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Guideline: In type 2 diabetes, ACP recommends metformin monotherapy if drugs are needed for glycemic control ACP Journal Club. 2017 Apr 18;166(8):JC39. Qaseem A, Barry MJ, Humphrey LL, Forciea MA, Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166:279-90. 28055075 [ABSTRACT FROM AUTHOR]

Question In adults with type 1 diabetes mellitus treated with insulin, does canaglifozin add-on treatment increase the risk for diabetic ketoacidosis (DKA)? Methods Design Randomized placebo-controlled trial. ClinicalTrials.gov NCT02139943. Allocation Unclear allocation concealment.* Blinding Blinded* {study sites and sponsor}†. Follow-up period 18 weeks. Setting Not reported. Patients 351 patients 25 to 65 years of age {mean age 42 y, 56% men}† who had type 1 diabetes for ≥1 year, hemoglobin (Hb) A1c level 7.0% to 9.0% (53 to 75 mmol/mol), body mass index 21 to 35 kg/m², and were receiving a stable insulin regimen (multiple daily injections or continuous subcutaneous infusion) for ≥8 weeks. Exclusion criteria included history of type 2 diabetes mellitus; DKA or severe hypoglycemic event in the past 6 months; myocardial infarction, unstable angina, coronary revascularization, or cerebrovascular accident in the past 12 weeks; history of New York Heart Association class III to IV cardiac disease; uncontrolled hypertension; estimated glomerular filtration rate >70 mL/min/1.73 m²; or treatment with an antihyperglycemic other than insulin in the past 12 weeks. Intervention Canagliflozin, 100 mg (n=117), canagliflozin, 300 mg (n=117), or placebo (n=117) once/d before the first meal. Outcomes Safety outcomes included ketone-related adverse events (i.e., acidosis, blood ketone body increased, blood ketone body present, DKA, diabetic ketoacidotic hyperglycemic coma, ketoacidosis, ketonemia, ketonuria, ketosis, metabolic acidosis, or urine ketone body present) and serious DKA. Patient follow-up 93%† (modified intention-to-treat analysis). Main results Risks for any ketone-related adverse events and for serious DKA events requiring hospitalization were increased with canagliflozin compared with placebo (Table). Conclusion In patients with insulin-treated type 1 diabetes mellitus, canagliflozin increased diabetic ketoacidosis. [ABSTRACT FROM AUTHOR]

Question In patients with diabetes mellitus, what is the effect of antihypertensive treatment at different blood pressure (BP) levels? Review scope Included studies compared any antihypertensive drug with placebo, any 2 drugs with 1 drug, or any BP target with another in = 100 patients with diabetes for = 12 months. Exclusion criteria were trials comparing 2 individual drugs or combined interventions. Outcomes included all-cause mortality, cardiovascular (CV) mortality, myocardial infarction (MI), stroke, heart failure, and end-stage renal disease (ESRD). Review methods MEDLINE, EMBASE/Excerpta Medica, Cochrane CENTRAL, BIOSIS (all to Feb 2013), and reference lists were searched for randomized controlled trials (RCTs). Authors, pharmaceutical companies, and authorities were contacted. 49 RCTs (n = 73 738, mean follow-up 3.7 y) met selection criteria. 24 RCTs included only patients with diabetes, and 25 included subgroups with diabetes; most patients had type 2 diabetes. 38 RCTs compared antihypertensive treatment with placebo. Risk for bias was low for randomization (45 RCTs), concealed allocation (39 RCTs), blinding of patients and personnel (26 RCTs), and blinding of outcome assessors (36 RCTs). Meta-analysis presented in this abstract was stratified by mean baseline systolic BP (SBP) within trials. Main results For trials with mean baseline SBP > 150 mm Hg, antihypertensive treatment reduced all-cause mortality, CV mortality, MI, stroke, and ESRD (Table). For mean baseline SBP 140 to 150 mm Hg, antihypertensive treatment reduced all-cause mortality, MI, and heart failure (Table). For baseline SBP < 140 mm Hg, antihypertensive treatment showed a borderline increase in CV mortality and did not differ for other outcomes (Table). Metaregression showed that, for each 10-mm Hg lower baseline SBP, hypertensive treatment increased risk for CV mortality (relative risk [RR] 1.15, 95% CI 1.03 to 1.29) and MI (RR 1.12, CI 1.03 to 1.22). Conclusions In patients with diabetes mellitus and systolic blood pressure = 140 mm Hg, antihypertensive treatment reduces mortality and myocardial infarction. In patients with systolic blood pressure < 140 mm Hg, antihypertensive treatment does not reduce mortality and is associated with increased cardiovascular mortality. [ABSTRACT FROM AUTHOR]

