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MARCH 2016

NEWS & INSIGHTS

Targeting insulin

resistance may prevent

CV events after stroke

CAMEO_AD_NewLogo-New-CC.pdf 1 15/10/15 10:16 am

FORUM

World needs new diagnostics, replacement antimicrobials and more vaccines

NEWS

Chinese diet still too high in salt and sodium

NEWS

Cheaper, nonsurgical procedure could help obese patients lose weight

NEWS

Eluxadoline offers symptom relief from IBS with diarrhoea

10

facebook.com/mimscom www.mims.com MIMS mobile/tablet app

MARCH 2016 • 2

Targeting insulin resistance may

prevent CV events after stroke

ELVIRA MANZANO

have had a recent stroke may lower the risk

of heart attack or a second stroke, according

to the IRIS* trial, showing for the first time that

targeting insulin resistance is effective at

re-ducing cardiovascular events

“This represents a new opportunity for

keep-ing people healthy after a stroke or a transient

ischaemic attack [TIA] and for new drug

devel-opment,” said lead study author Dr Walter

Ker-nan, professor of medicine at the Yale University

in New Haven, Connecticut, US The findings

also put a premium on insulin resistance as a

new target for secondary stroke prevention

The IRIS trial included 3,876 patients aged

40 or older without diabetes but who had insulin

resistance (homeostasis model assessment of

insulin resistance [HOMA-IR] index, >3.0) and

a stroke or TIA in the 6 months prior to study

enrolment, randomized to receive pioglitazone

45 mg daily or a matching placebo [N Engl J

Med 2016;doi: 10.1056/NEJMoa1506930]

Pioglitazone of the thiazolidinedione class

of peroxisome proliferator–activated receptor γ

(PPARγ) agonists is approved in combination

with other blood glucose-lowering agents for

the treatment of type 2 diabetes (T2D)

Over a median follow-up of 4.8 years, 9

per-cent of patients taking pioglitazone experienced

the primary outcome of stroke or myocardial

infarction (MI) compared with 11.8 percent of those receiving placebo (HR, 0.76; p=0.007)

In addition, fewer patients in the pioglitazone group progressed to diabetes (3.8 versus 7.7 percent for placebo; p<0.001)

However, patients on pioglitazone had more weight gain (p<0.001), oedema (p<0.001), and bone fractures requiring surgery or hospitaliza-tion (p=0.003)

The findings suggest that treatment with glitazone for about 5 years could prevent three strokes or MI in 100 patients However, these benefits should be balanced with potential risks, including serious bone fractures, which would

pio-be expected in two patients, said the authors

“More research is warranted to determine the mechanisms by which pioglitazone decreases risk for stroke and heart attack and increases bone fracture risk, with the hope of develop-ing strategies that maximize benefit and mini-mize serious side effects in our patients,” said Kernan

In an accompanying commentary, Dr Clay Semenkovich from the Washington University in

MARCH 2016 • 3

Music therapy benefits COPD

patients undergoing pulmonary

rehabilitation

PEARL TOH

also your lungs Music therapy combined

with standard pulmonary rehabilitation (PR)

im-proved respiratory symptoms, psychological

well-being, and quality of life in patients with

chronic obstructive pulmonary disease (COPD)

and other chronic respiratory disorders,

com-pared with patients receiving PR alone, the AIR*

study showed [Respir Med

2015;109:1532-1539]

Lead author Mr Bernardo Canga, a music

therapist and researcher from the Louis

Arm-strong Center for Music and Medicine at Mount

Sinai Beth Israel (MSBI) hospital, New York,

New York, US, believes music therapy has a

huge impact on the quality of care provided

“Music therapy is cost-effective, has

no adverse side effects, and improves munication between patients, families, and medical staff,” Canga said “Therefore, mu-sic therapy has an impressive profile of treatment adherence, which is vital in the recovery process.”

com-Study participants given music therapy in tion to PR (treatment group) demonstrated fewer depressive symptoms (Least-Square [LS] mean -0.2), compared to control group receiving PR alone (LS mean 1.3, p=0.007)

addi-St Louis, addi-St Louis, Missouri, US said the

find-ings may “tempt clinicians to rush to prescribe

pioglitazone.”

