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International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment

International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT) was a prospective, randomised, double-blind trial comparing nifedipine and the diuretic combination of hydrochlorothiazide and amiloride. The trial was designed to compare the effectiveness of Adalat® (nifedipine GITS) with that of standard diuretic therapy in lowering blood pressure (BP) in patients with hypertension. Two side-arm studies analysed the effects of Adalat® on coronary calcification and progression of intima-media thickness.

Method

A randomised, prospective, double-blind trial involving 6,321 patients with hypertension (BP >= 150/95mmHg or systolic BP >= 160mmHg) who were aged 55–80 years. Enrolled patients had at least one additional cardiovascular risk factor, such as smoking, diabetes, hyperlipidemia and family history of cardiovascular disease. The primary outcome was cardiovascular death, myocardial infarction, heart failure or stroke, and patients were followed for up to 4.5 years.

Results – Efficient and safe BP reduction

INSIGHT demonstrated that treatment with Adalat® reduces BP efficiently and safely. During the trial, BP control in patients receiving Adalat® was equivalent to that achieved in those receiving the diuretic combination therapy.1

Results – Cardiovascular Risk Reduction

INSIGHT demonstrated that Adalat® reduced cardiovascular risk more than would be expected by its BP-lowering effect alone. Using the Framingham study data, Adalat® was estimated to reduce cardiovascular risk by 50%.1

Results – Side-Arm Studies on Intima-Media Thickness, Coronary Calcification and Renal Function

From INSIGHT, two side-arm studies (investigating intima-media thickness and coronary calcification, both of which are intermediate markers of atherosclerosis) and a subanalysis (assessing renal function) showed that Adalat® had a beneficial effect on the vasculature in addition to its BP-lowering effects.2–4

The results of INSIGHT show that there were significantly fewer cases of newly diagnosed diabetes in patients treated with Adalat® compared with patients treated with diuretics;1 these results are further supported by the findings of two recent clinical trials:

In ALLHAT, which involved 42,000 hypertensive patients, the incidence of newly diagnosed diabetes was reduced in the calcium channel blocker (CCB) group compared with those receiving diuretic intervention.5

In INVEST, which involved 22,000 hypertensive patients with evidence of coronary artery disease, there was also a significantly lower incidence of new-onset diabetes in patients treated with a CCB.6

Conclusions

  • Adalat® is as effective as a diuretic combination for reducing BP and cardiovascular risk
  • Adalat® slows cardiovascular disease progression
    • Preserves renal function
    • Prevents development of diabetes
  • Adalat® prevents atherosclerotic vessel damage
    • Reduces coronary calcification
    • Blocks intima-media thickness progression
1. Brown MJ, et al. Lancet 2000;356:366–72.
2. Simon A, et al. Circulation 2001;103:2949–54.
3. Motro M, Shemesh J. Hypertension 2001;37:1410–3.
4. de Leeuw PW, et al. Arch Intern Med 2004;164:2459–64.
5. ALLHAT Officers. JAMA 2002;288:2981–97.
6. Pepine CJ, et al. JAMA 2003;290:2805–16.

Array

INSIGHT slide library