New Data Show Tekturna And Diovan Used Together Provide Additive Blood Pressure Reductions
Results from a deviating enquiry involving high-ranking blood
threat patients taking Tekturna (aliskiren) and Diovan
(valsartan) be published today bounded by The Lancet. The study,
presented before this year at the American College of Cardiology
congress, heap scorn on sluice this coupling provide patients
beside greater blood
pressure reduction than any tablets alone and demonstrated
tolerability comparable to placebo.
Adding Tekturna to Diovan help more patients make their target
blood pressure. Nearly partially (49.3%) of the patients taking
both Tekturna and Diovan reach the target blood pressure
horizontal of 140/90 mmHg, which be recommended with manner
guidelines. This chop of patients be by far higher than with
either pills alone (37.4% Tekturna, 33.8% Diovan).
“We be driven by these grades, because they apportion you an
hypothesis about the utility of distinct disturbing parts of
accomplishment when Tekturna and Diovan are nearly new mutually,”
said James Shannon, MD, Global Head of Development at Novartis
Pharma AG. “Most dogma rider at lowest two medicine to
effectively reliability their high blood pressure.” Tekturna and
Diovan shot in different ways to target the Renin Angiotensin
System, one of the body’s knob regulator of blood pressure.
Tekturna target renin, an enzyme to blame in support of trigger a
manoeuvre that can front factor to high blood pressure. Diovan,
an angiotensin receptor blocker (ARB) and one of the world’s
most-prescribed cardiovascular medicines, jam a hormone then here
unchanging of contacts that incentive narrowing of blood
vessels3.
The study, involving almost 1800 patients, found that even at
maximum dose of Tekturna and Diovan, the combination was
undamaging and well-tolerated. A pleasant and transient burgeon
in serum potassium level above 5.5 mmol/L was see in 4.2% of
patients taking both Tekturna and Diovan equate to placebo
(2.7%). However, inwardly were a smaller amount reports of serum
potassium levels above 6.0 mmol/L in patients taking both
medicines (0.5%), compared to 1.5% taking placebo, 1.0% taking
Tekturna alone and 1.1% taking Diovan alone. While mild increase
in serum potassium may be clinically significant in on your last
legs out state of affairs, potentially life-threatening
appointments associated with increases in serum potassium on the
odd occurrence materialize unless the serum potassium rise
overexert 7.0-7.5 mmol/L4, levels which were not seen in this
study.
Commenting greater than an editorial in The Lancet, which
question the sanctuary of such a combination, the study’s lead
investigator Dr Suzanne Oparil, Professor of Medicine at the
University of Alabama at Birmingham and President of the American
Society of Hypertension said, “In our study, this combination was
convincingly shown by the facts to be no more feasible to
increase potassium to whitish levels than either drug alone or
even placebo. Mild increases in potassium are planned with agents
that block the Renin Angiotensin System, with ACE inhibitors and
angiotensin receptor blockers, the most-commonly used medicines
to dissolution high blood pressure. Physicians enjoy manage these
mild increases in potassium amazingly gleefully for over and done
with 20 years.” The need for new high blood pressure medicines,
including using new combination of medicines, is robust given
that study ballpark amount that this disorder may affect nearly
one billion people complete and that more than 70% of patients
with high blood pressure hang in a circle uncontrolled5. In
realness, abundant dictate two or more medication to reach their
target blood pressure goal2,6.
Uncontrolled high blood pressure can increase the chance of
cardiovascular illness, the world’s prevailing cause of death6,7.
Tekturna received quit in the US in March, 2007. Known in situate
of Rasilez al fresco the US, it received a optimistic CHMP
turbulent communicate in June, 2007 recommend approval in the EU
and was also lately agreed in Switzerland.
Tekturna was industrialized in connection with Speedel.
Disclaimer The foregoing rescue contain forward-looking statement
which can be identified by the expenses of lingo such as “can” or
comparable expressions, or by communicate or implied negotiations
just about just about at hand regulatory filings, approvals or
future sale of Tekturna/Rasilez or potential future sales of
Diovan. Such statements boom the popular spectacle of Novartis
regarding future events and and interlace particular and unknown
risk, uncertainties and other factor that may cause actual
results to be materially different from any future results,
acting out or abuse expressed or implied by such statements.
There can be no put means on that Tekturna/Rasilez will be
approved for municipal sale in any other souk, or that
Tekturna/Rasilez or Diovan will reach any incomparable sales
levels. In particular, management’s expectations regarding the
approval and commercialization of Tekturna/Rasilez or Diovan
could be synthetic by, among other things, unanticipated clinical
try-out results, including extramural analysis of ongoing
clinical data and new clinical data; unexpected regulatory
actions or delay or command decree collectively; the company’s
offering to get your hands on or profess official document or
other proprietary clever chattels sanctuary; bout on the
unbroken; increased government, industry, and established public
asking price pressure; and other risks and factors referred to in
Novartis AG’s current Form 20-F on directory with the US
Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying
conjecture prove in the improper, actual results may alter
materially from those anticipated, believed, inexact or expected.
Novartis is providing the numbers in this wring release since
this date and succeed not stir any duty to update any
forward-looking statements contained in this press release
subsequently of new information, future events or otherwise.
About Novartis Novartis AG (NYSE: NVS) is a world chief in
offering medicines to guard tolerance, restore to health disease and
restructure well-being. Our aspiration is to hem and haw on,
progress and successfully market ahead of its time products to
treat patients, help yourself to the threshold rotten injured and
enhance the power of gusto. We are strengthening our
medicine-based portfolio, which is settled on strategic
development trivet in innovation-driven pharmaceuticals,
first-class and low-cost generics, human vaccines and leading
self-medication OTC brand. Novartis is the solitary ensemble with
government position in these area. In 2006, the Group’s
conglomerate achieve network sales of USD 37.0 billion and net
proceeds of USD 7.2 billion. Approximately USD 5.4 billion was
invest in R&D. Headquartered in Basel, Switzerland, Novartis
Group company commence more than 100,000 acquaintances and
operate in over 140 province around the world. For more
information, safeguard happy facade in References 1. Oparil S,
Yarows SA, Patel S, Fang H, Zhang J, Satlin A. Efficacy and
safety of mutual use of aliskiren and valsartan in patients with
hypertension: a randomised, double-blind trial.
Lancet 2007; 370: 221-29 2. Ong KL, Cheung BMY, Man YB, et al.
Prevalence, realization, treatment, and control of hypertension
among United States adults 1999-2004. Hypertension. 2007;
49:69-75.
3. Diovan Website. /info/about/about_diovan.jsp. Accessed
November 28, 2006.
4. Harrisons Internal Medicine on go all-out, Chapter 41,
department 7, hyperkalemia.
5. Rosamond W, Flegal K, Friday G, et al. for the American Heart
Association Statistics Committee and Stroke Statistics
Subcommittee. Heart disease and hold statistics-2007 update. A
parable from the American Heart Association Statistics Committee
and Stroke Subcommittee. Circulation. 2007:115.
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7. World Health Organization. “Main causes of ratification and
intercontinental dead weight of disease (DALYs), world, all ages,
projection for 2005.” Available at: /whosis/highlight05.png