Research confirms that patients with essential tremor and Parkinson’s disease have higher comorbidities and costs

SAN MATEO, Calif.–(BUSINESS WIRE)–Cala Health, the leader in bioelectronic medicine setting a new standard of care for patients with chronic diseases, today announced new clinical research presented at ISPOR 2022.

The study, titled “Co-morbidities and mechanistic similarities of essential tremor and Parkinson’s disease and resulting diagnostic challenges,” analyzed comorbidities in patients diagnosed with essential tremor and Parkinson’s disease at the using claims data from the Truven Health Analytics MarketScan® Commercial and Medicare Supplemental databases (2013 -2019).

The results show that patients 65 years of age or older in the essential tremor (ET) and Parkinson’s disease cohorts had a higher prevalence of the following disorders compared to those without TE or Parkinson’s disease: accidental falls (14, 1% versus 24.5% versus 2.0%); bradykinesia (14.9% vs. 10.0% vs. 0.3%); depression (22.4% versus 25.1% versus 14.4%); fatigue (28.1% versus 35.7% versus 17.4%); and sleep disorders (30.3% versus 30.5% versus 14.3%). These results are consistent with previous research by Cala, presented at the annual meeting of the American Academy of Neurology in April 2022,1 which shows that patients with ET (compared to those without ET) have a higher prevalence of depression (25.6% versus 15.3%), anxiety (27.7% versus 15.5%) and total psychiatric disorders (45.9% versus 31.1%).

Furthermore, among patients who had pharmaceutical and medical records ≥ 12 months before and ≥ 24 months after the index date, only 10.7% of ET patients had no diagnostic requests for Parkinson’s disease in their history. , and 20.4% of patients with Parkinson’s disease did not seek a diagnosis of ET at any time in their history. These common features may explain why many patients are often diagnosed with both TE and Parkinson’s disease within two years of their index date and suggest that similarities between these patients may contribute to misdiagnosis.

“These findings suggest that ET and action tremor in Parkinson’s disease may have similar central origins,” said Dhira Khosla, DO, abstract co-author and chief medical officer of Cala Health. “This builds on our previous research presented at ISPOR last year,2 which found that the average patient with ET has 5.3 comorbidities, further demonstrating the need for better therapeutic offerings for this population.

On average, people with ET have multiple comorbidities, traditionally requiring multiple medications that healthcare teams must consider when making clinical decisions. Prior to Cala TAPS therapy, 94% of patients in the study had tried medication and 77% had tried more than one.3 Available pharmacological treatments are often inadequate as they often do not effectively reduce the severity of tremors and may cause adverse events leading to discontinuation of treatment. Based on clinical evidence and peer-recommended treatment guidelines, Cala TAPS therapy is a valid treatment option as an adjunct or follow-up to first-line pharmacological therapy before invasive surgical approaches.4

Disclaimer: Cala TAPS therapy is not currently indicated for the treatment of hand tremors in patients with Parkinson’s disease. Cala has received Breakthrough Device designation for TAPS therapy in patients with Parkinson’s disease, and this data will be subject to review by the US FDA.

About Cala Health

Cala is a bioelectronic medicine company transforming the standard of care for chronic diseases. The company’s wearable neuromodulation therapies fuse innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation, and its vertically integrated business model is reshaping the delivery of prescription therapies. Cala’s flagship product, Cala TAPS Therapy, is the only non-invasive prescription therapy for essential tremor. New therapies are being developed in Parkinson’s disease and other neurology indications, as well as targets in psychiatry, cardiology and autoimmune diseases. The company is headquartered in the San Francisco Bay Area and is backed by leading healthcare and technology investors.

Indication: Cala therapy is indicated to aid in the temporary relief of hand tremor in the treated hand following stimulation in adults with essential tremor.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Before use, refer to the product label for complete product use instructions, contraindications, warnings and precautions at https://calatrio.com/Safety.

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  1. Increased health care cost and mental health burden in patients with essential tremor: a retrospective observational study in a large commercially insured and Medicare US population. Dai, D. et al.

  2. Patient characteristics and comorbidities in patients with essential tremor: a retrospective observational study in a US population with commercial insurance and Medicare Advantage. Dai, D. et al. Value in Health, Volume 24, S167

  3. Real-world evidence for symptomatic relief of essential tremor using transcutaneous afferent patterned stimulation therapy. Rajagopal, A. et al. Value in Health, Volume 23, S642

  4. International Essential Tremor Foundation. Essential tremor in adult patients. Retrieved from http://eguideline.guidelinecentral.com/i/1380755-essential-tremor-advisory-ietf/0?