The pharmaceutical industry maintains that, according to the STOP-NIDDM* study, up to 91% of myocardial infarctions can be avoided by administration of acarbose (GLUCOBAY) to patients with a pathological glucose tolerance test and that it is no longer ethically defensible to not use GLUCOBAY in prediabetics. Please tell me if you share this opinion based on available studies.

Dr. H. UNFRIED MD (specialist in surgery and general medicine)
D-69483 Wald-Michelbach
Conflict of interests: none

In the STOP-NIDDM* study on acarbose (GLUCOBAY) a surrogate parameter was the primary endpoint: the rate of positive diabetes diagnoses based on blood sugar increase after an oral glucose tolerance test (a-t 2002; 33: 72-3) (1). According to the protocol cardiovascular events were a secondary endpoint (2).

Secondary clinical endpoints in studies primarily investigating surrogate parameters have to be interpreted with extreme caution. In this context the ELITE study should be remembered, which demonstrated a surprising advantage of losartan (LORZAAR) over captopril (TENSOBON etc.) with respect to mortality in heart failure. The study was primarily designed to compare the renal tolerability of the two drugs (3). A subsequent study specifically designed to investigate mortality (ELITE-II) demonstrated no significant difference (a-t 2000; 31: 58-9) (4).

The clinical endpoint results of the STOP-NIDDM study have not yet been published in a manufacturer-independent peer-reviewed journal. Therefore, these results cannot be assessed. This does not prevent Bayer from using these non-verifiable results in a broad advertising campaign (5) helped by opinion leaders. However no obligation to treat can be deduced from manufacturer's advertising material, - ed.

(R = randomised study)

1

CHIASSON, J.-L. et al.: Lancet 2002; 359: 2072-7

2

CHIASSON, J.-L. et al.: Diabetes Care 1998; 21: 1720-5

3

PITT, B. et al.: Lancet 1997; 349: 747-52

4

PITT, B. et al.: Lancet 2000; 355: 1582-7

5

Bayer HealthCare: Press release January 2003

STOP-NIDDM = Study TO Prevent Non-insulin-dependent diabetes mellitus