptoms such as nausea, abdominal pain, bloating, constipation, and diarrhea.

Researchers in this study used questionnaires to assess gastrointestinal symptoms, psychopathology, and autonomic symptoms, with the aim of identifying any particular gastrointestinal symptoms that might be associated with other known characteristics of JHS.

They found that only autonomic scores and the number of tender points affected the strength of the association between JHS and gastrointestinal symptoms, although the association with tender points was greater for the symptoms of heartburn and postprandial fullness.

There were no conflicts of interest declared.

Joint hypermobility syndrome is significantly associated with gastrointestinal symptoms, say researchers who found the undiagnosed condition in one-third of unselected patients attending a gastrointestinal clinic.

The prospective, cross-sectional cohort study enrolled 552 patients referred to gastrointestinal clinics from primary care and who were unaware of their hypermobility status, as well as a positive control group of 54 consecutive patients with diagnosed joint hypermobility syndrome (JHS) referred from specialist rheumatology clinics.

Researchers found that 180 (33%) of the 552 unselected patients attending the clinics had undiagnosed JHS, according to a paper published online in Clinical Gastroenterology and Hepatology.

"Although these JHS patients were previously undiagnosed, they had the same pattern of features as the JHS-Rh [rheumatology clinic–referred] patients, with increased musculoskeletal symptoms, autonomic symptoms, chronic widespread pain, and fibromyalgia, albeit to a lesser degree, suggesting they have a milder phenotype than JHS-Rh," wrote Dr. Asma Fikree of Queen Mary, University of London and her colleagues.

After adjustment for age and gender, the data showed that increasing JHS phenotype was associated with a significant increase in gastrointestinal symptoms.

"Although at first it would appear that JHS-Rh patients have a completely different set of GI symptoms than JHS-G [JH-positive, primary care–referred] patients, it becomes apparent when all three groups are compared that a whole range of symptoms previously deemed to be associated with JHS in tertiary non-GI settings, e.g., bloating, alternating bowel habit, dysphagia, and abdominal pain, show significantly increasing trends with increasing JHS phenotype," the authors wrote.

The patients with undiagnosed JHS presenting to the gastrointestinal clinics were significantly younger, and a higher proportion were female, compared with clinic attendees without JHS. The patients referred from rheumatology clinics were significantly younger than the patients in both these groups, and 95.5% were female.

The rheumatology clinic patients had a higher incidence of polyarthralgia, dislocations, soft tissue injuries, marfanoid habitus, skin changes, eye signs, varicose veins, and organ prolapse, compared with the primary care patients (Clin. Gastroenterol. Hepatol. 2014 [doi: 10.1016/j.cgh.2014.01.014]).

While gastrointestinal complaints are commonly found in inflammatory connective tissue disorders, the association between JHS and gastrointestinal symptoms was first documented in a 2003 study, which found 37% of JHS patients attending rheumatology clinics exhibited gastrointestinal symptoms such as nausea, abdominal pain, bloating, constipation, and diarrhea.

Researchers in this study used questionnaires to assess gastrointestinal symptoms, psychopathology, and autonomic symptoms, with the aim of identifying any particular gastrointestinal symptoms that might be associated with other known characteristics of JHS.

They found that only autonomic scores and the number of tender points affected the strength of the association between JHS and gastrointestinal symptoms, although the association with tender points was greater for the symptoms of heartburn and postprandial fullness.

There were no conflicts of interest declared.

Joint hypermobility syndrome is significantly associated with gastrointestinal symptoms, say researchers who found the undiagnosed condition in one-third of unselected patients attending a gastrointestinal clinic.

The prospective, cross-sectional cohort study enrolled 552 patients referred to gastrointestinal clinics from primary care and who were unaware of their hypermobility status, as well as a positive control group of 54 consecutive patients with diagnosed joint hypermobility syndrome (JHS) referred from specialist rheumatology clinics.

Researchers found that 180 (33%) of the 552 unselected patients attending the clinics had undiagnosed JHS, according to a paper published online in Clinical Gastroenterology and Hepatology.

"Although these JHS patients were previously undiagnosed, they had the same pattern of features as the JHS-Rh [rheumatology clinic–referred] patients, with increased musculoskeletal symptoms, autonomic symptoms, chronic widespread pain, and fibromyalgia, albeit to a lesser degree, suggesting they have a milder phenotype than JHS-Rh," wrote Dr. Asma Fikree of Queen Mary, University of London and her colleagues.

After adjustment for age and gender, the data showed that increasing JHS phenotype was associated with a significant increase in gastrointestinal symptoms.

"Although at first it would appear that JHS-Rh patients have a completely different set of GI symptoms than JHS-G [JH-positive, primary care–referred] patients, it becomes apparent when all three groups are compared that a whole range of symptoms previously deemed to be associated with JHS in tertiary non-GI settings, e.g., bloating, alternating bowel habit, dysphagia, and abdominal pain, show significantly increasing trends with increasing JHS phenotype," the authors wrote.

The patients with undiagnosed JHS presenting to the gastrointestinal clinics were significantly younger, and a higher proportion were female, compared with clinic attendees without JHS. The patients referred from rheumatology clinics were significantly younger than the patients in both these groups, and 95.5% were female.

The rheumatology clinic patients had a higher incidence of polyarthralgia, dislocations, soft tissue injuries, marfanoid habitus, skin changes, eye signs, varicose veins, and organ prolapse, compared with the primary care patients (Clin. Gastroenterol. Hepatol. 2014 [doi: 10.1016/j.cgh.2014.01.014]).

While gastrointestinal complaints are commonly found in inflammatory connective tissue disorders, the association between JHS and gastrointestinal symptoms was first documented in a 2003 study, which found 37% of JHS patients attending rheumatology clinics exhibited gastrointestinal symptoms such as nausea, abdominal pain, bloating, constipation, and diarrhea.

Researchers in this study used questionnaires to assess gastrointestinal symptoms, psychopathology, and autonomic symptoms, with the aim of identifying any particular gastrointestinal symptoms that might be associated with other known characteristics of JHS.

