Narrative review of data supporting alternate first-line therapies over metformin in type 2 diabetes.

Purpose: Metformin has been the first-line treatment for type 2 diabetes mellitus as monotherapy or concomitantly with other glucose-lowering therapies due to its efficacy, safety, and affordability. Recent studies on the cardioprotective and renoprotective benefits of glucagon-like peptide-1 receptor agonists (GLP-1 RA) and sodium-glucose cotransporter-2 inhibitors (SGLT-2i) have influenced guidelines on diabetes management to consider these newer agents as alternative first-line therapies. This paper explores the literature supporting the use of these newer medications alone as a first-line agent in place of metformin. Methods: A review of citations from the most recent guidelines along with a literature search via PubMed was completed to review (1) what, historically, made metformin first-line (2) if newer agents' benefits remain when used without metformin (3) how newer agents compare against metformin when used without it. Results: Evaluation of the historical literature was completed to summarize the key findings that support metformin as a first-line therapy agent. Additionally, an assessment of the literature reveals that the benefits of these two newer classes are independent of concomitant metformin therapy. Finally, studies have demonstrated that these newer agents can be either non-inferior or sometimes superior to metformin when used as monotherapy. Conclusion: GLP-1 RA and SGLT-2i can be considered as first line monotherapies for select patients with high cardiovascular risks, renal disease, or weight loss requirements. However, pharmacoeconomic considerations along with lesser long-term safety outcomes should limit these agents' use in certain patients as the management of diabetes continues to transition towards shared-decision making. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-024-01406-6.

A review of CONCEPTT study findings including subanalyses in pregnant women using continuous glucose monitoring with type 1 diabetes and their offspring.

The main objective of this article is to provide a comprehensive review of continuous glucose monitor (CGM) use in pregnant women with type 1 diabetes (T1D) from the CONCEPTT study including subanalyses. Literature search was accessed through MEDLINE (1966-September 2023) using the key terms: CONCEPTT, pregnancy, women, T1D, and CGM with limitations set to distinguish human subjects written in English. A total of 17 publications including one main clinical trial and 15 subanalyses have been published to date regarding the use of CGM in pregnant women with T1D which were conducted by a research group identified as the CONCEPTT Collaborative Group. While advances in maternal care have resulted in safer pregnancy for both the mother and child, women with preexisting T1D and pregnancy still experience higher rates of complications both in the short and long term. The use of CGM in pregnancy has not been studied extensively until more recently. The CONCEPTT clinical trial was a landmark study that involved several subanalyses. The main trial proved that CGM use in T1D pregnancy resulted in less hyperglycemia in the third trimester, reduced large for gestational age (LGA, >90th percentile), reduced neonatal intensive care unit admissions lasting longer than 24 h, and reduced neonatal hypoglycemia. Although subanalyses showed a variety of results including 'inconclusive' due to lack of prespecification, it is believed that CGM in T1D during pregnancy is to be recommended and used for overall improved outcomes.

GLP1-RA Add-on Therapy in Patients with Type 2 Diabetes Currently on a Bolus Containing Insulin Regimen.

Adding glucagon-like peptide-1 receptor agonists (GLP-1 RAs) to basal insulin regimens has become a guideline-recommended treatment option for uncontrolled type 2 diabetes. However, limited data exist to support the use of GLP-1 RAs with insulin regimens, including bolus insulin in patients with type 2 diabetes. The primary objectives of this review were to identify if the combination of a GLP-1 RA and an insulin regimen containing bolus insulin resulted in improvements in HbA1c , weight loss, reduction in insulin doses, and to evaluate the side effect profile of this combination in terms of nausea and hypoglycemia risk. Eight studies using exenatide twice/day, liraglutide, and dulaglutide were reviewed ranging in average duration of follow-up from 3 to 15 months. Seven studies showed that addition of a GLP-1 RA was associated with significant HbA1c reductions ranging from 0.4% to 1.64% from baseline to follow-up. Patients in all eight studies had significant weight loss in the GLP-1 RA arm from baseline to follow-up ranging from 0.87 to 10.2 kg. In all the studies, total daily bolus insulin doses decreased 25-67% from baseline to follow-up. In some studies, a portion of patients were able to discontinue bolus insulin all together after initiation of a GLP-1 RA. In addition, in two randomized trials included in the review, the GLP-1 RA arm showed significant improvement in HbA1c and weight compared with the control group who received basal/bolus regimens. Nausea was identified in 7-42% of participants using GLP-1 RAs with insulin. Data support the use of GLP-1 RAs added to insulin regimens already containing bolus insulin for glycemic control, weight loss, and reduction or discontinuation of bolus insulin.