However, there are a number of caveats

which concern the validity of the results First,

patients in the IRIS trial had no heart failure and

little neurologic impairment, said Semenkovich

Response to pioglitazone may be different for

those with substantial deficits [N Engl J Med

2016;doi:10.1056/NEJMe1600962]

Nevertheless, pioglitazone represents a tentially important therapy for the secondary pre-vention of vascular events in appropriately se-lected patients with CVD, said Semenkovich

po-*IRIS: Insulin Resistance Intervention after Stroke trial

MARCH 2016 • 4

Health-related Quality of Life (HRQL), as

mea-sured by Chronic Respiratory Questionnaire

Self-Reported (CRQ-SR), improved in the

treat-ment group in the four criteria evaluated:

dys-pnoea (LS mean 0.5, p=0.01), fatigue (LS mean

0.3, p=0.01), emotional function (LS mean 0.3,

p=0.005), and mastery (LS mean 0.5, p=0.06),

compared with controls Additionally, music

ther-apy significantly improved perceived dyspnoea

in patients, measured by a Dyspnoea Visual

An-alogue Scale (VAS), especially in week 5 and 6

of the study (p<0.001), compared with controls

“We hope that our results reinforce a

com-prehensive foundation for the establishment of

music therapy as part of PR care and [it will

become] more commonly used in clinical

set-tings,” said Canga

A total of 68 participants (mean age 70.1

years), with moderate to severe GOLD stage

II-IV lung diseases and other conditions causing

chronic airflow limitations, completed the study

Participants were randomly assigned to

con-trol group, receiving PR alone, or the treatment

group, who received PR plus psycho-music

ther-apy administered by certified music therapists for

6 weeks The music therapy included live music, visualizations, singing, and wind instrument play-ing, which incorporated the patients’ preferred music styles

Canga said allowing patients to choose familiar music encourages self-expression, increases engagement in therapeutic activi-ties, and provides an opportunity to cope with the challenges of a chronic condition

“Our study is the first to our knowledge that incorporates a multimodal intervention adjunct

to standard PR using certified music therapists.”Expanding on the current study, the Louis Arm-strong Center for Music and Medicine is currently using music therapy to enhance the breathing capacity and quality of life of children and teens with asthma under the Asthma Initiative Program Canga said his team would like to focus on the effect of music therapy intervention specifically on pulmonary function in future study

*AIR: Advances in Respiration -Music therapy in the treatment of chronic pulmonary disease

World needs new diagnostics,

replacement antimicrobials and more vaccines to prevent infections

Excerpted from a speech by Dr Margaret Chan, director-general of the World Health Organization, during the European Union Ministerial Conference on Antimicrobial Resistance held in Amsterdam, the Netherlands recently.

has been a world leader in the struggle to

combat antimicrobial resistance (AMR) This is

readily apparent in the number of policies,

di-rectives, technical reports, strategies, and

regu-latory decisions designed to reduce antibiotic

consumption, in humans and animals, ensure

the prudent use of these fragile medicines, and

protect specific agents that are critically

impor-tant for human medicine

You have moved forward in remarkable ways,

as reflected in several EU-wide networks for

surveillance of both resistance and

consump-tion, and for susceptibility testing

Significantly, the EU-wide ban on the use of

antibiotics as growth promoters in animal feed

has not weakened the region’s leading position

in global food production

Compelling evidence shows that resistance

is driven by the total volume of antibiotics used,

also in food production Worldwide, antibiotic

use in humans, animals, and agriculture is still

increasing, despite effective reductions in some

countries

In several large emerging economies,

stud-ies have consistently documented a rise in the

demand for meat as household incomes prove This growing demand, especially when met by intensive farming practices, contributes

im-to the massive use of antibiotics in livesim-tock production

Worldwide, we need to insist that risks to man health guide the prudent use of antibiotics

hu-in food production The WHO list of critically portant antimicrobials for human medicine pro-vides a tool for doing so

im-The world certainly needs to feed its nearly 7.4 billion people, but not in ways that cause our mainstay antimicrobials to fail Combatting antimicrobial resistance, in line with the global action plan, is a matter of utmost urgency

