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Reactions 740 - 27 Feb 1999 Risk factors identified for adverse events after protamine chloride Neutral protamine Hagedorn (NPH) insulin use, fish allergy and nonprotamine drug allergy are all independent risk factors for developing clinically important adverse events following treatment with protamine chloride after cardiopulmonary bypass surgery, according to a US study. From a cohort of patients who underwent cardiopulmonary bypass surgery during a 4–year period, 53 patients * who had experienced an adverse event following treatment with protamine chloride and 223 controls were identified; controls were randomly selected from all subjects in the cohort who did not experience an adverse event. Multivariable analysis showed that NPH insulin use, fish allergy and nonprotamine drug allergy were associated with a statistically significant risk of developing adverse events following the administration of protamine chloride; multivariable odds ratios were 8.18 (95% CI 2.08–32.2), 24.5 (1.24–482.3) and 2.97 (1.25–7.07), respectively. The researchers say that a history of protamine allergy may be a risk factor for pulmonary hypertensive events, but further study is needed to validate this. According to the researchers, further progress needs to be made in developing preventative strategies and protamine substitutes, and in targeting the large number of patients who have an increased risk of developing adverse events following the administration of protamine chloride. * The primary case definition in this study was any event that occurred within 10 minutes of the administration of protamine chloride in the absence of other measurable causes of haemodynamic compromise. Adverse events included pulmonary hypertension, systemic hypotension, noncardiogenic pulmonary oedema and bronchospasm. Kimmel SE, et al. Risk factors for clinically important adverse events after protamine administration following cardiopulmonary bypass. Journal of the American College of Cardiology 32: 1916-1922, Dec 1998 800731622 1 Reactions 27 Feb 1999 No. 740 0114-9954/10/0740-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Risk factors identified for adverse events after protamine chloride

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Page 1: Risk factors identified for adverse events after protamine chloride

Reactions 740 - 27 Feb 1999

Risk factors identified for adverseevents after protamine chloride

Neutral protamine Hagedorn (NPH) insulin use, fishallergy and nonprotamine drug allergy are allindependent risk factors for developing clinicallyimportant adverse events following treatment withprotamine chloride after cardiopulmonary bypasssurgery, according to a US study.

From a cohort of patients who underwentcardiopulmonary bypass surgery during a 4–year period,53 patients* who had experienced an adverse eventfollowing treatment with protamine chloride and 223controls were identified; controls were randomlyselected from all subjects in the cohort who did notexperience an adverse event.

Multivariable analysis showed that NPH insulin use,fish allergy and nonprotamine drug allergy wereassociated with a statistically significant risk ofdeveloping adverse events following the administrationof protamine chloride; multivariable odds ratios were8.18 (95% CI 2.08–32.2), 24.5 (1.24–482.3) and 2.97(1.25–7.07), respectively. The researchers say that ahistory of protamine allergy may be a risk factor forpulmonary hypertensive events, but further study isneeded to validate this.

According to the researchers, further progress needsto be made in developing preventative strategies andprotamine substitutes, and in targeting the large numberof patients who have an increased risk of developingadverse events following the administration ofprotamine chloride.* The primary case definition in this study was any event that occurredwithin 10 minutes of the administration of protamine chloride in theabsence of other measurable causes of haemodynamic compromise.Adverse events included pulmonary hypertension, systemichypotension, noncardiogenic pulmonary oedema and bronchospasm.

Kimmel SE, et al. Risk factors for clinically important adverse events afterprotamine administration following cardiopulmonary bypass. Journal of theAmerican College of Cardiology 32: 1916-1922, Dec 1998 800731622

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Reactions 27 Feb 1999 No. 7400114-9954/10/0740-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved