Effectiveness of Amlodipine in the Control of 24-Hour Blood Pressure in Mild-to-Moderate Essential Hypertension: A Prospective, Multicenter, Observational Real-World Study from India.

Background Calcium-channel blockers (CCB) are a mainstay in the management of hypertension (HTN), and amlodipine is the preferred CCB due to its longer half-life and better safety. Patients and methods This practice-based, observational, real-world evidence study assessed the 24-hour ambulatory blood pressure (ABP) control in mild-to-moderate essential hypertensive patients (treatment naïve receiving amlodipine monotherapy, or as add-on therapy) in inadequately controlled blood pressure (BP goal not met after one month of existing therapy). One hundred four (62M/42F) patients between 18 and 65 years of age who received amlodipine 5/10 mg/day for >8 weeks were included after obtaining informed written consent. The primary outcome was a change from baseline in the mean 24-h SBP and DBP on ABP monitoring at eight (±1) weeks. Secondary outcomes were different from baseline in the mean morning, day-time, night-time, and last six-hour dosing interval period. Other outcomes assessed BP variability (dippers and non-dippers), and responder rates based on ABP monitoring and in-clinic trough cuff measurements. Safety outcomes included adverse effects reported, electrocardiogram, and laboratory abnormalities (hepatic and renal function). Changes in BP parameters in different sub-groups (age, gender, BMI, physical activity, occupation, duration of hypertension, the total daily dose of amlodipine, type of amlodipine therapy, and hypertension severity at baseline) were estimated. Results Of the 104 patients, 49 patients (completed eight weeks) were included in the per-protocol (PP) data for efficacy analysis. Safety analysis was done on the intent-to-treat (ITT) dataset. Significant reductions (p<0.0001) from baseline in all BP measurements on ABPM were observed at the end of eight weeks. Similar improvements were observed in office BP recordings. There was a marginal but non-significant (p>0.05) increase in the proportion of dippers and extreme dippers with amlodipine at the end of the eight-week treatment period. Conclusions Amlodipine 5/10 mg/day therapy used as monotherapy or adjuvant therapy provided significant reductions in both office BP and ambulatory BP over eight weeks.

Acarbose reduces body weight irrespective of glycemic control in patients with diabetes: results of a worldwide, non-interventional, observational study data pool.

OBJECTIVE: The objective of this study is to examine the effect of acarbose, an alpha-glucosidase inhibitor, on body weight in a real-life setting by pooling data from post-marketing surveillance. METHODS: Data from 10 studies were pooled (n=67,682) and the effect of acarbose on body weight was analysed taking into account baseline body weight, glycemic parameters and other baseline characteristics. RESULTS: The mean relative reduction in body weight was 1.45 ± 3.24% at the 3-month visit (n=43,510; mean baseline 73.4 kg) and 1.40 ± 3.28% at the last visit (n=54,760; mean baseline 73.6 kg) (both p<0.0001). These reductions were dependent on baseline body weight (overweight: -1.33 ± 2.98% [n=13,498; mean baseline 71.6 kg]; obese: -1.98 ± 3.40% [n=20,216; mean baseline 81.3 kg]). When analysed by baseline glycemic parameter quartiles, the reduction was independent of fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated hemoglobin (HbA1c) and postprandial glucose excursion (PPGE). A bivariate analysis of covariance identified female sex, South East Asian and East Asian ethnicity, younger age, higher body mass index, short duration of diabetes, and no previous treatment as factors likely to impact positively on body weight reduction with acarbose. CONCLUSIONS: This post-hoc analysis showed that acarbose treatment reduces body weight independent of glycemic control status but dependent on baseline body weight.

Therapeutic potential of α-glucosidase inhibitors in type 2 diabetes mellitus: an evidence-based review.

INTRODUCTION: Postprandial hyperglycemia (PPHG) contributes to micro- and macro-vascular complications more than fasting hyperglycemia in patients with type 2 diabetes mellitus. Due to the traditional carbohydrate-rich diet, Asians, particularly Indians and Chinese need agents to control the higher risk of uncontrolled PPHG. Targeting PPHG with α-glucosidase inhibitors (AGIs), either alone or in combination with other oral hypoglycemic agents and insulin, provide overall glycemic control with transient mild gastrointestinal disorders. Treatment with AGIs, especially acarbose, has also shown to provide beneficial effects on lipid levels, blood pressure, coagulation factors, carotid intima-media thickness and endothelial dysfunction. New insights of acarbose therapy obtained like increased activity of gut hormones and improved gut microbiota may explain the benefits on weight, whereas increased production of H2 may explains its cardiovascular benefits to some extent. AREAS COVERED: A systematic search strategy was developed to identify randomized controlled trials in MEDLINE, PubMed, EMBASE and ongoing trials databases. EXPERT OPINION: AGIs as a class and acarbose in particular, are most useful in combatting PPHG and glucose variability across the spectrum of diabetes therapy, particularly in Asian patients. Together with their effects on incretin hormones and gut-microbiota AGIs can be considered beyond glycemic control as 'cardio-protective agents.'

Acarbose plus metformin fixed-dose combination in the management of type 2 diabetes.