Inhaled technosphere insulin: a novel delivery system and formulation for the treatment of types 1 and 2 diabetes mellitus.

Complications from uncontrolled diabetes mellitus were reduced significantly with the introduction of insulin more than 90 years ago. Despite the proven benefits of normal glycemic levels, patients are deterred by the inconvenience and perceived pain related to multiple daily subcutaneous insulin injections. Inhaled insulin was first approved by the U.S. Food and Drug Administration (FDA) in 2006, but because profit margins did not achieve expectations, the drug manufacturer discontinued sales 2 years later. The second-generation inhaled insulin, developed with Technosphere technology, received FDA approval in 2014. The pharmacology, pharmacokinetics, drug interactions, clinical safety and efficacy, patient satisfaction, dosage and administration, warnings, precautions, contraindications, adverse effects, and place in therapy of inhaled Technosphere insulin are reviewed in this article.

Impact of a faculty orientation and development committee.

This paper describes the faculty enrichment activities and outcomes of a faculty orientation and development committee at a college of pharmacy. The committee used a continuous quality improvement (CQI) framework that included needs assessment, planning and implementation of programs and workshops, assessment of activities, and evaluation of feedback to improve future programming. Some of the programs established by the committee include a 3-month orientation process for new hires and development workshops on a broad range of topics including scholarship (eg, research methods), teaching (eg, test-item writing), and general development (mentorship). Evidence of the committee's success is reflected by high levels of faculty attendance at workshops, positive feedback on workshop evaluations, and overall high levels of satisfaction with activities. The committee has served as a role model for improving faculty orientation and retention.

Clevidipine for the treatment of severe hypertension in adults.

BACKGROUND: Intravenous antihypertensive agents are used when immediate control of blood pressure (BP) is required, including during the perioperative cardiac surgery period. Controlling postoperative BP is challenging because of the need to adequately reduce BP while maintaining appropriate end-organ perfusion. Clevidipine is an intravenous, ultra-short-acting, third-generation dihydropyridine calcium channel antagonist with selectivity for arteriolar vasodilatation. It is approved by the US Food and Drug Administration for the treatment of severe hypertension. OBJECTIVE: This paper reviews the clinical pharmacology, pharmacokinetic and pharmacodynamic properties, tolerability, and clinical efficacy of clevidipine. METHODS: To minimize selection bias, each author conducted an independent search for English-language publications indexed on MEDLINE and International Pharmaceutical Abstracts through January 2010 using the term clevidipine. All identified prospective, randomized and nonrandomized Phase III trials were included in the review. RESULTS: Seven Phase III trials were identified in which clevidipine was compared with baseline, placebo, or other intravenous antihypertensive agents in the settings of severe hypertension (1 study), preoperative cardiac surgery (1), perioperative cardiac surgery (1), and postoperative cardiac surgery (4). In a multicenter, randomized, double-blind, placebo-controlled study of the efficacy of clevidipine in treating preoperative hypertension, the mean reduction from baseline in mean arterial pressure was 31.2% with clevidipine and 11.2% with placebo (P < 0.001). In a randomized, open-label, prospective study involving separate comparisons of clevidipine with nitroglycerin, sodium nitroprusside, and nicardipine, the median total AUC for digression in systolic BP from the predetermined target range differed significantly between clevidipine and nitroglycerin (4.14 vs 8.87 mm Hg . min/h; respectively, P < 0.001) and between clevidipine and sodium nitroprusside (4.37 vs 10.5 mm Hg . min/h; P = 0.003), but not between clevidipine and nicardipine (1.76 and 1.69 mm Hg . min/h). Another study found no significant difference in efficacy in controlling BP during the 3-hour study period between clevidipine and sodium nitroprusside (AUC for mean [SD] arterial pressure, 106 [25] and 101 [28] mm Hg . min/h, respectively). Adverse events in these studies included atrial fibrillation (13.0%-36.1% clevidipine vs 12.0% placebo), nausea (5.0%-21.0% vs 12.0%, respectively), fever (19.0% vs 13.7%), insomnia (12.0% vs 6.1%), and acute renal failure (9.0% vs 2.0%). In the studies reviewed, only 1 case of chest discomfort in the setting of severe hypertension was considered a serious adverse event related to clevidipine therapy. CONCLUSION: In the Phase III trials reviewed, clevidipine was effective in controlling BP in the settings of perioperative cardiac surgery and severe hypertension and was associated with minimal adverse effects.

