Devada Singh-Franco

A review of the efficacy of smoking-cessation pharmacotherapies in nonwhite populations

BACKGROUND Cigarette smoking continues to be the leading cause of preventable morbidity and mortality in the United States. Research suggests that behavioral support strategies and pharmacotherapy can improve abstinence rates. However, both approaches, especially pharmacotherapy, have been understudied in nonwhite US populations. OBJECTIVE The aim of this review was to evaluate the efficacy of smoking-cessation pharmacotherapy in nonwhite US populations. METHODS Using search terms smoking cessation, nicotine replacement therapy, bupropion SR, varenicline, minority, ethnicity, African American, black, Hispanic, American Indian, and Alaska Native, a literature search was conducted to identify English-language studies that evaluated the use of smoking-cessation pharmacotherapies in nonwhite patients in MEDLINE (1966\2-December 2007), International Pharmaceutical Abstracts (1980\2-January 2008), Database of Abstracts of Reviews of Effectiveness (1990\2-December 2007), and EMBASE Drugs & Pharmacology (1991\2-third quarter 2007). RESULTS Nine studies were identified and assessed. Six studies looked at smoking-cessation pharmacotherapy in black smokers, 1 in Hispanic smokers, 1 in Native American smokers, and 1 in white and nonwhite smokers. In black smokers (N = 410; mean cigarettes per day [cpd], 20.4) who received the nicotine patch versus placebo, the 30-day self-reported abstinence rates were 21.5% versus 13.7% (P = 0.03) at 10 weeks and 17.1% versus 11.7% (P = NS) at 6 months. In black smokers (N = 600; mean [SD] cpd, 16.1 [7.5]) who received sustained-release (SR) bupropion 150 mg BID versus placebo for 7 weeks, the 7-day biochemically verified abstinence rates at weeks 6 and 26 were 36.0% versus 19.0% (Delta, 17%; 95% CI, 9.7\2-24.4; P < 0.001) and 21.0% versus 13.7% (Delta, 7.3%; 95% CI, 1.0\2-13.7; P = 0.02). Predictors of smoking cessation included use of bupropion SR (abstinence rate, 41.5% vs 21.1%; P<0.001); smoking nonmentholated cigarettes (abstinence rate, 28.3% in mentholated smokers [n = 417] vs 41.5% in nonmentholated smokers [n = 118]; P = 0.006); not smoking within 30 minutes of awakening (abstinence rate, 26.4% [n = 420] in those who did vs 48.7% [n = 115] in those who did not; P < 0.001); and lower baseline salivary cotinine levels (256.8 [137.0] ng/mL in those who became abstinent vs 305.6 [143.4] ng/mL in those who remained smokers; P < 0.001). In black light (<or=10 cpd) smokers (N = 753) who received nicotine gum 2 mg, the biochemically verified 7-day abstinence rates at weeks 8 and 26 in mentholated versus nonmentholated smokers were 22.6% versus 26.8% (P = NS) and 11.2% versus 18.8% (P = 0.015), respectively; at week 26, the abstinence rates in those who received gum + mentholated cigarettes (n = 309) versus gum + nonmentholated cigarettes (n = 67) were 14% versus 24% (P = 0.031). In Hispanic smokers (N = 108; mean [SD] cpd, 18.8 [10.2]) who received nicotine patch versus placebo for 10 weeks, 46% versus 26% (chi(2) = 4.01; P = 0.05) were abstinent from weeks 2 to 10 (completed all doses of patch); patients who were more acculturated and received active treatment had a higher abstinence rate than less acculturated patients (63% vs 47%; P value not provided). In Native American smokers (N = 252; cpd not provided) who received nicotine patch + counseling and were followed up at 3, 6, 9, and 12 months, selfreported abstinence rates were 31% (49/156), 30% (21/71), 24% (13/55), and 21% (4/19), respectively (P values not provided). In a 6-month study in white (n = 191) and nonwhite (n = 108) smokers (mean [SD] cpd, 21 [11]) randomized to receive a nicotine patch (n = 144) versus nasal spray (n = 155) for 8 weeks, the carbon monoxide\2-verified 7-day abstinence rates were 34.7% versus 29.0%; at 6 months, these rates were 18.1% versus 15.5% (P = NS). In nonwhite patients, logistic regression analysis at 6 months found that a higher proportion of patients randomized to receive nasal spray did not smoke for >or=7 consecutive days (odds ratio, 0.20; 95% CI, 0.05-0.77; P = 0.02). CONCLUSIONS Data from the studies in this review support the use of smoking-cessation pharmacotherapy (nicotine patch and bupropion SR) in nonwhite patients. Black patients, who smoked within 30 minutes of awakening, smoked mentholated cigarettes, and had high salivary cotinine levels may have difficulty quitting regardless of the number of cigarettes smoked per day; therefore, determining the type of cigarettes smoked (mentholated vs nonmentholated) and salivary cotinine levels may be helpful in assessing the severity of smoking addiction and guide pharmacotherapy (eg, starting at higher doses of nicotine-replacement therapy in a light smoker). Other than smoking-cessation behavioral studies, there is a lack of congruent smoking-cessation pharmacotherapy studies in American Indian/Alaska Native, Hispanic, and other ethnic populations.

