If you plan to become pregnant talk to your doctor aboutother medicines to treat

If you plan to become pregnant, talk to your doctor aboutother medicines to treat your high blood pressure before taking TEKTURNA orTEKTURNA HCT.Do not take TEKTURNA or TEKTURNA HCT if you are allergic to any of itsingredients. If you get pregnant, stop taking TEKTURNA or TEKTURNA HCT and call yourdoctor right away. It is not knownwhether additive effects are present when TEKTURNA or TEKTURNA HCT are used incombination with types of medications called ACE inhibitors or beta-blockers.TEKTURNA HCT can be used first if your doctor thinks you are unlikely toachieve your goal blood pressure with a single medicine.Important considerationsIMPORTANT WARNING:TEKTURNA or TEKTURNA HCT may harm an unborn baby, causing injury and evendeath. TEKTURNA and TEKTURNA HCT may be used alone or incombination with other high blood pressure medications.

The antihypertensive effect of TekturnaHCT were largely manifested within 1 week. The maximum antihypertensive effectwas generally attained after about 4 weeks of therapy.About Tekturna and Tekturna HCT TEKTURNA and TEKTURNA HCT are prescription medications for adults used totreat high blood pressure. Blood pressure reductions with thecombinations were greater than the reductions with the monotherapies. Thesafety and efficacy of Tekturna HCT as initial therapy was evaluated in thistrial. All patients randomized to the combination groups received thecombination treatment of Tekturna HCT at assigned doses as initial therapywithout titration from monotherapy. Patients were randomized to receive variouscombinations of Tekturna (75 mg to 300 mg) plus hydrochlorothiazide (6.25 mgto 25 mg) once daily (without titrating up from monotherapy) and followed forblood pressure response.

The combination of Tekturna and hydrochlorothiazideresulted in additive placebo-adjusted decreases in systolic and diastolicblood pressure at trough of 10-14/5-7 mmHg at doses of 150-300 mg/12.5-25 mg,compared to 5-8/2-3 mmHg for Tekturna 150 mg to 300 mg and 6-7/2-3 mmHg forhydrochlorothiazide 12.5 mg to 25 mg alone. The safety and efficacyof Tekturna HCT were evaluated in patients with mild-to-moderate hypertensionin an 8-week, randomized, double-blind, placebo-controlled, parallel-group,15-arm factorial trial (n=2762). The long-term potential of Tekturna is being studied in anextensive clinical program, including outcomes trials, known as ASPIRE HIGHER.Tekturna HCT is available in four strengths as tablets containing aliskirenand hydrochlorothiazide: 150 mg/12.5 mg tablets, 150 mg/25 mg tablets, 300mg/12.5 mg tablets and 300 mg/25 mg tablets.Study details The FDA approvals of Tekturna HCT were based on a clinical trial programinvolving over 6,200 patients and evaluated more than 2,700 patients exposedto combinations of Tekturna and hydrochlorothiazide. Diuretics work to lower blood pressure by removing excesswater and salt from the body.Tekturna was approved in the US in 2007 as the first direct renin inhibitor.In 2008, Tekturna HCT was approved in the US for second-line treatment of highblood pressure. Tekturnareduces renin activity and helps blood vessels relax and widen so bloodpressure is lowered. Renin is an enzymeproduced by the kidneys that starts a process that makes blood vessels narrowand, when inappropriately activated, may lead to high blood pressure. "Novartisis committed to supporting the research and development of effectivetreatments for high blood pressure that will help patients reach their bloodpressure treatment goals."Tekturna, a direct renin inhibitor, is the only drug that works by directlytargeting renin and decreasing the activity of the RAAS.

The use ofmultiple medications may help patients achieve blood pressure goals in a moretimely fashion."We are very pleased the FDA recognizes the benefit of Tekturna HCT for thefirst-line treatment of patients with moderately high blood pressure," saidTrevor Mundel, MD, Global Head of Development at Novartis Pharma AG. The Seventh Report of theJoint National Committee on Prevention, Detection, Evaluation, and Treatmentof High Blood Pressure (JNC7) recommends that physicians consider startingtheir high blood pressure patients with two treatment agents, one of whichshould be a diuretic, if blood pressure is >20/10 mmHg above goal. Of USadults being treated, an estimated 36% are not at their blood pressure goals.Current US treatment guidelines support the first-line use of combinationtherapy in appropriate high blood pressure patients. "Up to 85% of patients will need more than one medication to reach their bloodpressure goals," said Alan Gradman, MD, Cardiologist at The WesternPennsylvania Hospital and Professor of Medicine at Temple University. "Thisapproval gives doctors the opportunity to aggressively treat their patientswith a single-pill combination of the only approved drug, Tekturna, that worksby directly targeting renin and decreasing the activity of the reninangiotensin aldosterone system (RAAS) and, HCTZ, a diuretic. This results inmore significant blood pressure reductions, compared to taking either drugalone."Hypertension affects nearly 74 million US adults and is a major risk factorfor cardiovascular disease, the number one leading cause of death in the US.If left untreated, patients with high blood pressure are at risk forcardiovascular events such as stroke, heart attack and heart failure.

The FDA approval of Tekturna HCT as initial therapy was based on clinicaltrial data involving more than 2,700 patients, which showed that treatmentwith the combination of Tekturna and HCTZ offered greater blood pressurereductions than either drug alone. Tekturna HCT is asingle-pill combination of Tekturna((R)) (aliskiren), the first and onlyapproved direct renin inhibitor, and the diuretic hydrochlorothiazide (HCTZ),one of the most commonly-used high blood pressure medications. Details on pricing were not yet available, but Handy saidthe company was planning the transition so there would be nopenalty for buying POWER6 now and upgrading later. (Reporting by Ritsuko Ando; Editing by Phil Berlowitz) Stocks. FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely toAchieve Their Blood Pressure Goals With a Single Agent- Tekturna HCT combines the only approved direct renin inhibitor, Tekturna(R),with widely used diuretic, hydrochlorothiazide, in a single pillEAST HANOVER, N.J., July 21 /PRNewswire/ -- The US Food and DrugAdministration (FDA) has approved Tekturna HCT((R)) (aliskiren andhydrochlorothiazide) tablets as initial therapy for patients who are likely toneed multiple drugs to achieve their blood pressure goals. IBM software can also help to ease theprocess by allowing applications to run without anydisruptions, the company said. It also said POWER7 will be more efficient than the POWER6,which was launched in May 2007, capable of two to three timesperformance while using the same amount of energy.