Incidence and Characteristics of Angioedema Associated With Enalapril

Kostis, John B.; Kim, Harold J.; Rusnak, James M.; Casale, Thomas B.; Kaplan, Allen P.; Corren, Jonathan; Levy, Elliott

doi:10.1001/archinte.165.14.1637

Cited by 267 publications

(282 citation statements)

References 22 publications

(29 reference statements)

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“…Under MPA and ACEi therapy, we found a slightly higher incidence of angioedema (2.1%) in renal allograft recipients compared with hypertensive populations (5,6). In both trials, the incidence of angioedema in ACEi-treated populations ranged between 0.3% and 0.68%.…”

Section: Discussionmentioning

confidence: 70%

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Increased Incidence of Angioedema with ACE Inhibitors in Combination with mTOR Inhibitors in Kidney Transplant Recipients

Duerr¹,

Glander²,

Diekmann³

et al. 2010

Clinical Journal of the American Society of Nephrology

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Background and objective: The clinical manifestation of angioedema ranges from minor facial edema up to life-threatening swelling of mouth and throat. Hereditary defects, drugs, and food allergies may play a role in the development of angioedema. We systematically investigated the incidence of angioedema in renal allograft recipients treated with mTOR inhibitors (mTORis).Design, setting, participants, & measurements: All patients in the authors' electronic database who had received mTORis (n ‫؍‬ 309) between 2000 and 2008 were identified. Of these, 137 were additionally treated with angiotensin-converting enzyme inhibitors (ACEis).Results: Nine patients (6.6%, 3.8 per 100 treatment years) developed angioedema after a mean period of 123 days under combined therapy with mTORi and ACEi. Among the remaining 172 patients on mTORi, including 119 patients treated with angiotensin-receptor blockers, only two developed angioedema (1.2%, 0.5 per 100 treatment years, P ‫؍‬ 0.01). In patients receiving mycophenolate and ACEi (n ‫؍‬ 462), 10 instances of angioedema were found (2.1%, 0.8 per 100 treatment years, P ‫؍‬ 0.004).Conclusions: This systematic investigation demonstrated a noticeable incidence of 6.6% angioedema under combined therapy with mTORi and ACEi in kidney transplant recipients. Treatment with either ACEi or mTORi alone resulted in a significantly lower incidence of angioedema, suggesting that this combination should be avoided.

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Section: Discussionmentioning

confidence: 70%

“…In the randomized, double-blind OCTAVE trial with Ͼ12,000 patients, angioedema occurred in 0.68% of ACEi-treated patients (5). More recently, an overall incidence of 0.3% (n ϭ 25 of 8576) angioedema was reported for ACEi during the ONTARGET study (6).…”

mentioning

confidence: 99%

Increased Incidence of Angioedema with ACE Inhibitors in Combination with mTOR Inhibitors in Kidney Transplant Recipients

Duerr¹,

Glander²,

Diekmann³

et al. 2010

Clinical Journal of the American Society of Nephrology

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“…However, given the short duration of the present study, it may be difficult to conclude that the study drug is safe with a small adverse-events profile, even though there has been a relatively low frequency of reported adverse events. A particular concern for clinicians in Africa may be the increased risk of angio-oedema21 and deaths22 reported with enalapril in African-Americans compared to whites, suggesting that there may be racial differences in the predilection to angio-oedema with the use of ACE inhibitors. In the ASTRAL study, the incidence of ACE inhibitor-related angio-oedema was 0.45%, which closely approximates the incidence reported in the HOPE study 19…”

Section: Discussionmentioning

confidence: 99%

Achieving blood preSsure goals sTudy in uncontrolled hypeRtensive pAtients treated with a fixed-dose combination of ramipriL / hydrochlorothiazide : the ASTRAL study

Okpechi

Schoeman²,

Longo-Mbenza³

et al. 2011

CardioVascular Journal of Africa

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BackgroundHypertension is a common cardiovascular disease, affecting adults worldwide and it accounts for up to 30% of all deaths. The need for better control of arterial hypertension justifies observational studies designed to better understand the real-life management of hypertensive patients. The ASTRAL study was primarily designed to evaluate the percentage of hypertensive patients achieving blood pressure goals after eight weeks of treatment with a fixed-dose combination of ramipril/hydrochlorothiazide (HCTZ).MethodsThe study was a multi-centre, non-comparative, open-label, observational study conducted in 36 centres in five sub-Saharan African countries, namely Cameroon, Congo Brazzaville, Democratic Republic of Congo (DRC), Madagascar and Nigeria. Four hundred and forty-nine men and women 18 years of age or older with hypertension not controlled by an ACE inhibitor, a diuretic or any other monotherapy or anti-hypertensive combination not containing a diuretic in a fixed dose were considered eligible for inclusion in this eight-week study. The study consisted of three visits, visit one (V1) at baseline, visit two (V2) after four weeks and visit three (V3) after eight weeks.ResultsThe mean age of the patients was 54.7 ± 11.7 years (20–90 years) and most were categorised by the WHO criteria as either overweight or obese (71.6%). After four and eight weeks of treatment with the study drug, systolic and diastolic blood pressures significantly changed from baseline: –24.7/–14.2 mmHg (p < 0.001) and –31.7/–17.9 mmHg (p < 0.001), respectively. There were 60.2% of the non-diabetics on prior monotherapy who, at eight weeks, fulfilled the primary blood pressure goal for SBP and DBP, versus 26.5% of the diabetic patients, also on monotherapy. Few adverse events were reported, with facial oedema and dry cough recurring twice in two patients.ConclusionFixed-dose combination of ramipril/HCTZ is therefore effective, tolerable and has a good safety profile for blood pressure control in black Africans.

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“…Perhaps the definitive trial in this regard is Omapatril Cardiovascular TreAtment Versus Enalapril (OCTAVE), for it was designed to focus specifically on establishing the incidence and clinical features of angioedema. 8 These events were the primary end points of this trial, and the investigators were carefully trained in the recognition of angioedema events, either mild or serious. A total of 12 557 patients were treated with the ACE inhibitor, enalapril, in its full dosage range of 5 to 40 mg daily.…”

Section: Estimating the Incidence Of Angioedema With Ace Inhibitorsmentioning

confidence: 99%

“…Sadly, this reassuring statement has not turned out to be true. Reports during the past 3 years, 7,8 including that of Miller et al, 2 have emphasized that although a relatively high proportion of angioedema episodes occur during the early part of treatment, these serious events can be observed after months or even years of ACE inhibitor therapy. In fact, in a large clinical survey by Zingale et al the average ACE inhibitor exposure before the occurrence of angioedema was a full 12 months; remarkably, it took an additional 12 months from the occurrence of the angioedema until the ACE inhibitor therapy was discontinued.…”

mentioning

confidence: 99%