Rotigotine transdermal system for the treatment of Parkinson's disease.

BACKGROUND: Levodopa has been the cornerstone of the treatment of Parkinson's disease (PD) for >30 years, but long-term levodopa therapy is associated with development of such motor complications as motor fluctuations, dyskinesias, and drug-induced involuntary movements. Rotigotine is a dopamine agonist with high affinity for the D(2) receptor. Rotigotine transdermal system, the first such system approved by the US Food and Drug Administration for the management of PD, has been formulated to deliver a consistent concentration of drug to the bloodstream with the goal of minimizing the complications associated with pulsatile dosing. OBJECTIVE: This article reviews the clinical pharmacology, pharmacokinetic and pharmacodynamic properties, tolerability, and efficacy of rotigotine transdermal system in the treatment of PD. METHODS: MEDLINE (1966-April 2008) and International Pharmaceutical Abstracts (1971-April 2008) were searched using the term rotigotine. All prospective, randomized clinical efficacy trials in humans were included. The reference lists of the identified articles were reviewed for additional publications. RESULTS: In clinical trials, rotigotine transdermal system at doses ranging from 4.5 to 67 mg/d was associated with significant clinical benefit in patients with early and advanced PD. In 4 randomized, doubleblind, placebo-controlled trials of 6 months' duration, patients receiving rotigotine transdermal system had significant improvements on the Unified Parkinson's Disease Rating Scale (UPDRS) part II (activities of daily living) that ranged from -0.3 to -4.2, compared with +0.92 to -2 for placebo (P < 0.001, rotigotine transdermal system vs placebo). In one trial that included pramipexole as an active comparator, the change in UPDRS II at 6 months was -4.2 in the rotigotine transdermal system group and -4.6 in the pramipexole group (P = NS, rotigotine transdermal system vs pramipexole). Changes on the UPDRS III (motor examination) at 6 months ranged from -3.58 to -8.7 with rotigotine transdermal system, compared with +0.38 to -4.3 in the placebo group and -10.3 in the pramipexole group (P < 0.001 vs placebo; P = NS vs pramipexole). The change in "off" time at 6 months ranged from -2.1 to -2.7 hours with rotigotine transdermal system, compared with -0.9 hour with placebo and -2.8 hours with pramipexole (P < 0.001 vs placebo; P = NS vs pramipexole). The proportion of patients achieving a >30% reduction in "off" time ranged from 55.1% to 59.7% of patients receiving rotigotine transdermal system, compared with 34.5% to 35.0% of patients receiving placebo and 67.0% of patients receiving pramipexole (P<0.001 vs placebo; P = NS vs pramipexole). The most commonly reported adverse event was application-site reaction, occurring in 9% to 46% of patients receiving rotigotine transdermal system, compared with 5% to 13% of patients receiving placebo. Other adverse events occurring in >20% of patients receiving rotigotine transdermal system were somnolence(8%\2-33%)and nausea(12%-49%). Less than 5% of patients assigned to rotigotine transdermal system discontinued study medication because of an adverse drug event. CONCLUSIONS: The available evidence suggests that rotigotine transdermal system was effective compared with placebo in decreasing morbidity in patients with early and advanced PD. The most commonly reported adverse events associated with rotigotine transdermal system were application-site reaction, nausea, and somnolence. Additional clinical trials are needed to determine the long-term tolerability profile of rotigotine transdermal system and its clinical efficacy and tolerability compared with oral dopamine agonists.

Sitagliptin: a novel agent for the management of type 2 diabetes mellitus.

