Laparoscopic vs. Open Surgery for Diverticular Disease: A Meta-Analysis of Nonrandomized Studies

Purpose This study was designed to compare outcomes between laparoscopic and open surgery for patients with diverticular disease by using meta-analytic techniques. Methods Comparative studies published between 1996 and 2004 of open vs. laparoscopic surgery for diverticular disease were included. The end points that were evaluated are operative and functional outcomes and adverse events. A random effects model was used during analysis of these outcomes; heterogeneity was assessed and sensitivity analysis was performed to account for bias in patient selection. Results Twelve nonrandomized studies, incorporating 19,608 patients, were included in the analysis. One study with 18,444 patients accounted for 94.5 percent of the total sample. Laparoscopic surgery resulted in reduced infective (odds ratio, 0.61; P = 0.01), pulmonary (odds ratio, 0.4; P < 0.001), gastrointestinal tract (odds ratio, 0.75; P = 0.03), and cardiovascular complications (odds ratio, 0.28; P = 0.0008) with no significant heterogeneity. Operative time was longer with laparoscopic surgery (weighted mean difference, 67.59; P = 0.04), and length of stay was significantly shorter (weighted mean difference, −3.81; P < 0.0001); however, these outcomes demonstrated significant heterogeneity. These results remained significant throughout all the sensitivity analyses except when evaluating high-quality studies (when the study with 18,444 patients was excluded), in which only blood loss and length of stay were significantly in favor of the laparoscopic group. Conclusions The results for patients selected for laparoscopic surgery compared with open surgery for diverticular disease are equivalent with a potential reduction in complications and hospital stay. Laparoscopic surgery for diverticular disease performed by appropriately experienced surgeons in the elective setting may be safe and feasible; because of the potential of significant bias arising from the included studies, a randomized, controlled trial is recommended. Reprints are not available.     

Combination angiotensin-receptor blocker (ARB)/calcium channel blocker with HCTZ vs the maximal recommended dose of an ARB with HCTZ in patients with stage 2 hypertension: the exforge as compared to losartan treatment in stage 2 systolic hypertension (EXALT) study

This study compared the efficacy and safety of combination angiotensin-receptor blocker (ARB)/calcium-channel blocker (CCB) with hydrochlorothiazide (valsartan/amlodipine/HCTZ 160/5/2mg) vs maximal available combination doses of an ARB with HCTZ (losartan/HCTZ 100/25 mg) in the management of stage 2 hypertension. After 1 to 2 weeks of antihypertensive drug washout, patients with a mean sitting systolic blood pressure (MSSBP) of ≥ 160 mm Hg and <200 mm Hg were randomized to valsartan/amlodipine 160/5 mg (n = 241) or losartan 100 mg (n = 247). At week 3, HCTZ 25 mg was added to both treatments. The primary end point, reduction in MSSBP from baseline to week 6, was significantly greater in the valsartan/amlodipine group than in the losartan group (least-squares [LS] mean change, -31.8 mm Hg vs -26.4 mm Hg; P<.001). Additional reductions occurred after titrating to 320/10/25 mg at week 6 in the valsartan/amlodipine group and switching from losartan/HCTZ to valsartan/amlodipine/HCTZ (week 6, 160/5/25 mg; week 9, 320/10/25 mg) in the losartan group. Achievement of blood pressure <140/90 mm Hg also favored the valsartan/amlodipine group. Dizziness was the only adverse event reported in >5% of patients (5.4% valsartan/amlodipine group, 3.6% losartan group). Moderate doses of an ARB/CCB combination with HCTZ reduced blood pressure more effectively than the maximal dose of an ARB with HCTZ.     

Efficacy of combination therapy with amlodipine besylate/benazepril hydrochloride for lowering systolic blood pressure in stage 2 hypertension

The Systolic Evaluation of Lotrel Efficacy and Comparative Therapies (SELECT) study compared daily treatment with combination amlodipine besylate/benazepril hydrochloride 5/20 mg, amlodipine besylate 5 mg, and benazepril hydrochloride 20 mg in 505 patients aged 55 years of age or older with stage 2 hypertension (systolic blood pressure [BP] > or =160 and < or =200 mm Hg and diastolic BP > or =60 and < or =100 mm Hg). BP and pulse pressure were assessed by conventional office BP measurements and 24-hour ambulatory BP monitoring. In this analysis, combination therapy was associated with significantly greater reductions in mean 24-hour BP, pulse pressure, and mean ambulatory BP during various time intervals compared with either monotherapy in the intent-to-treat population, in those with isolated and predominantly systolic hypertension, and in dippers and nondippers. Adverse event rates were low and similar in all treatment groups. This study demonstrated that combination therapy is superior to monotherapy in older patients with stage 2 systolic hypertension and is well tolerated.     

