BP lowering effect

Adalat GITS provides:

Effective and sustained BP lowering

  • The INSIGHT study recorded blood pressure in patients (n=6321) with hypertension who were treated with co-amilozide or Adalat.*1 After 12 weeks of treatment, mean blood pressure had fallen by 33/17 mmHg (15/9), and remained close to 138/82 mmHg in the two groups through 48 months of follow-up1
  • 58% of patients treated with Adalat achieved the guideline-recommended BP target of 140/90 mmHg1
Brown M, et al. Lancet 2000;356:366-72
*The primary outcome of INSIGHT was cardiovascular death, myocardial infarction, heart failure, or stroke.

Smooth BP control over 24 hour dosing period

  • The antihypertensive effect of Adalat GITS is maintained for more than 24 hours postdose2
  • BP lowering is uniform over the 24 hour dosing period, without any undue imbalance between the peak BP effect and that observed immediately before the subsequent dose2
Zanchetti A, et al. Drugs 1994;48(Suppl 1):23-31.
  • Adalat GITS has been shown to significantly reduce BP throughout the 24-hour dosing period3

Long term BP control

Adalat GITS provides long-term (>5 years) BP lowering in hypertensive patients4

  • A prespecified subgroup analysis of the ACTION trial stratified the population into hypertensive (baseline SBP ≥140 mmHg) and normotensive groups4
  • The hypertensive group (n=3977/7665) had a mean baseline BP of 151/85 mmHg
  • Mean follow-up in the study was 4.9 years
  • In patients who were hypertensive at baseline, the overall mean changes in SBP/DBP were:
    • −14.5/−7.0 mmHg in Adalat-GITS-treated patients
    • −7.9/−3.5 mmHg in placebo-treated patients (P<0.001 vs Adalat GITS)4
Lubsen J, et al. J Hypertens 2005;23:641-8.

Favourable outcomes when compared with studies of other drugs

  • BP levels were reduced to near or below recommended target levels following treatment with Adalat GITS (INSIGHT study) or long-acting nifedipine (STONE study)3
  • The SBP change in INSIGHT was greater than that observed in other large-scale hypertensive studies3
  • BP control rates with Adalat GITS compare favourably with studies of other drugs, e.g.:
    • INSIGHT: 58% of patients treated with Adalat GITS achieved the BP target <140/90 mmHg3
    • LIFE: 49% of patients treated with losartan achieved the BP target <140 mmHg5
Mancia G, et al. J Hypertens 2002;20:1461-4
HOPE, Heart Outcomes Prevention Evaluation.
PROGRESS, Perindopril Protection Against Recurrent Stroke Study.
CAPP, Captopril Prevention Project.
NORDIL, Nordic Diltiazem Study.
HOT, Hypertension Optimal Trial.
STONE, Shanghai Trial Of Nifedipine in the Elderly.
STOP-2, Swedish Trial in Old Patients with Hypertension-2.
ALLHAT, Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.
LIFE, Losartan Intervention For Endpoint reduction in hypertension study.
INSIGHT, International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment.

Similar BP reduction with less SNS activation compared to amlodipine

  • A systematic review examined the effects of long-term treatment (≥1 week) with Adalat GITS (14 studies) or amlodipine (23 studies), with regard to their effects on SNS activation*6
  • SNS activation was assessed via plasma norepinephrine concentration, muscle sympathetic nerve activity, and power spectral analysis of ECG activity6
  • Adalat GITS was associated with marginally greater reductions in blood pressure6
  • Heart rate changes were comparable with the two drugs6
  • Amlodipine caused a small but significant activation of the SNS (consistent across all three surrogate measures), whereas no such activation occurred with Adalat GITS6
*One study included both amlodipine and Adalat GITS.
[De Champlain J, Karas M, Nguyen P, Cartier P, Wistaff R, Toal CB, Nadeau R, Larochelle P. J Hypertens. 1998;16:1357 – 1369.]
The effects of amlodipine and Adalat GITS on systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and plasma norepinephrine when the drug is given for at least 1 week.6


SNS: sympathetic nervous system

Adalat GITS reduces BP during the critical morning period

Achieving 24-hour BP control is critical for reducing CV risk7. Early morning increases in SBP and DBP may act as triggers for CV events, including stroke and myocardial infarction (MI), and are thought to be associated with target-organ damage.8-10

Adalat GITS and Adalat CR have been shown to control this early morning surge in BP.11-13

24-control of BP

  • Previously untreated hypertensive patients (n=238) treated with Adalat GITS showed efficient 24-control of their BP, including in the period of the morning BP surge12

Morning BP

  • The i-TECHO study was a randomised, open-label, 6-week, crossover study to examine the effects of Adalat controlled-release (CR) 20–80 mg/day and amlodipine 2.5–10 mg/day on BP
  • Adalat CR had a stronger antihypertensive effect in the morning compared to amlodipine13
*p<0.05 vs amlodipine

References

  1. Brown M, et al. Lancet 2000;356:366-72
  2. Zanchetti A, et al. Drugs 1994;48(Suppl 1):23-31.
  3. Mancia G, et al. J Hypertens 2002;20:545-53.
  4. Lubsen J, et al. J Hypertens 2005;23:641-8.
  5. Dahlöf B, et al. Lancet 2002;359:995-1003.
  6. Toal CB, et al. Blood Press. 2012;21 Suppl 1:3-10.
  7. Toal CB, et al. Clin Ther. 1997;19(5):924-35.
  8. Mead M,et al. British Journal of Cardiology 2008;15:31-4.
  9. Kario K, et al. J Cardiovasc Pharmacol 2003;42 Suppl 1:S87-S91.
  10. Weber MA. Am J Cardiol 2002;89:27A-33A.
  11. Kawano H, et al. Blood Press Suppl 2003;1:44–8.
  12. Hermida RC, et al. Blood Press Monit 2009;14:152-9
  13. Ryuzaki M et al. J Hypertens 2007;25:2352-58.

Homepage references

  1. Mancia G, et al. J Hypertens 2002;20:545-53.
  2. Brown M, et al. Lancet 2000;356:366-72.
  3. Mancia G, et al. Hypertension 2003;41:431-6.
  4. Bravo EL, et al. Am J Hypertens 1990;3:326S-32S.
  5. Mancia G, et al. Blood Press 2004;13:310-5.
  6. Mancia G, et al. J Hypertens 2011;29:600-9.
  7. Kuschnir E, et al. J Cardiovasc Pharmacol 2004;43:300-5.
  8. Hasebe N, et al. J Hypertens 2005;23:445-53.
  9. Ke Y-N, et al. Cardiovasc Ther 2012;30:326-32.
  10. Adalat Health Care Professional Information.