PURPOSE: The pharmacologic, pharmacokinetic, safety, clinical efficacy, and role of sitagliptin in the management of type 2 diabetes mellitus are reviewed. SUMMARY: Sitagliptin is a dipeptidyl-peptidase IV (DPP4) inhibitor that increases insulin release and decreases glucagon levels by preventing the activation of incretin hormones--glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide. The clinical trials reviewed provide evidence that sitagliptin, either alone or in combination with metformin or thiazolidinediones, is effective in reducing glycosylated hemoglobin (HbA(1c)), fasting plasma glucose, and two-hour postprandial glucose levels in patients with type 2 diabetes. Specifically, sitagliptin has a role in patients who have been compliant with their oral hypoglycemic agents but unable to attain target HbA(1c) values with monotherapy and lifestyle modifications. Sitagliptin is generally well tolerated, with the frequency of adverse events being similar to placebo and a low frequency of hypoglycemia. Sitagliptin does not appear to alter the pharmacokinetics of metformin, rosiglitazone, glyburide, simvastatin, warfarin, or oral contraceptives. The addition of sitagliptin to a patient's oral antidiabetic regimen would necessitate close monitoring for adverse events and possible drug interactions. The sitagliptin dosage recommended by the manufacturer is 100 mg once daily as monotherapy or in combination with metformin or a thiazolidinedione. No formal pharmacoeconomic evaluations of sitagliptin therapy have been conducted. CONCLUSION: Sitagliptin, a DPP4 inhibitor, offers a novel treatment option for patients with type 2 diabetes mellitus.

Inhaled human [rDNA origin] insulin, a novel formulation for diabetes mellitus.

Diabetic complications have been reduced significantly with the introduction of insulin more than 8 decades prior. Despite the proven benefits of normal glycemic levels, patients are deterred by the inconvenience and expect worse pain than there is on average with multiple daily insulin injections. Inhaled insulin was approved by the Food and Drug Administration in early 2006 and is a novel product that introduces inhaled insulin as an alternate to the traditional subcutaneous delivery system, and hence could potentially improve patient compliance. The objective of this article is to review the clinical pharmacology, pharmacokinetic and pharmacodynamic properties, clinical efficacy, and tolerability of inhaled insulin.

Cinnamon supplementation in patients with type 2 diabetes mellitus.

Diabetes mellitus is the sixth leading cause of death in the United States, and most patients with the disease have type 2 diabetes. The effectiveness of cinnamon supplementation in patients with type 2 diabetes has received a great deal of media attention after a study was published in 2003. Although the efficacy of cinnamon in patients with diabetes has not been established, many patients seek other therapies and supplement their prescribed pharmacologic therapy with cinnamon. We conducted a literature search, limited to English-language human studies, using MEDLINE (1966-August 2006), EMBASE (1980-August 2006), International Pharmaceutical Abstracts (1970-August 2006), and Iowa Drug Information Service (1966-August 2006). References from articles and clinical trials were reviewed for additional sources; no abstracts were reviewed. We found two prospective, randomized, double-blind, placebo-controlled, peer-reviewed clinical trials and one prospective, placebo-controlled, peer-reviewed clinical trial that evaluated the efficacy of cinnamon supplementation in patients with type 2 diabetes; a total of 164 patients were involved in these trials. Two of the studies reported modest improvements in lowering blood glucose levels with cinnamon supplementation in small patient samples. One trial showed no significant difference between cinnamon and placebo in lowering blood glucose levels. Overall, cinnamon was well tolerated. These data suggest that cinnamon has a possible modest effect in lowering plasma glucose levels in patients with poorly controlled type 2 diabetes. However, clinicians are strongly urged to refrain from recommending cinnamon supplementation in place of the proven standard of care, which includes lifestyle modifications, oral antidiabetic agents, and insulin therapy.

Interaction potential between cranberry juice and warfarin.

PURPOSE: The interaction potential between warfarin and cranberry juice is discussed. SUMMARY: Reports from the United Kingdom have raised concern over the interaction potential between cranberry juice and warfarin. Warfarin is the most commonly prescribed oral medication for anticoagulation therapy. Cranberry juice is a flavonoid, which has been shown to induce, inhibit, or act as a substrate for the biosynthesis of several cytochrome P-450 (CYP) isoenzymes. Specifically, cranberry juice may inhibit the activity of CYP2C9, the primary isoenzyme involved in the metabolism of S-warfarin. A search of the medical literature identified three peer-reviewed case reports and two peer-reviewed, prospective, randomized, placebo-controlled clinical trials using metabolic surrogates of warfarin (flurbiprofen and cyclosporine) that described possible interactions between cranberry juice and warfarin. Two case reports suggested that cranberry juice increased the International Normalized Ratio (INR) of patients taking warfarin, but neither clearly identified cranberry juice as the sole cause of INR elevation. One case report appeared to show a correlation between the effects of cranberry juice and warfarin metabolism. Both clinical trials indicated the lack of an interaction between cranberry juice and CYP isoenzymes 2C9 and 3A, both of which are necessary in warfarin metabolism. More studies are required to determine the potential interaction between cranberry juice and warfarin. CONCLUSION: The available data do not seem to show a clinically relevant interaction between cranberry juice and warfarin; however, patients taking warfarin with cranberry juice should be cautioned about the potential interaction and monitored closely for INR changes and signs and symptoms of bleeding.

