Every year the American Diabetes Association (ADA) releases its updated version that contains the revision of scientific literature and clinical recommendations pertaining to diabetes mellitus (DM), its prognosis, treatment, and management of co-morbidities and complications. In 2014, there have been several important updates based upon the research and conclusions of several systematic- and meta-analyses and clinical trials.
The following are the updates of past six months that hold great clinical significance.
1. Intensive glycemic control and its long-term effects on macrovascular outcomes in type 2 diabetes mellitus.
The ADVANCE trial compared standard therapy vs intensive therapy and its long-term effect on macrovascular outcomes in diabetic population. A total of 11,140 patients with long-standing DM were assigned to either standard therapy or intensive therapy (modified release gliclazide along with other drugs). The goal A1C was <6.5%. No net benefit was found on the primary composite endpoint i.e. cardiovascular death, nonfatal myocardial infarction (MI) or nonfatal stroke after a median of five years.
At the end of the median period, 8,494 participants, of the 10,082 living participants, were followed-up for a post-trial monitoring study. The cohort had periodic laboratory testing (AIC, fasting blood glucose, serum creatinine) and physical examination (blood pressure and weight measurements). Mean A1C had been similar throughout the monitoring period i.e. 7.2% (intensive group) and 7.4% (standard group).
After a median total follow-up of 9.9 years, no clear benefit of intensive therapy on macrovascular outcomes was noticed.
The ADA recommends continuance of standard therapy in patients with type 2 DM.
2. Inhaled Insulin
The US Food and Drug Administration (FDA) has approved an inhaled formulation of insulin – Afrezza – for glycemic control in adults with type 1 and type 2 diabetes mellitus. The drug is inhaled at the beginning of meal. Afrezza is expected to become available for clinical use in 2015.
While Afrezza has been a promising addition to the list of effective pharmacotherapies for DM, its use is contraindicated in patients with asthma and chronic lung disease (such as COPD). According to the Risk Evaluation and Mitigation Strategy of Afrezza, the drug increases the risk of acute bronchospasm.
The role of Afrezza in glycemic control will be clear when more published data about its safety and efficacy are available.
3. Effect of long-term antihypertensive therapy in diabetic patients.
The ADVANCE trial randomly assigned 11,000 diabetic patients to a regimen of ACE-inhibitor (perindopril) and diuretic (indapamide) for a median period of four years. The participants were both hypertensive and non-hypertensive. The hypertensive group was on concomitant antihypertensive therapy.
At the end of median period, the patients in perindopril-indapamide group showed lower rates of mortality i.e. cardiovascular mortality (3.8%) and all-cause mortality (7.3%) as compared to the placebo group i.e. cardiovascular mortality (4.6%) and all-cause mortality (8.5%). The post-trial cohort of 8,500 participants was followed for a median period of six years. When compared with the placebo group, the perindopril-indapamide group had a lower death rate i.e. 15.3% (placebo: 16.6%), and lower incidence of cardiovascular events i.e. 13.3% (placebo:14.2%).
Blood pressure lowering drugs decreases the risk of cardiovascular events and all-cause mortality in diabetic patients.
Please let us know in the comments if we have missed any other important updates in diabetes treatment. Also check out 5 tips for promoting lifestyle management in patients.