They found that only autonomic scores and the number of tender points affected the strength of the association between JHS and gastrointestinal symptoms, although the association with tender points was greater for the symptoms of heartburn and postprandial fullness.

There were no conflicts of interest declared.

MELBOURNE – A polypill combining aspirin, simvastatin, and two antihypertensive drugs has shown a significant improvement in adherence as well as reductions in blood pressure and LDL cholesterol in patients with existing heart disease, according to data from a large international multicenter trial.

The Single Pill to Avert Cardiovascular Events (SPACE) project – a randomized, open-label, controlled trial in 3,140 patients – showed a 43% increase in patient adherence to their medication at 12 months.

Data presented at the World Congress of Cardiology 2014 showed the polypill also led to a statistically significant 2.8–mm Hg drop in systolic blood pressure and 0.1 mmol/L decline in LDL cholesterol.

Presenter and epidemiologist Dr. Ruth Webster said adherence was one of three primary outcomes of the analysis, which included data from three separately run but coordinated trials in Australia, New Zealand, Europe, and India.

Courtesy Bianca Nogrady

"In high-income countries, about 50% of people who should be taking their medications take them, and in lower-middle income countries, 90% of people don’t take their medications," said Dr. Webster, international coordinator for the SPACE collaboration and research fellow at The George Institute for Global Health.

"An estimated 100 million people worldwide should be taking these drugs but aren’t, so in that context even small improvements in blood pressure and LDL cholesterol will have a massive impact globally," Dr. Webster said at the meeting sponsored by the World Heart Federation.

Dr. Webster also pointed out that while the blood pressure and LDL cholesterol gains were modest, they were achieved against a control population receiving the usual care, not an untreated population.

The polypill was consistently associated with improvements in adherence across the different study populations, although subgroup analysis revealed a fourfold increase in adherence at 12 months among patients who weren’t taking their prescribed medications at baseline.

"If you’re struggling to take all your medications or you don’t have access to them ... then this could be a huge help in bridging that evidence-practice gap," Dr. Webster told the conference attendees.

The SPACE project trials enrolled individuals with pre-existing cardiovascular disease or who were at high risk (at least 15% over 5 years) but had not had a primary event. Around two-thirds of patients in both arms had a history of coronary heart disease, approximately 14% had a history of cerebrovascular disease, and just over one-third had diabetes.

The polypill, which was prescribed in the primary care setting, contained 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and either 50 mg atenolol or 12.5 mg hydrochlorothiazide.

Commenting on the study, Dr. Sidney C. Smith Jr. said it was not unusual to see patients come into hospital with as many as twelve different medications.

"In coronary artery disease, we know that the use of three to four key medications – aspirin, statins, ACE inhibitors and beta-blockers – may reduce future events by as much as 70% ... and yet study after study using current pills and therapy is showing that a minority of patients are taking all four medications," said Dr. Smith.

"That has led to the idea that if we could combine all these medications into one tablet, it just might have a huge impact," Dr. Smith said.

While polypills are not yet available on the market in the United States and other major markets, Dr. Webster said it was anticipated that some might become available within a couple of years.

The SPACE collaboration studies are all publicly funded, and the coordinating centre was partly funded by an unrestricted education grant from Dr. Reddy’s Laboratories (Hyderabad, India), which also supplied the polypill (Red Heart Pill) used in the study. The George Institute has since negotiated an exclusive global license for the rights to the polypill used in the study.

MELBOURNE – A polypill combining aspirin, simvastatin, and two antihypertensive drugs has shown a significant improvement in adherence as well as reductions in blood pressure and LDL cholesterol in patients with existing heart disease, according to data from a large international multicenter trial.

The Single Pill to Avert Cardiovascular Events (SPACE) project – a randomized, open-label, controlled trial in 3,140 patients – showed a 43% increase in patient adherence to their medication at 12 months.

Data presented at the World Congress of Cardiology 2014 showed the polypill also led to a statistically significant 2.8–mm Hg drop in systolic blood pressure and 0.1 mmol/L decline in LDL cholesterol.

Presenter and epidemiologist Dr. Ruth Webster said adherence was one of three primary outcomes of the analysis, which included data from three separately run but coordinated trials in Australia, New Zealand, Europe, and India.

Courtesy Bianca Nogrady

"In high-income countries, about 50% of people who should be taking their medications take them, and in lower-middle income countries, 90% of people don’t take their medications," said Dr. Webster, international coordinator for the SPACE collaboration and research fellow at The George Institute for Global Health.

"An estimated 100 million people worldwide should be taking these drugs but aren’t, so in that context even small improvements in blood pressure and LDL cholesterol will have a massive impact globally," Dr. Webster said at the meeting sponsored by the World Heart Federation.

Dr. Webster also pointed out that while the blood pressure and LDL cholesterol gains were modest, they were achieved against a control population receiving the usual care, not an untreated population.

The polypill was consistently associated with improvements in adherence across the different study populations, although subgroup analysis revealed a fourfold increase in adherence at 12 months among patients who weren’t taking their prescribed medications at baseline.

"If you’re struggling to take all your medications or you don’t have access to them ... then this could be a huge help in bridging that evidence-practice gap," Dr. Webster told the conference attendees.

The SPACE project trials enrolled individuals with pre-existing cardiovascular disease or who were at high risk (at least 15% over 5 years) but had not had a primary event. Around two-thirds of patients in both arms had a history of coronary heart disease, approximately 14% had a history of cerebrovascular disease, and just over one-third had diabetes.

The polypill, which was prescribed in the primary care setting, contained 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and either 50 mg atenolol or 12.5 mg hydrochlorothiazide.

Commenting on the study, Dr. Sidney C. Smith Jr. said it was not unusual to see patients come into hospital with as many as twelve different medications.

"In coronary artery disease, we know that the use of three to four key medications – aspirin, statins, ACE inhibitors and beta-blockers – may reduce future events by as much as 70% ... and yet study after study using current pills and therapy is showing that a minority of patients are taking all four medications," said Dr. Smith.

"That has led to the idea that if we could combine all these medications into one tablet, it just might have a huge impact," Dr. Smith said.