Question In older men with low testosterone levels, does testosterone gel improve health outcomes compared with placebo? Methods Design 3 coordinated randomized placebo-controlled trials (RCTs) with minimization that were part of The Testosterone Trials program (Sexual Function Trial, Physical Function Trial, and Vitality Trial). ClinicalTrials.gov NCT00799617. Allocation {Concealed*}.† Blinding Blinded† (patients and clinicians). Follow-up period 12 months. Setting 12 centers in the USA. Patients 790 men ≥ 65 years of age (mean age 72 y) who had a mean serum testosterone level < 275 ng/dL and met additional criteria for ≥ 1 of the 3 RCTs: self-reported decreased libido, partner willing to have intercourse ≥ 2 times/mo, and Derogatis Interview for Sexual Functioning in Men-II sexual desire score ≤ 20 (Sexual Function Trial, n = 459*); self-reported difficulty with walking or climbing stairs and 6-minute walk speed < 1.2 m/s (Physical Function Trial, n = 390*); or self-reported low vitality and Functional Assessment of Chronic Illness Therapy-Fatigue scale score < 40 (Vitality Trial, n = 474*). Exclusion criteria included conditions that cause hypogonadism, previous prostate cancer, risk > 35% for prostate cancer or > 7% for high-grade prostate cancer, International Prostate Symptom Score > 19, high cardiovascular risk, severe depression, or use of testosterone-altering medication. Additional exclusion criteria for the Physical Function trial were disabling neuromuscular or arthritic conditions, or inability to walk. Patients could participate in > 1 of the 3 RCTs. Intervention Testosterone gel (Androgel 1%) (n = 395) or placebo gel (n = 395). Outcomes Primary outcomes for each of the 3 trials were sexual activity (Sexual Function Trial), 6-minute walk distance (Physical Function Trial), and fatigue (Vitality Trial). Patient follow-up 84% in the Sexual Function Trial, 86% in the Physical Function Trial, and 83% in the Vitality Trial (intention-to-treat analysis). Main results The main results are in the Table. Conclusion In older men with low testosterone levels, testosterone gel improved sexual function but not walk distance or fatigue compared with placebo at 1 year. [ABSTRACT FROM AUTHOR]

This article presents information related to the November 2005 issue. In this issue, the ACP Journal Club highlights and comments on a landmark randomized trial, the ACHOIS trial. The ACHOIS trial was designed to determine the extent to which aggressive treatment of mild gestational diabetes affects outcomes in the mothers, induction of labor and cesarean section, and in the infants. One might justify the effort of screening and managing gestational diabetes, the higher rate of labor inductions, and the increase in neonatal nursery admissions, if the intervention reduced serious perinatal complications in the infants. Another clinical trial is ongoing in this area, and perhaps only a meta-analysis of these and other randomized controlled trials will offer sufficient data on individual outcomes to draw confident inferences about the balance between a possible reduction in perinatal deaths, and the currently much stronger evidence of an increase in induced labor and admission to a neonatal nursery.

In their editorial about patients sharing decision-making responsibilities with physicians, authors review some of the evidence that patients favor involvement in their own care. They neglect a more complex body of evidence, however, that suggests that while patients like the idea of greater choice, they often find it to be less satisfying in practice. But, reliable information is difficult to obtain. The advent of the Internet has increased access to information, as author contends, but the information being accessed may be unreliable or untrustworthy. Obtaining additional opinions and performing research are potentially costly and time-consuming. Another problem is that as options multiply, patients' standards for what is an acceptable outcome rise, with a loss of perspective of what may reasonably be achieved. Most of the women with breast cancer preferred a passive role, leaving the decision-making responsibility to their physicians.

Looks at two online resources useful to physicians. Description on the User's Guides to the Medical Literature Interactive Web site; Information on the TRIP database.

Editorial. Advocates the abandonment of the phrase double blind, which is used as a marker of validity of a randomized controlled trial (RCT), and recommends transparent reporting of the blinding status of each group involved in a clinical trial. Information on blinding in RCT; Example of the use of blinding in scientific experimentation; Groups who can potentially introduce bias into an RCT.

The article focuses on a study related to the effectiveness of intensive insulin therapy (IIT) in reducing long term mortality. The study was conducted on the patients with type 1 diabetes for an average treatment period of 6.5 years. The findings revealed that in a mean 27-year follow up period, IIT reduced all long term causes of mortality.

