1.A post-marketing surveillance study on the effectiveness and safety of paliperidone ER among Filipino adult patients diagnosed with Schizophrenia.
Conde Bernardo L ; Sionzo Michael P ; Benedicto Erwin G
Acta Medica Philippina 2013;47(2):9-12
BACKGROUND: Schizophrenia affects 7 people per 1000 adult population worldwide and is a severe form of mental illness common in age group 15-35 year old. Paliperidone is the active metabolite of risperidone and was approved for treatment of schizophrenia in the Philippines by the Food and Drug Administration (FDA) in 2007. The drug has been shown to be safe and effective in clinical trials but no local study has investigated its effect among Filipino patients. Hence, the general objective of this study was to assess the safety and effectiveness of paliperidone ER among Filipino patients diagnosed with schizophrenia.
METHODS: The study was a non-randomized, non-comparative, open-label trial involving adult patients seen at initial consult and at the end of study visit. Study duration was eight weeks and was conducted for three years as required by the FDA. The primary outcome for the study was overall severity of the illness at the initial visit and end visit (visit 2) using the Clinical Global Impression tool (CGI-S). This rating scale was used to rate the severity of a subject's pyschotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
RESULTS: A total of 641 Filipino adults were enrolled in the study. Ninety one percent (N=586) had completed the follow-up into the second or end visit resulting in a 9% drop out for the duration of the study. Follow-up period had an average of 58.05 (SD+=9.36) days ranging from a minimum of 4 to a maximum of 98 days. Clinicians' assessment of the severity of illness showed that majority had shown improvement from their baseline clinical state with the use of Paliperidone ER. The proportion of severely ill had decreased by 15% while the proportion of those who were markedly ill had decreased by 15% while the proportion of those who where markedly ill had decreased by 35% by the end of the second visit. Overall, after eight weeks of paliperidone treatment, there was a decrease of 58% in the proportion of subjects evaluated to be mildly ill, borderline mentally ill and normal at the end of the second visit. This means that there was a marked improvement in patients observed and reported symptoms, behavior and functions as assessed by physicians using CGI. Fifteen percent of study participants experienced at least one non-serious adverse event during the study. The five most common non-serious adverse events observed include sleeplessness, extrapyramidal symptoms described as Pseudo parkinsonian tremors, stiffness of body and DOB/EPS reaction hand tremors, depression, akathisia and dizziness.
CONCLUSION: Paliperidone ER administered at 6 mg single dose improved symtoms and clinical signs among adult Filipinos diagnosed with schizophrenia who are moderately and markedly ill. The drug is will-tolerated, but the dose may need to be increased for more severely ill patients. Paliperidone ER is one of the current useful options for the treatment of patients with schizophrenia.
Human ; Male ; Female ; Adult ; Risperidone ; Psychomotor Agitation ; Dizziness ; Depression ; Sleep Initiation And Maintenance Disorders ; Mentally Ill Persons ; Tremor ; Schizophrenia ; Vertigo ; Depressive Disorder
2.Ustekinumab for adult Filipino patients with moderate to severe chronic plaque psoriasis: A clinical series.
Verallo-Rowell Vermen ; Frez Ma. Lorna F. ; Roa Francisca C. ; Salvino Roberto P. ; Benedicto Erwin G.
Journal of the Philippine Dermatological Society 2013;22(2):36-40
BACKGROUND: Psoriasis is a chronic inflammatory disease occurs worldwide. At the Philippine General Hospital dermatology clinic, psoriasis accounted for 2.2% -2.4 % of new consults seen in 2004-2010. Its pathogenesis remains obscure but current studies indicate that activated Thai and Thai response mechanisms mediate inflammation and are implicated as key players in psoriasis genesis. Ustekinumab is a fully human monoclonal antibody that targets two interleukins (IL): IL-12 and IL-23 which influence T-cell differentiation into Thi and Thai, respectively. These naturally occurring proteins help regulate the immune system secondary to their role in linking innate and adaptive immune responses.
