A. Ali

Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and...

Suggested Citation: Ali AK. Biases related to prescribing decisions in retrospective database research in diabetes. Value & Outcomes Spotlight. July-August 2015; 1(4):13-15.

Objective: To examine the comparative effectiveness of inhaled long-acting beta-agonist (LABA), inhaled corticosteroid (ICS), and ICS/LABA combinations. Methods: We used a retrospective cohort design of patients older than 12 years with asthma diagnosis in the Clinical Practice Research Datalink to evaluate asthma-related morbidity measured by ora...

Suggested Citation: Ali AK. Methodological challenges in observational research: a pharmacoepidemiological perspective. British Journal of Pharmaceutical Research. March 2013; 3(2):161-175.

BACKGROUND: Hypoglycemia is a major limiting factor in achieving glycemic control in persons with diabetes. In some instances, recovery from a severe hypoglycemia event may require health care resource utilization (HCRU), including the use of emergency medical services (EMS), visits to the emergency department (ED), and inpatient hospitalization. O...

Purpose To share better practice in establishing data monitoring committees (DMCs) for observational, retrospective safety studies with joint‐industry sponsorship. Methods A DMC model was created to monitor data from an observational, retrospective, post‐authorization safety study investigating risk of medullary thyroid cancer in patients treated...

Suggested Citation: Ali AK. Epidemiology of nonalcoholic fatty liver disease and steatohepatitis in pediatric population. Journal of Managed Care & Specialty Pharmacy. October 2020;26(10-a Suppl):S63-S64 [Abstract No. K21].

Suggested Citation: Ali AK, Bohm MS. Insulin glargine and hypersensitivity reactions as an example of biosimilars pharmacovigilance. Pharmacoepidemiology and Drug Safety. September 2020;29(S3):22 [Abstract No. 4167].

Suggested Citation: Ali AK. Epidemiology of heart failure with preserved ejection fraction in pediatric population with obesity. Pharmacoepidemiology and Drug Safety. September 2020;29(S3):455 [Abstract No. 4508].

Suggested Citation: Ali AK. Dulaglutide proactive safety surveillance program (PSSP). Pharmacoepidemiology and Drug Safety. September 2020;29(S3):425 [Abstract No. 4164].

Suggested Citation: Davies M, Hazell L, Dhanda S, Osborne V, Ali AK, Reingold J, Grill S, Overbeek J, Heintjes E, Herings R, Sultana J, Trifiro G, Shakir S. Incidence of acute pancreatitis among dulaglutide initiators: results from a multi-country post authorization safety study (PASS). Pharmacoepidemiology and Drug Safety. September 2020;29(S3):4...

Suggested Citation: Davies M, Hazell L, Dhanda S, Osborne V, Ali AK, Reingold J, Grill S, Overbeek J, Heintjes E, Herings R, Sultana J, Trifiro G, Shakir S. Incidence of arrhythmia and cardiac conduction disorder among dulaglutide initiators: results from a multi-country post authorization safety study (PASS). Pharmacoepidemiology and Drug Safety....

Suggested Citation: Hale PM, Ali AK, Buse JB, McCullen MK, Ross DS, Sabol ME, Tuttle RM, Stemhagen A. Medullary thyroid carcinoma surveillance study: a case-series registry. Thyroid. October 2020;30(10):1397-1398.

Suggested Citation: Wong-Jacobson SH, Chinthammit C, Liu D, Mitchell BD, Haynes G, Syring K, Ali AK, Bajpai S. Characteristics of patients with severe hypoglycemia among patients with diabetes using insulin in commercially insured, Medicare, and Medicaid population. The Diabetes Educator. August 2020;46(4) [Abstract No. IP19]

Suggested Citation: Chinthammit C, Wong-Jacobson S, Liu D, Mitchell BD, Haynes M, Syring K, Ali AK, Bajpai S. Healthcare resource utilization and cost of severe hypoglycemia treatment in patients with diabetes treated with insulin. The Diabetes Educator. August 2020;46(4) [Abstract No. IP17]

Suggested Citation: Chinthammit C, Wong-Jacobson SH, Liu D, Mitchell BD, Haynes G, Ali AK, Bajpai S. Characteristics of patients with severe hypoglycemia among patients with diabetes using insulin in commercially insured, Medicare, and Medicaid population. Value in Health. May 2020;23(S1):S121 [Abstract No. PDB68]

Due to COVID-19 pandemic, the conference was canceled but posters and abstracts were electronically presented and published. Suggested Citation: Wong-Jacobson S, Chinthammit C, Liu D, Mitchell B, Haynes G, Syring K, Ali A, Bajpai S. Healthcare Resource Utilization and Cost of Severe Hypoglycemia Treatment in Patients with Diabetes Treated with In...