Adjunctive therapy with pramlintide in patients with type 1 or type 2 diabetes mellitus.

Uncontrolled diabetes mellitus is associated with both microvascular and macrovascular complications. Despite an array of treatment options available, achievement of euglycemia in most patients with diabetes is still lacking. Pramlintide acetate, a synthetic analog of the human hormone amylin and belonging to a new class of agents, was approved in March 2005 as adjunctive treatment in patients with type 1 or 2 diabetes mellitus. To evaluate the data available on the efficacy and safety of pramlintide, we conducted a search of MEDLINE (January 1966-May 2006) and International Pharmaceutical Abstracts (January 1970-May 2006). Bibliographies of clinical trials were reviewed for additional references. The literature reviewed demonstrated that pramlintide is effective in reducing levels of glycosylated hemoglobin and potentially preventing weight gain. The most commonly reported adverse effects associated with pramlintide were nausea, anorexia, and hypoglycemia. These adverse effects occurred more often during the initiation of therapy and were usually mild to moderate in nature. Whether this therapy is a cost-effective option for patients with type 1 or type 2 diabetes mellitus is yet to be determined.

Evaluating the impact of clinical interventions by PharmD students on internal medicine clerkships: the results of a 3 year study.

BACKGROUND: As the practice of pharmacy evolves, requiring more clinically oriented healthcare providers, PharmD programs expand their training to more hospital sites to expose students to management of a variety of disease states. These hospital sites often require proof of the impact of PharmD students on patient care over an extended period. This is the first long-term (3 year) study reported. OBJECTIVE: To evaluate the impact of clinical interventions by PharmD students on internal medicine clerkships over a 3 year period at a 627 bed county hospital with 165 general medical/surgical beds and 10 internal medicine teams. METHODS: Between January 1, 2003, and December 31, 2005, all pharmacy interventions at Kings County Hospital Center in Brooklyn, NY, were recorded and analyzed for percentage of contribution, acceptance rate, type, frequency, and impact level. RESULTS: PharmD students contributed to 28.8% of all pharmacy interventions made, with an acceptance rate for interventions of 92%. The most frequent types of interventions performed by PharmD students involved providing drug information (46.8%), recommending alternative agents (10.8%), and providing drug indications (10.6%). Overall, 49.5% of PharmD student interventions were categorized as having moderate to high level impact. CONCLUSIONS: This study demonstrates that the impact of PharmD students on clinical interventions is significant and improves overall patient care over a long-term period.

Role of abatacept in the management of rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) has been associated with significant morbidity and economic burden. Traditional pharmacotherapy (eg, NSAIDs, corticosteroids, disease-modifying antirheumatic drugs [DMARDs]) can be inadequate in controlling symptoms and disease progression. Abatacept is the first selective co-stimulation modulator approved by the US Food and Drug Administration for the management of RA. It is a fusion protein developed to modulate the T-cell co-stimulatory signal that is mediated through the CD28-CD80/86 pathway. OBJECTIVE: The objective of this manuscript was to review the clinical pharmacology, pharmacokinetic and pharmacodynamic properties, tolerability, and clinical efficacy of abatacept. METHODS: MEDLINE and International Pharmaceutical Abstracts were searched through June and May, respectively, of 2006 using the term abatacept or CTLA4-Ig. All prospective, randomized, Phase II and III trials, and their extension phases, were included. RESULTS: Phase II and III clinical trials found that abatacept, at a dose of 10 mg/kg administered as a short i.v. infusion in combination with DMARDs, was associated with significant clinical benefit in patients with active RA. After 6 months of treatment, the American College of Rheumatology (ACR) criteria for 20% clinical improvement (ACR20 response) was attained in 41.9% to 67.9% of patients who received abatacept compared with 19.5% to 39.7% of patients who received placebo (P < 0.001). The percentages of patients achieving the ACR criteria for 50% and 70% clinical improvement (ACR50 and ACR70) were 20.3% to 39.9% and 10.2% to 19.8%, respectively, in the groups that received abatacept compared with 3.8% to 16.8% and 1.5% to 6.5%, respectively, in the patients who received placebo (P = 0.03 and P < 0.001). Additionally, abatacept was found to improve disease activity, physical function, pain, and health-related quality of life (HRQOL). The most commonly reported adverse effects associated with abatacept treatment were headache (18.2%), upper respiratory tract infection (12.7%), nasopharyngitis (11.5%), and nausea (11.5%). The incidences of infections and serious infections were higher in the group that received abatacept compared with patients who received placebo (53.8% vs 48.3% and 3.0% vs 1.9%, respectively; P not reported). No significant between-group differences in mortality were found. CONCLUSIONS: Available evidence suggests that abatacept was effective in controlling symptoms and improving HRQOL in patients with active RA and an inadequate response to DMARD therapy. The most commonly reported adverse effects associated with abatacept treatment were headache, upper respiratory infection, nausea, and nasopharyngitis. Additional trials are needed to determine the long-term safety profile of this agent and whether the clinical benefits of abatacept found in the current clinical trials will be sustained over time.

