Sanjay K Gandhi

• PhD
• Sr. Director at Teva Pharmaceutical Industries Ltd.

Introduction: Studies evaluating patient and healthcare professional (HCP) preferences regarding long-acting injectable (LAI) antipsychotic agent attributes are lacking. Methods: Surveys were administered to physicians, nurses, and patients who had at least two experiences with TV-46000, an investigational subcutaneous LAI antipsychotic agent fo...

Background: Huntington’s disease (HD) is a multifaceted neurodegenerative disorder characterized by involuntary movements, specifically chorea, as well as behavioral and psychiatric disturbance, and cognitive dysfunction. Tetrabenazine was the first approved treatment for chorea, although tolerability concerns exist. Objectives: To characterize dem...

Introduction: Through 2018, three calcitonin gene-related peptide pathway-targeted monoclonal antibodies (CGRP mAbs) had received US Food and Drug Administration (FDA) approval for migraine prevention: erenumab, fremanezumab, and galcanezumab. Methods: This retrospective analysis evaluated adverse events (AEs) spontaneously reported to the FDA A...

Background Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, including the fully humanized monoclonal antibody (IgG2Δa) fremanezumab, have demonstrated safety and efficacy for migraine prevention. Clinical trials include responders and nonresponders; efficacy outcomes describe mean values across both groups and thu...

Objective: To evaluate the impact of fremanezumab on the severity and duration of remaining migraine attacks in patients with chronic migraine (CM) or episodic migraine (EM). Background: Fremanezumab is a fully humanized monoclonal antibody (IgGΔa) that selectively targets calcitonin gene-related peptide and is efficacious in reducing migraine f...

Background: The long-term safety and efficacy of fremanezumab were evaluated in a 52-week extension study (NCT02638103). Patient satisfaction with fremanezumab, dosing preferences, and patient-reported outcomes were assessed in a subpopulation who completed the extension study and consented to a follow-up questionnaire. Methods: In the extension...

Objective To evaluate fremanezumab quarterly or monthly vs placebo on health-related quality of life, health status, patients’ global impression of change, and productivity in patients with chronic migraine (CM). Methods HALO CM was a double-blind, placebo-controlled trial in patients with CM. Patients were randomized 1:1:1 to treatment with frema...

Background: Open-HART was an open-label extension of HART, a randomized, double-blind, placebo-controlled study of pridopidine in Huntington disease (HD). Previously, we reported safety and exploratory efficacy data after 36 months of treatment with pridopidine 45 mg twice daily. In the interim, emerging data suggests pridopidine may have neuropro...

Background: Patient satisfaction with treatment in relapsing-remitting multiple sclerosis (RRMS) has a direct impact on adherence to treatment and, consequently, upon treatment outcomes and costs. Patient-reported outcomes (PROs) are a common method for determining patient satisfaction in MS and other diseases. Methods: The 12-month, open-label,...

Purpose Tardive dyskinesia (TD) is a common but serious hyperkinetic movement disorder and side effect of antipsychotic medications used to treat bipolar disorder (BD), major depressive disorder (MDD), and schizophrenia (SZ). The purpose of this study was to evaluate health-related quality of life (HRQoL) in a population with diagnoses for BD, MDD,...

Background: Patients who perceive their medication to be ineffective or inconvenient are less likely to be adherent to treatment, with potentially significant consequences on long-term clinical outcomes. Many patients with multiple sclerosis (MS) are nonadherent to treatment despite demonstrated efficacy of disease-modifying therapies (DMTs). Whil...

Objective: Identify opioid abuse risk factors among chronic noncancer pain (CNCP) patients receiving long-term opioid therapy and assess healthcare resource use (HRU) among patients at elevated abuse risk. Design: Data were obtained from an integrated administrative claims database. Classification and Regression Tree (CART) analysis identified r...

Background: Chorea is the hallmark motor feature of Huntington disease (HD) and can negatively impact daily functioning and health-related quality of life (HRQoL). Objective: The objective of this study was to evaluate how chorea impacts HRQoL and overall functioning among HD patients participating on the PatientsLikeMe website ( www.PatientsLik...

Introduction Tardive dyskinesia (TD), an often-irreversible movement disorder typically caused by exposure to antipsychotics, most commonly affects the face, mouth, and tongue and may be debilitating Objective To investigate TD burden on patients’ quality of life and functionality Methods Adults with clinician-confirmed schizophrenia, bipolar dis...

