title: Beneficial effects of angiotensin-converting enzyme inhibitor and nitrate association on left ventricular remodeling in patients with large acute myocardial infarction: the Delapril Remodeling after Acute Myocardial Infarction (DRAMI) trial.
abstract: BACKGROUND
  In the large-scale trial, Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-3 (GISSI-3), patients receiving the combination of lisinopril and glyceryl trinitrate benefited most from experimental therapy. Therefore, a multicenter, randomized, double-blind study, Delapril Remodeling After Acute Myocardial Infarction (DRAMI), was designed to assess (1) the possible additive beneficial effect on left ventricular remodeling of nitrates when combined with an angiotensin-converting enzyme inhibitor (ACEI), and (2) the tolerability of a new ACEI, delapril, in respect to lisinopril in patients with large myocardial infarction (MI).
  
  
  METHODS
  A total of 177 patients were randomized to receive delapril plus isosorbide-5-mononitrate (IS5MN) placebo, delapril plus IS5MN, lisinopril plus IS5MN placebo, or lisinopril plus IS5MN starting within the first 36 hours after the onset of symptoms and continuing for 3 months.
  
  
  RESULTS
  More than 80% of the patients showed extensive ST-segment changes and 36.7% had signs or symptoms of heart failure during the first 36 hours. Over 3 months, IS5MN reduced, by 76%, the increase in LVEDV (17.4 +/- 5.0 mL placebo vs 4.2 +/- 4.4 mL IS5MN, P =.0439), reversed the increase in LVESV (7.5 +/- 3.9 mL placebo vs -5.5 +/- 2.9 mL IS5MN, P =.0052), and increased the recovery of LVEF (1.9% +/- 1.3% placebo vs 6.7% +/- 1.2% IS5MN, P =.0119). Overall, 3-month mortality was 10.2%; the most frequent clinical events were new episodes of severe heart failure (18.1%), persistent hypotension (10.7%), and post-MI angina (18.1%), with no differences between treatment groups.
  
  
  CONCLUSIONS
  Administration for 3 months of IS5MN combined with an ACEI, both started within 36 hours from the onset of symptoms, was safe and effective in reducing LV dilation and dysfunction after MI. The 2 ACEIs, delapril and lisinopril, appeared to be equally well tolerated.
authors.affiliation: Istituto Mario Negri, Milano, Italy. latini@marionegri.it
authors.forename: Roberto
authors.initials: R
authors.lastname: Latini
authors.forename: Lidia
authors.initials: L
authors.lastname: Staszewsky
authors.forename: Aldo P
authors.initials: AP
authors.lastname: Maggioni
authors.forename: Paolo
authors.initials: P
authors.lastname: Marino
authors.forename: Francisco
authors.initials: F
authors.lastname: Hernandez-Bernal
authors.forename: Gianni
authors.initials: G
authors.lastname: Tognoni
authors.forename: Violeta
authors.initials: V
authors.lastname: Labarta
authors.forename: Silvana
authors.initials: S
authors.lastname: Gramenzi
authors.forename: Federico
authors.initials: F
authors.lastname: Bianchi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Sarcina
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cremonesi
authors.forename: Gian Luigi
authors.initials: GL
authors.lastname: Nicolosi
authors.forename: Enrico
authors.initials: E
authors.lastname: Geraci
mesh_terms: D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007189:Indans / Q000009:adverse effects / Q000627:therapeutic use*; D007548:Isosorbide Dinitrate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D017706:Lisinopril / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000503:physiopathology; D015990:Placebo Effect; D013223:Statistics as Topic; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D020257:Ventricular Remodeling / Q000187:drug effects* / Q000502:physiology
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D007189:Indans; D014665:Vasodilator Agents; D017706:Lisinopril; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate; C047759:delapril