以固定剂量合并药物改善高血压药物顺应性与持续性


  October 8, 2007(芝加哥讯)-根据一项发表于美国家庭医学会2007年科学会议中的研究,使用固定剂量合并药物的高血压病患,其血压控制持续性与服药顺从性比服用单一个别药物(FC)疗程病患佳。
  
  发表者Plymouth会议监视数据公司副总裁与主任医疗官员,同时也是宾州费城宾州大学Leonard Davis机构的Gregory Hess医师向Medscape家庭医学统整这项发现;这项研究的核心在于,使用固定剂量合并药物(FDC)的病患,在一个药物中有两种活性成分,其持续性与顺应性都会比服用单一个别药物的病患好,至少在这项研究所针对的高血压上。
  
  顺应性的增加理论上与预后的改善有关,且因此可以降低健康照护费用。
  
  这项研究收集来自大约100个管理照护组织商业及医疗保险病患族群的医疗与药物管理申报资料,涵盖了超过4百万个个体,来自MarketScan(Thomson Medstat)的数据收集2003年1月到2005年12月的资料。
  
  Hess博士向Medscape家庭医学表示,我们使用超过100个健康计画的资料库,所以我们的样本数目是非常大的,最后的样本数目大概是15,000位病患,分布在美国各州。
  
  这项研究比较服用FDC相较于服用FC降血压药物疗程病患,其12个月的服药顺应性与持续性。包括下列药物疗程:
  * valsartan + hydrochlorothiazide (Hctz) → 血管张力素受体抑制剂 + Hctz疗程;
  * amlodipine besylate + benazepril HCl → 血管张力素转化酶抑制剂 + 钙离子通道阻断剂疗程;
  * 以及其它FDC降血压药物疗程 → 相对应FC降血压药物疗程
  
  仍然接受FDC治疗的控制组病患与交换的病患以倾向指数进行比较,这以世代研究的方式设计,包括FDC世代(共有7226位)与接受FDC治疗但转换为FC的世代(共7226位)。
  
  这项研究将持续性定义为,病患接受治疗至少超过30天,且接受最后一次治疗后一个月后并未再发;顺应性的定义为,365天内药物持有比例(MPR);作者本身认知的试验限制包括主管机关申报资料先天性的限制,以及治疗世代缺乏随机分派。
  
  这项研究的结论是,相较于转换为FC降血压药物治疗的病患,仍然接受FDC治疗的病患维持性较高,且在转换为FC疗程的12个月内顺应性同样较高;FDC与FC疗程的顺应性差异(例如MPR),在12个月的评估阶段,从18.70到28.19(p<0.0001);而FDC与FC疗程的持续性差异,在同样的一段时间内,从39.12%到49.82%(p<0.0001)。
  
  当被问到这是否改变他的临床执业,Hess医师的答案是肯定的。
  
  Hess医师向Medscape家庭医学表示,因为表面上,在大部分的时候,个别的药物相较于合并药物显然是较便宜的,即使你同时处方这两种药物;但是因为我们所见到的,持续性与顺应性的上升,这使得我深思是否应该处方这些药物给我的病患们,以确保他们仍然接受治疗,且得到他们需要的疗效与效果。
  
  为社会安全主管机关进行社会安全失能评估的纽约Delmar机构Richard Blaber医师向Medscape家庭医学表示,这项研究结果并不令人意外。
  
  Blaber医师表示,我认为这是经常见到的事情,我确实对于看到这样特殊的研究而感到惊奇,但是了解其理由是基于费用经济分析是非常有趣的,我认为那是发表者一项有趣的观点,这是有道理的。
  
  当被问到如果这项研究发现是否会改变其临床执业时,Blaber医师表示,我认为许多执业者正在计划降低病患服药数量,这是人们一般会做的,也是很常见的执业方式。
  
  该研究由诺华药厂资助。

Hypertension Medication Compli

By Richard Hyer
Medscape Medical News

October 8, 2007 (Chicago) — Patients with hypertension who are placed on fixed-dose drug combinations have higher persistence and medication compliance than those receiving free combination (FC) regimens, according to a study presented here at the American Academy of Family Physicians 2007 Annual Scientific Assembly.

