Hypertensive patients not at BP goal?Turn to TEKTURNA. Proven BP reductions in mild-to-moderate hypertension

The primary endpoint was change in msDBP from baseline to week 8.

Change from baseline in msSBP (mm Hg)1,2

  • Placebo

    -3 to -10

  • TEKTURNA
    150 mg

    -9 to -13

  • TEKTURNA
    300 mg

    -13 to -16

Least square means (LSM) change from baseline in msSBP (mm Hg)
Range of non-placebo–subtracted SBP reductions across 6 trials (mm Hg)

msDBP=mean seated diastolic blood pressure; msSBP=mean seated systolic blood pressure.

Change from baseline in msDBP (mm Hg)1,2

  • Placebo

    -3 to -9

  • TEKTURNA
    150 mg

    -8 to -10*

  • TEKTURNA
    300 mg

    -9 to -12*

Least square means (LSM) change from baseline in msSBP (mm Hg)
Range of non-placebo–subtracted SBP reductions across 6 trials (mm Hg)

*P<.05 vs placebo by analysis of covariance (ANCOVA) with Dunnett’s procedure for multiple comparisons in 5 studies. Black patients tended to have smaller reductions than Caucasian and Asian patients with TEKTURNA, consistent with what has been seen with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs).

Study design

In 6 randomized, double-blind, placebo-controlled, 8-week clinical trials, TEKTURNA was studied in patients with mild-to-moderate hypertension (msDBP 95-109 mm Hg). The mean baseline SBP/DBP range was 153-155/99-100 mm Hg. The primary endpoint was change in msDBP from baseline to week 8.

Patients with BP ≥160/100 (formerly stage 2 hypertension)

For your appropriate hypertensive patients turn to TEKTURNA for BP ≥160/100 (formerly stage 2 hypertension)3

TEKTURNA: proven BP reductions in patients with BP ≥160/100 (formerly stage 2 hypertension)3

  • TEKTURNA
    300 mg

    -20

Baseline msSBP 167 mm Hg*
Least square means (LSM) change from baseline in msSBP (mm Hg) at primary endpoint

Efficacy was compared with the combination of aliskiren 300 mg and hydrochlorothiazide 25 mg (n=346), which achieved msSBP reductions of -30 mm Hg at week 12.

*Patients with stage 2 hypertension.

Study design

Study 2353: A 12-week, double-blind, randomized, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren 300 mg and hydrochlorothiazide 25 mg compared with aliskiren 300 mg in patients with BP ≥160/100 (formerly stage 2 hypertension). The primary efficacy variable was the change from baseline (visit 2/day 1) in msSBP at endpoint. For each patient, the last post-baseline measurement during the double-blind period was carried forward to week 12 as the endpoint measurement.3

At week 12, change from baseline in msDBP was -8 mm Hg for aliskiren 300 mg and -13 mm Hg for aliskiren 300 mg and hydrochlorothiazide 25 mg.3

Rebound hypertension

After abrupt cessation of therapy turn to TEKTURNA if rebound hypertension is a concern4,5

Primary endpoint: change in msDBP from baseline to week 8
Least square means (LSM) change from baseline in mean SBP (mm Hg)
Baseline msSBP: 153 mm Hg (TEKTURNA 300 mg)
Baseline msSBP: 151 mm Hg (placebo)

Study design

Study 2308: In this double-blind trial, 672 hypertensive patients with msDBP ≥95 mm Hg and <110 mm Hg were randomized to TEKTURNA 150 mg qd, 300 mg qd, or placebo. The primary endpoint of this study was change in msDBP from baseline to week 8. After 8 weeks, all study medications were discontinued. Blood pressure was measured 4 days later. Results were rounded to the nearest whole numbers. Data are from a clinical trial that measured rebound hypertension.4

    Blood pressure reductions continued after last dose and gradually returned toward baseline levels.4

  • TEKTURNA 300 mg: -15 mm Hg msSBP after 8 weeks of treatment; -12 mm Hg msSBP 4 days after last dose
  • Placebo: -4 mm Hg msSBP after 8 weeks of treatment; -4 mm Hg msSBP 4 days after last dose
  • TEKTURNA 300 mg: -11 mm Hg msDBP after 8 weeks of treatment; -10 mm Hg msDBP 4 days after last dose
  • Placebo: -6 mm Hg msDBP after 8 weeks of treatment; -5 mm Hg msDBP 4 days after last dose

TEKTURNA is dosed once daily and has an approximate accumulation half-life of 24 hours.2

There was no evidence of rebound hypertension after abrupt cessation of therapy.