Hypoglycemic potential of nateglinide versus glyburide in patients with type 2 diabetes mellitus

Antidiabetic agents that augment insulin secretion can cause hypoglycemia. With the current trend toward early and aggressive treatment of patients with type 2 diabetes, the hypoglycemic potential of insulinotropic agents is of concern. This study aimed to compare the propensity of the "glinide," nateglinide, and the sulfonylurea (SU), glyburide, to elicit hypoglycemia in type 2 diabetic patients with moderately elevated fasting plasma glucose (FPG). Hyperglycemic clamps (target plasma glucose = 11.1 mmol/L) were initiated, and 30 minutes later patients received a single oral dose of nateglinide (120 mg, n = 15) or glyburide (10 mg, n = 12) in a double-blind fashion. At the end of the 2-hour clamp when the glucose infusion was terminated, plasma glucose and insulin levels were measured for 4 additional hours. The minimum plasma glucose level achieved after terminating the glucose infusion (glucose nadir) was used as an index of hypoglycemic potential. The mean (+/-SEM) glucose nadir was significantly lower in patients given glyburide (3.3 +/- 0.2 mmol/L) versus nateglinide (4.4 +/- 0.3 mmol/L, P = .025). Confirmed hypoglycemia (plasma glucose < or = 2.8 mmol/L) occurred in 2 of 12 patients given glyburide and in none of those given nateglinide. Plasma insulin levels were significantly higher from 100 to 240 minutes after clamp termination in patients given glyburide versus nateglinide. Nateglinide has less hypoglycemic potential than glyburide, suggesting that nateglinide may be a more appropriate insulinotropic agent for patients with moderate fasting hyperglycemia, such as elderly patients and those with comorbid cardiac ischemia.     

Comparative efficacy of aliskiren/valsartan vs valsartan in nocturnal dipper and nondipper hypertensive patients: a pooled analysis

This pooled analysis of ambulatory blood pressure (BP) monitoring data from two 8-week randomized controlled trials compared the antihypertensive efficacy and safety of combination aliskiren/valsartan vs valsartan alone in hypertensive patients (nocturnal dippers or nondippers). At study end, patients were taking aliskiren/valsartan 300/320 mg or valsartan 320 mg. In dippers (n=138) and nondippers (n=132), aliskiren/valsartan provided significantly (P<.05) greater reductions from baseline to week 8 than valsartan in 24-hour, daytime, and last-4-hour mean ambulatory systolic BP (maSBP). Treatment differences were more pronounced in nondippers. Nighttime maSBP reductions with aliskiren/valsartan were significantly greater vs valsartan in nondippers (-17.0 mm Hg vs -8.9 mm Hg; P<.05) but not dippers (-7.6 mm Hg vs -4.5 mm Hg; P=.16). In all time periods, combination therapy was generally associated with BP reductions that were greater in nondippers than dippers. Conversion from nondipper to dipper status was 32% vs 22% for aliskiren/valsartan vs valsartan (P=.48). Both treatments were similarly well tolerated. Although the addition of aliskiren to valsartan did not significantly alter dipper status, our data suggest an increased contribution of the renin-angiotensin-aldosterone system to the nondipper status of hypertensive patients.     

Randomized Study of Antihypertensive Efficacy and Safety of Combination Aliskiren/Valsartan vs Valsartan Monotherapy in Hypertensive Participants With Type 2 Diabetes Mellitus

In this double‐blind study, 1143 hypertensive participants with type 2 diabetes and stage 1 or 2 chronic kidney disease (CKD) were randomized to receive combination aliskiren/valsartan 150/160 mg or valsartan 160 mg monotherapy for 2 weeks, with force‐titration to 300/320 mg and 320 mg, respectively, for another 6 weeks. Ambulatory blood pressure (ABP), the primary outcome, was available for 665 participants. Reductions from baseline to week 8 in 24‐hour ABP were −14.1/−8.7 mm Hg with aliskiren/valsartan vs −10.2/−6.3 mm Hg with valsartan (P<.001). Adverse events were reported in 202 participants (35.2%) taking aliskiren/valsartan and 182 participants (32.2%) taking valsartan. No participant had blood urea nitrogen values >40 mg/dL or serum creatinine values >2.0 mg/dL. There were no confirmed cases of serum potassium values ≥6.0 mEq/L. Combination aliskiren/valsartan has additive effects on blood pressure reduction and tolerability similar to valsartan in hypertensive/diabetic participants with early‐stage (stages 1 and 2) CKD. J Clin Hypertens (Greenwich). 2012;00:00–00. ©2012 Wiley Periodicals, Inc.

