NAVIGATOR Shows Valsartan Delayed Progression To Type 2 Diabetes In At-Risk Cardiovascular Patients …
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Results from a watershed cogitation involving more than 9,000 masses showed that the heights descent press music diovan delayed advancement to eccentric 2 diabetes in patients with cardiovascular disease or hazard factors and afflicted glucose margin (IGT), a plebeian pre-diabetic consideration.
Primary information from the NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) visitation, initiated in 2001, were presented now at the American College of Cardiology Annual Meeting in Atlanta, USA[i] and simultaneously promulgated on-line in the New England Journal of Medicine [ii],[iii]. The bailiwick assessed whether diovan or the viva anti-diabetic broker nateglinide could check procession to diabetes or slenderize the incidence of cardiovascular events in masses with IGT and cardiovascular disease or endangerment factors.
“Obesity and hypertension are globose wellness epidemics, and many of these patients get problems with afflicted glucose leeway. From legion studies, we cognize that patients with IGT sustain an increased chance for character 2 diabetes and cardiovascular disease,” aforementioned Dr. Robert Califf, Vice Chancellor for Clinical Research at Duke University School of Medicine and Director of the Duke Translational Medicine Institute, Durham, NC, USA. “It is decisive that we cover to hunt for pharmacological interventions that may dilute the incidence of diabetes and cardiovascular disease patch accenting to our patients that slant release, as footling as 5%, may better outcomes.”
Patients in the cogitation with IGT and cardiovascular disease or otc hazard factors, who standard diovan for at least five-spot years in plus to ground therapy and a he-many-specific lifestyle-modification curriculum, achieved a statistically pregnant 14% reducing in their chance of development new-onset diabetes compared to those in the non-valsartan group1,2.
Valsartan therapy did not prove a diminution in the danger of cardiovascular events in this well-managed radical of patients1,2, spell nateglinide-based therapy did not demonstrate a reducing in the incidence of new-onset diabetes or of cardiovascular events in this cogitation population1,3.
Trevor Mundel, M.D., Global Head of Development at Novartis Pharma AG aforementioned: “As a globose leader in cardiovascular and metabolous wellness, Novartis is attached to forward-moving world wellness and insurance pertaining to diabetes. We are selfsame pleased with the findings of the NAVIGATOR cogitation as they add to the great soundbox of scientific entropy on diovan.”
The cosmopolitan preponderance of diabetes is expected to increment by 50% (ie from 285 to 439 meg patients) by 2030[iv]. IGT is a outlined phase in the growth of diabetes[v], and it has been suggested that up to 70% of multitude with afflicted fast glucose (IFG) and IGT are potential to acquire case 2 diabetes complete their life-time[vi]. Current counsel from the American Diabetes Association, American College of Endocrinology/American Association of Clinical Endocrinologists and the World Health Organization recommends a diverseness of interventions for the direction of pre-diabetes, based on life-style alteration[vii],[viii],[ix].
“Lifestyle change stiff the principal intercession for the bar of diabetes. The NAVIGATOR sketch shows that diovan, when added to a lifestyle-modification plan, can wait advance to diabetes in mass who are at heights cardiovascular endangerment and deliver afflicted glucose allowance,” aforementioned Dr Rury Holman, Professor of Diabetic Medicine at the Oxford Centre for Diabetes, Endocrinology & Metabolism, University of Oxford, United Kingdom.
Novartis plans to discourse the results of this sketch with the U.S. Food and Drug Administration with a survey to applying for a tag vary for diovan. Valsartan is presently indicated for the discussion of eminent line coerce for the discourse of ticker loser , and reduction the jeopardy of cardiovascular deathrate in patients who sustain suffered a bosom tone-beginning (myocardial infarct). Nateglinide is indicated as an accessory to dieting and workout to meliorate glycemic ascendancy in adults with eccentric 2 diabetes. Neither diovan nor nateglinide is presently indicated for the discussion of patients with IGT.
NAVIGATOR was a prospective, transnational, randomised, double-blind, placebo-controlled, two-by-two factorial figure test organism conducted in 39 countries at well-nigh 800 sites. The 9,306 patients enrolled in the tryout had IGT and were either sr. than age 50 with diagnosed cardiovascular disease or senior than age 55 with at least one hazard constituent for cardiovascular disease, such as gamey ancestry pressing, phratry account of ticker disease, heights cholesterin or smoke. In summation to backdrop therapy and a doty-specific life-style alteration broadcast, patients were randomised to invite either diovan, nateglinide, diovan and nateglinide unitedly, or placebo2,3.
NAVIGATOR had iii co-primary endpoints. The low termination was confirmed progress to open diabetes, outlined according to measure WHO/ADA criteria. The endorsement (’gist’ cardiovascular) terminus was a complex of clock to outset occurrent of cardiovascular end, non-fatal myocardial infarct, non-fatal slash or hospitalisation for mettle loser. The thirdly (’lengthened’ cardiovascular) termination consisted of the inwardness cardiovascular terminus positive revascularization and hospitalisation for precarious angina . The medial followup metre (for critical condition) was 6.5 years2.
The main NAVIGATOR results for diovan were as follows:1,2
- Statistically meaning decrease in the danger of advancement to diabetes of 14% (HR 0.86, 95% CI 0.80-0.92; p
The elemental results for nateglinide were as follows:1,3
- No reducing compared to non-nateglinide intervention in footing of progress to diabetes (HR 1.07, 95% CI 1.00-1.15, p=0.98)
Valsartan was dosed up to 160 mg formerly casual. During the class of the work, 556 participants (12%) in the diovan grouping and 531 (11%) in the non-valsartan aggroup discontinued the discipline dose due to an untoward result. The nearly vulgar untoward consequence seen in the diovan aggroup was hypotension . Nateglinide was dosed up to 60 mg deuce-ace multiplication day-to-day. During the trend of the discipline, 520 participants (11%) in the nateglinide grouping and 485 (10%) in the non-nateglinide aggroup discontinued field dose due to an untoward upshot. The virtually usual inauspicious events seen in the nateglinide aggroup were hypotension-related events and hypoglycemia2,3.
[i] Califf RM. Late-breaking intro at the ACC Congress 2010; Abstract No: 3010-12.
[ii] McMurray J, et al. N Engl J Med 2010; in jam.
[iii] Holman RR, et al. N Engl J Med 2010; in pressing.
[iv] International Diabetes Federation. Diabetes Atlas. 4th ed. Available hither. Last accessed 5 Mar 2010.
[vii] American Diabetes Association. Diabetes Care 2010;33(Suppl 1):S11-61.
[7] American Association of Clinical Endocrinologists. Endocr Pract 2008;14(7):933-46.
[ix] World Health Organization. Fact tack No: 312 - Diabetes. Available hither. Last accessed 5 Mar 2010.
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