CASE SERIES: This is a retrospective chart review on the use of ustekinumab in 22 adult Filipinos (10 males and 12 females) conducted at six (6) dermatologists' clinics in 2010. Included were patients enrolled in the Named Patient Program (NPP) of Janssen Pharmaceutical Companies of Johnson & Johnson Philippines, diagnosed with moderate to severe long-standing plaque psoriasis and contraindicated for, or with inadequate response to, conventional systemic treatment. Patients received ustekinumab subcutaneously at loading doses of 45mg during the initial visit and at four weeks. Subsequently, it was given every twelve weeks. For patients who weighed 100 kg or more, 90mg of ustekinumab was administered. Clinical responses to the drug were assessed using Psoriasis Area and Severity Index (PASI) at initial visit and at the end of the program (52 weeks). At the end of the one-year program period, the median (range) PASI score of patients was 1.50 (0-29.2). Sixteen of the twenty-two subjects (72.73%) were able to achieve ±75% improvement from baseline (PASI 75). There was a significant (94.52%) reduction in median PASI scores of the patients from baseline to end visit (p < 0.0001). Overall, 27% (6/22) of patients with plaque psoriasis achieved complete clearance. Adverse events reported were relatively mild, including increased appetite, weight gain and body weakness/fatigue.
CONCLUSION: Ustekinumab was shown to significantly reduce the median PASI scores of 22 adult Filipino patients with moderate to severe plaque psoriasis. It was also shown to be well tolerated, with relatively mild adverse events.
Human ; Male ; Female ; Ustekinumab ; Psoriasis ; Dermatology ; Philippines
3.Stakeholder perceptions on the challenges of financing debilitating illnesses: The case of colorectal cancer and schizophrenia in the Philippines.
Carl Abelardo T. ANTONIO ; Amiel Nazer C. BERMUDEZ ; Kim L. COCHON ; Fernando B. GARCIA ; Jonathan P. GUEVARRA ; Jorel A. MANALO ; Romeo R. QUIZON ; Roberto P. SALVINO ; Erwin G. BENEDICTO
Philippine Journal of Health Research and Development 2017;21(2):.-
BACKGROUND: There is a perceived need among policymakers and other actors in the local health system to better address the challenges in financing healthcare, in general, and chronic or debilitating conditions, in particular, in order to develop appropriate policy and program responses.
OBJECTIVE: This paper aimed to present perceived issues and challenges in financing schizophrenia and colorectal cancer in the Philippine context, as identified by stakeholders.
METHODS: Verbatim transcription of the proceedings of a moderated discussion of stakeholders in schizophrenia and colorectal cancer care was analyzed for themes on challenges and recommendations in the financing of the two conditions in the local setting.
RESULTS: A total of 28 stakeholders representing healthcare providers, professional organizations, health maintenance organizations, patient support groups, and government participated in the meeting. Three main issues on financing debilitating conditions were identified by participants: a) government support for the two conditions is currently limited; b) coverage by third-party payors for schizophrenia or colorectal cancer is either absent or restricted; and c) the process of accessing medicines or alternative modes of financing for healthcare was perceived to be disparate and inconvenient for patients and their caregivers. Participants also provided recommendations in improving the mechanism of healthcare financing.
CONCLUSION: The general picture that emerged from this moderated discussion pointed to limitations in the prevailing mechanisms for financing schizophrenia and colorectal cancer in the Philippines. Improvements in the current financing mechanisms, and identification of alternative modes, is necessary to ensure universal health coverage.
Human ; Healthcare Financing ; Health Maintenance Organizations ; Caregivers ; Universal Coverage ; Delivery Of Health Care ; Insurance, Health, Reimbursement ; Government ; Self-help Groups ; Colorectal Neoplasms ; Schizophrenia
4.Advances in the treatment and management of Filipino patients with multiple myeloma: From deadly to chronic disease with possibility of remission.
Erwin G. Benedicto ; Kristine Joy L. Tomanan ; Marvin P. Angeles ; , Carl Abelardo T. Antonio
Journal of the Philippine Medical Association 2018;97(1):54-59
BACKGROUND:
Multiple myeloma is a malignant
proliferation of plasma cells that accumulate in the
bone marrow and results in several organ dysfunctions that are debilitating and fatal. For the past 20
years, advances in the understanding of genetic
abnormalities, interactions in the bone marrow
microenvironment, developments in the diagnosis
and staging in myeloma and introduction and
incorporation of novel agents early in the disease
course have been pivotal in the clinical treatment
and management of patients with multiple myeloma.
However, the burden associated with the disease,
including treatment costs, is significant for Filipino
patients as it is still incurable. In the Philippines, the
introduction of bortezomib in the market in the last
decade have brought hope to many patients by
expanding the availability of treatment options,
improving quality of life and extending survival.