The effect of pramlintide acetate on glycemic control and weight in patients with type 2 diabetes mellitus and in obese patients without diabetes: a systematic review and meta-analysis

Aim: The objective of this systematic review and meta‐analysis was to assess the effect of pramlintide on glycemic control, weight and incidence of nausea and hypoglycaemia in patients with type 2 diabetes mellitus (T2DM) and in obese patients without diabetes (OBP).

A review of exenatide as adjunctive therapy in patients with type 2 diabetes

Background Incretin glucagon-like peptide-1 (GLP-1) is a hormone released from cells in the gastrointestinal tract (GI), leading to glucose-dependent insulin release from the pancreas. It also suppresses postprandial hyperglycemia, glucagon secretion and slows gastric emptying. Exenatide (EXE), a functional analog of human GLP-1, was approved by the US FDA in April 2005. Objective This article reviews current primary literature on the clinical efficacy and safety of EXE in the treatment of type 2 diabetes mellitus (DM) and describes the pharmacokinetics, pharmacodynamics, dosing and administration of EXE. Methods English-language articles were identified through a search of MEDLINE (1966 to March 2009), International Pharmaceutical Abstracts (1970 to present), and Cochrane Database of Systemic Reviews (1995 to March 2009). Search terms included EXE, diabetes mellitus, postprandial hyperglycemia, gastric emptying, glucagon, pharmacokinetics and pharmacodynamics. Articles were selected for review if their designs were randomized, blinded and of controlled design that focused on clinical outcomes of patients with type 2 DM. Results EXE is administered subcutaneously in the thigh, abdomen or upper arm within the 60-minute period before the morning and evening meals. Its Cmax is reached within 2.1 hours, and its T1/2 in 2.4 hours. EXE’s metabolism is primarily through the kidneys. For the patients who received EXE 10 μg SC BID in three, 30-week, placebo-controlled studies with background sulfonylureas (SUs), metformin (MET), or SU + MET, there were significant reductions in HbA1c (0.77 to 0.86%), fasting plasma glucose (0.6 mmol/L) and body weight (1.6 to 2.8 kg) (P ≤ 0.05 vs PCB) that were sustained in patients who completed two open-label phase trials with an additional 52 weeks of therapy. The use of thiazolidinediones was associated with a slight advantage over EXE in improving HbA1c along with increased weight gain; those who received EXE lost weight, but experienced more GI adverse effects. Patients who received EXE lost significant body weight while patients who received insulin gained weight. Patients receiving insulin had lower fasting, prelunch and predinner glucose excursions while patients in the EXE groups had lower postprandial glucose levels. Nausea was most frequently (>20%) reported in patients receiving the highest dose of EXE (10 μg SC BID vs 5 μg SC BID). Conclusions EXE at the dose of 10 μg SC BID has been proven to decrease HbAlc by 1.3% ± 0.1% and decrease body weight by up to 5.3 ± 0.8 kg at week 82. Nausea was the most frequently reported adverse event (>20%) especially in patients being treated with EXE 10 μg SC BID. EXE can be safely added to MET therapy, SU therapy or MET + SU combination to effectively target glycemic goals in patients with type 2 DM. Long-term, head-to-head studies assessing the effect of the EXE ± oral agents/insulins in patients with HbAlc ≥ 10% are still needed to fully clarify the role of EXE in poorly controlled patients with type 2 DM.

The effect of linagliptin on glycaemic control and tolerability in patients with type 2 diabetes mellitus: a systematic review and meta-analysis

Aim: Linagliptin is a new dipeptidyl peptidase‐4 inhibitor recently approved for use in the USA. The objective of this systematic review and meta‐analysis was to assess effect of linagliptin on glycaemic control, biomarkers and incidence of adverse events (AEs) in patients with type 2 diabetes mellitus.

Concurrent use of an audience response system at a multi-campus college of pharmacy.

Objective. To assess the impact of an audience response system (ARS) on student engagement at a multi-campus college of pharmacy. Methods. An online questionnaire was designed and administered to measure the impact of an ARS on student engagement, distance education, projected use, and satisfaction among pharmacy students for a course delivered across 3 sites via synchronous video transmission. Results. Students reported that use of the ARS made it easier to participate (85.3%) and helped them to focus (75.7%) in classes when the lecturer was physically at a different site. They also valued that the ARS allowed them to respond anonymously (93.2%). A minority of students indicated that use of the ARS was distracting (11.8%). Conclusions. Implementation of an ARS was associated with positive student perceptions of engagement and may improve feelings of connectedness among students at schools with multiple sites. Use of ARSs could also represent a cognitive intercession strategy to help reduce communication apprehension.