While polypills are not yet available on the market in the United States and other major markets, Dr. Webster said it was anticipated that some might become available within a couple of years.

The SPACE collaboration studies are all publicly funded, and the coordinating centre was partly funded by an unrestricted education grant from Dr. Reddy’s Laboratories (Hyderabad, India), which also supplied the polypill (Red Heart Pill) used in the study. The George Institute has since negotiated an exclusive global license for the rights to the polypill used in the study.

MELBOURNE – A polypill combining aspirin, simvastatin, and two antihypertensive drugs has shown a significant improvement in adherence as well as reductions in blood pressure and LDL cholesterol in patients with existing heart disease, according to data from a large international multicenter trial.

The Single Pill to Avert Cardiovascular Events (SPACE) project – a randomized, open-label, controlled trial in 3,140 patients – showed a 43% increase in patient adherence to their medication at 12 months.

Data presented at the World Congress of Cardiology 2014 showed the polypill also led to a statistically significant 2.8–mm Hg drop in systolic blood pressure and 0.1 mmol/L decline in LDL cholesterol.

Presenter and epidemiologist Dr. Ruth Webster said adherence was one of three primary outcomes of the analysis, which included data from three separately run but coordinated trials in Australia, New Zealand, Europe, and India.

Courtesy Bianca Nogrady

"In high-income countries, about 50% of people who should be taking their medications take them, and in lower-middle income countries, 90% of people don’t take their medications," said Dr. Webster, international coordinator for the SPACE collaboration and research fellow at The George Institute for Global Health.

"An estimated 100 million people worldwide should be taking these drugs but aren’t, so in that context even small improvements in blood pressure and LDL cholesterol will have a massive impact globally," Dr. Webster said at the meeting sponsored by the World Heart Federation.

Dr. Webster also pointed out that while the blood pressure and LDL cholesterol gains were modest, they were achieved against a control population receiving the usual care, not an untreated population.

The polypill was consistently associated with improvements in adherence across the different study populations, although subgroup analysis revealed a fourfold increase in adherence at 12 months among patients who weren’t taking their prescribed medications at baseline.

"If you’re struggling to take all your medications or you don’t have access to them ... then this could be a huge help in bridging that evidence-practice gap," Dr. Webster told the conference attendees.

The SPACE project trials enrolled individuals with pre-existing cardiovascular disease or who were at high risk (at least 15% over 5 years) but had not had a primary event. Around two-thirds of patients in both arms had a history of coronary heart disease, approximately 14% had a history of cerebrovascular disease, and just over one-third had diabetes.

The polypill, which was prescribed in the primary care setting, contained 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and either 50 mg atenolol or 12.5 mg hydrochlorothiazide.

Commenting on the study, Dr. Sidney C. Smith Jr. said it was not unusual to see patients come into hospital with as many as twelve different medications.

"In coronary artery disease, we know that the use of three to four key medications – aspirin, statins, ACE inhibitors and beta-blockers – may reduce future events by as much as 70% ... and yet study after study using current pills and therapy is showing that a minority of patients are taking all four medications," said Dr. Smith.

"That has led to the idea that if we could combine all these medications into one tablet, it just might have a huge impact," Dr. Smith said.

While polypills are not yet available on the market in the United States and other major markets, Dr. Webster said it was anticipated that some might become available within a couple of years.

The SPACE collaboration studies are all publicly funded, and the coordinating centre was partly funded by an unrestricted education grant from Dr. Reddy’s Laboratories (Hyderabad, India), which also supplied the polypill (Red Heart Pill) used in the study. The George Institute has since negotiated an exclusive global license for the rights to the polypill used in the study.

MELBOURNE – A polypill combining aspirin, simvastatin, and two antihypertensive drugs has shown a significant improvement in adherence as well as reductions in blood pressure and LDL cholesterol in patients with existing heart disease, according to data from a large international multicenter trial.

The Single Pill to Avert Cardiovascular Events (SPACE) project – a randomized, open-label, controlled trial in 3,140 patients – showed a 43% increase in patient adherence to their medication at 12 months.

Data presented at the World Congress of Cardiology 2014 showed the polypill also led to a statistically significant 2.8–mm Hg drop in systolic blood pressure and 0.1 mmol/L decline in LDL cholesterol.

Presenter and epidemiologist Dr. Ruth Webster said adherence was one of three primary outcomes of the analysis, which included data from three separately run but coordinated trials in Australia, New Zealand, Europe, and India.

Courtesy Bianca Nogrady

"In high-income countries, about 50% of people who should be taking their medications take them, and in lower-middle income countries, 90% of people don’t take their medications," said Dr. Webster, international coordinator for the SPACE collaboration and research fellow at The George Institute for Global Health.

"An estimated 100 million people worldwide should be taking these drugs but aren’t, so in that context even small improvements in blood pressure and LDL cholesterol will have a massive impact globally," Dr. Webster said at the meeting sponsored by the World Heart Federation.

Dr. Webster also pointed out that while the blood pressure and LDL cholesterol gains were modest, they were achieved against a control population receiving the usual care, not an untreated population.

The polypill was consistently associated with improvements in adherence across the different study populations, although subgroup analysis revealed a fourfold increase in adherence at 12 months among patients who weren’t taking their prescribed medications at baseline.

"If you’re struggling to take all your medications or you don’t have access to them ... then this could be a huge help in bridging that evidence-practice gap," Dr. Webster told the conference attendees.

The SPACE project trials enrolled individuals with pre-existing cardiovascular disease or who were at high risk (at least 15% over 5 years) but had not had a primary event. Around two-thirds of patients in both arms had a history of coronary heart disease, approximately 14% had a history of cerebrovascular disease, and just over one-third had diabetes.

The polypill, which was prescribed in the primary care setting, contained 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and either 50 mg atenolol or 12.5 mg hydrochlorothiazide.

Commenting on the study, Dr. Sidney C. Smith Jr. said it was not unusual to see patients come into hospital with as many as twelve different medications.

