Long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes
Nayyar Iqbal,1 Elsie Allen,1 Peter Öhman2 1Bristol-Myers Squibb, Princeton, NJ, USA; 2AstraZeneca, Wilmington, DE, USA Background: Treatment decisions for older patients with type 2 diabetes mellitus must balance glycemic control and adverse event risk. The objective of this study was to...
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Dove Medical Press
2014
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oai:doaj.org-article:915c0e3d89df41358c1cd94b691a16462021-12-02T04:45:59ZLong-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes1178-1998https://doaj.org/article/915c0e3d89df41358c1cd94b691a16462014-09-01T00:00:00Zhttps://www.dovepress.com/long-term-safety-and-tolerability-of-saxagliptin-add-on-therapy-in-old-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Nayyar Iqbal,1 Elsie Allen,1 Peter Öhman2 1Bristol-Myers Squibb, Princeton, NJ, USA; 2AstraZeneca, Wilmington, DE, USA Background: Treatment decisions for older patients with type 2 diabetes mellitus must balance glycemic control and adverse event risk. The objective of this study was to evaluate the long-term safety and tolerability of saxagliptin 5 mg as add-on therapy to common antihyperglycemic drugs in patients aged ≥65 years and <65 years.Methods: Pooled adverse event data from three placebo-controlled trials of 76–206 weeks’ duration in older (≥65 years) and younger (<65 years) patients receiving saxagliptin 5 mg or matching placebo added to metformin, glyburide, or a thiazolidinedione were analyzed. Measurements were calculated from day of first dose to specified event or last dose and included time at risk for adverse events, treatment-related adverse events, serious adverse events, adverse events leading to discontinuation, and events of special interest. Weighted incidence rates (number of events/total time) and incidence rate ratios (saxagliptin/placebo) with 95% confidence intervals were calculated (Mantel-Haenszel test).Results: A total of 205 older (mean age 69 years; saxagliptin, n=99; placebo, n=106) and 1,055 younger (mean age 52 years; saxagliptin, n=531; placebo, n=524) patients were assessed. Regardless of age category, the adverse event incidence rates were generally similar between treatments, with confidence intervals for incidence rate ratios bridging 1. Treatment-related adverse events occurred in 36 older patients receiving saxagliptin versus 32 receiving placebo (incidence rate 34.1 versus 27.1 per 100 person-years) and in 150 younger patients in both treatment groups (incidence rate 24.0 versus 27.8 per 100 person-years). With saxagliptin versus placebo, serious adverse events occurred in eight versus 14 older (incidence rate 5.7 versus 9.9 per 100 person-years) and 49 versus 44 younger patients (incidence rate 6.5 versus 6.6 per 100 person-years). There were two deaths (one patient ≥65 years) with saxagliptin and six (none aged ≥65 years) with placebo. Older patients rarely experienced symptomatic confirmed hypoglycemia (fingerstick glucose ≤50 mg/dL; saxagliptin, n=1; placebo, n=2). Conclusion: Saxagliptin add-on therapy was generally well tolerated in older patients aged ≥65 years with type 2 diabetes mellitus, with a long-term safety profile similar to that of placebo. Keywords: older patients, glyburide, metformin, saxagliptin, thiazolidinedioneIqbal NAllen EÖhman PDove Medical PressarticleelderlyglyburidemetforminsaxagliptinthiazolidinedioneGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 9, Pp 1479-1487 (2014) |
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elderly glyburide metformin saxagliptin thiazolidinedione Geriatrics RC952-954.6 |
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elderly glyburide metformin saxagliptin thiazolidinedione Geriatrics RC952-954.6 Iqbal N Allen E Öhman P Long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes |
| description |
Nayyar Iqbal,1 Elsie Allen,1 Peter Öhman2 1Bristol-Myers Squibb, Princeton, NJ, USA; 2AstraZeneca, Wilmington, DE, USA Background: Treatment decisions for older patients with type 2 diabetes mellitus must balance glycemic control and adverse event risk. The objective of this study was to evaluate the long-term safety and tolerability of saxagliptin 5 mg as add-on therapy to common antihyperglycemic drugs in patients aged ≥65 years and <65 years.Methods: Pooled adverse event data from three placebo-controlled trials of 76–206 weeks’ duration in older (≥65 years) and younger (<65 years) patients receiving saxagliptin 5 mg or matching placebo added to metformin, glyburide, or a thiazolidinedione were analyzed. Measurements were calculated from day of first dose to specified event or last dose and included time at risk for adverse events, treatment-related adverse events, serious adverse events, adverse events leading to discontinuation, and events of special interest. Weighted incidence rates (number of events/total time) and incidence rate ratios (saxagliptin/placebo) with 95% confidence intervals were calculated (Mantel-Haenszel test).Results: A total of 205 older (mean age 69 years; saxagliptin, n=99; placebo, n=106) and 1,055 younger (mean age 52 years; saxagliptin, n=531; placebo, n=524) patients were assessed. Regardless of age category, the adverse event incidence rates were generally similar between treatments, with confidence intervals for incidence rate ratios bridging 1. Treatment-related adverse events occurred in 36 older patients receiving saxagliptin versus 32 receiving placebo (incidence rate 34.1 versus 27.1 per 100 person-years) and in 150 younger patients in both treatment groups (incidence rate 24.0 versus 27.8 per 100 person-years). With saxagliptin versus placebo, serious adverse events occurred in eight versus 14 older (incidence rate 5.7 versus 9.9 per 100 person-years) and 49 versus 44 younger patients (incidence rate 6.5 versus 6.6 per 100 person-years). There were two deaths (one patient ≥65 years) with saxagliptin and six (none aged ≥65 years) with placebo. Older patients rarely experienced symptomatic confirmed hypoglycemia (fingerstick glucose ≤50 mg/dL; saxagliptin, n=1; placebo, n=2). Conclusion: Saxagliptin add-on therapy was generally well tolerated in older patients aged ≥65 years with type 2 diabetes mellitus, with a long-term safety profile similar to that of placebo. Keywords: older patients, glyburide, metformin, saxagliptin, thiazolidinedione |
| format |
article |
| author |
Iqbal N Allen E Öhman P |
| author_facet |
Iqbal N Allen E Öhman P |
| author_sort |
Iqbal N |
| title |
Long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes |
| title_short |
Long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes |
| title_full |
Long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes |
| title_fullStr |
Long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes |
| title_full_unstemmed |
Long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes |
| title_sort |
long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes |
| publisher |
Dove Medical Press |
| publishDate |
2014 |
| url |
https://doaj.org/article/915c0e3d89df41358c1cd94b691a1646 |
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