title: Outcomes with nifedipine GITS or Co-amilozide in hypertensive diabetics and nondiabetics in Intervention as a Goal in Hypertension (INSIGHT).
abstract: To investigate the impact of treatment on cardiovascular mortality and morbidity, we assessed outcomes in patients with hypertension and diabetes who received co-amilozide or nifedipine in the International Nifedipine GITS Study: Intervention as a Goal in Hypertension. Participants had to be 55 to 80 years of age, with hypertension (> or =150/95 or > or =160 mm Hg) and at least one additional cardiovascular risk factor. Patients received 30 mg nifedipine once daily or co-amilozide (25 mg hydrochlorothiazide and 2.5 mg amiloride) daily. Doses were doubled if target blood pressures (<140/90 mm Hg) were not achieved. Primary (composite of cardiovascular death, myocardial infarction, heart failure, and stroke) and secondary outcomes (composite of primary outcomes, including all-cause mortality and death from vascular and nonvascular causes) were assessed by means of intent-to-treat analyses. There was no significant difference in the incidence of primary outcomes between nifedipine-treated and co-amilozide-treated patients with diabetes at baseline (n=1302) (8.3% versus 8.4%; relative risk, 0.99, 95% CI, 0.69 to 1.42; P=1.00). A significant benefit for nifedipine-treated patients was seen for the composite secondary outcome (14.2% versus 18.7%; relative risk, 0.76, 95% CI, 0.59 to 0.97; P=0.03). Among patients without diabetes at baseline (n=5019), there was a significant difference in the incidence of new diabetes (nifedipine 4.3% versus co-amilozide 5.6%, P=0.023). Nifedipine GITS once daily is as effective as diuretic therapy in reducing cardiovascular complications in hypertensive diabetics. Nifedipine-treated patients were also less likely to have diabetes or have secondary events (a composite of all-cause mortality, death from a vascular cause, and death from a nonvascular cause) than co-amilozide recipients. Our results suggest that nifedipine could be considered as first-line therapy for hypertensive diabetics.
authors.affiliation: University of Milano-Bicocca, St Gerardo Hospital, Monza, Milan, Italy. giuseppe.mancia@unimib.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mancia
authors.forename: Morris
authors.initials: M
authors.lastname: Brown
authors.forename: Alain
authors.initials: A
authors.lastname: Castaigne
authors.forename: Peter
authors.initials: P
authors.lastname: de Leeuw
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Palmer
authors.forename: Talma
authors.initials: T
authors.lastname: Rosenthal
authors.forename: Gilbert
authors.initials: G
authors.lastname: Wagener
authors.forename: Luis M
authors.initials: LM
authors.lastname: Ruilope
mesh_terms: D000368:Aged; D000584:Amiloride / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000401:mortality / Q000517:prevention & control; D048909:Diabetes Complications; D003920:Diabetes Mellitus / Q000453:epidemiology; D004232:Diuretics / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use*; D006973:Hypertension / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000627:therapeutic use*; D009937:Organizational Objectives; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004232:Diuretics; D004338:Drug Combinations; D006852:Hydrochlorothiazide; C010247:amiloride, hydrochlorothiazide drug combination; D000584:Amiloride; D009543:Nifedipine