Social Media Use and Educational Preferences Among First-Year Pharmacy Students

Background: Social media may offer a means to engage students, facilitate collaborative learning, and tailor educational delivery for diverse learning styles. Purpose: The purpose of this study is to characterize social media awareness among pharmacy students and determine perceptions toward integrating these tools in education. Methods: A 23-item survey was administered to 1st-year students at a multicampus college of pharmacy. Results: Students (95% response rate; N = 196) most commonly used wikis (97%), social networking (91%), and videosharing (84%). Tools reported as never used or unknown included social bookmarking (89%), collaborative writing (84%), and RSS readers (73%). Respondents indicated that educational integration of social media would impact their ability to learn in a positive/very positive manner (75%) and make them feel connected/very connected (68%). Conclusions: Selectively targeting social media for educational integration and instructing pharmacy students how to employ a subset of these tools may be useful in engaging them and encouraging lifelong learning.

An updated systematic review and meta-analysis on the efficacy and tolerability of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes with moderate to severe chronic kidney disease

Objective: This updated meta-analysis determines the effect of dipeptidyl peptidase-4 inhibitors on glycemic and tolerability outcomes in patients with type 2 diabetes mellitus and chronic kidney disease with glomerular filtration rate of ⩽60 mL/min or on dialysis. Methods: In all, 14 citations were identified from multiple databases. Qualitative assessments and quantitative analyses were performed. Results: There were 2261 participants, 49–79 years of age, 49% men and 44% Caucasians. In seven placebo-comparator studies, reduction in hemoglobin A1c at weeks 12–24 was 0.55% (95% confidence interval: −0.68 to −0.43), P < 0.00001). In three sulfonylurea-comparator studies, dipeptidyl peptidase-4 inhibitors did not significantly reduce hemoglobin A1c at weeks 52–54 (−0.15% (95% confidence interval: −0.32 to 0.02)). In one sitagliptin versus albiglutide study, albiglutide significantly reduced hemoglobin A1c in patients with moderate renal impairment (−0.51%). A similar reduction in hemoglobin A1c was seen with sitagliptin versus vildagliptin (−0.56% vs −0.54%). Compared with placebo or sulfonylurea, dipeptidyl peptidase-4 inhibitors did not significantly reduce hemoglobin A1c after 12 and 54 weeks in patients on dialysis. Hypoglycemia was reported by ~30% of patients in both dipeptidyl peptidase-4 inhibitors and placebo groups over 24–52 weeks. While hypoglycemia was more common with a sulfonylurea at 52–54 weeks (risk ratio: 0.46 (95% confidence interval: 0.18 to 1.18)), there was significant heterogeneity (I2 = 87%). Limitations included high drop-out rate from most studies and small number of active-comparator studies. Conclusions: Dipeptidyl peptidase-4 inhibitors in patients with chronic kidney disease caused a modest reduction in hemoglobin A1c versus placebo, but not when compared with sulfonylureas or albiglutide, or when used in patients on dialysis. Additional active-comparator studies are needed to further elucidate the role of dipeptidyl peptidase-4 inhibitors in patients with chronic kidney disease stages 3–5 or on dialysis.

Improvement in Surrogate Endpoints by a Multidisciplinary Team in a Mobile Clinic Serving a Low-income, Immigrant Minority Population in South Florida

To determine effect on surrogate endpoints for cardiovascular disease (CVD), we performed a retrospective chart review of 114 patients seen by a multidisciplinary team that provided primary care services in a mobile clinic over 12 months. Eligible patients had outcomes available for at least six months. Mixed effect modeling examined variation in surrogate markers for CVD: blood pressure (BP), heart rate, and body mass index. Repeated measures ANOVA compared lipids, hemoglobin A1c, and medication use from baseline and throughout study. Most patients were female (75%), Haitian (76%), and low-income (

Trends in benzodiazepine prescribing under Medicare Part D in USA: outpatient settings 2005–2009

747/month) with average age 63 years. Common diagnoses were hypertension (82%) and hyperlipidemia (63%). Significant reduction in systolic BP, total- and LDL-cholesterol, and hemoglobin A1c were found (p<.05). Use of ACE-inhibitors, beta-blockers, diuretics, aspirin, metformin, and statins increased significantly (p<.05). Mobile clinic with a multidisciplinary team improved surrogate endpoints over 12 months in underserved, low-income, mostly foreign-born, Haitian population in U.S.

Potential for dipeptidyl peptidase-4 inhibitor and sodium glucose cotransporter 2 inhibitor single-pill combinations

The objective of the study was to examine the trend of benzodiazepine prescribing under Medicare Part D formulary restriction.