METHODS:
This paper documents the proceedings of
a forum on multiple myeloma conducted last March
2018 at Makati City. The purpose of the forum was
to discuss the major clinical presentations of the
disease as well as treatment and management of
selected patients. Speakers were hematology and
medical oncology experts in the Philippines.
RESULTS:
Five cases of multiple myeloma with different clinical presentations and management were
discussed: (1) renal insufficiency, (2) easy fatigability, (3) bone pain, (4) autologous stem cell/bone
marrow transplantation and (5) coagulopathy. Short
videos of selected patients (or their family members)
after each presentation was showed, describing their
treatment journey with myeloma. Other patients with
multiple myeloma who were treated with bortezomib
were present in the forum and briefly shared their
experiences.
CONCLUSION
As multiple myeloma is a highly
heterogeneous molecular disease, approaches and
provision of care will need to be individualized
for each patient. Because of its impressive
performance, bortezomib is likely to continue being
an important part of the clinical treatment and
management of Filipino patients with myeloma.
Bortezomib
5.Proceedings from a symposium in the 2018 AFPA convention in the Philippines: Rethinking the role of Long-acting Antipsychotic Injectables (LAis) in a comprehensive, recovery-oriented treatment approach among patients with Schizophrenia
Erwin G. Benedicto ; Kristine Joy L. Tomanan ; Marvin P. Angeles ; Carl Abelardo T. Antonio
The Philippine Journal of Psychiatry 2019;41(2):34-41
Schizophrenia is a chronic, debilitating illness affecting
around 21 million people globally. It is a severe form of mental
health problem, affecting more individuals aged 15-35 years
(late adolescence to early adulthood) and commonly found
among males 1
• It is thought to result from a combination of
genetic, environmental and psychosocial factors.
In the Philippines, schizophrenia is the leading cause for
mental health consultation and treatment in hospitals2
•
Based from the Philippine Health Information System on
Mental Health data gathered from 2014 to 2015 in 14 health
facilities, around 42% out of 2,562 patients on record were
diagnosed with schizophrenia. From this data, it is estimated
that 1 % or around 1 million of the country's total population
are affected by this disorder.
Poor adherence to medication is a major cause of poor
outcomes in patients with schizophrenia, with non-adherence
as high as 50-74% in the initial phase of treatment3
-
5
• Nonadherence is associated with relapse, re-hospitalization and
poor quality of life among individuals with the illness3
•
While remission and ultimately, recovery, is the goal, the
foundation of successful treatment is appropriate medication
prescription and good adherence. The use of new generation,
long-acting injectable (LAI) antipsychotic medications is
one of the ways to improve patient's adherence to treatment
by reducing frequency of administration and improving the
consistency of drug delivery as well as bioavailability in the
circulation 6.On January 25, 2018, Johnson and Johnson Philippines
organized a symposium on LAI treatment during the
2018 International Congress of the Asian Federation of
Psychiatric Associations (AFPA) and 44th Philippine
Psychiatric Association Annual Convention at the
Philippine International Convention Center, Pasay City.
The purpose of the symposium was to discuss the role of
long-acting antipsychotic medications in a comprehensive
treatment approach for schizophrenia. A total of almost 300
psychiatrists and psychologists attended the activity.
The aim of this special report is to present the discussion of
the guest speaker Dr. Allan Tasman, and weigh the pros and
cons of using long-acting injectable (LAI) antipsychotics as
part of treatment for Filipino patients with schizophrenia.
Dr. Tasman is an internationally known psychiatrist and
advocate of integrative biopsychosocial treatment model
within a comprehensive, collaborative system of care and
innovation for psychiatric education and clinical services.
He is currently professor and emeritus chairman of the
Department of Psychiatry and Behavioral Sciences at the
University of Louisville, and Schwab Endowed Chair in
Social and Community Psychiatry.
The primary objectives of Dr. Tasman's presentation were
to: (1) review comprehensive treatment approaches in
schizophrenia, keeping in mind up-to-date medication
management as the foundation of treatment; and (2) use
evidence-based practice in maximizing the likelihood of
recovery in patients with schizophrenia.
Schizophrenia
6.A post marketing surveillance study on the efficacy and safety of bosentan for treatment of pulmonary arterial hypertension among adult Filipino patients.