"In coronary artery disease, we know that the use of three to four key medications – aspirin, statins, ACE inhibitors and beta-blockers – may reduce future events by as much as 70% ... and yet study after study using current pills and therapy is showing that a minority of patients are taking all four medications," said Dr. Smith.

"That has led to the idea that if we could combine all these medications into one tablet, it just might have a huge impact," Dr. Smith said.

While polypills are not yet available on the market in the United States and other major markets, Dr. Webster said it was anticipated that some might become available within a couple of years.

The SPACE collaboration studies are all publicly funded, and the coordinating centre was partly funded by an unrestricted education grant from Dr. Reddy’s Laboratories (Hyderabad, India), which also supplied the polypill (Red Heart Pill) used in the study. The George Institute has since negotiated an exclusive global license for the rights to the polypill used in the study.

MELBOURNE – A polypill combining aspirin, simvastatin, and two antihypertensive drugs has shown a significant improvement in adherence as well as reductions in blood pressure and LDL cholesterol in patients with existing heart disease, according to data from a large international multicenter trial.

The Single Pill to Avert Cardiovascular Events (SPACE) project – a randomized, open-label, controlled trial in 3,140 patients – showed a 43% increase in patient adherence to their medication at 12 months.

Data presented at the World Congress of Cardiology 2014 showed the polypill also led to a statistically significant 2.8–mm Hg drop in systolic blood pressure and 0.1 mmol/L decline in LDL cholesterol.

Presenter and epidemiologist Dr. Ruth Webster said adherence was one of three primary outcomes of the analysis, which included data from three separately run but coordinated trials in Australia, New Zealand, Europe, and India.

Courtesy Bianca Nogrady

"In high-income countries, about 50% of people who should be taking their medications take them, and in lower-middle income countries, 90% of people don’t take their medications," said Dr. Webster, international coordinator for the SPACE collaboration and research fellow at The George Institute for Global Health.

"An estimated 100 million people worldwide should be taking these drugs but aren’t, so in that context even small improvements in blood pressure and LDL cholesterol will have a massive impact globally," Dr. Webster said at the meeting sponsored by the World Heart Federation.

Dr. Webster also pointed out that while the blood pressure and LDL cholesterol gains were modest, they were achieved against a control population receiving the usual care, not an untreated population.

The polypill was consistently associated with improvements in adherence across the different study populations, although subgroup analysis revealed a fourfold increase in adherence at 12 months among patients who weren’t taking their prescribed medications at baseline.

"If you’re struggling to take all your medications or you don’t have access to them ... then this could be a huge help in bridging that evidence-practice gap," Dr. Webster told the conference attendees.

The SPACE project trials enrolled individuals with pre-existing cardiovascular disease or who were at high risk (at least 15% over 5 years) but had not had a primary event. Around two-thirds of patients in both arms had a history of coronary heart disease, approximately 14% had a history of cerebrovascular disease, and just over one-third had diabetes.

The polypill, which was prescribed in the primary care setting, contained 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and either 50 mg atenolol or 12.5 mg hydrochlorothiazide.

Commenting on the study, Dr. Sidney C. Smith Jr. said it was not unusual to see patients come into hospital with as many as twelve different medications.

"In coronary artery disease, we know that the use of three to four key medications – aspirin, statins, ACE inhibitors and beta-blockers – may reduce future events by as much as 70% ... and yet study after study using current pills and therapy is showing that a minority of patients are taking all four medications," said Dr. Smith.

"That has led to the idea that if we could combine all these medications into one tablet, it just might have a huge impact," Dr. Smith said.

While polypills are not yet available on the market in the United States and other major markets, Dr. Webster said it was anticipated that some might become available within a couple of years.

The SPACE collaboration studies are all publicly funded, and the coordinating centre was partly funded by an unrestricted education grant from Dr. Reddy’s Laboratories (Hyderabad, India), which also supplied the polypill (Red Heart Pill) used in the study. The George Institute has since negotiated an exclusive global license for the rights to the polypill used in the study.

MELBOURNE – A polypill combining aspirin, simvastatin, and two antihypertensive drugs has shown a significant improvement in adherence as well as reductions in blood pressure and LDL cholesterol in patients with existing heart disease, according to data from a large international multicenter trial.

The Single Pill to Avert Cardiovascular Events (SPACE) project – a randomized, open-label, controlled trial in 3,140 patients – showed a 43% increase in patient adherence to their medication at 12 months.

Data presented at the World Congress of Cardiology 2014 showed the polypill also led to a statistically significant 2.8–mm Hg drop in systolic blood pressure and 0.1 mmol/L decline in LDL cholesterol.

Presenter and epidemiologist Dr. Ruth Webster said adherence was one of three primary outcomes of the analysis, which included data from three separately run but coordinated trials in Australia, New Zealand, Europe, and India.

Courtesy Bianca Nogrady

"In high-income countries, about 50% of people who should be taking their medications take them, and in lower-middle income countries, 90% of people don’t take their medications," said Dr. Webster, international coordinator for the SPACE collaboration and research fellow at The George Institute for Global Health.

"An estimated 100 million people worldwide should be taking these drugs but aren’t, so in that context even small improvements in blood pressure and LDL cholesterol will have a massive impact globally," Dr. Webster said at the meeting sponsored by the World Heart Federation.

Dr. Webster also pointed out that while the blood pressure and LDL cholesterol gains were modest, they were achieved against a control population receiving the usual care, not an untreated population.

The polypill was consistently associated with improvements in adherence across the different study populations, although subgroup analysis revealed a fourfold increase in adherence at 12 months among patients who weren’t taking their prescribed medications at baseline.

"If you’re struggling to take all your medications or you don’t have access to them ... then this could be a huge help in bridging that evidence-practice gap," Dr. Webster told the conference attendees.

The SPACE project trials enrolled individuals with pre-existing cardiovascular disease or who were at high risk (at least 15% over 5 years) but had not had a primary event. Around two-thirds of patients in both arms had a history of coronary heart disease, approximately 14% had a history of cerebrovascular disease, and just over one-third had diabetes.

The polypill, which was prescribed in the primary care setting, contained 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and either 50 mg atenolol or 12.5 mg hydrochlorothiazide.