Contraindications

Do not use TEKTURNA or TEKTURNA HCT with angiotensin receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetes because of increased risk of renal impairment, hyperkalemia, and hypotension. TEKTURNA and TEKTURNA HCT are contraindicated in patients with hypersensitivity to any of the components. Because of the HCTZ component, TEKTURNA HCT is contraindicated in patients with anuria or hypersensitivity to sulfonamide-derived drugs like HCTZ.

Hypersensitivity reactions may range from urticaria to anaphylaxis.

Extensively studied in more than 6,000 patients2

TEKTURNA discontinuation rates less than placebo2

Discontinuation rates due to AEs in placebo-controlled clinical trials for hypertension2

  • 2.2%

    TEKTURNA

  • 3.5%

    Placebo

Data do not include information from the ALTITUDE study
Percentage of study population versus placebo

  • Infrequent hyperkalemia (increase in serum potassium >5.5 mEq/L) in hypertensive patients treated with TEKTURNA alone
  • TEKTURNA: 0.9% of study population vs 0.6% for placebo2

TEKTURNA safety profile2

Common adverse events (AEs) with TEKTURNA vs placebo2†

AE TEKTURNA Placebo
Diarrhea 2.3% 1.2%
Cough 1.1% 0.6%
Rash 1% 0.3%
Elevated uric acid 0.4% 0.1%
Gout 0.2% 0.1%
Renal stones 0.2% 0%
Edema 0.4% 0.5%

Does not include AEs from the ALTITUDE study.
At 300 mg.

Rate of cough with TEKTURNA ≈1/3 to 1/2 that of ACE inhibitors ramipril and lisinopril2

TEKTURNA is available in 2 dosage strengths

TEKTURNA dosing considerations

  • TEKTURNA is dosed once daily2

    • Recommended starting dose is 150 mg once daily
    • If BP remains uncontrolled, titrate up to 300 mg daily
  • Patients should take TEKTURNA at the same time every day2

    • TEKTURNA can be taken with or without food
    • Patients should establish a routine for taking TEKTURNA with meals

Antihypertensive effect of a given dose substantially attained (85%-90%) by 2 weeks.2

Turn to direct renin inhibition

TEKTURNA mechanism of action: works at the first and rate-limiting step of the RAAS2,6-8

The clinical implications of differences in effect on other RAAS components are not known.

References: 1. Data on file. Clinical study report SPP100A 2204. Novartis Pharmaceuticals Corp. 2. Tekturna [prescribing information]. Boston, MA: Noden Pharma USA Inc; 2016. 3. Data on file. Clinical study report 2353. Novartis Pharmaceuticals Corp. 4. Data on file. Clinical study report 2308. Novartis Pharmaceuticals Corp. 5. Oh BH, Mitchell J, Herron JR, Chung J, Khan M, Keefe DL. Aliskiren, an oral renin inhibitor, provides dose-dependent efficacy and sustained 24-hour blood pressure control in patients with hypertension. J Am Coll Cardiol. 2007;49(11):1157-1163. 6. Jackson EK. Renin and angiotensin. In: Brunton L, ed; Chabner B, Knollman B, assoc. eds. Goodman & Gillman’s The Pharmacologic Basis of Therapeutics. 12th ed. New York, NY: The McGraw-Hill Companies, Inc; 2011:721-741. 7. Wood JM, Maibaum J, Rahuel J, et al. Structure-based design of aliskiren, a novel orally effective renin inhibitor. Biochem Biophys Res Commun. 2003;308(4):698-705. 8. Azizi M, Ménard J, Bissery A, Guyene TT, Bura-Riviére A. Hormonal and hemodynamic effects of aliskiren and valsartan and their combination in sodium-replete normotensive individuals. Clin J Am Soc Nephrol. 2007;2(5):947-955.