Presenter Gregory Hess, MD, vice president and chief medical officer, Surveillance Data, Inc, of Plymouth Meeting, Pennsylvania, and adjunct senior fellow at the Leonard Davis Institute, University of Pennsylvania, Philadelphia, Pennsylvania, summarized his findings for Medscape Family Medicine: "The central point of the study is that patients who were on fixed dose combination [FDC] products, where you have 2 active ingredients in 1 form, tend to have better persistency and compliance, at least when studied within hypertension, than those patients who are taking 2 pills."

Increased compliance theoretically correlates with improved outcomes, and therefore lower healthcare costs.

The study reviewed medical and pharmacy administrative claims data from approximately 100 managed care organizations' commercial and Medicare patient populations covering more than 4 million individuals. Data came from MarketScan (Thomson Medstat) and covered the period from January 2003 to December 2005.

"We used a database that has over 100 health plans involved, so our sample size was extremely large. Our final study sample was approximately 15,000 patients [who were] well distributed across the United States," Dr. Hess told Medscape Family Medicine.

The study compared 12-month compliance and persistency of patients receiving FDCs with those who switched from FDC to FC antihypertensive therapies in the following regimens:

  • valsartan + hydrochlorothiazide (Hctz) → angiotensin receptor blocker + Hctz regimens;
  • amlodipine besylate + benazepril HCl → angiotensin-converting enzyme inhibitor + calcium-channel blocker regimens;
  • and other FDC antihypertensive therapies → equivalent FC antihypertensive regimens.

The control group remaining on FDC therapy was matched by propensity score to patients who switched. This was designed as a cohort study with 2 groups: the FDC cohort (n = 7226) and the cohort of patients receiving FDC who switched to FC (n = 7226).

The study defined persistence as the percentage of patients not having a lapse in therapy longer than 30 days in a given month after their last day of supply. Compliance was defined as the medication possession ratio (MPR) over 365 days. Study limitations acknowledged by the authors included possible flaws inherent in administrative claims data and lack of randomization in the treatment cohorts.

The study concluded that, "compared with patients who switched to [FC] antihypertensive therapies, patients who remained on [FDCs] had higher persistency and compliance in the 12 months following a switch to the [FC] regimen: differences in compliance (i.e., MPR) between FDC and FC regimens ranged from 18.70 to 28.19 (p<0.0001) at the end of a 12-month assessment period, and differences in persistence with therapy regimens between FDC and FC regimens ranged from 39.12% to 49.82% (p<0.0001) at the end of the same period."

When asked whether this had changed his clinical practice, Dr. Hess said it has.

"Because on the surface, many times, individual pills appear to be less expensive, even if you're prescribing 2 of them, than a branded [FDC] pill," Dr. Hess told Medscape Family Medicine. "But because of the increase we've seen in persistency and compliance, it makes me more thoughtful about prescribing those in many cases for my patients to make sure that they stay on therapy and get the efficacy and effectiveness that they need."

Richard Blaber, MD, of Delmar, New York, who performs Social Security Disability Assessments for the Social Security Administration, told Medscape Family Medicine that the findings did not come as a surprise.

"I think that's something that's seen on a regular basis," said Dr. Blaber. "I was actually surprised to see that particular study. But it was interesting to understand that the reason for it was from an economic analysis of cost. I thought that that was an interesting perspective from the presenter. It made sense."

When asked if the findings would change his clinical practice, he said, "I think many practitioners are attempting to decrease the pill load of patients. I think that's something people generally do. That's common practice," Dr. Blaber said.

The study was sponsored by Novartis Pharmaceuticals.

American Academy of Family Physicians 2007 Annual Scientific Assembly. Presented October 5, 2007.

    
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