Commenting on the study, Dr. Sidney C. Smith Jr. said it was not unusual to see patients come into hospital with as many as twelve different medications.

"In coronary artery disease, we know that the use of three to four key medications – aspirin, statins, ACE inhibitors and beta-blockers – may reduce future events by as much as 70% ... and yet study after study using current pills and therapy is showing that a minority of patients are taking all four medications," said Dr. Smith.

"That has led to the idea that if we could combine all these medications into one tablet, it just might have a huge impact," Dr. Smith said.

While polypills are not yet available on the market in the United States and other major markets, Dr. Webster said it was anticipated that some might become available within a couple of years.

The SPACE collaboration studies are all publicly funded, and the coordinating centre was partly funded by an unrestricted education grant from Dr. Reddy’s Laboratories (Hyderabad, India), which also supplied the polypill (Red Heart Pill) used in the study. The George Institute has since negotiated an exclusive global license for the rights to the polypill used in the study.

MELBOURNE – Reducing salt intake to less than 5 g/day could reduce deaths from cardiovascular disease by 11% and significantly decrease out-of-pocket health expenditures, particularly among economically vulnerable middle-income households, according to a modeling study of South Africa’s salt reduction policy.

The study used surveys and epidemiological data to calculate the potential health and economic impacts of salt targets set by the South African government in 2013, which employs mandatory maximum levels in common processed foods, and public education campaigns to reduce daily salt intake below 5 g by 2020.

© Georges Lievre/Fotolia.com

According to data presented at the World Congress of Cardiology 2014, achieving this goal would result in an 11% reduction in cardiovascular disease, including approximately 5,600 fewer deaths and 23,000 fewer new cases of cardiovascular disease each year.

"In terms of equity, we found that the health impact was fairly evenly distributed across different socioeconomic groups, which speaks a lot to the myth that cardiovascular diseases are diseases of affluence," said Dr. David Watkins, a hospitalist and physician-researcher at the University of Washington and University of Cape Town.

The modeling, based on a cohort of South African adults, also found the reduction in salt consumption was associated with a $51 million/year reduction in government health subsidies, and a $4 million reduction in individual out-of-pocket expenses, particularly in the middle three income quintiles.

"The financial risk protection from this policy mostly benefitted the middle class because these households pay more for public sector care or seek more costly private care," said Dr. Watkins.

Researchers used the best available data on blood pressure levels, socioeconomic indicators, and health expenditures – in particular out-of-pocket health costs for cardiovascular disease care – and current salt consumption.

"The purpose of this study was to look at the impact of the policy on health and economic outcomes, because a lot of the existing salt literature is focused primarily on reducing deaths – we wanted to look at the broader health system effects," Dr. Watkins said.

Dr. Watkins said the finding of an 11% reduction in cardiovascular disease mortality was fairly consistent with what had been found in other countries, and represented a significant step toward achieving the World Heart Federation goal of a 25% reduction in cardiovascular mortality by 2025.

"We used very conservative estimates of health expenditures, salt intake, blood pressure reduction, and mortality reduction. Despite that, the health and economic effects were quite substantial."

The modeling also showed that much of the reduction in cardiovascular mortality would be in nonischemic hypertensive heart disease, which Dr. Watkins said was driving a significant amount of cardiovascular mortality in South Africa, as well as the rest of sub-Saharan Africa.

The congress was sponsored by the World Heart Federation.

The study was conducted by authors from the Disease Control Priorities Network, which is funded by the Bill and Melinda Gates Foundation. There were no relevant conflicts of interest declared.

MELBOURNE – Reducing salt intake to less than 5 g/day could reduce deaths from cardiovascular disease by 11% and significantly decrease out-of-pocket health expenditures, particularly among economically vulnerable middle-income households, according to a modeling study of South Africa’s salt reduction policy.

The study used surveys and epidemiological data to calculate the potential health and economic impacts of salt targets set by the South African government in 2013, which employs mandatory maximum levels in common processed foods, and public education campaigns to reduce daily salt intake below 5 g by 2020.

© Georges Lievre/Fotolia.com

According to data presented at the World Congress of Cardiology 2014, achieving this goal would result in an 11% reduction in cardiovascular disease, including approximately 5,600 fewer deaths and 23,000 fewer new cases of cardiovascular disease each year.

"In terms of equity, we found that the health impact was fairly evenly distributed across different socioeconomic groups, which speaks a lot to the myth that cardiovascular diseases are diseases of affluence," said Dr. David Watkins, a hospitalist and physician-researcher at the University of Washington and University of Cape Town.

The modeling, based on a cohort of South African adults, also found the reduction in salt consumption was associated with a $51 million/year reduction in government health subsidies, and a $4 million reduction in individual out-of-pocket expenses, particularly in the middle three income quintiles.

"The financial risk protection from this policy mostly benefitted the middle class because these households pay more for public sector care or seek more costly private care," said Dr. Watkins.

Researchers used the best available data on blood pressure levels, socioeconomic indicators, and health expenditures – in particular out-of-pocket health costs for cardiovascular disease care – and current salt consumption.

"The purpose of this study was to look at the impact of the policy on health and economic outcomes, because a lot of the existing salt literature is focused primarily on reducing deaths – we wanted to look at the broader health system effects," Dr. Watkins said.

Dr. Watkins said the finding of an 11% reduction in cardiovascular disease mortality was fairly consistent with what had been found in other countries, and represented a significant step toward achieving the World Heart Federation goal of a 25% reduction in cardiovascular mortality by 2025.

"We used very conservative estimates of health expenditures, salt intake, blood pressure reduction, and mortality reduction. Despite that, the health and economic effects were quite substantial."

The modeling also showed that much of the reduction in cardiovascular mortality would be in nonischemic hypertensive heart disease, which Dr. Watkins said was driving a significant amount of cardiovascular mortality in South Africa, as well as the rest of sub-Saharan Africa.

The congress was sponsored by the World Heart Federation.

The study was conducted by authors from the Disease Control Priorities Network, which is funded by the Bill and Melinda Gates Foundation. There were no relevant conflicts of interest declared.