Objective: To survey neurologists and obtain clinical perceptions of tetrabenazine for the treatment of chorea in patients with Huntington disease (HD). Methods: Board-certified/board-eligible neurologists, in practice for ≥5 years, who treat ≥3 HD patients in the past 2 years, were recruited from an online physician panel to participate in a cross...

Background: Huntington's disease (HD) is a multifaceted neurodegenerative disorder characterized by involuntary movements, specifically chorea, as well as behavioral and psychiatric disturbance, and cognitive dysfunction. Tetrabenazine was the first approved treatment for chorea, although tolerability concerns exist. Objectives: To characterize...

Background: Open-HART is an open-label extension of HART, a randomized, placebo-controlled, dose-ranging, parallel-group study. Objective: To evaluate safety and exploratory efficacy of open-label pridopidine over 36 months in subjects with Huntington's disease (HD). Methods: Open-HART subjects were treated with pridopidine 45 mg twice daily (...

Background While studies have demonstrated the economic burden of migraines in terms of quality of life, health care resource use (HRU), and costs, there exists a notable paucity of data comparing such outcomes among migraineurs with nausea and vomiting (N/V) and those without. The current study aimed to address this gap. Methods This was a retros...

Background Vesicular monoamine transporter 2 (VMAT2) inhibitors can improve hyperkinetic movements, and are effective treatment options for chorea of Huntington disease (HD). Tetrabenazine was assessed for treating chorea in the TETRA-HD trial, and while efficacious, there are tolerability concerns possibly due to its pharmacokinetic properties. De...

Background In clinical trials of patients with Huntington’s disease (HD), treatment with TBZ resulted in more neuropsychiatric AEs compared to placebo, including insomnia, somnolence, anxiety, depression, and agitation. Aim To summarise post-marketing reports of AEs associated with TBZ by analysing case reports from FAERS. Methods FAERS data for...

Background DTB was efficacious and well tolerated in patients with Huntington’s disease (HD) chorea (First-HD). In the absence of a head-to-head trial with TBZ, we compared safety and tolerability outcomes of TBZ versus DTB using an indirect treatment comparison method and an NNH metric. Methods Safety data from First-HD and TETRA-HD were used to...

Objective No clinical trials have been conducted to directly compare the effect of the two high-intensity statins, rosuvastatin and atorvastatin, on cardiovascular outcomes. However, three such trials have been computer-simulated using the Archimedes model, an individual-based simulation of human physiology and behaviors, treatment interventions, a...

Abstract Objective: To evaluate psychometric,properties of the SF-12 health survey as a generic health-related quality of life (HQL) measure,in osteoarthritis (OA) and rheumatoid arthritis (RA) patient populations in clinical trials. Method: Data were aggregated from three clinical trials, evaluating efficacy of different NSAIDs in OA (N=651) and R...

Now that generic atorvastatin has become available, a process of switching from rosuvastatin to atorvastatin may occur and could persist until the patent on branded rosuvastatin expires. It is important to understand the impact that such therapy may have on patients' cardiovascular (CV) health. This simulated study estimates the impact of switching...

Purpose: Using simulation modeling, this study compared the effects of statin therapy with atorvastatin and rosuvastatin on patients with low-density lipoprotein cholesterol (LDL-C) above goal, considering patterns of initial dose assignment and intensification in follow-up reflective of the US today. Method: Two treatment scenarios were investig...

Many patients treated for dyslipidemia do not achieve recommended cholesterol goals despite the widespread availability of effective statins. Pharmaceutical claims show a strong tendency for patients to remain on their initially assigned treatment. With computer simulations, the impact of initial statin treatment decisions on medium- and long-term...

Objective: This study used simulation to compare the effectiveness of rosuvastatin 20 mg vs atorvastatin 40 mg, and rosuvastatin 40 mg vs atorvastatin 80 mg in preventing MACE in a range of patient populations with varying baseline cardiovascular risk. Research design and methods: The Archimedes Model was used to simulate head-to-head clinical t...

Objective: Using simulation modeling, we compared the effects of initiating statin therapy with atorvastatin and rosuvastatin on a population of patients with LDL-C levels above goal. Methods: Using the Archimedes Model, a clinically detailed simulation model of human physiology, disease progression, and healthcare delivery, two treatment scenarios...