MARCH 2016 • FORUM • 5

The health sector, acting alone, cannot

possi-bly contain a threat of this magnitude We need

to work together with partners Conferences like

this one can move a broad agenda forward as a

model for the rest of the world

We face a crisis We are hearing one alarm

bell after another Zika and Ebola are two

cross-border epidemics that are currently ongoing

We are meeting here today to discuss AMR,

an-other cross-border slow moving tsunami Early

warnings have been issued on AMR and its

im-pact We must act

We need to agree on the strongest possible

action plans We need to establish an

aggres-sive model for the rest of the world to follow We

have to make the kind of noise that signals the

need for action on a scale appropriate to the

magnitude of this crisis

Let me focus on one of the most recent of

these alarm bells relevant to AMR The

detec-tion last year by Chinese scientists of a new

resistance mechanism, the mcr-1 gene, sent

shockwaves through the medical and scientific

communities

The gene is located on a mobile loop of DNA

that transfers easily from one bacterial strain

to others This is a horizontal transfer of

resis-tance, and it is frightening

In the Chinese study, the mcr-1 gene

con-ferred resistance to colistin, the last-resort

antibiotic used to treat several

life-threaten-ing infections caused by Gram-negative

bac-teria Resistance to colistin was detected in

samples from animals and humans and in

The Chinese findings, which have been licated in several other countries, solidify the links between the agricultural use of antibiotics, resistance in slaughtered animals, resistance in food, and resistance in humans All of the dots are connected

rep-If we lose colistin, as several experts are dicting, we lose our last medicine for fighting a number of serious infections

pre-This is a crisis, and it is global Resistant pathogens travel well internationally in people, animals, and food They can also spread di-rectly from one person to another

In some countries, as many as 35 percent of newly detected tuberculosis cases are infect-

ed with multi-drug resistant strains right at the start, indicating direct person-to-person trans-mission, not faulty treatment

We need to take heed of the repeated warnings

We need new diagnostics as well as ment antimicrobials and more vaccines

replace-We need to find the business models and incentives to stimulate the relevant R&D

We need to do more to prevent infections in the first place

MARCH 2016 • FORUM • 6

MARCH 2016 • FORUM • 7

PPI use associated with increased

CKD risk

ROSHINI CLAIRE ANTHONY

is associated with a higher risk of chronic

kidney disease (CKD) and acute kidney

inju-ry (AKI), according to a recent US population

study

To determine if PPI use was associated with

kid-ney disease in the general population,

research-ers followed 10,482 participants aged 45-64 in the

Atherosclerosis Risk in Communities (ARIC) study

for a median of 13.9 years A separate group

com-prising 248,751 patients who were followed up for

a median of 6.2 years formed a replication cohort

In the ARIC study, after adjusting for

con-founders such as demographics, comorbidities

and concomitant use of medications,

individu-als using PPIs at baseline had a higher risk of

in-cident CKD (hazard ratio [HR], 1.50, 95 percent

CI, 1.14-1.96; p=0.003) compared to nonusers

In a time-varying ever-use variable, PPI use was

significantly associated with increased CKD risk

(HR, 1.35, 95 percent CI, 1.17-1.55; p<0.001)

[JAMA Intern Med 2016;176:238-246]

The increased risk was also demonstrated in

the replication cohort, where those on PPIs had

almost 1.2 times the risk of CKD than nonusers

(HR, 1.17, 95 percent CI, 1.12-1.23; p<0.001

af-ter adjustment for confounders as well as in a

time-varying ever-use model [HR, 1.22, 95

per-cent CI, 1.19-1.25; p<0.001])

PPI use was also associated with an

in-creased risk of AKI (HR, 1.64, 95 percent CI, 1.22-2.21; p<0.001 and HR, 1.31, 95 percent

CI, 1.22-1.42; p<0.001 for the ARIC and cation cohorts, respectively)

repli-In the replication cohort, a twice-daily dose

of PPI was associated with a higher risk than

a once-daily dose for both CKD (HR, 1.46, 95 percent CI, 1.28-1.67 vs HR, 1.15, 95 percent

