Tegaserod and the Risk of Cardiovascular Ischemic Events: An Observational Cohort Study

@article{Loughlin2010TegaserodAT,
  title={Tegaserod and the Risk of Cardiovascular Ischemic Events: An Observational Cohort Study},
  author={Jeanne E. Loughlin and Sherry Quinn and Elena Rivero and Judy Wong and Jiaquing Huang and Jeffrey Kralstein and David L. Earnest and John D. Seeger},
  journal={Journal of Cardiovascular Pharmacology and Therapeutics},
  year={2010},
  volume={15},
  pages={151 - 157}
}
Objectives: Tegaserod, a partial 5-HT4 agonist previously approved for treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, was suspended from US marketing in 2007, based on pooled clinical trial results which contained a signal suggesting increased risk of cardiovascular ischemic events (CVIEs). We sought to evaluate whether there was an association between tegaserod and CVIE in a setting of routine clinical practice. Methods: This was a matched cohort… 
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References

SHOWING 1-10 OF 18 REFERENCES

Lack of Association of Tegaserod With Adverse Cardiovascular Outcomes in a Matched Case-Control Study

This large epidemiologic study failed to confirm a reported large event differential for tegaserod that was noted incidentally in a clinical trials database, suggesting that the prior observation may have been due to chance.

Response to a comment on ‘the risk of coronary heart disease in type 2 diabetic patients exposed to thiazolidinediones compared to metformin and sulfonylurea therapy’

The results do not suggest a cardioprotective or deleterious effects of TZDs compared with combined M + S oral therapy on the short-term CHD event risk in persons with type 2 diabetes after accounting for the greater baseline CHD risk in TZD initiators.

Use of insurance claims in epidemiologic research: Identification of peptic ulcers, gi bleeding, pancreatitis, hepatitis and renal disease

Portmarketing surveillance for peptic ulcer, upper gastrointestinal hemorrhage and hepatic dysfunction is described in 68, 180 people who took non‐steroidal anti‐inflammatory drugs (NSAIDs), by using an automated data base together with review of selected medical records.

The effectiveness of right heart catheterization in the initial care of critically ill patients. SUPPORT Investigators.

RHC was associated with increased mortality and increased utilization of resources, and these findings justify reconsideration of a randomized controlled trial of RHC and may guide patient selection for such a study.

Tegaserod: a new 5-HT4 agonist.

The role of serotonin in gastrointestinal tract physiology, the structure and pharmacokinetic profile of tegaserod, and clinical applications of this new drug are discussed.

Evidence- and consensus-based practice guidelines for the diagnosis of irritable bowel syndrome.

An analysis of the literature and expert opinion resulted in the development of a diagnostic algorithm relevant to primary care that emphasizes a symptom-based diagnostic approach, refers patients with alarm symptoms to subspecialists, and reserves radiographic, endoscopic, and other tests for referral cases.

Serotoninergic neuroenteric modulators

Accuracy of Medicare claims-based diagnosis of acute myocardial infarction: estimating positive predictive value on the basis of review of hospital records.

Using Claims Data for Epidemiologic Research: The Concordance of Claims-Based Criteria With the Medical Record and Patient Survey for Identifying a Hypertensive Population

Combined evidence from medical service and pharmacy claims yielded a high level of agreement with alternative, more costly sources of data in identifying patients with essential hypertension.

An application of propensity score matching using claims data

This work has shown that in the context of a rich data source, applied to the study of an outcome that occurs infrequently, there will typically be many more variables available for control as potential confounders than traditional epidemiologic techniques will allow.