Suggested Citation: Ali AK, Hassan SW. Epidemiology of cholangiocarcinoma in adults with type 2 diabetes in the United Kingdom Clinical Practice Research Datalink. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):80-81 [Abstract No. 158].

Suggested Citation: Ali AK, Ayres JD. Batch-level pharmacovigilance following manufacturing change of biological products. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):55-56 [Abstract No. 105].

Suggested Citation: Kobayashi T, Nishikawa A, Schroeder KM, Ali AK. Prevalence and incidence of venous thromboembolism among patients with rheumatoid arthritis in Japan. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):493-494 [Abstract No. 1019].

Suggested Citation: Ali AK, Huang Y. Incidence and prevalence of systolic and diastolic heart failure among obese patients with type 2 diabetes in the United States. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):87-88 [Abstract No. 173].

Suggested Citation: Ali AK, Gurbuz S. Spontaneous reporting systems as proxy for drug utilization in pregnancy: the example of insulin maternal exposure. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):380-381 [Abstract No. 785].

Suggested Citation: Davies M, Hazell L, Dhanda S, Osborne V, Ali AK, Shakir S. Utilisation of dulaglutide in primary care in England: interim results from a post authorisation safety study. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):514 [Abstract No. 1064].

Suggested Citation: Ali AK, Lakshmanan MC. Epidemiology of non-fatal major adverse cardiovascular events in children with diabetes. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):88-89 [Abstract No.175].

Suggested Citation: Ali AK, Motsko SP. Celecoxib and cardiovascular safety: replicating clinical trial evidence from real world data. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):559 [Abstract No. 1158].

Suggested Citation: Ali AK, Kaiser JJ, Hensley IE. Assessment of the effectiveness of risk evaluation and mitigation strategies for dulaglutide: 18- and 36-month prescriber surveys. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):465 [Abstract No. 958].

Suggested Citation: Ali AK, Wells KE, Rosé M, Toussi M. European multi-country drug utilization study of dulaglutide. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):515 [Abstract No. 1065].

Suggested Citation: Ali AK, DeGuire BJ. Incidence and prevalence of gastrointestinal stenosis and obstruction in patients with diabetes in the United States. Pharmacoepidemiology and Drug Safety. August 2019;28(S2):92 [Abstract No. 183].

Suggested Citation: Ali AK, Ewing M. Assessment of the effectiveness of risk minimization measures for concentrated insulin lispro 200 units/ml: a multinational study. Diabetes. June 2019;68(S1) [Abstract No. 2324-PUB].

Suggested Citation: Ali AK. Epidemiology of non-fatal major adverse cardiovascular events in children with diabetes in the US. Value in Health. September 2018;21. Abstract No. PCV13.

Suggested Citation: Ali AK, Toussi M, Phillips S, Roset M. Real-world use of dulaglutide in Europe: a multi-country drug utilization study. Pharmacoepidemiology and Drug Safety. August 2018;27(S2). Abstract No. 3048.

Suggested Citation: Major-Pedersen A, McCullen MK, Sabol MB, Adetunji O, Massaro J, Neugut A, Sosa JA, Hollenberg A, for the MTC Registry Consortium (Ali AK). A Model for Data Monitoring Committees for Retrospective Study Designs in the Real-World Setting. Pharmacoepidemiology and Drug Safety. August 2018;27(S2):259 [Abstract No. 561].

Suggested Citation: Ali AK, Adetunji O. Incidence and prevalence of bile duct and gallbladder disease in patients with diabetes in the US. Diabetes. July 2018;67(S1). Abstract No. 1559-P.

Suggested Citation: Ali AK. Insulin maternal exposure during pregnancy: a descriptive pharmacovigilance analysis. Value in Health. May 2018;21(Suppl. 1). Abstract No. PDB5.

Suggested Citation: Ali AK. Celecoxib and cardiovascular outcomes: replicating evidence from US and UK real-world data. Value in Health. May 2018;21(Suppl. 1). Abstract No. PMS1 (Research Presentation Award Finalist)

Suggested Citation: Ali AK, Bomont H, McCaskill RM. Assessment of the effectiveness of risk minimization measures for concentrated insulin lispro 200 units/ml: a multi-national study. Value in Health. May 2018;21(Suppl. 1). Abstract No. PDB27.

Suggested Citation: Ali AK, DeGuire BJ. Epidemiology of gastrointestinal stenosis and obstruction in patients with diabetes. Value in Health. May 2018;21(Suppl. 1). Abstract No. PDB7 (Research Presentation Award Finalist).