To assess the long-term cost-effectiveness of rosuvastatin therapy compared with generic simvastatin and generic atorvastatin in reducing the incidence of cardiovascular events and mortality in a Swedish population with Framingham risk ≥20%. A PROBABILISTIC MONTE CARLO SIMULATION MODEL BASED ON DATA FROM JUPITER (THE JUSTIFICATION FOR THE USE OF ST...

This study estimated the long-term health outcomes, healthcare costs, and cost-effectiveness of rosuvastatin 20 mg therapy in primary prevention of major cardiovascular disease (CVD) in a Swedish population. Based on data from the JUPITER trial, long-term CVD outcomes with rosuvastatin vs no active treatment were estimated for patients with an elev...

Suboptimal adherence to lipid-lowering therapies is associated with and potentially contributes to increased cardiovascular morbidity and mortality. Single-pill combination (SPC) lipid-modifying therapies may improve patient adherence due to decreased pill burden and increased convenience for the patient. To compare adherence to SPC versus multi-pi...

Background: Many patients with dyslipidemia do not achieve goal low-density lipoprotein cholesterol levels. The barriers to achieving goal include inadequate assessment of cardiovascular risk status, medication cost, formulary restrictions, patient lack of adherence, and inadequate counseling time. Removing barriers may improve goal attainment and...

This study assessed the long-term cost effectiveness of rosuvastatin therapy compared with placebo in reducing the incidence of major cardiovascular (CVD) events and mortality. A probabilistic Monte Carlo simulation model estimated long-term cost effectiveness of rosuvastatin therapy (20 mg daily) for the prevention of CVD mortality and morbidity....

This investigation estimated medical costs attributable to treatment of patients diagnosed with atherosclerosis in routine US clinical practice. Using Medstat MarketScan claims data, direct costs of care and rates of cardiovascular (CV) events (i.e., myocardial infarction, stroke, revascularization) were examined for patients≥18 years of age with a...

This article reviewed the collective evidence from routine clinical practice to summarize the existing literature on the effectiveness of rosuvastatin in treating hypercholesterolemia. A comprehensive Medline literature search identified all published articles, in all languages, from January 2003 through September 2008 on the use of rosuvastatin in...

Clinical guidelines have recommended a LDL-C goal of <100 mg/dL for high-risk individuals and lipid-modifying therapy for patients not reaching this goal. This investigation assessed low-density lipoprotein cholesterol (LDL-C) levels and treatment patterns among patients diagnosed with atherosclerosis with or without a previous cardiovascular disea...

The availability of generic simvastatin has changed the relative cost structure within the statin marketplace and has been associated with third-party payer changes to formularies and statin utilization policies. The current study examines simvastatin therapy modification patterns and associated low-density lipoprotein cholesterol (LDL-C) goal atta...

We sought to examine the diagnoses and medical management patterns of patients before the incidence of a cardiovascular (CV) event. A retrospective study of claims data from a national managed care plan was conducted. Eligible patients had a myocardial infarction, stroke, or revascularization between January 1, 2004 and December 31, 2005, and at le...

This study assessed lipid-monitoring and statin therapy patterns in routine clinical practice for Medicare-eligible patients diagnosed with atherosclerosis. A retrospective study using a random sample of 1 million patients (>17 years of age) from a US outpatient electronic medical record database was conducted with patients > or =65 years of age ha...

Little is known about the lipid profiles and associated treatment patterns of patients in whom atherosclerosis is diagnosed. This investigation assessed and described the low-density lipoprotein (LDL) cholesterol levels and treatment patterns for hypercholesterolemia in patients with atherosclerosis who were treated in routine clinical practice. Th...

Patients may experience increased risk of adverse drug interactions when statins are administered concomitantly with cytochrome P450 3A4 (CYP3A4) inhibitors. To determine patient numbers in routine clinical practice with concomitant exposure to CYP3A4-metabolized statins and CYP3A4 inhibitors and highlight potential risk for adverse drug interactio...

The primary objective of this study was to assess the cost-effectiveness of the most commonly prescribed doses of rosuvastatin, atorvastatin, simvastatin, and pravastatin for managing various lipid parameters in patients with hypercholesterolemia over a 1-year time horizon from a Canadian health care perspective. Incremental cost-effectiveness rati...

To compare the effectiveness and cost-effectiveness among generic and branded statins in routine clinical practice. Retrospective database study of patients, 18+, who were newly prescribed statin therapy. Statin effectiveness and cost-effectiveness in reducing low-density lipoprotein cholesterol (LDL-C) and attaining LDL-C goals were evaluated. Of...