Clinical Briefs By Louis Kuritzky

Clinical Briefs

By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville

Dr. Kuritzky is an advisor for Endo, Kowa, Pricara, and Takeda.

Osteoporosis: Are Two Drugs Better Than One?

Source: Tsai JN, et al. Lancet 2013;382: 50-56.

Most women today who are receiving pharmacotherapy for treatment of osteoporosis receive oral bisphosphonates (e.g., alendronate, risedronate). Other effective treatments, like teriparatide (TERI) and denosumab (DENO) are usually reserved for more severe cases, in some part because they require parenteral administration.

Even though osteoporosis treatments have shown risk reduction for fracture and improved bone mineral density (BMD), restoration of full bone integrity remains a challenge. As one of the few anabolic tools (as opposed to anticatabolic tools like bisphosphonates), some investigators have tried to augment the favorable activity of TERI by combination with bisphosphonates, but the results have been disappointing. Whether the addition of DENO to TERI might be beneficial was the subject of investigation by Tsai et al. Postmenopausal women with osteoporosis (n = 100) were randomized to DENO, TERI, or both for 6 months. The primary outcome of the study was improvement in BMD.

Combination TERI+DENO appeared to be synergistic, with improvements in BMD greater than either agent alone and arithmetically greater than the anticipated benefit of combined monotherapies. For example, BMD increases at the hip were 4.2% for TERI+DENO, 0.8% for TERI, and 2.1% for DENO. These data support the consideration of TERI+DENO in highest-risk patients, those unable to take other treatments, or patients who fail to respond to other regimens.

Long-Term Impact of Weight Management on Blood Pressure

Source: Tyson CC, et al. J Clin Hypertens 2013;15:458-464.

The weight loss maintenance (wlm) trial randomized adults (n = 741) with hypertension (HTN) and/or dyslipidemia — but without evidence of cardiovascular disease — to one of several weight loss management programs. Although the initial outcome reports from WLM addressed the relative efficacies of different weight loss strategies over time, this report stratified study participants into those who lost, maintained, or gained weight over the 5-year study period. Tyson et al compared blood pressure effects between the three categories of weight impact, irrespective of which particular method of weight loss had been applied.

At study end, the weight-stable group had gained 0.6 kg, as compared with a 9.1 kg increase in the weight-gain group, and a 7.1 kg decrease in the weight-loss group. The weight-stable and the weightgain groups were noted to have similar increases in systolic blood pressure (SBP) over 5 years (SBP increase mean 4.2 mmHg), whereas the weight-loss group SBP was not statistically significantly changed.

In contrast to some other trials that report a "legacy effect" (prolonged beneficial impact of early intervention, even after the intervention has ceased), initial weight loss in WLM was not associated with favorable SBP effects if weight was regained. On the other hand, sustained modest weight reduction (< 10% of baseline BMI) had a sustained effect to maintain SBP. Although simply maintaining weight over the long term might appear to be a laudable goal, it is apparently insufficient to favorably affect SBP.

The WEAVE Study: Does Special Training in Domestic Violence Improve Outcomes?

Source: Hegarty K, et al. Lancet 2013; 382:249-258.

Intimate partner violence (ipv) is a public health problem that knows no boundaries of age, country of residence or origin, economic status, or education. Primary care clinicians, particularly family physicians, are often the first point of clinical contact for victims of IPV, but may lack confidence in their ability to identify and/or address IPV. Hegarty et al report on a trial from Australia in which women who screened positive for concerns about fear of their partner (n = 272) received care from family physicians who were randomized to receive special training in IPV or no intervention. The intervention group physicians participated in the Healthy Relationships Training program, which is intended to provide the ability to respond effectively to women who have experienced IPV and give brief counseling. The primary outcomes of the trial were changes in quality of life (as per the WHO QOL-BREF), safety planning and behavior, and mental health (as per the SF-12) at 1 year.

At 1 year, there was no difference in the primary endpoint between the intervention group and controls. A favorable impact on depression (a secondary endpoint) was seen. However, since the primary endpoint was not achieved, the potential for benefits on depression must remain considered as hypothesis generating.