Dual blockade of the renin‐angiotensin system (RAS) with angiotensin‐converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) reduced proteinuria by an additional 20% to 25% in individuals with advanced proteinuric nephropathy but failed to reduce cardiovascular events compared with ACE inhibitor monotherapy. ¹ , ² More recently, research has focused on combining a direct renin inhibitor with other blockers of the RAS. The combination of the direct renin inhibitor aliskiren with the ARB valsartan significantly lowered blood pressure (BP) over the individual components. ³ In contrast, ACE inhibitor/ARB combinations generally produce modest BP reductions that are not significantly different than treatment with either drug class alone. ⁴ Two studies with an aliskiren/ARB combination were performed in people with advanced kidney disease. In the Aliskiren in the Evaluation of Proteinuria in Diabetes (AVOID) study, aliskiren or placebo was added to the ARB losartan plus optimal antihypertensive therapy in participants with hypertension, type 2 diabetes mellitus, and advanced nephropathy (urinary albumin/creatinine [UAC] level >300 mg/g and estimated glomerular filtration rate [eGFR] ≥30 mL/min/1.73 m²). ⁵ The primary endpoint in AVOID was change in UAC, which declined by an additional 20% in the aliskiren arm (P<.001). There was no mortality endpoint. More recently, an outcome study (the Aliskiren Trial in Type 2 Diabetes Using Cardio‐Renal Endpoints [ALTITUDE] ⁶ ) evaluated whether the addition of aliskiren to standard therapy including an ACE inhibitor or ARB would reduce mortality and slow nephropathy progression in advanced diabetic nephropathy. The trial was stopped early by its independent Data Monitoring Committee (DMC). ⁷ The reasons for the early termination centered on the fact that this treatment approach was unlikely to provide clinical benefit. Further, there was an increased incidence of nonhemorrhagic stroke, significant worsening of kidney function, hypotension, and hyperkalemia in the aliskiren arm. ⁷ The preliminary findings of ALTITUDE appear consistent with previous reports of combination ACE inhibitor/ARB therapy when administered to high‐risk populations. ¹ , ⁸ , ⁹ , ¹⁰ In light of the results of ALTITUDE, it was of particular interest to evaluate the safety and antihypertensive action of the aliskiren/valsartan combination in earlier stage nephropathy. Therefore, we present the results of the Valsartan Aliskiren Hypertension Diabetes (VIvID) study, in which the antihypertensive efficacy and safety of combination aliskiren/valsartan were compared with valsartan monotherapy in hypertensive participants with type 2 diabetes mellitus and stage 1 or 2 chronic kidney disease (CKD).Based on the findings from the ALTITUDE study, the manufacturer has elected to withdraw Valturna^® (Novartis Pharmaceutical Corporation, East Hanover, NJ), the single‐pill combination of aliskiren and valsartan, from the market.     

Interventions to improve employee health and well‐being within health care organizations: A systematic review

In response to an increasing body of evidence on the importance of employee health and well‐being (HWB) within health care, there has been a shift in focus from both policymakers and individual organizations toward improving health care employee HWB. However, there is something of a paucity of evidence regarding the impact and value of specific HWB interventions within a health care setting. The aim of this article was to systematically review the literature on this topic utilizing the EMBASE, Global Health, Health Management Information Consortium, MEDLINE, and PsycINFO databases. Forty‐four articles were identified and, due to a large degree of heterogeneity, were considered under different headings as to the type of intervention employed: namely, those evaluating changing ways of working, physical health promotion, complementary and alternative medicine, and stress management interventions, and those utilizing multimodal interventions. Our results consider both the efficacy and reliability of each intervention in turn and reflect on the importance of careful study design and measure selection when evaluating the impact of HWB interventions.