Maria Paz B. Mateo ; Teresita S. De Guia ; Kristine Joy L. Tomanan ; Eileen Lara R. Ladines ; Erwin G. Benedicto ; Carl Abelardo T. Antonio
Journal of the Philippine Medical Association 2019;98(1):60-68
BACKGROUND:
Pulmonary arterial hypertension (PAH) is a chronic, debilitating disease affecting millions of
adults worldwide. With improved knowledge on PAH and better management, long-term survival in patients
has significantly increased in the past 20 years. Bosentan is a nonselective, dual endothelin receptor
antagonist used in the treatment of PAH. While the drug has already been established to improve exercise
capacity and patient survival globally, no study has investigated its clinical effectiveness and safety among
Filipino patients yet. A post marketing study was conducted to determine the efficacy and safety of
bosentan (125 mg administered twice daily) among adult Filipino patients with PAH.
METHODS:
A non-randomized, non-comparative, open-label trial was conducted involving adult patients at
a tertiary government hospital in Metro Manila. Study duration was from March to September 2012.
Primary end points of the study were patients' response to efficacy and safety.
RESULTS:
A total of 14 patients were enrolled in the study and 13 included in the analysis. Mean age of the
participants was 34 ± 11.54 years. Remarkable changes were observed for 6WMD and small improvements
noted for Borg dyspnea index and CPET. There was no difference between baseline and 12th week WHO
functional classification. FEVl /FVC, MVV, RV /TLC and sRaw showed modest improvement; there was a
notable difference in the systolic PAP vs baseline; PVR, PVRI, SVR and SVRI demonstrated the largest
changes via cardiac catherization and iloprost. Four patients experienced at least one serious adverse event,
with one reported as suspected unexpected serious adverse reaction. Out of 13 patients, 1 O (76.9%)
considered bosentan as effective while 11 (84.6%) considered it safe.
CONCLUSION
Bosentan improved exercise capacity, pulmonary function and cardiopulmonary hemodynamics
among study participants. The drug is generally well-tolerated and effective. Bosentan is among the useful
options for treatment of adult Filipino patients with PAH.
7.Advanced prostate cancer management: Proceedings of a scientific session, 20-21 July 2018, Manila, Philippines.
Carl Abelardo T. ANTONIO ; Chelseah Denise H. TORRES ; Aneliese H. TORRES ; Erwin G. BENEDICTO
Philippine Journal of Health Research and Development 2018;22(4):56-62
Prostate cancer, the second most common cancer worldwide in 2012, poses a high public burden prompting the need to develop effective treatment strategies. To determine the progress made through the years, this paper documented the timeline of treatment strategies for advanced prostate cancer as presented in a scientific session held in July 2018. Two treatment strategies for metastatic prostate cancer were emphasized: the addition of docetaxel (chemotherapy) and abiraterone acetate plus prednisone to androgen-deprivation therapy (i.e. standard of care). Related clinical trials including but not limited to the CHAARTED trial, STAMPEDE trial, and LATITUDE trial showed that addition of either DOC or ABI led to a general increase in the overall survival of the patient. Furthermore, treatment strategies for non-metastatic castration resistant prostate cancer were also discussed. Evidence from clinical trials showed that addition of enzalutamide or apalutamide to ADT yielded better outcomes than ADT-placebo. These recent advancements have broadened the physician's options for treatment.
Prostatic Neoplasms
8.Clinical experience of Filipino clinicians on the use of Bedaquiline for treating multidrug-resistant Tuberculosis.
Carl Abelardo T. ANTONIO ; Chelseah Denise H. TORRES ; Vivian S. LOFRANCO ; Aneliese H. TORRES ; Stephanie M. LAO ; Amiel Nazer C. BERMUDEZ ; Erwin G. BENEDICTO
Philippine Journal of Health Research and Development 2019;23(2):20-25
BACKGROUND: The Philippines is among countries globally with high multidrug-resistant tuberculosis (MDR-TB) burden. An operations research on Bedaquiline (BDQ), a new drug for MDR-TB, was launched by the Department of Health (DOH) in 2016.
OBJECTIVES: This paper aimed to gather the opinions and first-hand experiences of clinicians in the Philippines regarding BDQ.
METHODS: A facilitated roundtable discussion among nine clinicians included in the operations research on BDQ in the Philippines was conducted in June 2018. Topics covered included: (a) considerations in the use of BDQ, (b) outcomes of patients given BDQ, and (c) perceptions on effectiveness and safety of BDQ. Recordings and field notes from the discussion were subjected to framework analysis.