Vitamin E supplementation in Alzheimer's disease, Parkinson's disease, tardive dyskinesia, and cataract: Part 2.

OBJECTIVE: To review clinical trials evaluating the safety and efficacy of vitamin E supplementation in Alzheimer's disease, Parkinson's disease, tardive dyskinesia, and cataract. DATA SOURCES: Using the MeSH terms alpha-tocopherol, tocopherols, vitamin E, Parkinson disease, tardive dyskinesia, Alzheimer disease, cataract, and clinical trials, a literature review was conducted to identify peer-reviewed articles in MEDLINE (1966-July 2005). STUDY SELECTION AND DATA EXTRACTION: Published materials including original research, review articles, and meta-analyses were reviewed. Only English-language articles and trials that included vitamin E alone or in combination with other vitamins or minerals were reviewed. Emphasis was placed on prospective, randomized, double-blind, placebo-controlled clinical trials. DATA SYNTHESIS: The clinical studies demonstrated contradicting results regarding the benefits of vitamin E in Parkinson's disease, tardive dyskinesia, and cataract. The study reviewed for Alzheimer's disease seemed to show benefit when vitamin E was used; however, the statistical methods employed are questionable. There is enough evidence from large, well-designed studies to discourage the use of vitamin E in Parkinson's disease, cataract, and Alzheimer's disease. We recommend that vitamin E be considered a treatment option in patients with tardive dyskinesia only if they are newly diagnosed. CONCLUSIONS: We encourage patients to supplement with vitamin E-rich foods. The use of a daily multivitamin, which usually contains 30 IU of alpha-tocopherol, may be beneficial; however, we discourage individual vitamin E supplements that usually contain 400 IU of alpha-tocopherol.

Vitamin E supplementation in cardiovascular disease and cancer prevention: Part 1.

OBJECTIVE: To review clinical trials evaluating the safety and efficacy of vitamin E supplementation in cardiovascular disease and cancer prevention. DATA SOURCES: Using the MeSH search terms alpha-tocopherol, tocopherols, vitamin E, cardiovascular diseases, cancer, malignancy, and clinical trials, a literature review was conducted to identify peer-reviewed articles in MEDLINE (1966-July 2005). STUDY SELECTION AND DATA EXTRACTION: Published materials including original research, and previous meta-analyses were included. Only English-language articles and trials on vitamin E alone or in combination with other vitamins or minerals were reviewed. Emphasis was placed on prospective, randomized, double-blind, placebo-controlled clinical trials. DATA SYNTHESIS: Eight clinical studies demonstrated contradicting results regarding the benefits of vitamin E in the prevention of cardiovascular disease and cancer. There is enough evidence from large, well-designed studies to discourage the use of vitamin E in the primary prevention of cardiovascular disease. Secondary prevention requires more adequate clinical trials with selected populations to examine protective effects of vitamin E in cardiovascular disease. The findings of the studies reviewed do not provide evidence that vitamin E may reduce the risk of cancer; thus, at the present time, we do not recommend daily vitamin E intake for cancer prevention is not recommended. CONCLUSIONS: Available data do not support the supplementation of vitamin E in cardiovascular disease and cancer prevention.