Available from: http://onlinelibrary.wiley.com/doi/10.1002/phar.2035/full Study Objective: Ipilimumab, pembrolizumab, and nivolumab are checkpoint inhibitors (CPI) that activate T-cells to attack cancer cells. CPI can provide durable benefits to a minority of cancer patients with melanoma, renal cell cancer, non-small cell lung cancer, and a growi...

Purpose To identify the characteristics and initial disease severity of patients with nonalcoholic fatty liver disease (NAFLD) and assess incidence and risk factors for disease progression in a retrospective study. Methods Patients ≥18 years of age without alcoholism or other liver diseases (eg, hepatitis B/C) were selected from Geisinger Health S...

Suggested Citation: Ali AK. TZD Anti-Diabetes Therapy and Bladder Cancer: Example of “Ripple Effect” in Pharmacovigilance. Pharmacoepidemiology and Drug Safety. 2017;26(S2):398. [Abstrct No. 659].

Suggested Citation: Nordstrom B, Simeone J, Hoogwerf BJ, Li Q, Haupt A, Ali AK, Boardman MK, Bae J. Natural History of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis: A Longitudinal Assessment of Severity, Progression, and Risk Factors. Pharmacoepidemiology and Drug Safety. 2017;26(S2):292. [Abstract No. 483].

Suggested Citation: Davies M, Fan L, Ali AK, Araz M, Bain SC, Beshya S, Caballero AE, Curtis BH, Fernandes V, Linetzky B, Montenegro Jr RM, Adame LM, Matsuba I, Peng X, Polonsky WH, Tsoukas M, Zhao Z, Ray K. Global patterns of treatment changes among patients with type 2 diabetes (T2DM) treated with insulin: insights from the MOSA1c observational s...

Suggested Citation: Ray K, Fan L, Ali AK, Araz M, Bain S, Caballero AE, Chawla M, Curtis B, Davies M, Fernandes V, Funnell M, Linetzky B, Matsuba I, Montenegro Jr RM, Peng X, Polonsky W, Zhao Z, Adame LM. Patients, physician and healthcare-system factors associated with HbA1c improvement after initial insulin therapy in the MOSA1c study. Diabetes....

Suggested Citation: Caballero AE, Fan L, Ali AK, Beshya S, Chawla M, Curtis B, Davies M, Linetzky B, Matsuba I, Montenegro Jr RM, Peng X, Polonsky W, Ray K, Tsoukas M, Zhao Z, Adame LM. Factors associated with individualized HbA1c target selection in the MOSA1c type 2 diabetes study. Diabetes. June 2017;66(S1):A414 [Abstract No. 1547-P].

Suggested Citation: Chawla M, Jia N, Ali AK, Araz M, Beshya S, Caballero AE, Curtis B, Fernandes V, Linetzky B, Adame LM, Peng X, Polonsky W, Ray K, Suzuki J, Tsoukas M, Zhao Z, Davies M. Global insulin treatment patterns and attainment of individualized goals: insights from the MOSA1c global observational study. Diabetes. June 2017;66(S1):A447 [Ab...

OBJECTIVES: To describe the extent of insulin therapy use among patients with diabetes mellitus (DM) who started injectable glucagon in the United States. METHODS: Patients with DM (ICD-9-CM 250*) who initiated injectable glucagon therapy between 2004 and 2012 in Truven Health MarketScan® database were included in the study. Insulin treatment patt...

OBJECTIVES: Injectable glucagon was approved in the United States in 1998 for the treatment of severe hypoglycemia in patients with diabetes mellitus (DM) and as a diagnostic aid in gastrointestinal radiologic examinations. This study describes the patterns of glucagon utilization in patients with DM who initiated insulin therapy in the United Stat...

OBJECTIVES: To describe prognostic characteristics of patients with type-2-diabetes (T2D) prior to initiating antidiabetes medications (ADM). METHODS: Humedica EHR database was used to describe characteristics of adult ADM initiators between 2006 and 2012. ADM classes included metformin, sulfonylureas, thiazolidinediones (TZD), incretin enhancers...

OBJECTIVES: To illustrate selection bias when choosing inappropriate anti-diabetes medications (ADM) as comparison to incretin enhancers in cardiovascular outcome studies using real-world data. METHODS: Adults with type 2 diabetes (T2D) who initiated ADM between 2006 and 2012 and enrolled in Humedica HER database were included in this retrospectiv...

OBJECTIVES: On October 1, 2015 payers in US required all medical claims to be submitted using ICD-10-CM instead of ICD-9-CM. Increased quantity and specificity of codes in ICD-10-CM will likely enhance misclassification in claims data during transition. This study describes real-world ICD-10-CM coding patterns for several diseases during ICD-10-CM...