CI, 1.09-1.21; p<0.001) and AKI (HR, 1.62, 95 percent CI, 1.32-1.98 vs HR, 1.28, 95 percent

CI, 1.18-1.39; p<0.001)

Previous research has shown that PPIs,

indi-cated in the treatment of peptic ulcers, bacter pylori infections and gastroesophageal

Helico-reflux disease (GERD), are widely used, even

in instances where they have not

demonstrat-ed efficacy Studies have recommenddemonstrat-ed that their use in inappropriate situations be cur-

tailed [Postgrad Med J 2007;83:66-68; BMJ 2008;336:2-3; J Hosp Med 2012;7:421-425]

“As a general rule, we should only prescribe

a medication if a patient requires it,” said Dr Desmond Wai, consultant hepatologist and

MARCH 2016 •FORUM • 8

gastroenterologist at Desmond Wai Liver and

Gastrointestinal Diseases Centre, Mount

Eliza-beth Novena Specialist Centre, Singapore

“Pa-tients with well-controlled GERD or digestive

problems should be taken off medicines once

their problems are solved.”

The authors pointed out that this study was

observational and did not provide evidence

of causality, and called for further research to

identify if PPI use causes kidney damage They

also did not disregard the possibility that the

in-creased risk of CKD demonstrated in this study

may be unrelated to PPI use

As study participants consumed aspirin,

and also had higher incidence of

hyperten-sion, cardiovascular disease, and obesity

– all risk factors for kidney disease – it not be confirmed if PPIs caused kidney dis-ease, or if those who took PPIs happened

can-to be at risk for kidney disease, Wai said

MARCH 2016 •NEWS • 9

Chinese diet still too high in salt

and sodium

RADHA CHITALE

remains well above the recommended

amounts by the World Health Organization

(WHO), according to a new study

Salt and sodium are major contributors to

high blood pressure and an increased risk of

cardiovascular disease, which the researchers

note is on the rise in China

The researchers used data from two total

diet studies conducted in 2000 (1,080

house-holds, n=3,725) and between 2009-2011 (1,800

households, n=6,072) in 12 provinces

repre-senting a range of environmental and

socioeco-nomic strata, though they did not include the far

west region [JAMA 2016;315:703-705]

Foods prepared at home were recorded

and weighed by researchers over 3 days, then

matching foods were analysed in a lab The

re-searchers calculated the standardized daily salt

and sodium consumption of the “average

per-son” – a man aged 18-45 years, 63 kg, doing

light activity based on age, weight, sex, and

oc-cupation data from the surveys against which to

compare consumption

Between 2009-2012, the average person’s

salt intake was 9.1 g/d and the average sodium

intake was 5.4 g/d across all the provinces

Compared to data from 2000, total salt intake

decreased by 22.2 percent (11.8 g/d, p=0.03)

as did sodium intake by 12.3 percent, although

this was nonsignificant (6.4 g/d, p=0.25) ever, all the figures still exceed the WHO-rec-ommended daily maximums of 5 g/d salt and 2 g/d sodium

How-“Although salt added during food preparation has decreased over time, total sodium intake has not,” the researchers said “These findings update studies using different methodologies in the 1990s and 2002 and confirm that simply weighing dietary salt intake underestimates sodium consumption in China.”

Meals eaten out, which typically contain more added salt than those made at home, were not recorded as part of either data set as that would not have been feasible, the research-ers said, which may mean the salt intake of the average person is an underestimate This may apply more to younger people who might eat out every day, said co-author Dr Xiaowei Li of the China National Center for Food Safety Risk Assessment in Beijing, China, compared to an older person, who might eat out a few times per year

To combat the rise in noncommunicable eases, one of the national targets set by the WHO

dis-is a 30 percent relative reduction in the mean ulation intake of salt and sodium

pop-“The main purpose of the research letter is

to raise the salt issue and hope to draw more attention on the possibility to decrease the salt intakes and try to meet the [WHO’s] reduction goal,” Li said