RESULTS AND CONCLUSION: Participants gave BDQ an overall positive feedback due to the effectiveness, less toxicity, and ease of administration compared to other anti-TB drugs. Issues on BDQ included the novelty of the drug that caused doubts at first use and the limited application of the drug as dictated by the inclusion criteria within the context of the operations research, among others. The significant number of patients lost to follow up and ways to address this challenge were also discussed.
Tuberculosis, Multidrug-Resistant ; Physicians ; Philippines
9.Financial assistance for the treatment of schizophrenia in select institutions in the Philippines.
Jonathan P. Guevarra ; Carl Abelardo T. Antonio ; Kim L. Cochon ; Amiel Nazer C. Bermudez ; Fernando B. Garcia, Jr. ; Jorel A. Manalo ; Gary T. Pagtiilan ; Ernest Genesis M. Guevara ; Stephanie M. Lao ; Erwin G. Benedicto
Acta Medica Philippina 2022;56(5):68-74
Objective: This paper aims to characterize existing financial assistance available to patients with schizophrenia. Specifically, we described (1) the funding mechanisms for the treatment of patients with schizophrenia; (2) the process for accessing financial assistance; and (3) the experiences of consumers of services of these support mechanisms.
Methods: We employed qualitative techniques using key informant interviews (KII) and focus group discussion (FGD). Key informants were officials from institutions providing or offering financial assistance for patients with any health-related concerns, including schizophrenia. Focus group participants were support group members or caregivers of patients with schizophrenia. Purposive sampling was used to select participants for both providers and consumers of financial assistance or scheme. Topic guides for KII and FGD were used for data collection. Thematic analysis was performed on the qualitative data gathered from the informants and focus group participants.
Results: Securing financial assistance for schizophrenia followed a generally similar process, whether the source is from government offices or civil society organizations, and can be grouped into three main stages: (a) pre-application, (b) application, and (c) post-application. While the process of seeking financial assistance appears to be straightforward, issues were encountered in all of the stages by both providers and recipients alike, namely: (a) Financial assistance as an augmentation to patient resources; (b) Mismatch between demand and service capability; (c) Measures of organizational effectiveness; (d) Health professionals and support groups as "bridges" / "facilitators" to financial assistance providers; (e) Financial and non-financial costs incurred by caregivers in applying for financial assistance; and (f) Recipient-provider relationship as a barrier to the feedback process.
Conclusion: This study provides a glimpse of available financial and other relevant assistance to clients, including clients suffering from schizophrenia. More extensive research covering more organizations, support groups, and caregivers from different parts of the country is recommended.
Schizophrenia
10.Recovery in schizophrenia: Perspectives from psychiatrists in the Philippines.
Michael P. Sionzon ; Chelseah Denise H. Torres ; Carl Abelardo T. Antonio ; Carlo Eugenio V. Banaag ; Ma. Lourdes Rosanna E. de Guzman ; Monina Garduñ ; o-Cruz ; Mariano S. Hembra ; Benita Sta. Ana-Ponio ; Edgardo Juan L. Tolentino, Jr. ; Jessa Joy C. Malipot ; Dorothy Jean N. Ortega ; Ma. Sophia Graciela L. Reyes ; Angelica Beth T. Sia ; Charlene J. Tinaja ; Patrick Joseph Aldea ; Erwin G. Benedicto
Journal of the Philippine Medical Association 2019;97(2):52-60
BACKGROUND:
A reliable and socially validated definition of recovery in schizophrenia is essential to decrease
stigma associated with the illness. This study aimed to define recovery in schizophrenia in the Philippine context,
determine its specific elements, and describe methods of assessment in clinical practice.
METHODS:
We invited a group of purposively selected Filipino psychiatrists to participate in six simultaneous
roundtable discussions to gather their opinions and perspectives on recovery in schizophrenia. Transcripts of the
discussions were then subjected to framework analysis.
RESULTS AND CONCLUSION
Most Filipino psychiatrists were of the considered opinion that recovery in schizophrenia
is possible, and their vision of a recovered patient resembles a combination of psychological and medical models.
The mini-FROGS tool was deemed generally applicable in the Philippine setting except for self-esteem and sense of
independence primarily because it is difficult to evaluate. The SWN was received with mixed reactions among the
psychiatrists. Spirituality as an element of recovery and the family-oriented culture of the Filipinos were emphasized as important considerations in assessing patients. Other suggestions were given to tailor-fit these tools to
the Philippine context.
Schizophrenia
;
Philippines