Purpose: To investigate the link between benzodiazepine antiepileptic therapy and serious skin reactions (SSR), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). Methods: We conducted a comparative pharmacovigilance analysis of adverse event cases reported to the FDA...

Suggested Citation: Linetzky B, Curtis BH, Rogers JR, Bae JP, Duan R, Ali AK, Chawla M, Tsoukas MA, Rista L, Toledano Y, Polonsky WH, Funnell MM, Kim SC. Effect of patient-physician relationship on insulin progression, diabetes distress, adherence and HbA1c control over time: insights from the MOSAIc study. Diabetes & Primary Care. December 2016; 1...

Suggested Citation: Bae J, Curtis BH, Rogers JR, Linetzky B, Ali AK, Tsoukas M, Beshyah S, Matsuba I, Araz M, Megalhaes Montenegro R, Kim S. The MOSAIc Study: regional variation in treatment patterns associated with progression from initial insulin regimen. Value in Health. November 2016; 19(7):A681-A682 [Abstract No. PDB93].

Suggested Citation: Ali AK. Cancer immunotherapy with checkpoint inhibitors is associated with immune-mediated reactions: a pharmacovigilance study. Value in Health. November 2016; 19(7):A708 [Abstract No. PCN2].

Suggested Citation: Koro CE, Hale PM, Ali AK, Qiao Q, Tuttle RM. The rationale, objectives, design and status of the medullary thyroid carcinoma (MTC) surveillance study: a case-series registry. Thyroid. September 2016; 26(S1):A-125 [Abstract No. 357].

Poster available here: http://m.easdvirtualmeeting.org/#ePosters/29917/extend Suggested Citation: Ali AK, Curtis BH, Eddings W, Rogers JR, He M, Abdurrob A, Linetzky B, Bae J, Duan R, Bain S, Chawla M, Toledano Y, Matsuba I, Araz M, Polonsky WH, Kim SC. Demographic and clinical factors may predict insulin progression and glycaemic control among pa...

Suggested Citation: Ali AK. Postmarketing safety profile of ledipasvir/sofosbuvir chronic HCV infection therapy. Pharmacoepidemiology and Drug Safety. August 2016; 25(S3):432-433 [Abstract No. 745].

Suggested Citation: Ali AK, Meyers, KJ, Huang YJ, Salinas CA, Li H. The landscape of active surveillance systems for postmarketing drug safety monitoring. Pharmacoepidemiology and Drug Safety. August 2016; 25(S3):406 [Abstract No. 697].

Suggested Citation: Ali AK, Meyers, KJ, Huang YJ, Salinas CA, Li H. The landscape of active surveillance systems for postmarketing drug safety monitoring. Pharmacoepidemiology and Drug Safety. August 2016; 25(S3):406 [Abstract No. 697].

Suggested Citation: Ali AK, Curtis BH, Eddings W, Rogers JR, He M, Abdurrob A, Linetzky B, Bae J, Duan R, Bain S, Chawla M, Toledano Y, Matsuba I, Araz M, Polonsky WH, Kim SC. Demographic and clinical factors may predict insulin progression and glycemic control among patients with type 2 diabetes using insulin: Learning from the MOSAIc study. Diabe...

Suggested Citation: Abdurrob A, Curtis BH, Eddings W, He M, Rogers JR, Duan R, Ali AK, Bae J, Bain S, Rista L, Tsoukas M, Toledano Y, Funnell MM, Kim SC. The effect of insulin adherence on HbA1c levels: The MOSAIc study. Diabetes. June 2016;65(S1):A211 [Abstract No. 824-P]. Encore: Abdurrob A, Curtis BH, Eddings W, He M, Rogers JR, Duan R, Ali AK,...

Suggested Citation: He M, Curtis BH, Eddings W, Jiang D, Bae J, Ali AK, Polonsky WH, Rista L, Beshyah S, Funnell MM, Montenegro Jr RM, Fernandes V, Kim SC. Factors associated with insulin adherence among patients with type 2 diabetes: The MOSAIc study. Diabetes. June 2016;65(S1):A203 [Abstract No. 789-P]. 789-P — 2016 Factors Associated with Insul...

Background: Spontaneous reporting systems (SRS) of adverse drug events are important sources for postmarketing evaluation and monitoring of adverse drug events. However, these sources have limitations. Objectives: This abstract describes common sources of bias in signal detection and clarification utilizing SRS to guide researchers on appropriate a...

