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Με την ευγενική χορηγία:

CHIESI HELLAS


SANOFI

The Study of Trandolapril-verapamil And insulin Resistance

STAR determined whether glycaemic control was maintained to a greater degree by an RAS inhibitor/non-DHP CCB than an RAS inhibitor/thiazide diuretic in hypertensive patients with metabolic syndrome.

STAR: rationale
Metabolic syndrome associated with increased risk of new-onset diabetes and cardiovascular disease.

Antihypertensive therapy may be beneficial in reducing cardiovascular risk in subjects with metabolic syndrome.

Certain antihypertensive agents may decrease insulin sensitivity and impair glycaemic control.

STAR: primary objective

  • To compare the effect of an RAS inhibitor combined with a non-dihydropyridine calcium channel blocker and an RAS inhibitor combined with a thiazide diuretic on glycaemic control in hypertensive patients with metabolic syndrome

STAR: primary and secondary endpoints

Primary endpoint

  • Change from baseline to end of study on 2-hour postprandial plasma glucose, using an oral glucose tolerance test (OGTT)

Secondary endpoints

  • Changes in BP, pulse rate, and BP control
  • Change in insulin and glucose levels
  • Effect on HbA1c levels
  • Fasting glucose ≥126mg/dl and/or 2-hour OGTT ≥200mg/dl(new-onset diabetes)
  • Insulin sensitivity and release
  • Albuminuria
  • Lipid profile
  • Safety profile

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