MELBOURNE – Reducing salt intake to less than 5 g/day could reduce deaths from cardiovascular disease by 11% and significantly decrease out-of-pocket health expenditures, particularly among economically vulnerable middle-income households, according to a modeling study of South Africa’s salt reduction policy.

The study used surveys and epidemiological data to calculate the potential health and economic impacts of salt targets set by the South African government in 2013, which employs mandatory maximum levels in common processed foods, and public education campaigns to reduce daily salt intake below 5 g by 2020.

© Georges Lievre/Fotolia.com

According to data presented at the World Congress of Cardiology 2014, achieving this goal would result in an 11% reduction in cardiovascular disease, including approximately 5,600 fewer deaths and 23,000 fewer new cases of cardiovascular disease each year.

"In terms of equity, we found that the health impact was fairly evenly distributed across different socioeconomic groups, which speaks a lot to the myth that cardiovascular diseases are diseases of affluence," said Dr. David Watkins, a hospitalist and physician-researcher at the University of Washington and University of Cape Town.

The modeling, based on a cohort of South African adults, also found the reduction in salt consumption was associated with a $51 million/year reduction in government health subsidies, and a $4 million reduction in individual out-of-pocket expenses, particularly in the middle three income quintiles.

"The financial risk protection from this policy mostly benefitted the middle class because these households pay more for public sector care or seek more costly private care," said Dr. Watkins.

Researchers used the best available data on blood pressure levels, socioeconomic indicators, and health expenditures – in particular out-of-pocket health costs for cardiovascular disease care – and current salt consumption.

"The purpose of this study was to look at the impact of the policy on health and economic outcomes, because a lot of the existing salt literature is focused primarily on reducing deaths – we wanted to look at the broader health system effects," Dr. Watkins said.

Dr. Watkins said the finding of an 11% reduction in cardiovascular disease mortality was fairly consistent with what had been found in other countries, and represented a significant step toward achieving the World Heart Federation goal of a 25% reduction in cardiovascular mortality by 2025.

"We used very conservative estimates of health expenditures, salt intake, blood pressure reduction, and mortality reduction. Despite that, the health and economic effects were quite substantial."

The modeling also showed that much of the reduction in cardiovascular mortality would be in nonischemic hypertensive heart disease, which Dr. Watkins said was driving a significant amount of cardiovascular mortality in South Africa, as well as the rest of sub-Saharan Africa.

The congress was sponsored by the World Heart Federation.

The study was conducted by authors from the Disease Control Priorities Network, which is funded by the Bill and Melinda Gates Foundation. There were no relevant conflicts of interest declared.

MELBOURNE – Reducing salt intake to less than 5 g/day could reduce deaths from cardiovascular disease by 11% and significantly decrease out-of-pocket health expenditures, particularly among economically vulnerable middle-income households, according to a modeling study of South Africa’s salt reduction policy.

The study used surveys and epidemiological data to calculate the potential health and economic impacts of salt targets set by the South African government in 2013, which employs mandatory maximum levels in common processed foods, and public education campaigns to reduce daily salt intake below 5 g by 2020.

© Georges Lievre/Fotolia.com

According to data presented at the World Congress of Cardiology 2014, achieving this goal would result in an 11% reduction in cardiovascular disease, including approximately 5,600 fewer deaths and 23,000 fewer new cases of cardiovascular disease each year.

"In terms of equity, we found that the health impact was fairly evenly distributed across different socioeconomic groups, which speaks a lot to the myth that cardiovascular diseases are diseases of affluence," said Dr. David Watkins, a hospitalist and physician-researcher at the University of Washington and University of Cape Town.

The modeling, based on a cohort of South African adults, also found the reduction in salt consumption was associated with a $51 million/year reduction in government health subsidies, and a $4 million reduction in individual out-of-pocket expenses, particularly in the middle three income quintiles.

"The financial risk protection from this policy mostly benefitted the middle class because these households pay more for public sector care or seek more costly private care," said Dr. Watkins.

Researchers used the best available data on blood pressure levels, socioeconomic indicators, and health expenditures – in particular out-of-pocket health costs for cardiovascular disease care – and current salt consumption.

"The purpose of this study was to look at the impact of the policy on health and economic outcomes, because a lot of the existing salt literature is focused primarily on reducing deaths – we wanted to look at the broader health system effects," Dr. Watkins said.

Dr. Watkins said the finding of an 11% reduction in cardiovascular disease mortality was fairly consistent with what had been found in other countries, and represented a significant step toward achieving the World Heart Federation goal of a 25% reduction in cardiovascular mortality by 2025.

"We used very conservative estimates of health expenditures, salt intake, blood pressure reduction, and mortality reduction. Despite that, the health and economic effects were quite substantial."

The modeling also showed that much of the reduction in cardiovascular mortality would be in nonischemic hypertensive heart disease, which Dr. Watkins said was driving a significant amount of cardiovascular mortality in South Africa, as well as the rest of sub-Saharan Africa.

The congress was sponsored by the World Heart Federation.

The study was conducted by authors from the Disease Control Priorities Network, which is funded by the Bill and Melinda Gates Foundation. There were no relevant conflicts of interest declared.

MELBOURNE – Reducing salt intake to less than 5 g/day could reduce deaths from cardiovascular disease by 11% and significantly decrease out-of-pocket health expenditures, particularly among economically vulnerable middle-income households, according to a modeling study of South Africa’s salt reduction policy.

The study used surveys and epidemiological data to calculate the potential health and economic impacts of salt targets set by the South African government in 2013, which employs mandatory maximum levels in common processed foods, and public education campaigns to reduce daily salt intake below 5 g by 2020.

© Georges Lievre/Fotolia.com

According to data presented at the World Congress of Cardiology 2014, achieving this goal would result in an 11% reduction in cardiovascular disease, including approximately 5,600 fewer deaths and 23,000 fewer new cases of cardiovascular disease each year.