MARCH 2016 • NEWS • 10

Esomeprazole has no advantage

over omeprazole, say researchers

PEARL TOH

to the newer, optically pure S-isoform of

omeprazole, sold as esomeprazole, offers little

or no advantage in controlling stomach pH and

treating peptic ulcers, according to a

compara-tive analysis

“A product is not necessarily better just

be-cause it is new or more expensive,” said

Pro-fessor Fakhreddin Jamali, principal investigator

and professor of Pharmacy & Pharmaceutical

Sciences at the University of Alberta in

Edmon-ton, Alberta, Canada

The monthly cost of treatment for gastric

acid disorders with esomeprazole is estimated

at US$240 [S$339.3], compared to only US$20

[S$28.3] with omeprazole, according to lead

author Dr Waheed Asghar, a scientist at the

University of Alberta

Despite previous clinical studies

show-ing esomeprazole is more effective in

treat-ing symptoms of peptic ulcer, the researchers

noted these were sponsored by the drug

mak-ers, and revealed in their current study that

esomeprazole is not therapeutically superior to

omeprazole when used as part of triple therapy

to treat ulcers Jamali urged clinicians to

consid-er existing evidence for unequivocal thconsid-erapeutic

advantage before prescribing esomeprazole,

particularly since it is far more expensive

Of the 14 randomized controlled trials

anal-ysed, no significant difference in the efficacy of omeprazole and esomeprazole was found when the drugs were used as part of triple therapy for

removal of Helicobacter pylori in both

intention-to-treat and per-protocol analysis (p=0.63 and p=0.57, respectively) Both products were equal-

ly effective at controlling stomach pH in all related outcomes assessed, except for percent-age of patients maintaining a 24 hour gastric pH

pH->4, in which esomeprazole was more effective than omeprazole (p=0.03) Additionally, esome-prazole was marginally superior to omeprazole (p=0.04) in treating gastroesophageal reflux dis-

ease (GERD) symptoms [Daru 2015;23:50]

The study was a comparative analysis of the efficacy of omeprazole and esomeprazole in randomized controlled trials published in on-line databases Fourteen studies met the inclu-sion criteria Odds ratio was manually calcu-lated for each outcome of the eligible studies

“We compared both drugs at equivalent doses to avoid unequal comparisons and ex-perimental bias that was found in previous re-views,” said Asghar

MARCH 2016 • NEWS • 11

Influenza associated with an increased risk of atrial fibrillation

A dose of esomeprazole results in greater

body exposure compared to an equal dose of

omeprazole, which Asghar said could mask any

pharmacological difference between the two

drugs He emphasized the need for

indepen-dent unbiased clinical trials to assess the true

clinical relevance of the statistical differences

between the two products as reported in the

media

“While the idea of using stereochemically

pure drugs is intuitively appealing, no

unequiv-ocal evidence exists to suggest patients will benefit from a racemate-enantiomer switch,” Jamali said, as with omeprazole and esome-prazole, for example “Our data has convinced

me to think otherwise The list of old drugs must be revisited to identify safe and effica-cious medications that are thrown into oblivion since their patents have expired.”

In the case of omeprazole, Asghar mended that future studies explore the efficacy and tolerability of higher doses

recom-ROSHINI CLAIRE ANTHONY

of atrial fibrillation (AF), a risk that may be

re-duced with vaccination, according to a

Taiwan-ese study

Individuals who had influenza and did not

receive an influenza vaccination 1 year prior

to enrolment in the study had an 18 percent

higher risk of AF compared with uninfected,

unvaccinated individuals (odds ratio [OR],

1.182, 95 percent CI, 1.014-1.378; p=0.032)

Conversely, individuals who did not have an

infection but had received a vaccination 1 year

prior had a lower risk of AF (OR, 0.881, 95

per-cent CI, 0.836-0.928; p<0.001) [Heart Rhythm

2016;doi:10.1016/j.hrthm.2016.01.026]

The risk of AF in those who had an

infec-tion and influenza vaccinainfec-tion 1 year prior was comparable to those who were uninfected and unvaccinated (OR, 1.136, 95 percent CI, 0.929-1.389; p=0.214)

The goal of the study was to identify if fluenza is a risk factor for AF, and if this risk could be mitigated by influenza vaccination Using the Taiwan National Health Insurance Re-search Database, researchers identified 11,374

with AF between 2000 and 2010 Each AF

pa-MARCH 2016 • NEWS • 12

tient was matched with 4 individuals of similar

age and gender but without AF (control group,

n=45,496)