Suggested Citation: Ali AK. Pharmacovigilance trend analysis of medication off-label use. Value in Health. May 2016;19(3)[Abstract No. PHP97].

Suggested Citation: Ali AK. Pharmacovigilance trend analysis of medication errors. Value in Health. May 2016;19(3)[Abstract No. PHP106].

Suggested Citation: Ali AK. Myocarditis as a feature of Churg-Strauss syndrome could be manifested with exposure to leukotriene receptor antagonists. Value in Health. May 2016;19(3)[Abstract No. PRS2].

Suggested Citation: Ali AK. Psychiatric safety profile of suvorexant, a first-in-class orexin receptor antagonist. Value in Health. May 2016;19(3)[Abstract No. PND1].

Suggested Citation: Ali AK. Mono- and combination antihypertensive therapy with olmesartan is associated with enteropathy risk. Value in Health. May 2016;19(3)[Abstract No. PCV5].

Background: Diabetes is a leading cause of morbidity, mortality, and medical resource utilization in the United States and worldwide. Treatment is aimed at keeping blood glucose levels close to normal and preventing or delaying medical complications. It has been estimated that only 50% of patients with diabetes in the United States achieve glycosy...

BACKGROUND: Diabetes is a leading cause of morbidity, mortality, and medical resource utilization in the United States and worldwide. Treatment is aimed at keeping blood glucose levels close to normal and preventing or delaying medical complications. It has been estimated that only 50% of patients with diabetes in the United States achieve glycosyl...

Suggested Citation: Ali AK. Torsade de pointes and QT prolongation could result from desloratadine anti-allergy treatment. Value in Health. November 2015; 18(7):A493-A494 [Abstract No. PRS1].

Suggested Citation: Ali AK. The link between proton pump inhibitors and ischemic heart disease could be explained by protopathic bias: a pharmacovigilance analysis. Value in Health. November 2015; 18(7):A373-A374 [Abstract No. PCV1].

Suggested Citation: Ali AK. Spontaneous Reporting of Adverse Drug Events Could be Motivated by Increased Awareness Brought About by the Introduction of Risk Evaluation and Mitigation Strategies: An Example of Stimulated Reporting Bias. Annals of Epidemiology. 2015;25(9):714. [Abstract No. P49].

Background: Given stepwise pharmacologic therapy of diabetes, residual confounding due to selection bias in studies of anti-diabetes medications (ADM) is likely for outcomes that are linked to diabetes severity. Objectives: This real-world study assessed residual confounding attributed by selection bias among ADM classes when studying the distribu...

Background: Asthma is a chronic respiratory inflammatory disease that is increasing in prevalence and burdens; however, it is under-diagnosed and under-treated in the elderly. Although clinical consequences of asthma in the elderly can be similar to those in younger patients, the presence of comorbidities influences treatment choice in older patien...

Background: Epilepsy treatment involves frequent switching between antiepileptic medications (AM), and combination therapy with AM—including clonazepam—is common to control seizures. Therefore, the likelihood of adverse events, for example, rhabdomyolysis, due to interactions between AM is high. Striated muscle damage, including rhabdomyolysis, is...

Finasteride, a 5α-reductase inhibitor, is marketed in a low dose (1 mg) as a popular therapy for androgenic alopecia in young men. As case reports and small surveys have suggested a link between persistent sexual dysfunction (SD) and suicidal ideation (SI) with low-dose finasteride, the aim of this study was to detect signals of SD and SI secondary...

A pharmacovigilance analysis of spontaneously submitted adverse event reports for proton pump inhibitors shows no signal was detected for ischemic heart disease, including heart attacks in relation to proton pump inhibitor use. The associations in the recently published study (PLoS One. 2015 Jun 10;10(6):e0124653) could have been explained by proto...

Suggested Citation: Ali AK. Treatment with some bisphosphonates is associated with aortic and mitral valve calcification. Value in Health. May 2015; 18(3):A152 [Abstract No. PMS1].

Suggested Citation: Ali AK. Bone safety profile of denosumab therapy: a pharmacovigilance characterization analysis. Value in Health. May 2015; 18(3):A190 [Abstract No. PCN1].

Rationale Nicotine and non-nicotine based products, including bupropion and varenicline, are used as pharmacological interventions to aid smoking cessation. There has been a growing concern regarding the psycho-behavioral safety of these agents. However, there is no comparative safety analysis between these products to characterize suicidality ris...

Suggestec Citation: Ali AK. Patterns of asthma treatment utilization in newly diagnosed elderly patients are inconsistent with asthma management guidelines. Value in Health. November 2014; 17(7):A602-A603 [Abstract No. PRS83].