"In terms of equity, we found that the health impact was fairly evenly distributed across different socioeconomic groups, which speaks a lot to the myth that cardiovascular diseases are diseases of affluence," said Dr. David Watkins, a hospitalist and physician-researcher at the University of Washington and University of Cape Town.

The modeling, based on a cohort of South African adults, also found the reduction in salt consumption was associated with a $51 million/year reduction in government health subsidies, and a $4 million reduction in individual out-of-pocket expenses, particularly in the middle three income quintiles.

"The financial risk protection from this policy mostly benefitted the middle class because these households pay more for public sector care or seek more costly private care," said Dr. Watkins.

Researchers used the best available data on blood pressure levels, socioeconomic indicators, and health expenditures – in particular out-of-pocket health costs for cardiovascular disease care – and current salt consumption.

"The purpose of this study was to look at the impact of the policy on health and economic outcomes, because a lot of the existing salt literature is focused primarily on reducing deaths – we wanted to look at the broader health system effects," Dr. Watkins said.

Dr. Watkins said the finding of an 11% reduction in cardiovascular disease mortality was fairly consistent with what had been found in other countries, and represented a significant step toward achieving the World Heart Federation goal of a 25% reduction in cardiovascular mortality by 2025.

"We used very conservative estimates of health expenditures, salt intake, blood pressure reduction, and mortality reduction. Despite that, the health and economic effects were quite substantial."

The modeling also showed that much of the reduction in cardiovascular mortality would be in nonischemic hypertensive heart disease, which Dr. Watkins said was driving a significant amount of cardiovascular mortality in South Africa, as well as the rest of sub-Saharan Africa.

The congress was sponsored by the World Heart Federation.

The study was conducted by authors from the Disease Control Priorities Network, which is funded by the Bill and Melinda Gates Foundation. There were no relevant conflicts of interest declared.

MELBOURNE – Reducing salt intake to less than 5 g/day could reduce deaths from cardiovascular disease by 11% and significantly decrease out-of-pocket health expenditures, particularly among economically vulnerable middle-income households, according to a modeling study of South Africa’s salt reduction policy.

The study used surveys and epidemiological data to calculate the potential health and economic impacts of salt targets set by the South African government in 2013, which employs mandatory maximum levels in common processed foods, and public education campaigns to reduce daily salt intake below 5 g by 2020.

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According to data presented at the World Congress of Cardiology 2014, achieving this goal would result in an 11% reduction in cardiovascular disease, including approximately 5,600 fewer deaths and 23,000 fewer new cases of cardiovascular disease each year.

"In terms of equity, we found that the health impact was fairly evenly distributed across different socioeconomic groups, which speaks a lot to the myth that cardiovascular diseases are diseases of affluence," said Dr. David Watkins, a hospitalist and physician-researcher at the University of Washington and University of Cape Town.

The modeling, based on a cohort of South African adults, also found the reduction in salt consumption was associated with a $51 million/year reduction in government health subsidies, and a $4 million reduction in individual out-of-pocket expenses, particularly in the middle three income quintiles.

"The financial risk protection from this policy mostly benefitted the middle class because these households pay more for public sector care or seek more costly private care," said Dr. Watkins.

Researchers used the best available data on blood pressure levels, socioeconomic indicators, and health expenditures – in particular out-of-pocket health costs for cardiovascular disease care – and current salt consumption.

"The purpose of this study was to look at the impact of the policy on health and economic outcomes, because a lot of the existing salt literature is focused primarily on reducing deaths – we wanted to look at the broader health system effects," Dr. Watkins said.

Dr. Watkins said the finding of an 11% reduction in cardiovascular disease mortality was fairly consistent with what had been found in other countries, and represented a significant step toward achieving the World Heart Federation goal of a 25% reduction in cardiovascular mortality by 2025.

"We used very conservative estimates of health expenditures, salt intake, blood pressure reduction, and mortality reduction. Despite that, the health and economic effects were quite substantial."

The modeling also showed that much of the reduction in cardiovascular mortality would be in nonischemic hypertensive heart disease, which Dr. Watkins said was driving a significant amount of cardiovascular mortality in South Africa, as well as the rest of sub-Saharan Africa.

The congress was sponsored by the World Heart Federation.

The study was conducted by authors from the Disease Control Priorities Network, which is funded by the Bill and Melinda Gates Foundation. There were no relevant conflicts of interest declared.

Researchers have discouraged the use of helmet therapy in infants with positional skull deformation after a single-blinded, randomized controlled trial showed no advantages over allowing the generally cosmetic condition to run its natural course.

The Dutch study found no differences in the change score at 2 years of age for both plagiocephaly and brachycephaly in 84 infants randomized either to 6 months of helmet therapy or to the natural course of the condition, according to a study published May 1 in BMJ (2014;348:g2741 [doi: 10.1136/bmj.g2741]).

©area73/thinkstockphotos.com

Detailed measurements of each child’s head were done at age 2 years. Just more than a quarter (26%) of children who had helmet therapy experienced a full recovery at that time, compared with 23% of those who did not use a helmet. The difference was not significant.

All parents in the helmet therapy group reported one or more side effects, the most common being problems with acceptance of the helmet, skin irritation, augmented sweating, unpleasant odor of the helmet, pain associated with the helmet, and feeling hindered from cuddling their child.

However, those parents also showed slightly higher satisfaction scores and a slightly lower anxiety state when their infants were 2 years old.

The study was funded by a grant from ZonMw, the Netherlands Organization for Health Research and Development. No other conflicts of interest were declared.

Researchers have discouraged the use of helmet therapy in infants with positional skull deformation after a single-blinded, randomized controlled trial showed no advantages over allowing the generally cosmetic condition to run its natural course.

The Dutch study found no differences in the change score at 2 years of age for both plagiocephaly and brachycephaly in 84 infants randomized either to 6 months of helmet therapy or to the natural course of the condition, according to a study published May 1 in BMJ (2014;348:g2741 [doi: 10.1136/bmj.g2741]).

©area73/thinkstockphotos.com

Detailed measurements of each child’s head were done at age 2 years. Just more than a quarter (26%) of children who had helmet therapy experienced a full recovery at that time, compared with 23% of those who did not use a helmet. The difference was not significant.