The article focuses on a study on the association of saxagliptin intake with the risk of heart failure (HF) hospitalization in type 2 diabetes patients. Topics discussed include increasing risk of hospitalization for heart failure (HF) compared with placebo in diabetes patient, uncertain effect of dipeptidyl peptidase (DPP) 4 inhibitors on cardiovascular (CV) events and diabetes, and similar risk of HF hospitalization in patients with or without a HF history.

Review: In type 2 diabetes, GLP-1 agonists plus basal insulin reduce HbA[sub 1c] without increasing hypoglycemia ACP Journal Club. 2015 Jan 20;162(2):JC6. Eng C, Kramer CK, Zinman B, Retnakaran R. Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis. Lancet. 2014:Sep 11. [Epub ahead of print]. 25220191 [ABSTRACT FROM AUTHOR]

The article focuses on a study regarding efficacy of bariatric surgery and medical therapy for glycemic control in obese patients with uncontrolled type 2 diabetes. It reports that the study was carried out in 150 adults along with consideration of several exclusion criteria such as previous bariatric surgery. Also it reveals that in obese patients with diabetes adding gastric bypass to intensive medical therapy (IMT) improved glycemic control more than IMT alone at 3 years after surgery.

The article focuses on a study regarding the prevalence of increased pancreatitis due to dipeptidyl peptidase-4 inhibitors (DPP4is) in type 2 diabetes. Topics discussed include the increase the risk for pancreatitis in patients with type 2 diabetes mellitus due to (DPP4is), pancreatitis, pancreatic cancer, and total treatment-emergent serious adverse events as major outcomes and the benefits of alternative antihyperglycemic agents.

The article focuses on a study regarding the efficacy and safety of saxagliptin as with placebo for cardiovascular (CV) outcomes as with placebo for cardiovascular (CV) outcomes in patients with type 2 diabetes mellitus. Topics discussed include the of CV death, nonfatal myocardial infarction, or nonfatal ischemic stroke as major outcomes, 17 percent relative risk reduction with saxagliptin compared with placebo and the assessment of the risk for pancreatic cancer.

The article presents information on a study related to the effect of intensive blood pressure (BP) control on microvascular events in patients with type 2 diabetes, hypertension, and high cardiovascular (CV) risk. The method includes a randomized controlled trial of 4733 patients who had type 2 diabetes, hypertension and CV disease. The results conclude that intensive blood pressure control does not reduce microvascular events more than standard control in patients with type 2 diabetes.

The article reflects on pragmatic clinical trials carried out by methodologists in the field of medical research. It argues that the current concept of pragmatic trials only serves a small proportion of health care decision makers. It offers an interpretation of a self-described pragmatic trial of the drug nortriptyline as an adjunct to nicotine replacement for smoking cessation. It discusses the trial under three perspectives and their inherent results.

The article reports that in healthy older adults with elevated C-reactive protein levels who do not have hyperlipidemia, rosuvastatin reduced stroke and myocardial infarction. The randomized placebo-controlled trial titled "Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin," supports the possibility that high-sensitivity C-reactive protein could be helpful in selecting candidates for higher-dose statins.

The article provides an answer to the question if intensive glucose control prevents adverse outcomes more than standard glucose control in type 2 diabetes.

The article provides an answer to the question whether intensive glucose control prevents cardiovascular events more than standard glucose control in patients suffering from type 2 diabetes and cardiovascular disease or risk factors.

The article presents the author's comments on the efficacy of atorvastatin in preventing cardiocvascular events in type 2 diabetes. A meta-analysis of randomized trials of statins in patients with diabetes that showed a 20% relative risk reduction in major coronary events in the primary prevention groups and 21% in the secondary prevention groups offers the best estimate of statin effects.

The article comments on a study conducted on the interventions focusing on patient behaviors in provider-patient interactions and improvements in diabetes outcomes. The systematic study support at least 2 conclusions. First, providers with more patient-centered behaviors enhance patient satisfaction with care. Second, interventions empowering patients to participate actively in the encounter and to make informed choices on their own improve self-efficacy measures and metabolic control. Most of the decisions that affect patient-important outcomes in diabetes occur in the patient space.

This article focuses on a study regarding diagnosis of adrenal insufficiency (AI), published in the 2003 issue of the journal "Annals of Internal Medicine." Systematic reviews may provide highly precise estimates of the properties of diagnostic tests. These reviews can offer evidence of different test performances in different settings or in patients with different spectrums of disease. The strongest inference from this study is that the cosyntropin test performs well in patients with AI, the group in which it is needed the least. Given that primary AI is rare, patients with a positive cosyntropin test will require additional testing to avoid unnecessary lifelong corticosteroid replacement. Clinicians considering the diagnosis of primary AI in a patient with nonspecific symptoms may consider measuring plasma cortisol and adrenocorticotropic hormone.