INTRODUCTION: The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Concerns in the management of diabetes include drug-induced hypoglycemia, poor control of postprandial blood glucose level and weight gain. A carbohydrate-rich diet can cause more load on the intestinal cells producing α-glucosidase. Many patients need combination treatment based on their level of glycemic control and other associated parameters. In such cases, a therapy that provides effective glycemic control with minimal or no risk of adverse events like hypoglycemia or weight gain is highly desired. The chances of cardiovascular events are high in diabetes patients; hence, medicines providing benefits beyond glycemic control such as reduced cardiovascular risk factors may be ideal in such patients. AREAS COVERED: Current available data are related to the rationale and clinical trials on the fixed-dose combination of acarbose plus metformin in management of type 2 diabetes. EXPERT OPINION: Combination therapy is routinely prescribed in the management of T2DM. Drugs with complimentary mechanisms should be used to maximize the efficacy of combination therapy. The combination of metformin and acarbose is a rational therapy because of their different and complimentary mechanisms of action, which provides effective glycemic control with additional cardiovascular benefits and minimizes adverse events.

Provider attitudes toward Standardized Clinical Assessment and Management Plans (SCAMPs).

INTRODUCTION: Despite the growing importance of clinical guidelines, their adoption has encountered significant resistance among clinicians. We developed Standardized Clinical Assessment and Management Plans (SCAMPs) as an innovative, clinician-led approach to building, implementing, and constantly improving flexible guidelines. We hypothesized that SCAMPs would fit well within the culture of medicine and that clinicians would therefore prefer SCAMPs over other guidelines. METHODS: We implemented an anonymous, computer-based survey to analyze provider attitudes toward SCAMPs at our institution. RESULTS: Sixty-nine providers completed the questionnaire (73% response rate). Most providers reported a positive opinion about SCAMPs along axes of overall familiarity (83%), trust (91-94%), utility (75-87%), and overall attitude (64%). Fewer providers felt familiar with the SCAMP improvement process (60% neutral to unfamiliar) or knew that they played a role in this process (62% said no or unsure). Sixty-five percent reported experiencing an erosion in their autonomy with SCAMPs; when comparing this to other guidelines, 38% said other guidelines erode more, 26% felt SCAMPs erode more, and 36% were neutral. The plurality of providers chose SCAMPs as their preferred means to incorporate evidence-based medicine into their practice (46% vs 29% for clinical practice guidelines, 25% for other guidelines). CONCLUSION: Providers look upon SCAMPs favorably and believe that SCAMPs successfully address numerous barriers to guideline adoption. Furthermore, SCAMPs are the preferred means to incorporate evidence-based medicine into practice among providers surveyed. SCAMPs may represent an important step in building guidelines that fit into the culture of medicine, obtain clinician "buy-in," and better influence clinical decision making.

A novel approach to gathering and acting on relevant clinical information: SCAMPs.

The current tools to adequately inform the process of improving health-care delivery consist primarily of retrospective studies, prospective trials, and clinical practice guidelines. We propose a novel and systematic approach that bridges the gap of our current tools to affect change, provides an infrastructure to improve health-care delivery, and identifies unnecessary resource utilization. The objective of this special article is to introduce the rationale and methods for this endeavor entitled "Standardized Clinical Assessment and Management Plans" (SCAMPs). SCAMPs take a relatively heterogeneous patient population and through a process of iterative analysis and modification of standardized assessment and management algorithms, SCAMPs allow the intrinsic biologic variability in a patient population to emerge and be understood. SCAMPs can be used to complement our currently available tools in order to result in incremental and sustained improvement in health-care delivery.

Results of a single blind, randomized, placebo-controlled clinical trial to study the effect of intravenous L-carnitine supplementation on health-related quality of life in Indian patients on maintenance hemodialysis.

BACKGROUND: Carnitine insufficiency is responsible for various co-morbid conditions in maintenance hemodialysis (MHD) patients. L-carnitine supplementation is expected to improve the quality of life (QoL) of patients on MHD. AIMS: To study the effect of L-carnitine supplementation on QoL of Indian patients on MHD. SETTING AND DESIGN: This was a single (patient) blind, randomized, placebo-controlled clinical trial conducted on patients on MHD attending hemodialysis unit of the study center. MATERIALS AND METHODS: Twenty patients on MHD suffering from hemodialysis-related symptoms were randomly assigned to receive intravenous L-carnitine 20 mg/kg or placebo after every dialysis session for 8 weeks. SF36 (Short Form with 36 questions) score for QoL, laboratory investigations and dialysis related symptoms were recorded at baseline and after 8 weeks. Improvement in QoL, laboratory parameters and dialysis related symptoms in the two groups after 8 weeks was compared. STATISTICAL ANALYSIS USED: Depending on normality of data, unpaired T test or Mann Whitney U test was used for comparison of change (8 weeks-baseline) in SF36 scores and laboratory parameters observed in the two groups. RESULTS: L-carnitine supplementation increased total SF36 score by 18.29 +/- 12.71 (95% CI: 10.41 to 26) while placebo resulted in reduction in total SF36 score by 6.4 +/- 16.39 (95% CI: -16.59 to 3.73). L-carnitine also resulted in significant increase in hemoglobin and serum albumin and decrease in serum creatinine as compared to placebo. More patients were relieved of dialysis related symptoms in L-carnitine group. CONCLUSION: Intravenous L-carnitine supplementation improves QoL in patients on MHD.