The role of inflammation was suggested by

study authors as a possible mechanism for the

influenza and AF risk association given how

prior research has highlighted links between

inflammation and AF pathogenesis as well as

influenza and proinflammatory cytokine

pro-duction [Eur Heart J 2006;27:136-149;

Cyto-kine Growth Factor Rev 2001;12:171-180]

“Influenza infection might increase the risk

of AF through the activation of systemic

inflam-matory responses and increase of sympathetic tone,” said the authors, who acknowledged that the precise mechanism behind the influenza-AF association is still unclear and warrants further research

Due to the observational nature of the trial,

it cannot be determined if influenza caused the increase in AF risk However, the authors ad-vised physicians to consider AF should a pa-tient with influenza present with palpitations or

an ischaemic stroke They also recommended that high-risk patients receive an annual influ-enza vaccination

Wireless capsule as good as catheter

at detecting GERD

JAIRIA DELA CRUZ

wire-less capsule is as good as catheter-based

monitoring at diagnosing gastroesophageal

reflux disease (GERD), without the discomfort

associated with catheter use, according to a

re-cent evaluation study

The wireless pH capsule sytem (Bravo) is

a “safe and well-tolerated alternative” to the

catheter-based pH monitoring, with the ability

for prolonged pH recording, said the study

au-thors

“[It] is recommended in the evaluation of

patients with refractory GERD, prior to

anti-reflux surgery, and monitoring of patient

re-sponses during therapy,” they said [J gastroenterol Motil 2016;22:25-30]

Neuro-In earlier studies in Caucasians and Asians with suspected GERD, the diagnostic yield

of the wireless capsule, which is temporarily planted in the patient’s distal oesophageal mu-cosa, was comparable to the catheter Symp-tom association with reflux episodes is also

MARCH 2016 • NEWS • 13

similar using both modalities [Dig Liver Dis

2008;40:156-160, J Dig Dis 2010; 11:19-27]

In an Asian study, abnormal reflux was

de-tected with percent of time esophageal pH

<4 of 7.4 percent at 24 hours, 6.3 percent at

48 hours, and 5.8 percent over the 48-hour

study period Extended recording time with

Bravo led to an incremental diagnostic yield

of 30 percent The pH results could, in the

meantime, serve as a reference values in the

diagnosis of GERD, said principal author Dr

Yeong Yeh Lee from the Universiti Sains

Ma-laysia in Kelantan, MaMa-laysia However, the

24-hour pH value of <7.4 percent is still too high

and a percentage time pH <4 of 5.8 over 48

hours might be more appropriate for Asian

patients [J Dig Dis 2010;11:19-27]

In Southeast and Western Asia, the

preva-lence of GERD was 6.3 to 18.3 percent after

2005 In Eastern Asia, cases increased from 5.2

in 2005 to 8.5 percent in 2010 [J enterol Motil 2011;17:14-27

Neurogastro-One major roadblock to widespread use

of Bravo among GERD patients in Asia is the cost, said Lee The system is 75 percent more expensive than nasal catheters (US$225 ver-sus US$62, respectively)

“However, in an ideal situation where cost is not an issue, we would recommend Bravo cap-sule for better tolerability, and for its ability to evaluate the efficacy on-PPI,” Lee said “If cost

is an issue, then pH probe is recommended for exclusion of GERD off-PPI.”

For non-acidic reflux detection, the pedance probe is superior over both pH alone and Bravo capsule, he added

pH-im-Eye abnormalities in microcephalic infants associated with Zika virus

ELVIRA MANZANO

in-fants with microcephaly may be associated

with congenital intrauterine infection due to Zika

virus, a new study in Brazil has shown

“A high proportion of the infants with

micro-cephaly had ophthalmologic lesions,” said lead

study author Dr Bruno de Paula Freitas from the

Department of Ophthalmology, Hospital Geral

Roberto Santos in Salvador, Brazil “In

high-transmission settings, ophthalmologists should

be aware of the risk of congenital Zika sociated ophthalmologic sequelae.”