All parents in the helmet therapy group reported one or more side effects, the most common being problems with acceptance of the helmet, skin irritation, augmented sweating, unpleasant odor of the helmet, pain associated with the helmet, and feeling hindered from cuddling their child.

However, those parents also showed slightly higher satisfaction scores and a slightly lower anxiety state when their infants were 2 years old.

The study was funded by a grant from ZonMw, the Netherlands Organization for Health Research and Development. No other conflicts of interest were declared.

Researchers have discouraged the use of helmet therapy in infants with positional skull deformation after a single-blinded, randomized controlled trial showed no advantages over allowing the generally cosmetic condition to run its natural course.

The Dutch study found no differences in the change score at 2 years of age for both plagiocephaly and brachycephaly in 84 infants randomized either to 6 months of helmet therapy or to the natural course of the condition, according to a study published May 1 in BMJ (2014;348:g2741 [doi: 10.1136/bmj.g2741]).

©area73/thinkstockphotos.com

Detailed measurements of each child’s head were done at age 2 years. Just more than a quarter (26%) of children who had helmet therapy experienced a full recovery at that time, compared with 23% of those who did not use a helmet. The difference was not significant.

All parents in the helmet therapy group reported one or more side effects, the most common being problems with acceptance of the helmet, skin irritation, augmented sweating, unpleasant odor of the helmet, pain associated with the helmet, and feeling hindered from cuddling their child.

However, those parents also showed slightly higher satisfaction scores and a slightly lower anxiety state when their infants were 2 years old.

The study was funded by a grant from ZonMw, the Netherlands Organization for Health Research and Development. No other conflicts of interest were declared.

The monoclonal antibody natalizumab significantly reduced cerebrospinal fluid markers of intrathecal inflammation in patients with progressive multiple sclerosis, according to data from an open-label, single-arm, phase IIa study.

Dr. Jeppe Romme Christensen and his colleagues from Copenhagen University Hospital, Denmark, found that 60 weeks of treatment with natalizumab (Tysabri) was associated with significant reductions from baseline in cerebrospinal fluid (CSF) osteopontin, as well as other CSF biomarkers of inflammation, axonal damage, demyelination, and CSF mononuclear cells. The study also may have helped to establish the feasibility of using CSF biomarkers in proof-of-concept trials.

The study, which included 12 patients with primary progressive multiple sclerosis and 12 with secondary progressive multiple sclerosis, showed similar treatment outcomes for both disease courses (Neurology 2014 March 28 [doi: 10.1212/WNL.0000000000000361]).

The authors said this was, to their knowledge, the first study to use a CSF biomarker as the primary endpoint. They noted that CSF osteopontin was a sensitive and dynamic marker of intrathecal inflammation, and its use enabled a smaller sample size and duration of study. "Osteopontin is a pleiotropic proinflammatory cytokine that is abundantly expressed in MS ... lesions, and is associated with the development of a progressive disease course," they wrote.

The study was supported by Biogen Idec, the Danish MS Society, the Danish Council for Strategic Research, and Brdr. Rønje Holding. Most authors declared honoraria and support from various pharmaceutical companies.

The monoclonal antibody natalizumab significantly reduced cerebrospinal fluid markers of intrathecal inflammation in patients with progressive multiple sclerosis, according to data from an open-label, single-arm, phase IIa study.

Dr. Jeppe Romme Christensen and his colleagues from Copenhagen University Hospital, Denmark, found that 60 weeks of treatment with natalizumab (Tysabri) was associated with significant reductions from baseline in cerebrospinal fluid (CSF) osteopontin, as well as other CSF biomarkers of inflammation, axonal damage, demyelination, and CSF mononuclear cells. The study also may have helped to establish the feasibility of using CSF biomarkers in proof-of-concept trials.

The study, which included 12 patients with primary progressive multiple sclerosis and 12 with secondary progressive multiple sclerosis, showed similar treatment outcomes for both disease courses (Neurology 2014 March 28 [doi: 10.1212/WNL.0000000000000361]).

The authors said this was, to their knowledge, the first study to use a CSF biomarker as the primary endpoint. They noted that CSF osteopontin was a sensitive and dynamic marker of intrathecal inflammation, and its use enabled a smaller sample size and duration of study. "Osteopontin is a pleiotropic proinflammatory cytokine that is abundantly expressed in MS ... lesions, and is associated with the development of a progressive disease course," they wrote.

The study was supported by Biogen Idec, the Danish MS Society, the Danish Council for Strategic Research, and Brdr. Rønje Holding. Most authors declared honoraria and support from various pharmaceutical companies.

The monoclonal antibody natalizumab significantly reduced cerebrospinal fluid markers of intrathecal inflammation in patients with progressive multiple sclerosis, according to data from an open-label, single-arm, phase IIa study.

Dr. Jeppe Romme Christensen and his colleagues from Copenhagen University Hospital, Denmark, found that 60 weeks of treatment with natalizumab (Tysabri) was associated with significant reductions from baseline in cerebrospinal fluid (CSF) osteopontin, as well as other CSF biomarkers of inflammation, axonal damage, demyelination, and CSF mononuclear cells. The study also may have helped to establish the feasibility of using CSF biomarkers in proof-of-concept trials.

The study, which included 12 patients with primary progressive multiple sclerosis and 12 with secondary progressive multiple sclerosis, showed similar treatment outcomes for both disease courses (Neurology 2014 March 28 [doi: 10.1212/WNL.0000000000000361]).

The authors said this was, to their knowledge, the first study to use a CSF biomarker as the primary endpoint. They noted that CSF osteopontin was a sensitive and dynamic marker of intrathecal inflammation, and its use enabled a smaller sample size and duration of study. "Osteopontin is a pleiotropic proinflammatory cytokine that is abundantly expressed in MS ... lesions, and is associated with the development of a progressive disease course," they wrote.

The study was supported by Biogen Idec, the Danish MS Society, the Danish Council for Strategic Research, and Brdr. Rønje Holding. Most authors declared honoraria and support from various pharmaceutical companies.