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Theresa M. Dombi, Kenneth K. Kwoc, Robert L. Wiseman, Marla B. Sultan; Systemic Safety of Pegaptanib Sodium in the Treatment of Age-Related Macular Degeneration (AMD) in Subjects with Diabetes Mellitus (DM): A Pooled Analysis. Invest. Ophthalmol. Vis. Sci. 2011;52(14):1666.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the incidence of prespecified Antiplatelet Trialists’ Collaboration (APTC) adverse events (AEs) in controlled AMD studies in subjects with DM treated with pegaptanib sodium 0.3 mg or sham injections.
Using data from 9 controlled AMD clinical trials, APTC AEs identified by MedDRA preferred terms were retrospectively summarized and compared between pegaptanib vs sham injection-treated subjects with DM. All subjects with a history of DM who received treatment with 0.3 mg pegaptanib (by way of randomization, crossover design, protocol amendment, or change in dose assignment) or sham were included.
In all, 191 subjects with DM had been enrolled (165, pegaptanib; 26, sham); median age: 76.0 years. At least 1 APTC AE was reported for 13/191 subjects; the incidence was lower in the pegaptanib group occurring in 10/165 (6.1%; 13 events) pegaptanib- and 3/26 (11.5%; 3 events) sham-treated subjects. AEs were serious in 10/165 (6.1%, 12 events) and 2/26 (7.7%, 2 events), respectively. At least 1 severe APTC AE occurred in 6/165 (3.6%; 8 events) pegaptanib- and 2/26 (7.7%; 2 events) sham-treated subjects; 0/191 and 1/26 (3.8%) subjects, respectively, discontinued due to an APTC AE. Few subjects in either group reported APTC AEs, and those reported would be expected in an elderly diabetic population. Cerebrovascular accident (CVA) and myocardial infarction (MI) were reported for 3/165 (1.8%) and 2/165 (1.2%) pegaptanib-treated subjects and acute MI was reported for 1/26 (3.8%) sham-treated subject. No APTC AE was considered related to study treatment with the exception of 1 CVA, which was considered possibly related in a patient with history of DM, hypertension, and MI.
The low number of subjects with DM makes it difficult to draw conclusions and to interpret between-group differences in individual AE’s. However, these findings, together with those reported previously in pegaptanib trials, suggest that there is no increased risk of APTC AEs for the diabetic population as a result of treatment with pegaptanib sodium 0.3 mg.
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